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DRUG INSPECTOR Practice Question & Answers – DI Exam Practice Paper

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DRUG INSPECTOR PRACTICE QUESTION & ANSWERS – DI EXAM PRACTICE PAPER

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DRUG INSPECTOR Practice Questions

1. Long term use of cemetidine may cause
1. Sexual disfunction 2. Renal failure
3. Rebound acidity 4. Parietal cell blockade

3. Piperazine is used in the treatment of
1. Amoebiasis 2. Helminthiasis
3. Giardiasis 4. Malaria

4. The drug of choice for the treatment of filariasis is
1. CocaDiethyl carbamazine
2. Niclosamide
3. Biloscanate 4. None of the above

16. Cancer of epithelial tissue is called
1. Carcinoma 2. Sarcoma
3. Lukemia 4. Hodgkin’s disease

17. The Latin term for ointment is
1. Ungentum 2. Pasta
3. Oculentum 4. Linimentem

18. The Latin term for “When required” is
1. si opus sit 2. Dolor urgente
3. tussi urgente 4. statim

19. Material used to assist adhesion of skin graft is
1. Human thrombin 2. Human
immunoglobulin
3. Plasma protein fraction 4. Gum saline

20. The incompatibility encountered when aspirin is powdered together with phenazone is

1. Insolubility 2. Liquefaction
3. Immiscibility 4. Precipitation

21. Existence of antibiotic was first proposed by
1. Pasteur 2. Paul Ehrlich
3. Fleming 4. Dubos

22. The Antibiotics are manufactured in large scale by
1. Surface culture in liquid medium
2. Surface culture in solid medium
3. Submerged culture in liquid medium
4. Submerged culture in solid medium

23. Increased hepatic angiotensinogen production is responsible for following
1. Renal hypertension 2. Pills hypertension
3. Vascular hypertension 4. Endocrine hypertension

24. The following type of pulse is seen in myocardial infraction
1. Pulsus deficit 2. Pulsus alternens
3. Anacrotic pulse 4. Water hammer pulse

25. Drugs of choice for grandmal epilepsy are
1. Phenytoin and sodium valproate
2. Sodium valproate and carbamazepin
3. Carbamazepin and phenobarbital
4. Phenobarbital and phenytoin

26. Morphine is contraindicated for patients with head injury because it produces
1. Sedation
2. Hyperactive spinal refluxes
3. Respiratory depression
4. Analgesia

27. Which of the following is anti metabolite ?
1. Cyclophosphamide 2. Thiotepa
3. Methotrexate 4. Chlorambucil

28. Which of the following anticancer drug is obtained from plant ?
1. Cisplatin 2. Uracil
3. Vincristine 4. Tamoxifen

29. In prescription the Latin term “fiat” means
1. Let it be mixed 2. Let it be made
3. Let it be warmed 4. Let it be sent

30. Most dangerous organism infecting the eye is
1. Pseudomonas aeruginosa
2. Staphylococcus aureus
3. Proteus vulgaris
4. Bacillus subtilis

42. The word posology is derived from Greek word “posos” which means
1. “How much” 2. Quantity
3. Amount 4. How long
You are looking for the Drug Inspector Exam Question Paper, i am giving here:

Of the following, who is elected 5.
unopposed in the recent election to
Rajya Sabha
(1) Mayawati
(2) Vilasa Rao Deshmukh
– (3) Rajiv Shukla
( 4) All the above

1. Senna is
1. Irritant laxative 2. Osmotic laxative
3. Bulk laxative 4. Emollient laxative

2. Long term use of cemetidine may cause
1. Sexual disfunction 2. Renal failure
3. Rebound acidity 4. Parietal cell blockade

3. Piperazine is used in the treatment of
1. Amoebiasis 2. Helminthiasis
3. Giardiasis 4. Malaria

4. The drug of choice for the treatment of filariasis is
1. CocaDiethyl carbamazine
2. Niclosamide
3. Biloscanate 4. None of the above

5. The prescription starts with the symbol Rx, means
1. Send 2. Prescribe
3. Take thou 4. Prepare

6. Which type of prescription should contain the age of the patient ?
1. Prescription for a child
2. Prescription containing special formula
3. Prescription containing patient medicament
4. Prescription for elderly patient

7. The plasma substitute, dextran is a homo polymer of glucose, which is produced by
1. Polymerization of glucose
2. Chemical modification of starch
3. Chemical modification of cellulose
4. By growing the organism leuconostoc mesenteroides in sucrose containing medium

DRUG INSPECTOR Practice Paper 2018

8. Mot acceptable absorbable hemostat is
1. Human fibrin foam 2. Gelatin sponge
3. Oxidized cellulose 4. Calcium alginate

9. Bacteria which can derive their nutritional requirements and energy from simple inorganic
source are called

1. Autotrophic 2. Heterotrophic
3. Parasite 4. Saprophyte

10. Ziehl Neelsen’s method is used to identify
1. Acid fast bacteria 2. Gram positive bacteria
3. Spores 4. Flagella

11. P wave of ECG is the result of

1. Atrial depolarization 2. Atrial repolarization
3. Ventricular depolarization
4. Ventricular repolarization

12. Incompatible blood transfusion can result in

1. Hypovolemic shock 2 Anaphylactic shock
3. Cardiogenic shock 4. Obstructive shock

13. Sucralftate is used in the treatment of
1. Vomit 2. Constipation
3. Duodenal ulcer 4. Diarrhoea

14. Which property of chlorpromazine is responsible for its antipsychotic effect ?
1. Antidopaminergic 2. Antimuscarinic
3. A adrenoreceptor blocking
4. Anti 5-HT property

15. Which of the following is broad spectrum anthelmintic ?
1. Mebendazole 2. Piperazine
3. Diethylcarbamazine 4. Chloroquine

16. Cancer of epithelial tissue is called
1. Carcinoma 2. Sarcoma
3. Lukemia 4. Hodgkin’s disease

17. The Latin term for ointment is
1. Ungentum 2. Pasta
3. Oculentum 4. Linimentem

18. The Latin term for “When required” is
1. si opus sit 2. Dolor urgente
3. tussi urgente 4. statim

19. Material used to assist adhesion of skin graft is
1. Human thrombin 2. Human
immunoglobulin
3. Plasma protein fraction 4. Gum saline

20. The incompatibility encountered when aspirin is powdered together with phenazone is

1. Insolubility 2. Liquefaction
3. Immiscibility 4. Precipitation

21. Existence of antibiotic was first proposed by
1. Pasteur 2. Paul Ehrlich
3. Fleming 4. Dubos

22. The Antibiotics are manufactured in large scale by
1. Surface culture in liquid medium
2. Surface culture in solid medium
3. Submerged culture in liquid medium
4. Submerged culture in solid medium

23. Increased hepatic angiotensinogen production is responsible for following
1. Renal hypertension 2. Pills hypertension
3. Vascular hypertension 4. Endocrine hypertension

24. The following type of pulse is seen in myocardial infraction
1. Pulsus deficit 2. Pulsus alternens
3. Anacrotic pulse 4. Water hammer pulse

25. Drugs of choice for grandmal epilepsy are
1. Phenytoin and sodium valproate
2. Sodium valproate and carbamazepin
3. Carbamazepin and phenobarbital
4. Phenobarbital and phenytoin

26. Morphine is contraindicated for patients with head injury because it produces
1. Sedation
2. Hyperactive spinal refluxes
3. Respiratory depression
4. Analgesia

27. Which of the following is anti metabolite ?
1. Cyclophosphamide 2. Thiotepa
3. Methotrexate 4. Chlorambucil

28. Which of the following anticancer drug is obtained from plant ?
1. Cisplatin 2. Uracil
3. Vincristine 4. Tamoxifen

29. In prescription the Latin term “fiat” means
1. Let it be mixed 2. Let it be made
3. Let it be warmed 4. Let it be sent

30. Most dangerous organism infecting the eye is
1. Pseudomonas aeruginosa
2. Staphylococcus aureus
3. Proteus vulgaris
4. Bacillus subtilis

31. In the extemporaneous preparation of eye drops the final clarification done by passing
through

1. Sintered glass filters
2. Gooch crucible
3. Whatman filter paper
4. Micro-porous plastic membrane

32. One of the advantages of IR heat sterilization of syringes is
1. Determination of internal temperature to assess the efficiency of sterilization is simple
2. More efficient than autoclaving
3. Unaffected by thermal resistance by static surface air films
4. Fast sterilization

33. International Pharmacopoeia is published by
1. WHO
2. International Pharmaceutical Federation
3. United Nations
4. US food and drug administration

34. In the case of sterilization by dry heat the microbes are killed by
1. Oxidation 2. Dehydration
3. Decomposition 4. Precipitation

35. Communicable disease caused by Rickettsiae is
1. Scrub typhus 2. Chancroid
3. Mumps 4. Influenza

36. One of the first aid in poisoning is by administering
1. Universal antidote
2. Table spoonful of mustered
3. Egg white
4. All the above

37. In hemolytic jaundice the following are true EXCEPT
1. Unconjugated bilirubin level increases
2. Anemia is common
3. Serum alkaline phosphatase level increases
4. Liver function test normal

38. The mechanism of action of penicillin is
1. By inhibition of protein synthesis
2. By interference with ribosome function
3. By antimetabolite action
4. By interference with cell wall synthesis

39. Cotrimoxazole is more effective than individual administration of sulphame-thoxazole or
trimethoprim since
1. Both set sequentially in nucleotide synthesis
2. Sulphamethoxazole is antimetabolite and trimethoprin interfere with cell wall synthesis
3. Both binds to enzyme required for DNA replication
4. Sulphamethoxazole interfere with folic acid synthesis and trimethoprin interfere with cell
wall synthesis

40. Which of the following is fluoroquinolone derivative ?
1. Nitrofurantoin 2. Lomifloxacin
3. Prontocil 4. Penicillin

Who is the winner of the prestigious
ABEL PRIZE of the Norwegian
Academy of Sciences and Letters for
2012?
(1) Endre Szemeredi
(2) Paul Erdos
(3) M. Gelfand
( 4) Niel Henrik

3 percent of votes polled?
(1) RLD
(2) BSP
(3) Congress
(4) BJP

GS/500
20th New Delhi World Book Fair was in
augurated by
(1) Kapil Sibal
(2) Manmohan Singh
(3) Karan Singh
(4) Pratibha Patil

Some questions are given below :
1. All of the following ate psychotropic substances, except:
1. Amobarbital 2. Meprobamate
3. Barbital 4. All of the above

2. As per schedule P of Drugs and Cosmetics
Act, the Diphtheria toxoid has expiry period
of :
1. 6 months 2. 12 months
3. 2 years 4. 5 years

3. Chloramphenicol comes under schedule :
1. G 2. H
3. W 4. P

4. Example of Narcotic drug is :
1. Coca 2. Opium
3. Charas 4. Doxapram

5. Ergot and its preparation belongs to schedule :
1. P 2. Q
3. C1 4. L

6. Schedule X drug is :
1. Amphetamine 2. Cyclobarbital
3. Glutethimide 4. All of the above

7. Drug Inspector is appointed under section :
1. 19 2. 42
3. 21 4. 30

8. Schedule M and Y were introduced in Drugs
and Cosmetics Act in :
1. 1976 2. 1982
3. 1988 4. 1980

9. Example of Schedule G drug is :
1. Tetracycline 2. Ampicillin
3. Ibuprofen 4. Tolbutamide

10. Example of Schedule X drug is :
1. Diazepam 2. Emetine
3. Quinidine 4. Ciprofloxacin

11. Opium has been under legislative control
since :
1. 1820 2. 1857
3. 1925 4. 1949

12. Standards for mechanical contraceptives are given in schedule :
1. S 2 R
3. Q 4. T

13. The Drugs and Cosmetics Act has been divided
into …… parts
1. 15 2. 16
3. 18 4. 24

14. The Central Drugs Laboratory is established
in :
1. Calcutta 2. Lucknow
3. Mumbai 4. Kasauli

15. The members of the D.T.A.B. hold the office
for :
1. 1 year 2. 3 years
3. 5 years 4. 7 years

1. Senna is
1. Irritant laxative 2. Osmotic laxative
3. Bulk laxative 4. Emollient laxative

2. Long term use of cemetidine may cause 2
1. Sexual disfunction 2. Renal failure
3. Rebound acidity 4. Parietal cell blockade

