The typical process that is followed in an analytical method validation is chronologically listed below:

  • 1. Planning and deciding on the method validation experiments
  • 2. Writing and approval of method validation protocol
  • 3. Execution of the method validation protocol
  • 4. Analysis of the method validation data
  • 5. Reporting the analytical method validation
  • 6. Finalizing the analytical method procedure

The method validation experiments should be well planned and laid out to ensure efficient use of time and resources during execution of the method validation. The best way to ensure a well – planned validation study is to write a method validation protocol that will be reviewed and signed by the appropriate person (e.g., laboratory management and quality assurance). The validation parameters that will be evaluated will depend on the type of method to be validated. Analytical methods that are commonly validated can be classified into three main categories: identification, testing for impurities, and assay.

Table below lists the ICH recommendations for each of these methods. Execution of the method validation protocol should be carefully planned to optimize the resources and time required to complete the full validation study. For example, in the validation of an assay method, linearity and accuracy may be validated at the same time as both experiments can use the same standard solutions.

A normal validation protocol should contain the following contents at a minimum:

  1. (a) Objective of the protocol
  2. (b) Validation parameters that will be evaluated
  3. (c) Acceptance criteria for all the validation parameters evaluated
  4. (d) Details of the experiments to be performed
  5. (e) Draft analytical procedure

The data from the method validation data should be analyzed as the data are obtained and processed to ensure a smooth flow of information. If an experimental error is detected, it should be resolved as soon as possible to reduce any impact it may have on later experiments. Analysis of the data includes visual examination of the numerical values of the data and chromatograms followed by statistical treatment of the data if required.


Note: −, characteristic not normally evaluated; +, characteristic normally evaluated. a In cases where reproducibility has been performed, intermediate precision is not needed. b Lack of specificity of one analytical procedure could be compensated by other supporting analytical procedure(s). c May be needed in some cases.

How to Format References for Thesis & Research Paper Article

How to Format References for Thesis & Research Paper Article

Reference formatting  when you cite references in research article different publishers will follow the different guidelines according to their society rules. When writing a thesis for any piece of work you need to refer and your text material  produced by other people. This procedure is called citing or quoting references. References need to be cited in two different places.

How to Format References for Thesis & Research Paper Article

  1. At a point at which a document is referred to in the text of the work.
  2. In the list at the end of the work the bibliography other reference section

Let us discuss some general views on this.

Article Reference Formating

You put a superscript number after where you want to reference. I mean you can put a superscript number one after a statement.

You always need to put the reference after punctuation. For example if there is a comma and then the citation number.. If you have two citations for the same comment we put a comma between the two numbers separated by a space.

If you have more than two citations we put in the range of numbers separated by dash again after the punctuation point.

Author’s the journal title and then the author’s names the initials first separated by full stops and the last author is has the word and before him then you need to give the journal name appreciated appropriately and those abbreviations are available on the right side.

The year should be mentioned and insert a comma then give the volume in bold. Give issue number and then the first page number and then as a full stop.

Book Reference Formating

If its a Book reference you need to give the author’s names with and before the last author you’ve got the book title in italics. Then the publisher name. If there’s more than if this was more than the first edition we put in the Edition number. The publication site then the year of publication and all of that information is on the inside of a book cover.Book section reference and the page numbers at the end the rest of the format is the same so here we have the author who’s written a section in the book title we’ve got the book editors preceded by the words EDS heads had the publication year and strictly speaking this reference should also have the publication city and the publishers.

UGC Journals Update 2020 – SELF-PLAGIARISM

ucg journals latest news

20rh April,2020 update on UGC Journals SELF-PLAGIARISM

In the interests of lndian academia, to promote Indian research among the nations, and to ensure credibility and quality. from time to time the UGC has instituted various measures. In its efforts to curb plagiarism the
UGC issued the University Grants Commission (Promotion of Academic lntegrity and Prevention of Plagiarism in Higher Educational Institutions) Regulations, 2018, so that plagiarised work does not acquire any credibility or value in evaluation. In continuation of its initiative, and in line with global standards of ethical publishing established by leading institutions and Committee on Publication Ethics (COPE), the UGC draws the attention of the academic community to the following:

ucg journals latest news

(i) Reproduction, in part or whole, of one’s own previously published work without adequate citation and proper acknowledgment and claiming the most recent work as new and original for any
academic advantage amounts to ‘text-recycling’ (also known as’selfplagiarism’) and is g! acceptable.
( ii) Text-recycling/self-plagiarism includes:

  • republishing the same paper already published elseutherc without due andfull citotion;
  • publishing smaller/excerpted work from a longer and previous without due andfull cilations in order to show a larger number ofpublications;
  • reusing data already used in a published work, or communicated for publication, in another work withoul due and full citation;
  •  breaking up a longer/larger study into smaller sections and publishing them as altogether new work without due andfull citation;
  • paraphrasing one’s own previously published work without due andfull citation of the original.
    (iii) Self-citations do not add any number/s to the individual’s citation index or h-index in global academia.
    (iv) Vice Chancellors, Selection Committees, Screening Committees, IQACs and all/any experts involved in academic performance/evaluation and assessment are hereby strongly advised that their
    decisions in the case of promotions, selections, credit allotment, award ofresearch degrees must be based on an evaluation ofthe applicant’s published work to ensure that the work being submitted
    for promotion/selection is not self-plagiarized.
    The UCC will be issuing a set of parameters to evaluate instances of text recycling/self- plagiarism soon.
  • ucg journals UNIVERSITY GRANTS COMMISSION rules new

(Prof. Rajnish Jain)


UGC Indexed Journals Approved Care List PDF

Here we present UNIVERSITY GRANTS COMMISSION approved and indexed Journals which are called UGC Care list. Pharmacy UGC Journals New Updated journals with high impact factor. The cost for these journals might be different some might be low cost and some can be at a higher end. 2020 2021. Pharmacy UGC approved journals need to be first verified before you contact them in the official website of University Grants Commission.  

UGC indexed journals – Approved List

  • Pharma Science UNIV Science Pharma Science Monitor
  • journal of Hospital and Clinical Pharmacy UNIV Science Wiley-Blackwell Publishing Ltd 22296921 India
  • Int J Ayu Pharm Chem (IJAPC) UNIV Science Green Tree Group
  • American Journal of Pharmacological Sciences UNIV Science Science and Education Publishing Co. Ltd 23276711 2327672 United States
  • Bulletin of Faculty of Pharmacy, Cairo University UNIV Science Faculty of Pharmacy, Cairo University 1110093 Egypt
  • Indo Global Journal of Pharmaceutical Sciences UNIV Science Rajeev K Singla, Ed.& Pub. 22491023 India
  • Pharmacophore An International Research Journal UNIV Science Jadoun Science Publishing Group 22295402 India
  • International journal of Medicinal Chemistry UNIV Science Hindawi 20902069 20902077 India
  • Tuberculosis Research and Treatment UNIV Science Hindawi, US 2090150x Egypt 44575
  • Open Pharmaceutical Sciences Journal UNIV Science Bentham Open 18748449 U.A.E
  • Journal of Pharmacognosy &Phytochemistry UNIV Science Society of Pharmacognosy and
  • Phytochemistry 23498234 22784136 India
  • Functional Foods in Health and Disease UNIV Science Functional Food Center, Inc. 21603855 United States
  • UNIVERSITY GRANTS COMMISSION approved and indexed Journals pdf
  • Current Pharma Research UNIV Science Unicorn Publications, India 22307842 India Inventi Rapid Molecular Pharmacology
  • Journal of Drug Delivery and Therapeutics UNIV Multidisciplinary Society of Pharmaceutical Technocrats 22501177 IndiaUNIV Science Inventi Journals Pvt. Ltd 22294171 09763856 India
  • Journal of New Results in Science UNIV Science Gaziosmanpasa University 13047981 Turkey
  • Pharmaceutical Nanotechnology UNIV Science Bentham Science Publishers Ltd 22117393 U.A.E
  • The Pharma Innovation Journal UNIV Science AkiNik Publications,AkiNik Publications India
  • International Journal of Pharmacy and Biological Sciences UNIV Science Jayapal Reddy Gangadi, Ed. & Pub. 22307605 India
  • journal of Pharmasceutical and scientific innovation UNIV Science Moksha Publication 22774572 India
  • Research Journal of Life Sciences, Bioinformatics, Pharmaceutical and Chemical Sciences (RJLBPCS)UNIV Science Jaysingpur India
  • International Research Journal of Humanities, Engineering & Pharmaceutical Sciences, UNIV Social Science Gayatri Publications India
  • Journal of Pharmaceutical ,Chemical and Biological Sciences UNIV Science : India
  • Asian Journal of Pharmaceutical Biochemical Research UNIV Science Dr Bharat Parashar 22312560 India
  • International Journal of Pharmaceutical and Biological UNIV Science Mandsaur Institute of Pharmacy 09763333 India
  • Pharmaceutical Methods UNIV Science Phcog.Net India
  • International Journal of Pharmaceutical investigation UNIV Science Medknow Publication and media pvt. Ltd 2230973 India
  • Asian Journal of Pharmacy and Pharmacology UNIV Science Pharmaceutical research information group 24552674 India
  • International journal of Pharmaceutical Research UNIV Science Association of Indian Pharmacist 09752366 India
  • Medicines, Ethics and Practice UGC Science Royal Pharmaceutical Society United Kingdom
  • International Journal of Bio Pharma Research UNIV Science International journal of biopharma and research 22876898 India
  • Future journal of pharmaceutical sciences UNIV Science Elsevier 23147245 United Kingdom
  • Journal Biosciences and Technology UNIV Science Pharma Info Publications 09760172 India
  • International Journal Pharmacology, phytochemistry and ethnomedicine UNIV Science Scipress 22976922 22976922 Switzerla
  • Asian Journal of Research in Chemistry and Pharmaceutical Sciences UNIV Science Uptodate Research Publications, India 23497106 India