3. Piperazine is used in the treatment of
1. Amoebiasis 2. Helminthiasis 2
3. Giardiasis 4. Malaria
4. The drug of choice for the treatment of filariasis is 4
1. CocaDiethyl carbamazine
2. Niclosamide
3. Biloscanate 4. None of the above
5. The prescription starts with the symbol Rx, means 3
1. Send 2. Prescribe
3. Take thou 4. Prepare
6. Which type of prescription should contain the age of the patient ? 1
1. Prescription for a child
2. Prescription containing special formula
3. Prescription containing patient medicament
4. Prescription for elderly patient
7. The plasma substitute, dextran is a homo polymer of glucose, which is produced by 1
1. Polymerization of glucose
2. Chemical modification of starch
3. Chemical modification of cellulose
4. By growing the organism leuconostoc mesenteroides in sucrose containing medium
8. Mot acceptable absorbable hemostat is 3
1. Human fibrin foam 2. Gelatin sponge
3. Oxidized cellulose 4. Calcium alginate
9. Bacteria which can derive their nutritional requirements and energy from simple inorganic
source are called
1
1. Autotrophic 2. Heterotrophic
3. Parasite 4. Saprophyte
10. Ziehl Neelsen’s method is used to identify 1
1. Acid fast bacteria 2. Gram positive bacteria
3. Spores 4. Flagella
11. P wave of ECG is the result of
1
1. Atrial depolarization 2. Atrial repolarization
3. Ventricular depolarization
4. Ventricular repolarization
12. Incompatible blood transfusion can result in
2
1. Hypovolemic shock 2 Anaphylactic shock
3. Cardiogenic shock 4. Obstructive shock
13. Sucralftate is used in the treatment of 3
1. Vomit 2. Constipation
3. Duodenal ulcer 4. Diarrhoea
14. Which property of chlorpromazine is responsible for its antipsychotic effect ? 2
1. Antidopaminergic 2. Antimuscarinic
3. A adrenoreceptor blocking
4. Anti 5-HT property
15. Which of the following is broad spectrum anthelmintic ? 4
1. Mebendazole 2. Piperazine
3. Diethylcarbamazine 4. Chloroquine
16. Cancer of epithelial tissue is called 1
1. Carcinoma 2. Sarcoma
3. Lukemia 4. Hodgkin’s disease
17. The Latin term for ointment is 1
1. Ungentum 2. Pasta
3. Oculentum 4. Linimentem
18. The Latin term for “When required” is 1
1. si opus sit 2. Dolor urgente
3. tussi urgente 4. statim
19. Material used to assist adhesion of skin graft is
1. Human thrombin 2. Human
immunoglobulin
3. Plasma protein fraction 4. Gum saline
20. The incompatibility encountered when aspirin is powdered together with phenazone is
2
1. Insolubility 2. Liquefaction
3. Immiscibility 4. Precipitation
21. Existence of antibiotic was first proposed by 1
1. Pasteur 2. Paul Ehrlich
3. Fleming 4. Dubos
22. The Antibiotics are manufactured in large scale by 4
1. Surface culture in liquid medium
2. Surface culture in solid medium
3. Submerged culture in liquid medium
4. Submerged culture in solid medium
23. Increased hepatic angiotensinogen production is responsible for following 1
1. Renal hypertension 2. Pills hypertension
3. Vascular hypertension 4. Endocrine hypertension
24. The following type of pulse is seen in myocardial infraction
1. Pulsus deficit 2. Pulsus alternens
3. Anacrotic pulse 4. Water hammer pulse
25. Drugs of choice for grandmal epilepsy are 1
1. Phenytoin and sodium valproate
2. Sodium valproate and carbamazepin
3. Carbamazepin and phenobarbital
4. Phenobarbital and phenytoin
26. Morphine is contraindicated for patients with head injury because it produces 3
1. Sedation
2. Hyperactive spinal refluxes
3. Respiratory depression
4. Analgesia
27. Which of the following is anti metabolite ? 3
1. Cyclophosphamide 2. Thiotepa
3. Methotrexate 4. Chlorambucil
28. Which of the following anticancer drug is obtained from plant ? 1
1. Cisplatin 2. Uracil
3. Vincristine 4. Tamoxifen
29. In prescription the Latin term “fiat” means
1. Let it be mixed 2. Let it be made
3. Let it be warmed 4. Let it be sent
30. Most dangerous organism infecting the eye is 1
1. Pseudomonas aeruginosa
2. Staphylococcus aureus
3. Proteus vulgaris
4. Bacillus subtilis
31. In the extemporaneous preparation of eye drops the final clarification done by passing
through
1
1. Sintered glass filters
2. Gooch crucible
3. Whatman filter paper
4. Micro-porous plastic membrane
32. One of the advantages of IR heat sterilization of syringes is 3
1. Determination of internal temperature to assess the efficiency of sterilization is simple
2. More efficient than autoclaving
3. Unaffected by thermal resistance by static surface air films
4. Fast sterilization
33. International Pharmacopoeia is published by 1
1. WHO
2. International Pharmaceutical Federation
3. United Nations
4. US food and drug administration
34. In the case of sterilization by dry heat the microbes are killed by 2
1. Oxidation 2. Dehydration
3. Decomposition 4. Precipitation
35. Communicable disease caused by Rickettsiae is 4
1. Scrub typhus 2. Chancroid
3. Mumps 4. Influenza
36. One of the first aid in poisoning is by administering 1
1. Universal antidote
2. Table spoonful of mustered
3. Egg white
4. All the above
37. In hemolytic jaundice the following are true EXCEPT 4
1. Unconjugated bilirubin level increases
2. Anemia is common
3. Serum alkaline phosphatase level increases
4. Liver function test normal
38. The mechanism of action of penicillin is 1
1. By inhibition of protein synthesis
2. By interference with ribosome function
3. By antimetabolite action
4. By interference with cell wall synthesis
39. Cotrimoxazole is more effective than individual administration of sulphame-thoxazole or
trimethoprim since 2
1. Both set sequentially in nucleotide synthesis
2. Sulphamethoxazole is antimetabolite and trimethoprin interfere with cell wall synthesis
3. Both binds to enzyme required for DNA replication
4. Sulphamethoxazole interfere with folic acid synthesis and trimethoprin interfere with cell
wall synthesis
40. Which of the following is fluoroquinolone derivative ? 2
1. Nitrofurantoin 2. Lomifloxacin
3. Prontocil 4. Penicillin G
41. Number of mole of ATPs produced when on mole of glucose is completely oxidized is
1. 38 2. 8 1
3. 6 4. 24
42. The word posology is derived from Greek word “posos” which means 1
1. “How much” 2. Quantity
3. Amount 4. How long
43. The dose for children can be calculated on the basis of body weight by 1
1. Young’s rule or Dilling’s rule
2. Young’s rule or Catzel rule
3. Dilling’s rule or Catzel rule
4. Catzel rule or Young’s rule
44. The metabolic fate of pyruate in the anaerobic condition is formation of
1. ATP 2. Acetyl Co-A 3
3. Lactate 4. Citric Acid
45. The samples taken from drug store by Drug Inspector for analysis shall be divided into
1. 3 2. 4 2
3. 5 4. 2
46. More scientific way of calculating paediatric dose is based on 1
1. Age 2. Body weight
3. Body surface area 4. Body height
47. The dose for a twelve year old child in terms of adult dose is 1
1. 20% 2. 12%
3. 75% 4. 50%
48. In hospitals Infra Red Radiation heat sterilization in high vacuum can be used for
sterilization of 4
1. Extemporaneous ophthalmic preparation
2. Extemporaneous ophthalmic Large Volume parenterals
3. Large instruments used in Operation Theatre
4. Rubber Cloves
49. The small knots in cotton fibre caused by uneven growth or formed during processing is
called 1
1. Neps 2. Staple
3. Card 4. Scales
50. Adsorbent cotton wool is used for 3
1. Absorbing wound exudate
2. Retaining dressing in toes
3. Skin grafting
4. Protecting Dressing
51. Which of the following is ex-officio member of Drug Technical advisory Board ? 4
1. President of Indian Medical Association
2. President of Indian Pharmaceutical Association
3. President of Indian Council of Medical Research
4. President of Medical Council of India
52. Number of schedules to Drugs and cosmetics act 1940 is 4
1. 12 2. 2
3. 40 4. 32

DRUG INSPECTOR Practice Papers

53. The dressing used for burn injury is
1. Rayon 2. Cellulose wading
3. Capsicum cotton wool 4. Paraffin gauze dressing
54. In the case of sterilization by moist heat the microbes are killed by 1
1. Oxidation 2. Reduction
3. Decomposition 4. Coagulation of protein
55. Saturated steam is better heating agent than air for sterilization because it has 1
1. High latent heat
2. High pressure
3. High sensible heat
4. Low coefficient of expansion
56. Which schedule to Drugs and Cosmetics Rule provides the list of disease which a drug
may not purport to prevent or cure or make claims to prevent or cure ? 2
1. Schedule C 2. Schedule J
3. Schedule M 4. Schedule Y
57. Every record, register, or other documents seized by Drug Inspector under clause cc or cca
of Section 22 of drugs and cosmetics act 1940 shall be returned to the person within
1. 10 days 2. 20 days
3. 25 days 4. 30 days
58. Valuable test for confirmation that the steam has displaced all the air from a porous
load in a high vacuum autoclave is 3
1. Bowie – Dick Test 2. Klintex Paper Test
3. Browne’s Tube Test 4. Hour Glass Test
59. The label of package containing the drugs coming under the purview of Narcotic Drugs
and Psychotropic Substance act 1985 should 4
1. Have the symbol NRx in Red in the left top corner
2. Have warming: “Poison”
4. Have caution : it is dangerous to take the medicine except under supervision of
Registered Medical Practitioner
4. All the above
60. First step in glycolysis is 2
1. Conversion of glucose-6-phosphate to fructose-6-phosphate
2. Conversion of glucose to glucose-6-phosphate
3. Conversion of phosphoenolpyruvate to pyrite
4. Fructose-6-phosphate to fructose 1,6 diphosphate
61. Chemical incompatibility is caused due to any of the following EXCEPT : 2
1. pH change 2. Double decomposition
3. Complex formation 4. Dissociation
62. What is the preferred pH to dispense a weakly acidic drug with pKa of 7.5 as solution ? 1
1. Less than 5 2. Less than 3
3. 7.5 4. 9
63. Oxytetracycline is produced by 1
1. Streptomyces rimous
2. Streptomyces grises
3. Streptomyces Venezuela
4. Streptomyces garyphalous
64. The precursor used in the manufacture of benzyl penicillin is 2
1. Phenyl acetic acid
2. 6-aminopenicillonic acid
3. Phenoxy acetic acid
4. 2-6, dimethoxyphenylacetic acid
65. Fainting is due to pooling of blood in lower extremities in the following 2
1. Collar syncope 2. Orthostatic syncope
3. Carotid sinus syncope 4. Vaso-vagal syncope
66. Lipase is not present in one of the following secretion 2
1. Saliva 2. Gastric juice
3. Pancreatic juice 4. Intestinal juice
67. Which of the following ins the selective COX – 2 inhibitor ? 4
1. Nimesulide 2. Mefenamic acid
3. Naproxene 4. Diclofenac
68. Which of the following NSAID is para aminophenol derivative ? 2
1. Indomethacin 2. Diclofenac
3. Paracetamol 4. Ketoprofen
69. Conversion of glycogen to glucose is known as 3
1. Glycogenesis 2. Glycolysis
3. Glycogenolysis 4. Gluconeogenesis
70. Conversion of glucose to pyruvate or lactate is called 1
1. Embden-Mayerhof pathway
2. Pentose phosphate pathway
3. Uronic acid pathway
4. Glycerophosphate shuttle
71. Opthalmic preparation may contain the medicaments as a suspension provided the
size of the 90% of the particle is less than 2
1. 1 micron 2. 5 micron
3. 7 micron 4. 10 micron

DRUG INSPECTOR Exam Practice Paper

72. The most important property of ophthalmic preparation which causes pain and irritation
is 1
1. Hypertonic solution 2. Acidic pH
3. High viscosity 4. Hypotonic solution
73. Dispensing of alkaline bicarbonate and soluble magnesium salt together will produce 4
1. Double decomposition
2. Complexation
3. Therapeutic incompatibility
4. Physical incompatibility
74. Current Pharmacopoeia of India was published in 4
1. 1955 2. 1966
3. 1986 4. 1996
75. Which of the following is NOT sexually transmitted disease ? 4
1. Gonorrhoea 2. Chancroid
3. Granuloma inguinale 4. Kala azar
76. Malaria is caused by 2
1. Protozoa 2. Bacteria
3. Fungi 4. Virus
77. Intrinsic factor is secreted by 2
1. S cells 2. K cells
3. Parietal cells 4. Duodenal mucosa
78. Pepsinogen is activated by 2
1. Enterokinase 2. HCl
3. Trypsin 4. Cl–
79. Which of the following is long acting barbiturate ? 4
1. Amylobarbitone 2. Secobarbitone
3. Thiopentone 4. Phenobarbitone
80. Which of the following is opioid antagonist ? 3
1. Buprenorphine 2. Meptazinol
3. Nalorphine 4. Nalbuphine
81. Choose the correct statement : 3
1. Buffering capacity of eye drops should be low
2. Buffering capacity of eye drops should be high
3. Eye drops should be buffered at the pH of lachrymal secretion
4. Buffer should not be used in eye drops
82. British standard tests for ophthalmic containers include all the following tests EXCEPT 1
1. Resistance for autoclaving
2. Light resistance
3. Closure efficiency
4. Gas permeability
83. Pharmacopoeia gives all the following information EXCEPT 4
1. Dose 2. Solubility
3. Therapeutic category 4. Manufacturing method
84. Pharmacopoeia is a book 4
1. Describing preparation of formulations
2. Describing dispensing techniques
3. Of standards published by respective government agency
4. All the above
85. Filariasis is caused by 1
1. Wuchereria bancrofti
2. Strongyloides stercoralis
3. Dracunculus medinensis
4. Schistosoma mansonia
86. Which of the following is NOT a mode of transmission of AIDS ? 3
1. Sexual contact
2. Transfusion of infected blood
3. Contact with infected towels and clothing
4. From infected mother to foetus
87. Oxyntic cells secrete one of the following : 2
1. Pepsinogen 2. HCl
3. Bicarbonate 4. Gastrin
88. Mass peristalsis is seen in 2
1. Small intestine 2. Stomach
3. Large intestine 4. Esophagus
89. Who is known as father of modern chemo-therapy ? 1
1. Paul Ehrlich 2. Louis Pasteur
3. Alexander Fleming 4. Domagle
90. The effect of sulpha drug is antagonized by 1
1. PABA 2. Folic acid
3. Sulphanilic acid 4. Thiamin
91. Hardening is one of the steps in the preparation of catguts. It is done by soaking the ribbon
obtained from the intestine in
1. Potassium Permanganate solution
2. Potassium sulphate solution
3. Chromium salt solution
4. Vanadium sulphate solution
92. Material used in the non-absorbable suture is 1
1. Silk 2. Linen
3. Metals and alloys 4. All the above
93. Children from slum area develop immunity to a variety of disease more quickly than those
children from affluent area due to 2
1. Frequent clinical infection
2. Frequent subclinical infection
3. Inadequate artificial immunization schedule
4. Acquired passive immunization
94. New born babies show high resistance to Chicken pox due to 1
1. Naturally acquired active immunization
2. Artificially stimulated active immunization
3. Naturally stimulated passive immunization
4. Artificially stimulated passive immunization
95. The following is a major relay station for sensory impulses 4
1. Medulla 2. Pons
3. Cerebellum 4. Thalamus
96. Feeding is regulated by centers in the 3
1. Cerebral cortex 2. Thalamus
3. Hypothalamus 4. Cerebellum
97. Which of the following antacid has laxative action also ? 1
1. Aluminium hydroxide 2. Magnesium hydroxide
3. Calcium Carbonate 4. Sodium bicarbonate
98. Omeprazole is used in the treatment of peptic ulcer since it 4
1. Increases the secretion of mucus
2. Is H2
receptor antagonist
3. Is H1
receptor antagonist
4. Is proton pump inhibitor
99. WHO recommended drug regime for the treatment of tuberculoid leprosy is
1. Dapsone 100 mg/day + Rifampicin 600 mg/month (supervised) for 6 months
2. Dapsone 100 mg/day + Clofazimine 50 mg/month (unsupervised) for 12 months
3. Rifampicin 600 mg/month + Clofazimine 300 mg/month (unsupervised) for 12 months
4. Rifampicin 600 mg/month (supervised) + Clofazimine 300 mg/month (unsupervised) for 3
months
100. Which of the following disease is caused by parasitic protozoa ? 1
1. Leishmaniasis 2. Leprosy
3. Syphilis 4. Plague
101. How much theobroma oil is required to prepare ten suppositories containing 300 mg of
bismuth subgallate using one gram suppository mould ? (Displacement value of bismuth
subgallate is 6)
1. 9.5 g 2. 0.5 g
3. 9.5 ml 4. 0.5 ml
102. Turbidity is often produced initially when
alcohol is mixed with water which disappears subsequently. It is due to 3
1. The formation of temporary emulsion
2. Less solubility of alcohol in water
3. The precipitation of impurities
4. Liberation of air dissolved in water
103. Maximum volume blood collected at one attendance from a donor is 2
1. 420 ml 2. 250 ml
3. 100 ml 4. 940 ml
104. The blood from human volunteer is collected
from 2
1. Median cubital vein 2. Jugular vein
3. Pulmonary vein 4. Any of the above
105. The toxins are converted to toxoid by treating with 1
1. Formaldehyde
2. Autoclaving
3. By heating to 80o Celsius
4. All the above
106. Which of the following vaccine contains attenuated living bacteria ? 1
1. BCG 2. Tetanus
3. Poliomyelitis 4. Diphtheria
107. Acetylcholine is not the neurotransmitter in
the following fibers 1
1. Pre-ganglionic parasympathetics fibers
2. Post-ganglionic parasympathetics fibers
3. Pre-ganglionic sympathetic fibers
4. Pre-ganglionic sympathetic fibers of sweet glands
108. Lumbar puncture is performed for the
following reasons EXCEPT 2
1. To produce spinal anesthesia
2. To relieve intracranial pressure
3. To introduce drugs into CNS
4. To record the electrical activities of spinal cord
109. Which of the following is anti-emetic ? 2
1. Domperidone 2. Apomorphine
3. Mustard 4. Ipecacuanha
110. Which of the following is irritant purgative ? 3
1. Magnesium sulphate
2. Dioctyl sodium sulphosuccinate
3. Liquid paraffin
4. Castor oil
111. Amodiaquine is active against which phase of the life cycle of malarial parasite ? 3
1. Hepatic phase 2. Asexual parasites
3. Latent tissue phase 4. Gametocytes in mosquito
112. Drug acting against only extra intestinal amoebiasis is 2
1. Quinidochlor 2. Dilaxanide furoate
3. Tetracycline 4. Chloroquine
113. How much 95% alcohol is required to prepare 1000 ml of 60% alcohol ?
1. 631.5 2. 621.6
3. 658.33 4. 641.6
114. A prescription is an order, to supply medicine, from 4
1. Doctor 2. Dentist
3. Veterinary surgeon 4. All the above
115. Blood collected from donor is stored in sealed containers at ? 3
1. –20o Celsius 2. –80o Celsius
3. 4
o
to 6o Celsius 4. 15o
to 20o Celsius
116. In emergency conditions where the whole blood is not available or until matching test
are known the following can be used 2
1. Concentrated human RBC
2. Dried human plasma
3. Human plasma protein fraction
4. Human fibrinogen
117. Venereal disease is contracted by 1
1. Physical contact 2. Hand infection
3. Arthopod vector 4. Droplet infection
118. Rod shaped bacteria are called 2
1. Cocci 2. Bacilli
3. Spirochetes 4. Vibrio
119. Decoction process is used for 4
1. Alcohol soluble and heat stable constituents of plants
2. Water soluble and thermo labile constituents of plants
3. Water insoluble and heat stable constituents of plants
4. Water soluble and heat stables constituents of plants
120. The normal pace maker of the heart is 2
1. Atrio-ventricular node 2. Sino-atrial node
3. Bundle of His 4. Purkinje fibers
121. Which of the following is the primary effect of digitalis in congestive cardiac failure ?
2
1. Decreased heart rate
2. Increased force of contraction of myocardium
3. Decreased venous out put
4. Increased urinary out put
122. Plant extract in the form of plastic mass is known as : 1
1. Pilular extract 2. Liquid extract
3. Fluid extract 4. Powder extract
123. Which of the following is penicillinase resistant penicillin ? 1
1. Benzyl penicillin 2. Phenoxymethyl penicillin
3. Cloxacillin 4. Penicillin G
124. Which of the following is not a macrolide antibiotic ? 1
1. Erythromycin 2. Oleandomycin
3. Spiromycin 4. Gentamicin
125. Choose the correct statement with respect to requirement of paediatric dose 1
1. The dose requirement is directly proportional
to age
2. The dose requirement is directly proportional
to height
3. A child require larger dose per/kg than adult
4. A child require lesser dose per/kg than adult
126. The percentage by volume of alcohol in proof spirit is 3
1. 57.10 2. 42.9
3. 49.28 4. 95
127. The bandage prepared from fabrics with cotton warp and wool weft is
1. Domette bandage 2. Stretch bandage
3. Cambric bandage 4. Cotton stretch bandage
128. Crepe bandage is helpful in all the following conditions EXCEPT 2
1. For giving light support to sprains and strains
2. For correctional purpose
3. As a compression bandage
4. To protect clothing from dressing
129. Bactericides used in sterilization by heating with bactericide are 1
1. Chlorocresol and Phenylmercuric Nitrate
2. Fomaldehyde and Chlorocresol
3. Phenyl mercuric nitrate and Methyl paraben
4. Chlorocresol and Methyl paraben
130. Presence of antibacterial agents in injectables requires that the antibacterial agent
inactivated before sterility testing. One of te methods to inactivation is by dilution with 3
1. Water 2. Normal saline
3. Culture medium 4. (2) or (3)
131. During prolonged starvation the glucose required for brain function is made available
by 3
1. Citric acid cycle 2. Glycogenesis
3. Gluconeogenesis 4. Glycogenesis
132. Increased blood glucose level may be due to 1
1. Diabetes mellitus 2. Hyper activity of thyroid
3. Emotional stress 4. All the above
133. Which of the following cardiovascular drug produce tachycardia ? 3
1. Propranolol 2. Procainamide
3. Quinidine 4. Lignocaine
134. Which of the following is calcium channel blocker ? 2
1. Amlodipin 2. Atenalol
3. Isesorbide dinitrate 4. Minoxidil
135. Cephalosporins are derivative of 1
1. Betalactam 2. Quinoline
3. Fluoroquinolone 4. Carbapenem
136. Which of the following antifungal agent is a polyene derivative ? 2
1. Amphotericin B 2. Clotrimazole
3. Griseofulvin 4. Flucytosine
137. 30 degree under proof spirit means 2
1. 100 volume of the spirit contains 30 volume of proof spirit
2. 100 volume of the spirit contains 70 volume of proof spirit
3. 100 volume of the spirit when diluted give 130 ml of proof spirit
4. 100 volume of the spirit when diluted give 170 ml of proof spirit
138. Intra venous injection of hypotonic solution may cause 4
1. Hemolysis
2. Shrinkage of RBC
3. Crenulation of blood cells
4. All the above

DRUG INSPECTOR PRACTICE QUESTION & ANSWERS – DI EXAM PRACTICE PAPER
139. Catgut is prepared from the intestine of 2
1. Cat 2. Pig
3. Ox 4. Sheep
140. Strings used for tying blood vessels during surgery is called 2
1. Ligature 2. Suture
3. Catgut 4. Fibers
141. Exotoxins are 1
1. Structural elements of bacteria
2. Normally found in Gram negative bacteria
3. Water soluble, high molecular weight protein or enzyme
4. Much less toxic
142. Virulence of bacteria is increased by 2
1. Growing under artificial condition
2. Successive and fairly rapid transfer from one susceptible host to another
3. Growing in an unfavorable condition
4. Growing in unnatural host
143. Which of the following is obtained from animal ? 2
1. Cantharidin 2. Ichthamnol
3. Diatomaceous earth 4. Vincristine
144. Sensory cortex is located in the following lobe of the cerebral cortex 1
1. Frontal lobe 2. Parietal lobe
3. Occipital lobe 4. Temporal lobe
145. Which of the following increases the steady state plasma concentration of digitalis when
co-administered ? 2
1. Aspirin 2. Verapamil
3. Paracetamol 4. Steroids
146. Maceration in which gentle heat is used during the process of extraction is called 2
1. Percolation 2. Infusion
3. Decoction 4. Digestion
147. Use of antibiotic is not justified in the prophylaxis of all the following conditions EXCEPT
3
1. Meningococcal infection in children
2. Endocarditis
3. Infection during catheterization
4. Infection due to climatic change
148. All the following are the reason for the difficulty in the treatment of T.B. EXCEPT 2
1. Occurrence of persister
2. Non availability of effective drug
3. Tubercle bacilli can remain viable and multiply even when ingested by macrophage
4. The cessation and fibrosis tend to block the
blood vessel making penetration of drugs
difficult
149. Which of the following injection is made slightly hypertonic ? 1
1. IV injection for rapid action
2. IM injection for rapid absorption
3. Intracutaneo injection is for rapid absorption
4. Subcutaneous injection for rapid absorption
150. Displacement value of zinc oxide with reference to theobroma oil is 5. That means 2
1. 1 g of zinc oxide replaces 5 g of theobroma oil
2. 5 g of zinc oxide replaces 1 g of theobroma oil
3. 1 ml of zinc oxide replaces 5 ml of theobromaoil
4. 5 ml of zinc oxide replaces 1 ml of theobroma oil

11. Williamson Synthesis is used for the preparation of:
(a) Aldehydes
(b) Alcohols
(c) Ethers
(d) Amides

12. Ketoconazole structure contains :
(a) Imidazole ring
(b) Triazole ring
(c) Tetrazole ring
(d) Thiazole ring

13. Vitamin containing steroidal moiety is:
(a) Vitamin D
(b) Vitamin A
(c) Vitamin E
(d) Vitamin B12

14. Dragendorff’s reagent is employed for the identification of :
(a) Carbohydrates
(b) Alkaloids
(c) Flavonoids
(d) Proteins

15. In which one among the following is Pteridine ring system present?
(a) Ascorbic acid
(b) Thiamine
(c) Pyridoxine
(d) Folic acid

16. Aminophylline is a combination of:
(a) Theophylline and dimethylamine
(b) Caffeine and theophylline
(c) Theophylline and ethylenediamine
(d) Caffeine and ethylenediamine

17. Purine ring system is a fusion of:
(a) Pyridine and imidazole
(b) Pyrimidine and imidazole
(c) Piperidine and pyrazole
(d) Piperidine and imidazole

18. Furosemide contains the following heterocycle:
(a) Furan
(b) Thiophene
(c) Pyrrole
(d) Imidazole

19. Term of every patent in India (under Indian Patent Act) from the date of filing is:
(a) 10 years
(b) 14 years
(c) 20 years
(d) 24 years

20. Raloxifene is indicated for use in:
(a) Rickets
(b) Hypoparathyroidism
(c) Postmenopausal osteoporosis
(d) Intestinal osteodystrophy