UNIVERSITY GRANTS COMMISSION approved and indexed Journals pdf

UGC care list of journals pdf will be provided here soon. Updated journals list 2020 to publish Pharmaceutics, Pharmacology, Pharmacognosy, Pharmaceutical analysis, Pharmaceutical chemistry.

Pharmacology MCQ for NEET PG GPAT PHARMACIST Nursing Questions with Answers pdf Book

Pharmacology MCQ for NEET PG GPAT PHARMACIST Nursing Questions with Answers pdf Book

Today Pharmawiki is here with very important 40+ Pharmacology multiple choice questions along with answers. These are published especially for all our pharmacy students who are ready to take up different competitive exams like NEET PG GPAT PHARMACIST qualifying examinations. These questions are also very helpful to all the students and professionals of Nursing to take up different examinations for their career growth. This article specifically provides questions with answers pdf Book at the end for our readers convenience. You can click on the right side and download the entire copy to study easily. 

Pharmacology MCQ for Anti Cancer Chemotherapy Drugs


All of the following antiviral drugs are the analogs of nucleosides, EXCEPT:

a) Acyclovir

b) Zidovudine

c) Saquinavir

d) Didanozine

Tick the drug, a derivative of adamantane:

a) Didanozine

b) Rimantadine

c) Gancyclovir

d) Foscarnet

Tick the drug, a derivative of pyrophosphate:

a) Foscarnet

b) Zidovudine

c) Vidarabine

d) Acyclovir

Tick the drug, inhibiting viral DNA synthesis:

a) Interferon

b) Saquinavir

c) Amantadine

d) Acyclovir

Tick the drug, inhibiting uncoating of the viral RNA:

a) Vidarabine

b) Rimantadine

c) Acyclovir

d) Didanozine

Tick the drug, inhibiting viral reverse transcriptase:

a) Zidovudine

b) Vidarabine

c) Rimantadine

d) Gancyclovir

Tick the drug, inhibiting viral proteases:

a) Rimantadine

b) Acyclovir

c) Saquinavir

d) Zalcitabine

Tick the drug of choice for herpes and cytomegalovirus infection treatment:

a) Saquinavir

b) Interferon alfa

c) Didanozine

d) Acyclovir


Tick the drug which belongs to nonnucleoside reverse transcriptase inhibitors:

a) Zidovudine

b) Vidarabine

c) Nevirapine

d) Gancyclovir

All of the following antiviral drugs are antiretroviral agents, EXCEPT:

a) Acyclovir

b) Zidovudine

c) Zalcitabine

d) Didanozine

Tick the drug used for influenza A prevention:

a) Acyclovir

b) Rimantadine

c) Saquinavir

d) Foscarnet

Tick the drug used for HIV infection treatment, a derivative of nucleosides:

a) Acyclovir

b) Zidovudine

c) Gancyclovir

d) Trifluridine

Tick the antiviral drug which belongs to endogenous proteins:

a) Amantadine

b) Saquinavir

c) Interferon alfa

d) Pencyclovir

Tick the drug which belongs to nucleoside reverse transcriptase inhibitors:

a) Didanosine

b) Gancyclovir

c) Nevirapine

d) Vidarabine

All of the following antiviral drugs are anti-influenza agents, EXCEPT:

a) Acyclovir

b) Amantadine

c) Interferons

d) Rimantadine

Pharmacology MCQ for NEET PG GPAT PHARMACIST Nursing Questions with Answers pdf Book

Tick the unwanted effects of zidovudine:

a) Hallucinations, dizziness

b) Anemia, neutropenia, nausea, insomnia

c) Hypertension, vomiting

d) Peripheral neuropathy

Tick the unwanted effects of intravenous acyclovir infusion:

a) Renal insufficiency, tremors, delerium

b) Rash, diarrhea, nausea

c) Neuropathy, abdominal pain

d) Anemia, neutropenia, nausea, insomnia

Tick the drug that can induce peripheral neuropathy and oral ulceration:

a) Acyclovire

b) Zalcitabine

c) Zidovudine

d) Saquinavir

Tick the unwanted effects of didanozine:

a) Hallucinations, dizziness, insomnia

b) Anemia, neutropenia, nausea

c) Hypertension, vomiting, diarrhea

d) Peripheral neuropathy, pancreatitis, diarrhea, hyperuricemia

Tick the unwanted effects of indinavir:

a) Hypotension, vomiting, dizziness

b) Nephrolithiasis, nausea, hepatotoxicity

c) Peripheral neuropathy, pancreatitis, hyperuricemia

d) Anemia, neutropenia, nausea

Tick the drug that can induce nausea, diarrhea, abdominal pain and rhinitis:


a) Acyclovire

b) Zalcitabine

c) Zidovudine

d) Saquinavir

All of the following effects are disadvantages of anticancer drugs, EXCEPT:

a) Low selectivity to cancer cells

b) Depression of bone marrow

c) Depression of angiogenesis

d) Depression of immune system

Rational combination of anticancer drugs is used to:

a) Provide synergism resulting from the use of anticancer drugs with different mechanisms combination

b) Provide synergism resulting from the use of anticancer drugs with the same mechanisms combination

c) Provide stimulation of immune system

d) Provide stimulation of cell proliferation

Tick the anticancer alkylating drug, a derivative of chloroethylamine:

a) Methotrexate

b) Cisplatin

c) Cyclophosphamide

d) Carmustine

Tick the anticancer alkylating drug, a derivative of ethylenimine:

a) Mercaptopurine

b) Thiotepa

c) Chlorambucil

d) Procarbazine

Tick the group of hormonal drugs used for cancer treatment:

a) Mineralocorticoids and glucocorticoids

b) Glucocorticoids and gonadal hormones

c) Gonadal hormones and somatotropin

d) Insulin

Tick the anticancer alkylating drug, a derivative of alkylsulfonate:

a) Fluorouracil

b) Carboplatin

c) Vinblastine

d) Busulfan

Tick the anticancer drug of plant origin:

a) Dactinomycin

b) Vincristine

c) Methotrexate

d) Procarbazine

Action mechanism of alkylating agents is:

a) Producing carbonium ions altering protein structure

b) Producing carbonium ions altering DNA structure

c) Structural antagonism against purine and pyrimidine

d) Inhibition of DNA-dependent RNA synthesis

Tick the anticancer drug, a pyrimidine antagonist:

a) Fluorouracil

b) Mercaptopurine

c) Thioguanine

d) Methotrexate

Methotrexate is:

a) A purine antagonist

b) A folic acid antagonist

c) An antibiotic

d) An alkylating agent

Tick the antibiotic for cancer chemotherapy:

a) Cytarabine

b) Doxorubicin

c) Gentamycin

d) Etoposide

Fluorouracil belongs to:

a) Antibiotics

b) Antimetabolites

c) Plant alkaloids

d) Bone marrow growth factor

Tick the action mechanism of anticancer drugs belonging to plant alkaloids:

a) Inhibition of DNA-dependent RNA synthesis

b) Cross-linking of DNA

c) Mitotic arrest at a metaphase

d) Nonselective inhibition of aromatases


General contraindications for anticancer drugs are:

a) Depression of bone marrow

b) Acute infections

c) Severe hepatic and/or renal insufficiency

d) All of the above

Action mechanism of methotrexate is:

a) Inhibition of dihydrofolate reductase

b) Activation of cell differentiation

c) Catabolic depletion of serum asparagine

d) All of the above

Tick the anticancer drug belonging to inorganic metal complexes:

a) Dacarbazine

b) Cisplatin

c) Methotrexate

d) Vincristine

Tick the indication for estrogens in oncological practice:

a) Leukemia

b) Cancer of prostate

c) Endometrial cancer

d) Brain tumors

Enzyme drug used for acute leukemia treatment:

a) Dihydrofolate reductase

b) Asparaginase

c) Aromatase

d) DNA gyrase

All of the following drugs are derivatives of nitrosoureas, EXCEPT:

a) Carmustine

b) Vincristine

c) Lomustine

d) Semustine

Tick the group of drugs used as subsidiary medicines in cancer treatment:

a) Cytoprotectors

b) Bone marrow growth factors

c) Antimetastatic agents

d) All of the above

Tick the estrogen inhibitor:

a) Leuprolide

b) Tamoxifen

c) Flutamide

d) Anastrozole

Tick the antiandrogen drug:

a) Flutamide

b) Aminoglutethimide

c) Tamoxifen

d) Testosterone

Tick the drug belonging to aromatase inhibitors:

a) Octreotide

b) Anastrozole

c) Flutamide

d) Tamoxifen

Tick the drug belonging to gonadotropin-releasing hormone agonists:

a) Leuprolide

b) Tamoxifen

c) Flutamide

d) Anastrozole

Pharmacology MCQ for Anti Cancer Chemotherapy Drugs

Pharmacology MCQ for Anti Cancer Chemotherapy Drugs

Please keep visiting our website as we assure you great  content with loads of valid information. Do not hesitate to speak to us if you have any doubts. We will guide you through any of your academic doubts. To be a successful pharma professional all you need is great pool of knowledge and network.  it is recommended you to build your network right from the day you enter your college. Every contact can count. So never miss an opportunity to meet your alumni or any meet ups to build your building is great for you in this competitive field. 🙂

Please share your comments in the comments section below.‎

How To Become A MedPlus Pharmacy Franchisee in India? Profitable Money Making Pharma

Here in this article give you a perfect answer for you with your question How to get a pharmacy franchise in India. This will also help you to know more about other questions like Is a Mediplus franchise profitable? How much money can I make from a franchise of MedPlus? in detail.

How To Become A MedPlus Pharmacy Franchisee in India ?

Pharmacies can be operated all round the year, round the clock because medicines are one of the basic needs and families may cut down on luxuries but continue to purchase medicines to maintain health. When it comes to pharmacy business it’s obviously a recession free business and if the stock is well managed and the necessary products are available in time, then success is assured. The operational activities involved in running a retail pharmacy are similar to a trading business. Operations of pharmacy primarily consist of channelizing the required and some general products from many suppliers and selling them to the end customers through the retail counter.

Who are eligible to become a MedPlus Pharmacy Franchisee?

The experience would really matter alongside the education background. A pharmacist qualification is helpful however at a minimum level the candidate should have completed SSC or Intermediate level education. Ideally a Pharmacy diploma/degree holder can be able to understand the pros and cons of the technicality of the products. Prior experience in Pharmacy or managing a small business is countable. Individuals possessing the quality to work hard, diligent and dedicated would see growth from the inception. The determination to personally manage the pharmacy operations rather than through employees is important and the ability of understanding trade terms, margins, profit & loss in terms of mathematics are sufficient.