1. Zero order kinetics is seen in all except:
(a) Salicylates
(b) Barbiturates
(c) Phenytoin
(d) Ethanol

2. Which one of the following is not a prodrug?
(a) Chloral hydrate
(b) Diazepam
(c) Enalapril
(d) Oxcarbazepine

3. Which one of the following drugs does not cross the placental barrier?
(a) Morphine
(b) Lithium
(c) Warfarin
(d) Heparin

4. The evidence which indicates that a drug is stored extravascularly is:
(a) Small clearance
(b) Small apparent volume of distribution
(c) Large apparent volume of distribution
(d) Large clearance

5. Which one among the following drugs can be given safely during pregnancy?
(a) Tetracycline
(b) Chloroquine
(c) Thalidomide
(d) Primaquine

6. Lignocaine is used in the treatment of :
(a) Atrial Flutter
(b) Atrial Fibrillation
(c) PSVT
(d) Ventricular tachycardia

7. Which one among the following drugs is used in AV block?
(a) Isoprenaline
(b) Propranolol
(c) Dopamine
(d) Disopyramide

8. Mineralocorticoids cause:
(a) Gluconeogenesis
(b) Glycogen synthesis
(c) Lipolysis
(d) Sodium reabsorption

9. In UV spectrophotometer, the light source is:
(a) Tungsten lamp
(b) Sodium lamp
(c) Deuterium lamp
(d) None of these

10. The principle of infrared spectra is based upon:
(a) Electronic excitation
(b) Resonance
(c) Dissociation
(d) Molecular vibrations

182 : –: : 210 : 380
(1)-. 342
(2) 272
(3) 240
(4) 156

In a particular code FACE is written as GBDF. In the same code BADE is to be
written as
(1) CBEF
(2) CEBF
(3) CFBE
(4) CBFE

In a patricular code TAP is written as SZO. In the same code FREEZE is to be written as .f~!>O’Y !’
(1) EQDFYG
(2) •ESDFYF
(3) GQFDYF
(4) EQDDYD

In a code MHUSMD is written as LI’ITLE. In the same code NTUD is to be written as
(1) MOVE
(2) MUTE
(3) MITE
(4) MATE

In a particular code AUTHOR is written as AUOTHR. In the same code PUBLIC is to be written as
(1) UBIPLC
(2), UIPBLC
(3) PCUBIL
(4) PBILCU

86, 48, 38, 14, 96, 54, 78, –
(1) 56
(2) 62
(3) 81
(4) 76

Fill the gap in the following with proper number
5,8, 13,21,34,55,
1) 85
(2) 92
(3) 89
(4) 58

A person saves Rs. 100/- after spending”from his income 1/5 on food and 3/5 on clothes. What is total income?
(1) Rs. 20
(2) Rs. 80
(3) Rs. 400
C4Y Rs. 500

Person ate 7 apples in 7 minutes. One person could eat one Apple in how many
minutes
(1) 7
(2) 2
(3) 49
(4) 117

Fill the gaps m the following with pro er numbers
5;6, 12, 10,28,26,62,62,-,-
(1) I 1_32, 126
(2) 132, 185
(3) 123, 126
( 4) 126, 132-

Fill the gap in the following with proper numbers
2, 12,36,80, 150,
1) 252
(2) 264•
(3) 384
(4) 272

6. Lignocaine is used in the treatment of :
(a) Atrial Flutter
(b) Atrial Fibrillation
(c) PSVT
(d) Ventricular tachycardia

7. Which one among the following drugs is used in AV block?
(a) Isoprenaline
(b) Propranolol
(c) Dopamine
(d) Disopyramide

8. Mineralocorticoids cause:
(a) Gluconeogenesis
(b) Glycogen synthesis
(c) Lipolysis
(d) Sodium reabsorption

9. In UV spectrophotometer, the light source is:
(a) Tungsten lamp
(b) Sodium lamp
(c) Deuterium lamp
(d) None of these

10. The principle of infrared spectra is based upon:
(a) Electronic excitation
(b) Resonance
(c) Dissociation
(d) Molecular vibrations

Pharmacology Notes: PPT PDF – ANTICANCER DRUGS – What is Cancer? Types/ Causes

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Pharmacology Notes PPT PDF - ANTICANCER DRUGS - What is Cancer Types Causes

Pharmacology Notes

ANTICANCER DRUGS

Cancer cells have lost the normal regulatory mechanisms that control cell growth and multiplication.

What is Cancer?

• Cancer cell have lost their ability to differentiate (that means to specialize). Cancer refers to any one of a large number of diseases characterized by the development of abnormal cells that divide uncontrollably and have the ability to infiltrate and destroy normal body tissue. Cancer often has the ability to spread throughout your body.

Types of Cancer?

• Benign cancer cell stay at the same place
Malignant cancer cells invade new tissues to set up secondary tumors, a process known as metastasis

Causes of cancer

Common Causes of Cancer:

Smoking and Tobacco. Diet and Physical Activity. Sun and Other Types of Radiation. Viruses and Other Infections

• Chemicals causing cancer are called mutagens
• Cancer can be caused by chemicals, life style (smoking), and viruses

Gene mutations

A gene mutation can instruct a healthy cell to Allow rapid growth or Fail to stop uncontrolled cell growth or cells lose the controls (tumor suppressor genes) or even Make mistakes when repairing DNA errors

Definitions of cancer

genes that are related to cause cancer are called oncogenes.
Genes that become onogenic upon mutation are called protooncogenes.

Pharmacology Notes PPT PDF - ANTICANCER DRUGS - What is Cancer Types Causes

General signs and symptoms of cancer

Unexplained weight loss
Fever
Fatigue
Pain
Skin changes
Darker looking skin (hyperpigmentation)
Yellowish skin and eyes (jaundice)
Reddened skin (erythema)
Itching (pruritis)
Excessive hair growth
Change in bowel habits or bladder function
Long-term constipation, diarrhea,
Sores that do not heal
White patches inside the mouth or white spots on the tongue
Unusual bleeding or discharge
Thickening or lump in the breast or other parts of the body
Indigestion or trouble swallowing
Recent change in a wart or mole or any new skin change
Nagging cough or hoarseness

Top 10 Anti Cancer Drugs

anti cancer drugs list ppt pharmacology

List of Anti cancer Drugs

ALKYLATING AGENTS:

BUSULFAN
CARMUSTINE (BCNU)
CYCLOPHOSPHAMIDE
DACARBAZINE
LOMUSTINE (CCNU)
MECHLORETHAMINE
MELPHALAN
THIOTEPA

NATURAL PRODUCTS

BLEOMYCIN
DACTINOMYCIN
DAUNORUBICIN
DOXORUBICIN
ETOPOSIDE (VP-16)
IRINOTECAN
MITOMYCIN C
PACLITAXEL
VINBLASTINE
VINCRISTINE

MISCELLANEOUS:

Angiostatin
AMSACRINE
L-asparaginase
Bortezomib
CARBOPLATIN
CISPLATIN
Erlotinib
Gefitinib
Hydroxyurea
Imatinib
Pentostatin
PROCARBAZINE
Thalidomide

ANTIMETABOLITES:

Azathioprine
5-fluorouracil
6-thioguanine
6-mecaptopurine
Cytarabine (ara-c)
Gemcitabine
Methotrexate

IMMUNOTHERAPY:

Alemtuzumab
Aminoglutethimide
Bevacizumab
Cetuximab
Cyclosporine
Dexamethasone
Edrecolomab
Gemtuzumab
Ibritumomab
Interferon α
Interleukin 2
Interleukin-12
Prednisone
Rituximab
Tacrolimus (fk506)
Tositumomab
Trastuzumab
Tumour necrosis factor α

HORMONES and RELATED AGENTS:

Aminoglutethimide
Anastrozole
Exemestane
Flutamide
Letrozole
Goserelin
Leuprolide
Letrozole
Tamoxifen

SUPPORTING AGENTS:

Allopurinol
Erythropoietin
Filgrastim
Interleukin 11
Leucovorin
MESNA
Sargramostim (GM-CSF)

anti cancer drugs ppt pdf notes b pharm m pharm medicos d pharm pharmacology

Pharmacology anti cancer drugs ppt pdf notes b pharm m pharm medicos d pharm

anti neoplastic anti cancer drugs ppt pdf notes b pharm m pharm medicos d pharm

Anticancer drugs pharmacology pdf anticancer drugs list pdf classification of anticancer drugs wikipedia anticancer drugs classification ppt classification of anticancer drugs with mechanism of action classification of anticancer agents anticancer drugs classification mnemonics top 10 anti cancer drugs.

Process Validation Protocol – Pharmaceutical Template PDF PPT XLS

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Process Validation Protocol - Pharmaceutical Template PDF PPT XLS

Effective process validation contributes significantly to assuring drug quality. The basic principle of quality assurance is that a drug should be produced that is fit for its intended use.
This principle incorporates the understanding that the following conditions exist:
• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product inspection or testing.

As we have discussed effective process validation contributes significantly to assuring drug quality. The basic principle of quality assurance is that a drug should be produced that is fit for its intended use. Pharmaceutical Process Validation Protocol & Report Format Example PPT PDF is given here for autoclave and sterilization. First let us know what is Pharmaceutical Process Validation. Validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes. It is mandatory to have a system stock list put in place, the appropriate SOPs in place, and additionally to check the critical techniques and their documentation. Having a powerful efficient Computer System Validation System put in place will help ensure the stability of the electronic documents, allocate resources better and subsequently can yield long run cost discounts to the company.

Approach to Process Validation: 

For purposes of this guidance, process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific
evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This
guidance describes process validation activities in three stages.
• Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
• Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
• Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

Validation Protocol:

A written plan stating how validation will be conducted, including test parameters, product characteristics, production and packaging equipment, and decision points on what constitutes acceptable test results. This document should give details of critical steps of the manufacturing process that should be measured, the allowable range of variability and the manner in which the system will be tested.
The validation protocol provides a synopsis of what is hoped to be accomplished. The protocol should list the selected process and control parameters, state the number of batches to be included in the study, and specify how the data, once assembled, will be treated for relevance. The date of approval by the validation team should also be noted.
In the case where a protocol is altered or modified after its approval, appropriate reasoning for such a change must be documented.
The validation protocol should be numbered, signed and dated, and should contain as a minimum the following information:
1. Title
2. Objective & Scope
3. Responsibility
4. Protocol Approval
5. Validation Team
6. Product Composition
7. Process Flow Chart
8. Manufacturing Process
9. Review of Equipments / Utilities
10.Review of Raw Materials and Packing Materials
11. Review of Analytical and Batch Manufacturing Records
12. Review of Batch Quantities for Validation (Raw Materials)
13. Review of Batch Quantities for Validation (Packing Materials)
14. HSE Requirements
15. Review of Process Parameters
16. Validation Procedure
17. Sampling Location
18. Documentation
19. Acceptance Criteria
20. Summary
21. Conclusion

Process Validation Protocol – Pharmaceutical Template PDF PPT XLS

PROCESS VALIDATION PROTOCOL -Pharmaceutical (Autoclave)

1. PRE-EXECUTION APPROVAL

Successful completion of this protocol will provide documented evidence that all key aspects of the Autoclave used in LARGE VOLUME PARENTRALS SECTION adheres to appropriate application criteria, comply with standard operating procedures, and meet current Good Manufacturing Practices (cGMP) requirements.

1.1       SIGNATORY LIST

The signature below indicates approval of this protocol and its attachments for execution.

(Name & Designation, Signature, Date, Prepared By, Checked and Reviewed By, Approved By are the rows and columns you need to fill in the signatory list)

Name & Designation Signature Date
PreparedBy
Checkedand Reviewed By
ApprovedBy

1.2 Validation Team

All individuals participating in the execution of this protocol must fill out a row in the table below. with all the details like Name & Designation, Responsibility, Signature & Initial along with the Date of the process.

Prepare the protocol and coordinate the validation study. Generate amendments to the protocol as required
Microbiological validation of the sterilization process. document the microbiological aspects of the study

Protocol training of operators and provide the resources for validation study

3.0 INSTRUCTIONS

3.1. General Instruction
All performers and reviewers must complete qualification forms using the following guidelines:
· Complete all items on a form in full, except the optional comment’s section.
· Document any deviation from defined protocols and expected results. Owner approval of protocol deviations must be documented before final approval signatures can be obtained.
· Write additional comments on an addendum sheet when there is not enough space on a form to accommodate all comments. Use these three steps when adding an addendum sheet.
1. Number the page alphanumerically.
2. Initial and date additions.
3. Insert the addendum sheet behind the original page.
· Make all entries in permanent black or blue ball pen.
3.2 Correcting Entries
If you need to make corrections on a form, use the procedures described below:

3.2.1 Correcting Short Entries

To correct a short entry [such as a single word or test result] on a form:
1. Draw a diagonal line, bottom left to upper right, through the miss entered or incorrect information.
2. Write the correction to the upper right of the original entry.
3. Give brief explanation of change
4. Initial and date the change.

3.2.2 Correcting Long Entries
To correct a long entry or information block on a form:
1. Draw a diagonal line, bottom left to upper right, through the miss entered or incorrect information.
2. Write the correction on a separate addendum page.
3. Give brief explanation of change.
4. Initial and date the changes.
5. Number the page alphanumerically
6. Place the addendum page behind the original page.