Investment Details for MedPlus Franchise

To set up a MedPlus Franchise one requires a total investment up to 20 lakhs depending on the location and the size and condition of the premises. The refundable security deposit to premise-owner/rental advance franchisee fee, interior decors, storage racks, computer systems, branded stationary and initial inventory (stocks) are inclusive of the amount. Of this amount, the franchisee should be able to invest Rs 6-7 lakhs of his own to receive a loan under the special scheme towards remaining investment through State Bank of India across India, subject to having collateral of around 6 lakhs.

Location & Premises Criteria for MedPlus franchisee

The location plays an important role in setting up of the MedPlus franchisee. The clutter size determines the demand of the products availability. Considering any city with more than population count of 50,000 would be suitable for a MedPlus Pharmacy to run. Across India, MedPlus Franchises are being offered only in the states of Andhra Pradesh, Telangana, Tamil Nadu and Karnataka presently.

For the pharmacy premise a minimum of 300 Sq.ft or more is required in the main market area with good frontage and unrestricted access to the customers. The enrollment procedure is simple as any individual interested in joining hands with MedPlus Pharmacy Business can register themselves by dropping a mail at [email protected] or make a call to head office.

Running the Franchise Business

Firstly maintaining necessary registrations, documentation and procedures to comply with the laws of the state and drug regulatory authorities is inevitable. Also, to be able to do the operational activities successfully, a pharmacy should be well versed in these:

  1. Identifying and estimating the demand for the products in the area
  2. Maintaining stock levels of the most sold products and continuous updating of stock over time
  3. Minimizing stock loss due to expiry, damage, theft or pilferage
  4. Locating multiple suppliers for all the products
  5. Negotiating prices, discounts and payment terms with the suppliers
  6. Procuring in time and as per need
  7. Keeping records of customer details, sales data and stock outs
  8. Managing cash with an understanding of costs, revenue, profit and loss
  9. Managing the staff members so as to satisfy customers with great service
  10. Generating demand by marketing and promotional schemes

MedPlus Franchise Training and Support

For setting up a MedPlus franchise one need some help that is backed by the Training & support team. The following services are afforded by the franchisor

  • Assistance in selecting the proper location for the store and all aspects of operating the franchise  
  • Help with store identification and lease finalization, in entire layout plan, branding materials and furniture and systems required.
  • Facilitate a bank loan if required.
  • Supply of all products sold through the store, all types of equipment to manipulate the pharmacy related purchases, sales, bank deposits, customer records without any complications.
  • Training for the franchise and its staff with Audit support.

How To Become A MedPlus Pharmacy Franchisee in India Profitable Money Making Pharma.

MedPlus Franchisee Benefits – Profitable Money making Pharmacy

  • Be the pride owner of the brand in a reputable profession with assured income
  • Get assured of the best training, knowledge, and support for running a large pharmacy because of strong operations expertise and sourcing, technology and execution capabilities
  • Initial credit facility or loan from State Bank of India under a special scheme for about 60% of your basic investment requirement
  • You generate a volume of business that is 2 or 3 times higher than other marketers and enjoy higher customer retention yielding high profit margins.
  • Repeat purchases due to brand pull and enjoy the attractiveness of the loyalty and reward program naming as FlexiRewards

Hope this article have helped you with your question How to get a pharmacy franchise in India. Let us know more about other questions like Is a Medplus franchise profitable? How much money can I make from a franchise of MedPlus? in detail in next articles.

Banned Drugs Latest News – Govt Banned Medicines News – Recent Update -3 FCD’s

Banned drugs in India 2018 Recent news update 3 drugs

Banned drugs in India 2018 has one Breaking news recently. As we all know the verdict of Supreme Court Banned 328 list of FCD drugs in India. But now there is a change in the verdict of supreme court. The Supreme Court on Monday has given permission restrictively for the sale of three fixed dose combination (FDC) drugs.  

Here is the Latest news update list of exempted Ban Drugs:

  1. Saridon,
  2. Piriton
  3. Dart

Banned drugs: Latest News & Videos, Photos about Banned drugs

These are the three fixed dose combination (FDC) drugs that got the manufacturing rights again.

Lets see these Supreme Court allowed Drugs for sale in detail.


Piramal Healthcare’s Saridon

Saridon is from Piramal Healthcare’s manufacturing unit.

Saridon Tablet, classified as a mild analgesic, is used to treat fever and is the most commonly used pain reliever. It is used to relieve pain in case of a backache, a headache, arthritis and a toothache.


GlaxoSmithKline’s Piriton

Piriton an Expectorant is from GlaxoSmithKline’s company.

Piriton 4 mg Tablet is an antihistamine that is used to prevent or treat allergic reactions like hay fever or urticaria caused by pollen, dust, or animal hair.
Piriton Syrup and Piriton Tablet formats make a great hay fever treatment option for all the family. Piriton can relieve the symptoms of hay fever and other allergies, and so aid restful sleep when symptoms are troublesome at night. Piriton can also be used to relieve the itchy rash of chickenpox.


Juggat Pharma’s Dart

Dart is the medicine from Juggat Pharma’s industry.

Dart stimulates the brain; hence it is used as a central nervous stimulant. It is used along with analgesics and/or ergotamine for migraine (severe headaches with nausea). It is also used for a breathing condition (apnea) in premature infants

Three fixed dose combination (FDC) drugs including Piramal Healthcare’s Saridon, GlaxoSmithKline’s Piriton Expectorant, Juggat Pharma’s Dart have now got free from the ban.

Latest Health News and Research on Drugs Banned in India 2018

As we all aware, these three drugs were among 328 fixed dose combination banned by Union health ministry on September 7th officially released on 12th of September 2018 through a government notification following a Drugs Technical Advisory Committee report. The order to this effect was issued by a bench of Justices R F Nariman and Indu Malhotra following a petition by drug manufacturers.

Then the government took the decision on the recommendation of a panel constituted by the Centre on the SC’s direction to review safety, efficacy and therapeutic justification of fixed dose combination banned by Union health ministry.

The DTAB in its report recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in these FDCs.

The drug firms argued that they have been manufacturing these drugs since 1988 and should be exempted from the ban. They cited the apex court’ earlier relief to 15 drugs on the basis of the similar grounds.

The bench asked the Union health ministry to give its opinion on the petitions filed against the order.

History of Banned Drugs in India

Manufacturers challenged the government’s decision to ban the drugs and, argued that they have been making these combinations since before 1988. The companies also said that since the Supreme Court had earlier exempted 15 such combination drugs from the ban, the same exemptions should be extended to them, as well, the report quoted lawyers as saying.

Earlier the Delhi High Court on Friday permitted Wockhardt to carry out sale of its anti-inflammatory drug, Ace Proxyvon till September 18. Wockhardt has been manufacturing Ace Proxyvon since last 11 years. Though the health ministry has banned Wockhardt’s anti-inflammatory drug among others based on DTAB report, the company pointed out that it has not yet received the copy of the report.

Banned drugs in India 2018 Recent news update 3 drugs

Earlier, the Central government had, through its notifications published on the March 10, 2016 in the Gazette of India, prohibited the manufacture for sale, sale and distribution for human use of 344 FDCs under section 26 A of the Drugs and Cosmetics Act, 1940. Subsequently, the Government had prohibited five more FDCs in addition to the 344 under the same provisions.However, the matter was contested by the affected manufacturers in various High Courts and the Supreme Court of India. In compliance with the directions given by the Supreme Court of India in its judgment dated the December 15, 2017, the matter was examined by the DTAB constituted under section 5 of the Drugs and Cosmetics Act, 1940 which furnished its report on these drugs to the Central Government.

The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under section 26 A of the Drugs and Cosmetics Act, 1940 as they lacked therapeutic justification.

With regard to six FDCs, the Board recommended that their manufacture, sale and distribution be restricted subject to certain conditions based on their therapeutic justification. Fifteen FDCs out of the 344 prohibited on the 10th March, 2016, which were claimed to be manufactured prior to 21st September, 1988, have been kept out of the purview of current notifications.

As we come to know that the Delhi high court had earlier allowed Indian pharma major Wockhardt to sell its Ace Proxyvon tablets, which is a mixture of three salts — aceclofenac, paracetamol and rabeprazol — a combination that is banned. Now these three drugs that are fixed dose combination (FDC) drugs including Piramal Healthcare’s Saridon, GlaxoSmithKline’s Piriton Expectorant, Juggat Pharma’s Dart have now got free from the ban.