3.3 Marking Elements That Are Not Applicable

Mark each element carefully according to the instruments below, so that it will be clear that the element is unnecessary and that you have not skipped or forgotten the element.
1. Draw a diagonal line, bottom left to upper right corner, through the element that is not required.
2. Write the letters NA [Not Applicable], your initials, and the date above the line. Include comments above the line or on the form to document the reason the element is not required.
3. Where NA is indicated as an option, select this field.
The performer and reviewer must sign and date all forms, as usual, even when part or all of the form is marked “NA”.
Note: All original entries must remain legible after any corrections have been made.
3.4 Caution

The following conditions require “re-qualification”;
· When a Instrument modification has been completed, it affects the installation qualification.
· When the software or firmware has been upgraded or changed
· When this Instrument is being removed from where it was originally installed.
3.5 Re-calibration / Re-certification Requirements
The following conditions require “re-calibration / re-certification;
· For a pre-determined period of time or use.
· After any minor service has been done or replacement of parts.
· When this Instrument is being removed from where it was originally installed.

4. RESPONSIBILITIES

4.1 Validation Team

· Prepare and approve the validation protocol.
· Provide training to the personnel regarding protocol execution.
· Assure complete adherence to the protocol during the execution
· Generate amendment to the validation protocol, as required.
· Document any deviations that occur during protocol execution.
· Document Operator SOP Training.
· Provide the resources required in executing the validation protocol.

4.2 PRODUCTION MANAGER
· Review the validation protocol and the final reports

4.3 QUALITY CONTROL/ASSURANCE MANAGER
· Approve the validation protocol and the final reports

5.0 Objectives:

To verify and establish that the Autoclave is working as per recommendations of the manufacturer.
6.0 Scope:

This validation protocol is applicable to the Autoclave intended to be used for steam sterilization in LARGE VOLUME PARENTRALS SECTION.
The protocol will be implemented under the following conditions

§ The validation of sterilization process using saturated steam as the steriliant
§ Prior to the production of a new sterilizer.
§ A change In the load design or weight that would result in a load that is more difficult to sterilize.

7.0 Equipment Identification

Qualification of utilities and equipment generally includes the following activities:
• Selecting utilities and equipment construction materials, operating principles, and performance characteristics based on whether they are appropriate for their specific uses.
• Verifying that utility systems and equipment are built and installed in compliance with the design specifications (e.g., built as designed with proper materials, capacity, and
functions, and properly connected and calibrated).
• Verifying that utility systems and equipment operate in accordance with the process requirements in all anticipated operating ranges.

Equipment Name

Autoclave

Time controller
¨
2
Pressure controller
¨
2
Temperature controller
¨
3
Pressure gauge
¨
4
Safety Valve
¨
5
Thermometer
¨
Completed By:__________________ Date:_____________

Reviewed By:___________________ Date:_____________

8.0 EQUIPMENT DESCRIPTION

The Autoclave intended to be used for steam sterilizations process. It has following specifications:-

S. No.
Parameter
Range
Readability
Check
01
Timer
0—60 min
1 min
¨
02
Pressure
0—60 Lb/inch²
2.0 Lb/inch²
¨
03
Temperature
0 –150°C
0.5°C
¨
8.1 LOAD IDENTIFICATION

Nature of load
1000ml bottles
Quantity of load
2000 Bottles
8.2 STERILIZATATION CYCLE PARAMETERS
Sterilization set point
106°C
Temperature range
106°C +0.5°C
Expose time
45 minutes

Process Validation Protocol - Pharmaceutical Template PDF PPT XLS

8.3 Equipment Used for PROCESS VALIDATION
Equipment
Calibration
Certificate No.
Issue Date
YES
NO
Recording potentiometer
¨
¨
___________
________
Thermocouples & lead wires
¨
¨
___________
________
Biological indicator i.e.
B. stereothermophyllus
¨
¨
___________
________
Completed By:__________________ Date:_____________

Reviewed By:___________________ Date:_____________

9.0 strerilizatation procedure:

§ Place six thermocouples in the load at the slow to heat points as determined
Previously by(Heat Distribution and Heat Penetration studies)
§ Place thermocouples exterior and near to (Penetration TC)and expose to chamber steam distribution TC)
§ Place BIs (Biological Indicators) at each of the slow to heat penetration location.
§ Load autoclave extend TC out of autoclave and attach to potentiometer
§ Position one TC by controller record sensor
§ Close autoclave door
§ Perform, function check of TC .replace if defective.
§ Replace autoclave sensor chart with a new one
§ Check to make sure that cycle parameters are set
§ Set potentiometer for a 3.0 Hours scan cycle.
§ Initiate sterilization cycle and potentiometer cycle at same time
§ Allow cycle to continue until it is completed. Collect all potentiometers, controls and computer control record and place with protocol.
§ Have computer graph results and calculate Fo value. After load has cooled, remove BIs and have tested
§ Incubate BIs in incubator at 55Cº for 48 hrs

10.0 ACCEPTANCE CRITERIA
1- BDS Strip
All four colors segment of the processed indicator are black. If all other critical process parameters such as temperature, pressure and sterilization are in accordance with cycle reference.
2- Bio-Indicator i.e. B. stereothermophyllus
No growth should be observed after incubation for 48 Hours.
10.1 Results
Temperature : 106°C
Pressure : 10 Lb/inch²
Sterilization Time : 30 minutes
1- Evaluation of the BDS strip.

S.#.
Position of Indicator strip
Stick BDS-test indicator strip on
Acceptance Criteria
Results
All four color segment of indicators strip are black
Yes
No
1
¨
¨

2
¨
¨
2- Evaluation of the Bio-indicator i.e. B. stereothermophyllus

S.#.
Position of
B. stereothermophyllus
Acceptance Criteria
Observation
No growth is observed after incubation for 48 Hours
Yes
No
1
Front/top
left
Fornt/bttm
center
Middle
/centleft
¨
¨

2
Middle/
bttmleft
Rare/top
center
Rare/bttm
left
¨
¨

3
Front/top
center
Front/bottm
center
Middle/cent
left
¨
¨

4
Middle/bttm
right
Rare/top
bottom
Rare/bottm
center
¨
¨

5
Front/top
right
Front/
bottmleft
Middle/
center
¨
¨

6
Middle/
Bttm/Cent
Rare/top
right
Rare/bttm
center
¨
¨
All acceptance criteria have been met. Verified By / Date
Yes ____________No _____________ _____________
If No or N/A, explain in Comments.
Comments:_____________________________________________________________

Completed By:__________________ Date:_____________
Reviewed By:________________ Date:_____________
11.0. Incidents/Deviations

To document any discrepancy or variations noted during the execution of the Process Validation Protocol. Any action to be taken to resolve an outstanding issue is to be identified within the incident report.

INCIDENT #
DESCRIPTION OF INCIDENT
RECORDED BY
DATE

COMMENTS:
____________________________________________________________
____________________________________________________________

12.0 FINAL COMMENTS ABOUT PROCESS VALIDATION
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________

13.0 SIGNATURE IDENTIFICATION SHEET

This sheet is a record of each individual who signs or initials any page included in this protocol or in the attached document. Each person shall be identified by typed or printed name.

Name Signature and Initials Company

__________________ _________________________ _____________________

__________________ _________________________ _____________________

__________________ _________________________ _____________________

__________________ _________________________ _____________________

__________________ _________________________ _____________________

__________________ ________________________ _____________________

__________________ ________________________ _____________________

__________________ ________________________ _____________________

__________________ _________________________ _____________________
FINAL APPROVAL OF QUALIFICATION
This document certifies that the process of Autoclavation has been validated as specified and complies with Standard Operating Procedures, and satisfies the requirements for cGMPs.
Name & Designation
Signature
Date
Prepared By

Tahir Ibrahim
Quality Assurance Executive

checked and Reviewed By

Abdul Hafeez
Production manager
Approved By
Tajjamal A Qurashi
Manager Quality Control
PROTOCOL TRAINING
Training Session Date : ____________________
Instructor : ____________________
Protocol Reference : ____________________

Name
Title
Signature
Date

PROCESS VALIDATION PROTOCOL -Pharmaceutical Template PDF PPT XLS
In conclusion, there is far to think about about your Computer System Validation system last to a strong inspection. Make every effort to have a system stock list put in place, the appropriate SOPs in place, and additionally to check the critical techniques and their documentation just before a powerful FDA inspection. Again, simply because the FDA can be inspecting the institution for other factors, doesn’t discount the potential the couple need to audit your pc System Validation School. As mentioned, so many of our businesses respective company procedures are carried out by way of electronic systems in this young age of technologies. Therefore, it could be useful to evaluate the Computer Validation Program whether you foresee a strong inspection or otherwise not. Having a powerful efficient Computer System Validation System put in place will help ensure the stability of the electronic documents, allocate resources better and subsequently can yield long run cost discounts to the company.
more information

DOCUMENTATION

Documentation at each stage of the process validation lifecycle is essential for effective communication in complex, lengthy, and multidisciplinary projects. Documentation is important
so that knowledge gained about a product and process is accessible and comprehensible to others involved in each stage of the lifecycle. Information transparency and accessibility are
fundamental tenets of the scientific method. They are also essential to enabling organizational units responsible and accountable for the process to make informed, science-based decisions that
ultimately support the release of a product to commerce.
The degree and type of documentation required by CGMP vary during the validation lifecycle. Documentation requirements are greatest during Stage 2, process qualification, and Stage 3,
continued process verification. Studies during these stages must conform to CGMPs and must be approved by the quality unit in accordance with the regulations .
Viral and impurity clearance studies, even when performed at small scale, also require quality
unit oversight.
CGMP documents for commercial manufacturing (i.e., the initial commercial master batch production and control record and supporting procedures) are key outputs of Stage 1,
process design. We recommend that firms diagram the process flow for the full-scale process.
Process flow diagrams should describe each unit operation, its placement in the overall process, monitoring and control points, and the component, as well as other processing material inputs
(e.g., processing aids) and expected outputs (i.e., in-process materials and finished product). It is also useful to generate and preserve process flow diagrams of the various scales as the process
design progresses to facilitate comparison and decision making about their comparability.

In conclusion, there is far to think about about your Computer System Validation system last to a strong inspection just before a powerful FDA inspection. Again, simply because the FDA can be inspecting the institution for other factors, doesn’t discount the potential the couple need to audit your pc System Validation School. As mentioned, so many of our businesses respective company procedures are carried out by way of electronic systems in this young age of technologies. Therefore, it could be useful to evaluate the Computer Validation Program whether you foresee a strong inspection or otherwise not.

GLOSSARY OF TERMS

2.1 List of Abbreviation

CGMP Current Good Manufacturing Practices
FDA Food and Drug Administration
GAMP Good Automated Manufacturing Practice
GMP Good Manufacturing Practice
IQ Installation Qualification
OQ Operation Qualification

2.2 Definitions

Acceptance Criteria Agreed standards or ranges, which must be achieved.
Critical component A component within a system where the operation, contact, data, control, alarm, or failure may have a direct impact on the quality of the product.
Critical Instrument Any instrument that directly affects product safety, purity, or efficacy.
Direct Impact System An engineering system that may have a direct impact on product quality.
Factor Acceptance Test Documenting the performance characteristics of equipment prior to shipment to site.
Impact Assessment The process of evaluating the impact of the operating, controlling alarming and failure conditions of a system on the quality of a product.
Indirect Impact System An engineering system considered not having a direct impact on product quality.
Installation Qualification Documenting the process equipment and ancillary system are constructed and installed according to pre-determined specifications and functional requirements.
No Impact System This is a system that will not have any impact, either directly or indirectly, on product quality. These systems are designed and commissioned following Good engineering Practice only.
Non-critical Component A component within a system where the operation, contact, alarm or failure may have an indirect impact or no impact on the quality of product.
Operating Limits The minimum and /or maximum values that will ensure that product and safety requirements are met.
Operational Qualification Establishing confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.
Performance Qualification The documented verification that al aspects of a facility, utility or equipment that can affect product quality perform as intended meeting pre-determined acceptance criteria.
Performance Testing The process by which the performance of interdependent system is demonstrated as within the required tolerances, the output of interdependent system is demonstrated as delivering the required duty or capacity, the interdependent functions of system are interdependent to be as specified and appropriate.
Piping and Instrumentation
Diagrams Primary source of design information for utility systems and process equipment. They are used to depict the process flow, equipment configuration, process parameters, instrumentation, and materials of construction. They also are used to perform overall material and energy balances and pressure balances.

Capability of a process: Ability of a process to produce a product that will fulfill the requirements of that product. The concept of process capability can also be defined in statistical terms. (ISO 9000:2005)

Commercial manufacturing process: The manufacturing process resulting in commercial product (i.e., drug that is marketed, distributed, and sold or intended to be sold). For the purposes of this guidance, the term commercial manufacturing process does not include clinical trial or treatment IND material.

Concurrent release: Releasing for distribution a lot of finished product, manufactured following a qualification protocol, that meets the lot release criteria established in the protocol, but before the entire study protocol has been executed.

Continued process verification: Assuring that during routine production the process remains in a state of control. Performance indicators: Measurable values used to quantify quality objectives to reflect the performance of an organization, process or system, also known as performance metrics in some regions. (ICH Q10)

Process design: Defining the commercial manufacturing process based on knowledge gained through development and scale-up activities.

Process qualification: Confirming that the manufacturing process as designed is capable of reproducible commercial manufacturing.

Process validation: The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

Quality: The degree to which a set of inherent properties of a product, system, or process fulfils requirements. (ICH Q9)

State of control: A condition in which the set of controls consistently provides assurance of continued process performance and product quality. (ICH Q10)

RRB Pharmacist Exam Government Pharmacist DI Exam Books Preparation PDF

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RRB Pharmacist Exam Government Pharmacist DI Exam Books Preparation PDF

Pharmacist Exam Books Preparation PDF

Before any exam, the collection of study materials and books are inevitable. When it comes to competitive exams those are held nationally, the hurdle gets tougher. But there is no need to worry, for those who are keen to put their all-out effort in getting the exams cleared. The same applies to the Pharmacist exams being mostly held in government sector for some seats every year. Contenders who are applying the Pharmacist jobs need to take part the written test and further selection process.

Interested candidates need to take the Pharmacist Exam study materials including the previous question papers and books. It will make effective preparation for the applicants at the time of the Pharmacist Exam. Applicants need to go through the Pharmacist Solved question papers. While coming to books, those are written in the very concise form and designed for the candidates who are preparing for the competitive examination. In fact, it is far more advantageous if one keeps soft copies of all these materials handy. These books conglomerate the comprehensive information of the diverse subject in this discipline. Apart from getting basic subject knowledge of pharmacy, these books will help immensely to inculcate the subject matter to prepare themselves for different competitive examination either to go for higher studies or in a different level of written text for recruitment procedure. Presented in a simple manner to understand the matter and can memorize in the easiest way. You can access all the essential areas of major subjects in Pharmacy i.e. Pharmaceutics, Pharmaceutical Chemistry, Pharmacognosy, Pharmacology, Forensic Pharmacy, Biochemistry, Analytical Chemistry, and Microbiology to some extent.

It may happen that some candidates are unable to download the online files quickly but here we have tried to compile the direct and redirecting links which will surely be helpful for them.

Following are the books of Pharmacist Exam

Alfonso-R-Gennaro . Remington:

 The .Science and Practice of Pharmacy. [] 

               

Alfonso-R-Gennaro . Remington:

 The Science and Practice of Pharmacy. []

               

Gary D. Hall & Barry S. Reiss –

Appleton & Lange’s Review of Pharmacy

               

  1. B. Hugo & A. D. Russel –

Pharmaceutical Microbiology            

               

Mathews, Van Holde & Ahern –

Biochemistry         

               

W C Evans –

Trease & Evans-Pharmacognosy

               

Arun Bahl, BS Bahl and G.D take –

Basics of Physical Chemistry

               

Thomas L. Lemke & David A. Williams –

Principles Of Medicinal Chemistry

               

Loyd V. Allen Jr., Nicholas G. Popovich –

Ansel’s Pharmaceutical Dosage Forms

RRB Pharmacist Exam Government Pharmacist DI Exam Books Preparation PDF               

Sally S. Roche –

Roche Clinical Pharmacology primaries

               

ME Aulton –

pharmaceuticals: science design dosage form

               

Bertram G. Katzung –

basic clinical pharmacy

Best Books and How to prepare for Pharmacist Paramedical exam               

Spalding Gray –

Gray’s Anatomy

  1. F. Ganong –

Medical Physiology

                Arther C. Guyton –

Medical Physiology

                Mark G. Papich –

Saunders Veterinary E Directory Drugs book: small and large animals

                Jahangir Mweene –

pharmacy technician: comprehensive approach

                Morrison and Boyd –

Organic Chemistry

                Patrick J. Cinco –

Pharmacy Martin physical & Pharmaceutical-Sciences

                Donald C. Singer –

Audit Quality Laboratory of compliance and regulatory

                Albert L. Lehninger, David Lee Nelson, Michael Cox M. –

Principles of Biochemistry Lehninger

                Lauren Zentz –

Mathematics for pharmacy technicians

                John Bell and M. John Block –

book Wilson and Gisvold of Organic Chemistry medical and pharmaceutical

                Graham L. Patrick –

Introduction to Medicinal Chemistry

                Karen Baxter –

source book interactions, mechanisms, and clinical significance Management

                BNF for Children –

                Leon Shargel, Susanna Wu Bong, Andrew Yu –

bio-pharmacy and Applied Pharmacokinetics

                Dr. Gary Walsh –

biopharmaceuticals: biochemistry and biotechnology

                Howard_C. Ansel –

pharmaceutical_calculations

                Leon_Shargel, Alan_H_Mutnick, Paul-F-Souney, Larry-N-Swanson –

Comprehensive_Pharmacy_Review

                Leon Shargel, Alan H Mutnick, Paul-F-Souney, Larry-N-Swanson –

Comprehensive_Pharmacy_Review

                Shane Desselle, David Zgarrick –

Pharmacy Management: Essentials for all practice settings

  1. P. Rang, M. M. Dale, J. M. Ritter, P. K. Moore –

Pharmacology

                Manual pharmaceutical excipients

                Ryan Donnelly, Johan Barry –

choice questions in pharmaceutical calculations

                Donald_Cairns –

Essentials_of_Pharmaceutical_Chemistry

Review

Here the reader will get a brief fundamental content having a degree or diploma or going to be a qualified person in this field. While going through, hope the reader will be benefitted out of this effort of collective compilation. Wish you all the best for your bright future.

Indian Pharma Blogs – Pharmacy Jobs Websites -How to Get Your Job Search Organized

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Indian Pharma Blogs - Pharmacy Jobs Websites -How to Get Your Job Search Organized

Here we provide a little help for pharma students looking for job.

List of Indian Pharma Blogs – Pharmacy Jobs Websites:

pharmatutor.org

gpatindia.com/government-jobs-pharma/

naukri.com/ pharmacist-jobs

indeed.co.in/

pharmajobs.channelindia.in

simplyhired.co.in

glassdoor.com

fresherslive.com

placementindia.com

pharmajobportal.com/

pharmapathway.com

wisdomjobs.com

pharmawisdom.blogspot.com

pharmaclub.in

pharmaguidances.com

pharmajogot.com

How to Get Your Job Search Organized

What was the name of the manager you met at last month’s business mixer? Did you ever follow up on the application you mailed two weeks ago? Which version of your résumé is the most recent one — without the typos? If you’re asking yourself questions like these, your job search could benefit from some organization.
The typical job search can generate a daunting stack of paper and a backlog of communications from many channels at once. If you are actively looking for work, you may quickly find yourself buried in multiple versions of your résumé, copies of cover letters, clippings and printouts of job listings, business cards from people you have met, e-mails sent and received, bookmarked web pages, phone messages, flyers for networking events, and much more.

Indian Pharma Blogs - Pharmacy Jobs Websites -How to Get Your Job Search Organized
To keep all these essential job search components organized, here’s what you will need:
1. Calendar – You’ll need to keep track of appointments, when you sent out résumés or placed phone calls, and what date you should be following up with people you speak to. Use whatever system works best for your personal style: a pocket datebook, a PDA (e.g. Palm Pilot), or task management software on your computer (e.g. Outlook) are all appropriate choices.
2. Contact Manager – To take full advantage of your personal connections, you will want to maintain a list of everyone you speak with about your job search, along with their complete contact information, when you last spoke, and what you discussed. Contact management software such as Outlook or ACT! is one option, but you can also use a card file, notebook, or large address book.
3. Filing System – On your computer, set up a special folder to hold all your job search materials, and create sub-folders to help you find items quickly. Be sure to give all your documents distinct names. Instead of simply “Resume,” for example, you might use names like “Resume updated with feedback from Ken” or “Resume sent to Marshall Co” to identify different versions.
For your e-mail, use the same idea to save copies of e-mails you send or receive in separate folders in your e-mail system. You might create one folder for all your job search correspondence, or if you are a heavy e-mail user, add sub-folders for each prospective employer or opportunity. Also use a folder to organize bookmarked web pages, such as job postings you check regularly.
With paper documents and clippings, the type of system you choose should depend on whether your job search needs to be mobile. File folders in a drawer or standing file work well if you will always be conducting your job search in the same location. If your job search needs to travel, a better solution might be a three-ring binder with dividers or an accordion file with several pockets.
4. Task List – You’ll need a way to keep track of what may seem like an endless list of things to do. Appointments and notes to follow up on a certain date can be put in your calendar, but you’ll also need a way to track tasks with no date assigned as well as daily or weekly activities. Some PDA’s and contact or task management software offer this feature, or you can keep your master task list in a document on your computer, in a notebook, or on a bulletin board or whiteboard.
Once you have set up a system to organize your job search, you’ll need to remember to use it. Get in the habit of making entries in your calendar or contact manager immediately, rather than saving them up for later. When you print documents, open postal mail, or receive e-mails, file them right away, making a note of any action you need to take on your task list. Don’t try to use a pile of paper as your reminder.
One technique that can help to keep your job search visibly organized is creating a “job wall.” Dedicate some wall space or the back of a door to your job search and post a large calendar, list of job postings to check regularly, events to attend, people to talk to, and important tasks you want to keep in mind. Use sticky notes to highlight important deadlines or projects. You could also keep the same material in a three-ring binder prominently displayed on your desk.
Whatever organization system you choose, find a way to keep your job search activities constantly in front of you and check your to-do list often. If everything you need is buried in a drawer, a pile, or your briefcase, your job search won’t get as much attention.

Geographical Indication – IPR Notes PDF PPR Pharmawiki.in M Pharm

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Geographical Indication - IPR Notes PDF PPR

Here you Get:

What is meant by geographical indication?
Why is geographical indications and appellations of origin important?
What is a protected geographical indication?
What is GI registration?

A geographical indication is basically a notice stating that a given product originates in a given geographical area. An appellation of origin is a more precise form of geographical indicator, which specifies that the product has qualities that are derived specifically from the fact that it is made in a particular region.
As stated above a geographical indication is a broad term, which includes appellation of origin, indication of source, and geographical indication in strict sense. In the literature, the term geographical indication is generally used in its broader sense to embody all these terms (appellation of origin, indication of source, and geographical indication in strict sense. Geographical indications can be protected nationally either by decree or by a register.
Internationally they can be protected by reciprocal arrangements between countries or in the case of appellations of origin by the Lisbon Agreement. Furthermore the TRIPS Agreement requires all members of the World Trade Organization to protect geographical indications.

The use of geographical indications is an important method of indicating the origin of goods and services. One of the aims of their use is to promote commerce by informing the customer of the origin of the products. Often this may imply a certain quality, which the customer may be looking for. They can be used for industrial and agricultural products. Protection of such indications is on a national basis but there are various international treaties that assist the protection in a range of countries.

Geographical Indication - IPR Notes PDF PPR

Geographical indications in a broad sense include indications of source, appellation of origin, and geographical indication (in the strict sense). It should be pointed out that the Paris Convention does not use in its terminology the term geographical indication; it rather utilizes the terms,indications of source and appellations of origin.
An indication of source means any expression or sign used to indicate that a product or service originates in a country, a region, and a specific place where the product originated. Example: Made in Japan.

An appellation of origin means the geographical name of a country, region, specific place which serves to designate a product originating therein, the characteristic qualities of which are due exclusively or essentially to the geographical environment, including natural or human factors or both.
Example: Champagne.

Got for:

What is meant by geographical indication?
Why is geographical indications and appellations of origin important?
What is a protected geographical indication?
What is GI registration?

Primary Drinking Water Standards – PDF EPA Magnesium Aluminum – Safe

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Primary drinking water standards

Primary drinking water standards

The standards set by the United States Environmental Protection Agency (EPA) for drinking water quality is denoted by Maximum Contaminant Levels (MCLs). It reveals the legal threshold limit of the substance on the amount allowed in public water systems under the Safe Drinking Water Act. This is measured as a concentration in milligrams or micrograms per litre of water.

For a contaminant to set a Maximum Contaminant Level EPA first determines the amount of contaminant that may be present with no adverse health effects and this determined level is called the Maximum Contaminant Level Goal (MCLG). MCLGs are non-enforceable public health goals. Then the MCL (legally enforced) is set to the nearest possible level of MCLG. The MCL for a contaminant may be higher than the MCLG because

  • Difficulties in measuring small quantities of a contaminant
  • Lack of available treatment technologies
  • If the costs of treatment would outweigh the public health benefits of a lower MCL. In this case, EPA is allowed to select an MCL that balances the cost of treatment with the public health benefits.

A Treatment Technique (TT) is established instead of an MCL for some contaminants. TTs by EPA are enforceable procedures compulsory for drinking water systems to follow in treating their water for a contaminant.

MCLs and TTs when combined are known as “National Primary Drinking Water Regulations” (NPDWRs), or primary standards. As mentioned separately as well as jointly, The National Primary Drinking Water Regulations (NPDWRs) is legally enforceable primary standards and treatment techniques that are applicable for public water systems.  To protect public health by limiting the levels of contaminants in drinking water the Primary standards and treatment techniques are maintained.

In some cases of contaminants that may not cause health problems but they cause aesthetic problems with drinking water, such as the presence of unpleasant tastes or odours, or cosmetic problems, such as tooth discolouration there are no legally enforceable limits on their presence in drinking water. However, EPA recommends maximum levels of these contaminants in drinking water since these contaminants directly don’t affect health problems. This is where the “National Secondary Drinking Water Regulations” (NSDWRs) or secondary standards are being practised. For public water systems in Indian states and Tribes, EPA delegates the primary enforcement responsibility called primacy to those who meet certain requirements.

Below is the NPDWRs table shown.

Microorganisms
Contaminant MCLG1(mg/L)2 MCL or TT1(mg/L)2 Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term) Sources of Contaminant in Drinking Water
Cryptosporidium zero TT3 Gastrointestinal illness (such as diarrhea, vomiting, and cramps) Human and animal fecal waste
Giardia lamblia zero TT3 Gastrointestinal illness (such as diarrhea, vomiting, and cramps) Human and animal fecal waste
Heterotrophic plate count (HPC) n/a TT3 HPC has no health effects; it is an analytic method used to measure the variety of bacteria that are common in water. The lower the concentration of bacteria in drinking water, the better maintained the water system is. HPC measures a range of bacteria that are naturally present in the environment
Legionella zero TT3 Legionnaire’s Disease, a type of pneumonia Found naturally in water; multiplies in heating systems
Total Coliforms (including fecal coliform and E. Coli)

  • Quick reference guide
 zero 5.0%4 Not a health threat in itself; it is used to indicate whether other potentially harmful bacteria may be present5 Coliforms are naturally present in the environment; as well as feces; fecal coliforms and E. coli only come from human and animal fecal waste.
Turbidity n/a TT3 Turbidity is a measure of the cloudiness of water. It is used to indicate water quality and filtration effectiveness (such as whether disease-causing organisms are present). Higher turbidity levels are often associated with higher levels of disease-causing microorganisms such as viruses, parasites and some bacteria. These organisms can cause symptoms such as nausea, cramps, diarrhea, and associated headaches. Soil runoff
Viruses (enteric) zero TT3 Gastrointestinal illness (such as diarrhea, vomiting, and cramps) Human and animal fecal waste
Disinfection By-products

Quick reference guide: Stage 1 and 2 Disinfectants and Disinfection By-products Rules
Contaminant MCLG1(mg/L)2 MCL or TT1(mg/L)2 Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term) Sources of Contaminant in Drinking Water
Bromate zero 0.010 Increased risk of cancer By-product of drinking water disinfection
Chlorite 0.8 1.0 Anaemia; infants and young children: nervous system effects By-product of drinking water disinfection
Haloacetic acids (HAA5) n/a6 0.060 Increased risk of cancer By-product of drinking water disinfection
Total Trihalomethanes (TTHMs) –> n/a6 ========–>–> 0.080 Liver, kidney or central nervous system problems; increased risk of cancer By-product of drinking water disinfection
Disinfectants

Quick reference guide: Stage 1 and 2 Disinfectants and Disinfection Byproducts Rules
Contaminant MCLG1(mg/L)2 MCL or TT1(mg/L)2 Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term) Sources of Contaminant in Drinking Water
Chloramines (as Cl2) MRDLG=41 MRDL=4.01 Eye/nose irritation; stomach discomfort, anaemia Water additive used to control microbes
Chlorine (as Cl2) MRDLG=41 MRDL=4.01 Eye/nose irritation; stomach discomfort Water additive used to control microbes
Chlorine dioxide (as ClO2) MRDLG=0.81 MRDL=0.81 Anaemia; infants and young children: nervous system effects Water additive used to control microbes
 

Inorganic Chemicals
Contaminant MCLG1(mg/L)2 MCL or TT1(mg/L)2 Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term) Sources of Contaminant in Drinking Water
Antimony 0.006 0.006 Increase in blood cholesterol; decrease in blood sugar Discharge from petroleum refineries; fire retardants; ceramics; electronics; solder
Arsenic

  • Quick reference guide
  • Consumer fact sheet
 0 0.010 as of 01/23/06 Skin damage or problems with circulatory systems, and may have increased risk of getting cancer Erosion of natural deposits; runoff from orchards, runoff from glass and electronics production wastes
Asbestos (fiber > 10 micrometers) 7 million fibers per liter (MFL) 7 MFL Increased risk of developing benign intestinal polyps Decay of asbestos cement in water mains; erosion of natural deposits
Barium 2 2 Increase in blood pressure Discharge of drilling wastes; discharge from metal refineries; erosion of natural deposits
Beryllium 0.004 0.004 Intestinal lesions Discharge from metal refineries and coal-burning factories; discharge from electrical, aerospace, and defense industries
Cadmium 0.005 0.005 Kidney damage Corrosion of galvanized pipes; erosion of natural deposits; discharge from metal refineries; runoff from waste batteries and paints
Chromium (total) 0.1 0.1 Allergic dermatitis Discharge from steel and pulp mills; erosion of natural deposits
Copper 1.3 TT7; Action Level=1.3 Short term exposure: Gastrointestinal distress

Long term exposure: Liver or kidney damage

People with Wilson’s Disease should consult their personal doctor if the amount of copper in their water exceeds the action level

 Corrosion of household plumbing systems; erosion of natural deposits
Cyanide (as free cyanide) 0.2 0.2 Nerve damage or thyroid problems Discharge from steel/metal factories; discharge from plastic and fertilizer factories
Fluoride 4.0 4.0 Bone disease (pain and tenderness of the bones); Children may get mottled teeth Water additive which promotes strong teeth; erosion of natural deposits; discharge from fertilizer and aluminum factories
Lead

  • Quick reference guide
  • Rule information
 zero TT7; Action Level=0.015 Infants and children: Delays in physical or mental development; children could show slight deficits in attention span and learning abilities

Adults: Kidney problems; high blood pressure

 Corrosion of household plumbing systems; erosion of natural deposits
Mercury (inorganic) 0.002 0.002 Kidney damage Erosion of natural deposits; discharge from refineries and factories; runoff from landfills and croplands
Nitrate (measured as Nitrogen) 10 10 Infants below the age of six months who drink water containing nitrate in excess of the MCL could become seriously ill and, if untreated, may die. Symptoms include shortness of breath and blue-baby syndrome. Runoff from fertilizer use; leaking from septic tanks, sewage; erosion of natural deposits
Nitrite (measured as Nitrogen) 1 1 Infants below the age of six months who drink water containing nitrite in excess of the MCL could become seriously ill and, if untreated, may die. Symptoms include shortness of breath and blue-baby syndrome. Runoff from fertilizer use; leaking from septic tanks, sewage; erosion of natural deposits
Selenium 0.05 0.05 Hair or fingernail loss; numbness in fingers or toes; circulatory problems Discharge from petroleum refineries; erosion of natural deposits; discharge from mines
Thallium 0.0005 0.002 Hair loss; changes in blood; kidney, intestine, or liver problems Leaching from ore-processing sites; discharge from electronics, glass, and drug factories
 

Organic Chemicals
Contaminant MCLG1(mg/L)2 MCL or TT1(mg/L)2 Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term) Sources of Contaminant in Drinking Water
Acrylamide zero TT8 Nervous system or blood problems; increased risk of cancer Added to water during sewage/wastewater treatment
Alachlor zero 0.002 Eye, liver, kidney or spleen problems; anemia; increased risk of cancer Runoff from herbicide used on row crops
Atrazine 0.003 0.003 Cardiovascular system or reproductive problems Runoff from herbicide used on row crops
Benzene zero 0.005 Anemia; decrease in blood platelets; increased risk of cancer Discharge from factories; leaching from gas storage tanks and landfills
Benzo(a)pyrene (PAHs) zero 0.0002 Reproductive difficulties; increased risk of cancer Leaching from linings of water storage tanks and distribution lines
Carbofuran 0.04 0.04 Problems with blood, nervous system, or reproductive system Leaching of soil fumigant used on rice and alfalfa
Carbon tetrachloride zero 0.005 Liver problems; increased risk of cancer Discharge from chemical plants and other industrial activities
Chlordane zero 0.002 Liver or nervous system problems; increased risk of cancer Residue of banned termiticide
Chlorobenzene 0.1 0.1 Liver or kidney problems Discharge from chemical and agricultural chemical factories
2,4-D 0.07 0.07 Kidney, liver, or adrenal gland problems Runoff from herbicide used on row crops
Dalapon 0.2 0.2 Minor kidney changes Runoff from herbicide used on rights of way
1,2-Dibromo-3-chloropropane (DBCP) zero 0.0002 Reproductive difficulties; increased risk of cancer Runoff/leaching from soil fumigant used on soybeans, cotton, pineapples, and orchards
o-Dichlorobenzene 0.6 0.6 Liver, kidney, or circulatory system problems Discharge from industrial chemical factories
p-Dichlorobenzene 0.075 0.075 Anemia; liver, kidney or spleen damage; changes in blood Discharge from industrial chemical factories
1,2-Dichloroethane zero 0.005 Increased risk of cancer Discharge from industrial chemical factories
1,1-Dichloroethylene 0.007 0.007 Liver problems Discharge from industrial chemical factories
cis-1,2-Dichloroethylene 0.07 0.07 Liver problems Discharge from industrial chemical factories
trans-1,2-Dichloroethylene 0.1 0.1 Liver problems Discharge from industrial chemical factories
Dichloromethane zero 0.005 Liver problems; increased risk of cancer Discharge from drug and chemical factories
1,2-Dichloropropane zero 0.005 Increased risk of cancer Discharge from industrial chemical factories
Di(2-ethylhexyl) adipate 0.4 0.4 Weight loss, liver problems, or possible reproductive difficulties. Discharge from chemical factories
Di(2-ethylhexyl) phthalate zero 0.006 Reproductive difficulties; liver problems; increased risk of cancer Discharge from rubber and chemical factories
Dinoseb 0.007 0.007 Reproductive difficulties Runoff from herbicide used on soybeans and vegetables
Dioxin (2,3,7,8-TCDD) zero 0.00000003 Reproductive difficulties; increased risk of cancer Emissions from waste incineration and other combustion; discharge from chemical factories
Diquat 0.02 0.02 Cataracts Runoff from herbicide use
Endothall 0.1 0.1 Stomach and intestinal problems Runoff from herbicide use
Endrin 0.002 0.002 Liver problems Residue of banned insecticide
Epichlorohydrin zero TT8 Increased cancer risk, and over a long period of time, stomach problems Discharge from industrial chemical factories; an impurity of some water treatment chemicals
Ethylbenzene 0.7 0.7 Liver or kidneys problems Discharge from petroleum refineries
Ethylene dibromide zero 0.00005 Problems with liver, stomach, reproductive system, or kidneys; increased risk of cancer Discharge from petroleum refineries
Glyphosate 0.7 0.7 Kidney problems; reproductive difficulties Runoff from herbicide use
Heptachlor zero 0.0004 Liver damage; increased risk of cancer Residue of banned termiticide
Heptachlor epoxide zero 0.0002 Liver damage; increased risk of cancer Breakdown of heptachlor
Hexachlorobenzene zero 0.001 Liver or kidney problems; reproductive difficulties; increased risk of cancer Discharge from metal refineries and agricultural chemical factories
Hexachlorocyclopentadiene 0.05 0.05 Kidney or stomach problems Discharge from chemical factories
Lindane 0.0002 0.0002 Liver or kidney problems Runoff/leaching from insecticide used on cattle, lumber, gardens
Methoxychlor 0.04 0.04 Reproductive difficulties Runoff/leaching from insecticide used on fruits, vegetables, alfalfa, livestock
Oxamyl (Vydate) 0.2 0.2 Slight nervous system effects Runoff/leaching from insecticide used on apples, potatoes, and tomatoes
Polychlorinated biphenyls (PCBs) zero 0.0005 Skin changes; thymus gland problems; immune deficiencies; reproductive or nervous system difficulties; increased risk of cancer Runoff from landfills; discharge of waste chemicals
Pentachlorophenol zero 0.001 Liver or kidney problems; increased cancer risk Discharge from wood preserving factories
Picloram 0.5 0.5 Liver problems Herbicide runoff
Simazine 0.004 0.004 Problems with blood Herbicide runoff
Styrene 0.1 0.1 Liver, kidney, or circulatory system problems Discharge from rubber and plastic factories; leaching from landfills
Tetrachloroethylene zero 0.005 Liver problems; increased risk of cancer Discharge from factories and dry cleaners
Toluene 1 1 Nervous system, kidney, or liver problems Discharge from petroleum factories
Toxaphene zero 0.003 Kidney, liver, or thyroid problems; increased risk of cancer Runoff/leaching from insecticide used on cotton and cattle
2,4,5-TP (Silvex) 0.05 0.05 Liver problems Residue of banned herbicide
1,2,4-Trichlorobenzene 0.07 0.07 Changes in adrenal glands Discharge from textile finishing factories
1,1,1-Trichloroethane 0.20 0.2 Liver, nervous system, or circulatory problems Discharge from metal degreasing sites and other factories
1,1,2-Trichloroethane 0.003 0.005 Liver, kidney, or immune system problems Discharge from industrial chemical factories
Trichloroethylene zero 0.005 Liver problems; increased risk of cancer Discharge from metal degreasing sites and other factories
Vinyl chloride zero 0.002 Increased risk of cancer Leaching from PVC pipes; discharge from plastic factories
Xylenes (total) 10 10 Nervous system damage Discharge from petroleum factories; discharge from chemical factories

Primary drinking water standards

Radio nuclides

Quick Reference Guide
Contaminant MCLG1(mg/L)2 MCL or TT1(mg/L)2 Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term) Sources of Contaminant in Drinking Water
Alpha particles none ———- zero 15 picocuries per Litre (pCi/L) Increased risk of cancer Erosion of natural deposits of certain minerals that are radioactive and may emit a form of radiation known as alpha radiation
Beta particles and photon emitters none ———- zero 4 millirems per year Increased risk of cancer Decay of natural and man-made deposits of

certain minerals that are radioactive and may emit forms of radiation known as photons and beta radiation
Radium 226 and Radium 228 (combined) none ———- zero 5 pCi/L Increased risk of cancer Erosion of natural deposits
Uranium zero 30 ug/L as of 12/08/03 Increased risk of cancer, kidney toxicity Erosion of natural deposits

Notes

1Definitions:

  • Maximum Contaminant Level Goal (MCLG) – The level of a contaminant in drinking water below which there is no known or expected risk to health. MCLGs allow for a margin of safety and are non-enforceable public health goals.
  • Maximum Contaminant Level (MCL) – The highest level of a contaminant that is allowed in drinking water. MCLs are set as close to MCLGs as feasible using the best available treatment technology and taking cost into consideration. MCLs are enforceable standards.
  • Maximum Residual Disinfectant Level Goal (MRDLG) – The level of a drinking water disinfectant below which there is no known or expected risk to health. MRDLGs do not reflect the benefits of the use of disinfectants to control microbial contaminants.
  • Treatment Technique (TT) – A required process intended to reduce the level of a contaminant in drinking water.
  • Maximum Residual Disinfectant Level (MRDL) – The highest level of a disinfectant allowed in drinking water. There is convincing evidence that addition of a disinfectant is necessary for control of microbial contaminants.

2 Units are in milligrams per liter (mg/L) unless otherwise noted. Milligrams per liter are equivalent to parts per million (PPM).
3 EPA’s surface water treatment rules require systems using surface water or ground water under the direct influence of surface water to

  1. Disinfect their water, and
  2. Filter their water, or
  3. Meet criteria for avoiding filtration so that the following contaminants are controlled at the following levels:
  • Cryptosporidium: Unfiltered systems are required to include Cryptosporidium in their existing watershed control provisions
  • Giardia lamblia: 99.9% removal/inactivation.
  • Viruses: 99.99% removal/inactivation.
  • Legionella: No limit, but EPA believes that if Giardia and viruses are removed/inactivated, according to the treatment techniques in the Surface Water Treatment Rule, Legionella will also be controlled.
  • Turbidity: For systems that use conventional or direct filtration, at no time can turbidity (cloudiness of water) go higher than 1 Nephelometric Turbidity Unit (NTU), and samples for turbidity must be less than or equal to 0.3 NTUs in at least 95 percent of the samples in any month. Systems that use filtration other than the conventional or direct filtration must follow state limits, which must include turbidity at no time exceeding 5 NTUs.
  • Heterotrophic Plate Count (HPC): No more than 500 bacterial colonies per milliliter.
  • Long Term 1 Enhanced Surface Water Treatment: Surface water systems or groundwater under the direct influence (GWUDI) systems serving fewer than 10,000 people must comply with the applicable Long Term 1 Enhanced Surface Water Treatment Rule provisions (such as turbidity standards, individual filter monitoring, Cryptosporidium removal requirements, updated watershed control requirements for unfiltered systems).
  • Long Term 2 Enhanced Surface Water Treatment Rule: This rule applies to all surface water systems or ground water systems under the direct influence of surface water. The rule targets additionalCryptosporidium treatment requirements for higher risk systems and includes provisions to reduce risks from uncovered finished water storage facilities and to ensure that the systems maintain microbial protection as they take steps to reduce the formation of disinfection byproducts.
  • Filter Backwash Recycling: This rule requires systems that recycle to return specific recycle flows through all processes of the system’s existing conventional or direct filtration system or at an alternate location approved by the state.

4 No more than 5.0% samples total coliform-positive (TC-positive) in a month. (For water systems that collect fewer than 40 routine samples per month, no more than one sample can be total coliform-positive per month.) Every sample that has total coliform must be analyzed for either fecal coliforms or E. coli if two consecutive TC-positive samples, and one is also positive for E.coli fecal coliforms, system has an acute MCL violaton.

5 Fecal coliform and E. coli are bacteria whose presence indicates that the water may be contaminated with human or animal wastes. Disease-causing microbes (pathogens) in these wastes can cause diarrhea, cramps, nausea, headaches, or other symptoms. These pathogens may pose a special health risk for infants, young children, and people with severely compromised immune systems.

6 Although there is no collective MCLG for this contaminant group, there are individual MCLGs for some of the individual contaminants:

  • Trihalomethanes: bromodichloromethane (zero); bromoform (zero); dibromochloromethane (0.06 mg/L): chloroform (0.07 mg/L.
  • Haloacetic acids: dichloroacetic acid (zero); trichloroacetic acid (0.02 mg/L); monochloroacetic acid (0.07mg/L). Bromoacetic acid and dibromoacetic acid are regulated with this group but have no MCLGs.

7 Lead and copper are regulated by a treatment technique that requires systems to control the corrosiveness of their water. If more than 10% of tap water samples exceed the action level, water systems must take additional steps. For copper, the action level is 1.3 mg/L, and for lead is 0.015 mg/L.

8 Each water system must certify, in writing, to the state (using third-party or manufacturer’s certification) that when acrylamide and epichlorohydrin are used to treat water, the combination (or product) of dose and monomer level does not exceed the levels specified, as follows:

  • Acrylamide = 0.05% dosed at 1 mg/L (or equivalent)
  • Epichlorohydrin = 0.01% dosed at 20 mg/L (or equivalent)

GMP Requirements for Pharmaceutical Industry -Good Manufacturing Practice

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GMP Requirements for the Pharmaceutical Industry -Good Manufacturing Practice

GMP requirements for the Pharmaceutical Industry

 

Good Manufacturing Practice (GMP) is required for all the manufactured products to ensure their quality standards. GMP is designed to minimize the risks involved in any pharmaceutical production that are not eliminated through testing the final product. The compliance putting product quality first, being the best way to conduct business is widely-accepted. It covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff.

For each process, a detailed written procedure is maintained that could affect the quality of the finished product. There are systems providing documented proof that correct procedures are consistently followed every time a product is made.

 

Each step in the manufacturing process follows these basic principles:-

 

  • A clean, controlled and hygienic environment to prevent cross-contamination of the product from adulterants and allergens that may render it unsafe for use.
  • All the processes must be clearly defined controlled; critical processes are validated to ensure consistency and compliance with specifications. Any changes to the process must be evaluated with those affecting the quality of the drug are validated accordingly.
  • Trained Operators to carry out the document procedures as instructions and procedures need to be clear and unambiguous applying good documentation practices.
  • During manufacturing, manual or electronic records be kept demonstrating all the steps required by the defined procedures and instructions taken and the quantity and quality of the food or drug should be as expected. Deviations must be investigated and documented.
  • Keeping records of manufacturing including distribution process for the complete history of a batch to be traced in a comprehensible and accessible form.
  • A system must be in place for recalling any batch from sale or supply. Distribution of products shall minimize any risk to their quality.
  • A proper examination of complaints of marketed products with the investigation of the causes of quality defects. Appropriate measures must be taken with respect to the defective products and prevent recurrence.

GMP Requirements for the Pharmaceutical Industry -Good Manufacturing Practice

 

 

GMP Implementation

Good manufacturing practice guidelines include manufacturing, testing, and quality assurance. Many countries have legislated that manufacturers follow GMP procedures guidelines in order to assure that a manufactured product is safe for human consumption or use. The procedure encompasses the following:

  • Quality Systems
  • Facilities and Equipment Systems
  • Materials Systems
  • Production Systems
  • Packaging and Labelling Systems
  • Laboratory Control Systems

 

 

 

Trade Marks – IPR notes PDF PPT Regulatory Affairs M Pharmacy Study Material

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Trade Marks - IPR notes PDF PPT Regulatory Affairs M Pharmacy Study Material

“A trademark is a sign that individualizes the goods or services of a given enterprise and distinguishes them from its competitors.”

This section has covered the basics of trademarks. You have learned that a trademark is a word, a logo, a number, a letter, a slogan, a sound, a color, or sometimes even a smell which identifies the source of goods and/or services with
which the trademark is used.
Trademarks are one area of intellectual property and their purpose is to protect the name of the product rather than the invention or idea behind the product.

Trade Marks

Trademarks can be owned by individuals or companies and should be registered at a governmental agency, which is usually referred to as the Trademarks Office. When a trademark is used in connection with services, it is sometimes referred to as a “service mark”.

Trade Marks - IPR notes PDF PPT Regulatory Affairs M Pharmacy Study Material
Generally speaking, trademarks should be distinctive and should neither be generic nor merely descriptive of the goods or services they represent. For example, the word “vegetable” cannot be registered as a trademark of a supermarket, since it is certainly descriptive of items which a supermarket sells. In addition, it cannot be
registered as a trademark for carrots, since it is a generic term for carrots. On the other hand, the word “vegetable” might well serve as a trademark for bicycles since it has little or nothing to do with bicycles.
Trademarks should preferably not be geographical or primarily a surname. Thus, “Paris” cannot serve as a trademark for perfume. In many countries, trademarks which comprise mere letters and/or numbers (i.e. the proposed trademark cannot be pronounced as a word or words or just has too few letters) or are surnames are considered to be indistinct.

Trade Marks Registration 

In some instances, trademark registration can still be obtained for trademarks that are merely (i) descriptive, (ii) a surname, (iii) geographic or (iv) indistinct.Trademarks, also known as brand names, are part of everyday life. The average person sees or hears more than 1,500 trademarks each day! Just as your own name identifies and distinguishes you, the main purpose of a trademark is to identify the source of a product and to distinguish that product from products coming from other sources. For example, a trademark helps you to choose between Ivory soap and Dial soap.
It should be mentioned that collective marks and certification marks are also protected in a large number of countries. Famous marks or well-known marks have also been granted a special protection.
© WIPO/OMPI
25
Trademarks usually ensure a consistent level of quality – be it good or bad. A mark helps you to use your experience either to return to a desirable product or service or to avoid an undesirable one.
Legislative Texts:
• Paris

Trademarks existed in the ancient world. As long as 3000 years ago, Indian craftsmen used to engrave their signatures on their artistic creations before sending them to Iran. Later on, over 100 different Roman pottery marks were in use, including the FORTIS brand that became so famous that it was copied and counterfeited. With the flourishing trade in the Middle Ages the use of trademarks increased.
Today trademarks (often abbreviated as TM in English) are in common usage and most people on the planet could distinguish between the trademarks for the two soft drinks Pepsi-Cola and Coca-Cola.
The growing importance of trademarks in commercial activities is due to the increased competition among companies undertaking trade in more than one country.
Trademarks have been used to simplify the identification by consumers of goods or services, as well as their quality and value. Thus, a trademark may be considered as a tool of communication used by producers to attract consumers.
In this module you will learn what sort of signs can be used for trademarks and what characteristics they must have. You will be able to distinguish between a collective mark and a certification mark. This module will also explain how well known or famous marks are given special protection under the Paris Convention and the TRIPS Agreement.

A trademark may consist of words, designs, letters, numerals or packaging, slogans, devices, symbols, etc.
The Coca-Cola Company ® PepsiCo, Inc. ®

It is necessary to say that a service mark is similar to a trademark, differing only in that the latter protects goods, while the former protects services. Generally speaking the term trademarks includes both trademark and service marks

How to prepare for Drug Inspector Exam? DI Examination Preparation Guide

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How to prepare for Drug Inspector Exam? DI Examination Preparation Guide

How to prepare for Drug Inspector Exam? If You have this in your mind this article is for you. When you want to crack government DI Examination then you must read this post from pharmawiki.in. We will help you to get Drug Inspector job in an easy and smarter way. Even though hard work pays you success these days you need to work smart to punch the door of success.

Every year hundreds of thousands of candidates aim to sit for the exams held by the central and the state Govt. Drug Inspector is one of those posts of government sector that people acquiring background in medicine and pharmacy field have always wanted to go for. Hence, just sitting in exam is not fruitful until one cracks it. So, tight preparation for this exam is very essential.

Basically the Drug Inspector exam is divided into two parts one is written and the other is viva-voce. One has to qualify a written examination and interview along with the physical fitness test to become eligible for appointment. The papers shall comprise of objective type multiple choice based questions.

The Paper I shall contain subject specific questions. The Paper II shall consist of general studies and mental ability questions. The candidates should also prepare for the General Science questions including recent developments in the field of Science & Technology.

How to prepare for Drug Inspector Exam?
Few tips for the best preparation:

  • Start as early as possible for the preparation. Firstly you have to learn about the syllabus and important topics of the examination. You need proper basic knowledge of the entire subject, hence focus to improve your basics.
  • Make notes for every subject. Prepare pharmacy portion strongly with daily revision. Also keep an eye over the GK & Current affairs. Practice is the key to crack DI exam. Solve more and more MCQ so that it enhances your accuracy. By doing this, you can eliminate the wrong options easily during exam.
  • Go through the question bank papers of DI examination. You should study at least 8 to 10 hours regularly to leave no place unseen.
  • Lastly you have to be stress free and dehydrated, full with energy. Preferably, don’t waste time for a particular question in exam hall.

Role of Drug Inspectors

They are qualified persons working in the manufacturing and distribution sector of drugs. Using their technical and intellectual ability these professionals grade diverse products.

Their prime responsibility is to inspect whether the medicines maintain legal standards of sanitation, limpidness, and grading. They visit various pharmacies, laboratories and drug-manufacturing stores to check the quality of the manufactured products those are sold.

How to prepare for Drug Inspector Exam? DI Examination Preparation Guide

All the very best for your preparation time which consequently lead you to the family of government sector  Pharmaceutical Drug Inspector Job vacancy.