This is the Latest news and update on Banned drugs in India 2018. For more latest news. Please visit us again.

LIST OF DRUGS BANNED IN INDIA PDF – 2018 || 329 Full list Recently Banned Drugs News

LIST OF DRUGS BANNED IN INDIA PDF – 2018 || 329 Full list Recently Banned Drugs

Recently health ministry has  Banned 328 drugs for different reasons. The main reason is the safety concern. Here we provide the FULL LIST OF DRUGS BANNED IN INDIA PDF – 2018 for our readers.

Banned drugs: Latest News & Videos, Photos about Banned drugs

Who Banned these listed 328 Drugs?

The Union health ministry on 12th September 2018 banned the manufacture, sale or distribution of 328 varieties of FDC drugs for human consumption. The action has been taken under Section 26A of the Drugs and Cosmetics Act, 1940 with the help of the Drug Technical Advisory Board or DTAB.

LIST OF DRUGS BANNED IN INDIA PDF – 2018 || 329 Full list Recently Banned Drugs

Why Did Union health ministry has Banned these FDC Drugs? Reasons:

Reasons of Banned Drugs 2018

  1.  To stop the irrational use of fixed-dose combination (FDC) medicines,
  2. There’s no therapeutic justification for the ingredients contained in 328 FDC drugs, and that these may involve risk to human beings.

What are FDC Drugs?

A fixed-dose combination drug contains two or more active ingredients in a fixed dosage ratio in single dosage form. So these can also be called as Combination products. Abbreviated as FDC

Examples of Banned FDC Drugs?

Aceclofenac (SR) + Paracetamol 750

Aceclofenac + Paracetamol + Famotidine

naproxen plus paracetamol


1 Aceclofenac (SR) + Paracetamol 750
2 Aceclofenac + Paracetamol + Famotidine 744
3 Aceclofenac + Paracetamol + Rabeprazole 705
4 Aceclofenac + Zinc Carnosine 745
5 Acetaminophen + Guaifenesin + Dextromethorphan + Chlorpheniramine 945
6 Acetaminophen + Loratadine + Ambroxol + Phenylephrine 906
7 Acriflavine + Thymol + Cetrimide 1014
8 Acrivastine + Paracetamol + Caffeine + Phenylephrine 915
9 Albuterol + Bromhexine + Theophylline 1033
10 Albuterol + Etofylline + Bromhexine + Menthol 1032
11 Alginic Acid + Sodium Bicarbonate + Dried Aluminium Hydroxide + Magnesium Hydroxide 842
12 Allantoin + Dimethieone + Urea + Propylene + Glycerin + Liquid Paraffin 1013
13 Ambroxol + Levocetirizine + Phenylephrine + Guaiphenesin + Menthol 956
14 Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine 927
15 Ambroxol + Salbutamol + Choline Theophyllinate + Menthol 987
16 Ambroxol + Salbutamol + Theophylline 942
17 Ambroxol + Terbutaline + Dextromethorphan 895
18 Ambroxol+ Guaiphenesin + Ammonium Chloride + Phenylephrine + Chlorpheniramine Maleate + Menthol
19 Ammonium Chloride + Dextromethorphan + Cetirizine + Menthol 964
20 Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol 740
21 Ammonium Citrate + Vitamin B 12 + Folic Acid + Zinc Sulphate 1042
22 Amoxicillin + Cefixime + Potassium Clavulanic Acid 757
23 Amoxicillin + Dicloxacillin 753
24 Amoxicillin 250 mg + Potassium Clavulanate Diluted 62.5 754
25 Amoxycillin + Dicloxacillin + Serratiopeptidase 771
26 Amoxycillin + Tinidazole 764
27 Ascorbic Acid + Manadione Sodium Bisulphate + Rutin + Dibasic Calcium Phosphate + Adrenochrome mono Se
28 Atorvastatin + Vitamin D3 + Folic Acid + Vitamin B12 + Pyridoxine 784
29 Azithromycin + Acebrophylline 865
30 Azithromycin + Ambroxol 781
31 Azithromycin + Cefixime 752
32 Azithromycin + Cefpodoxime 772
33 Azithromycin + Levofloxacin 755
34 Azithromycin + Ofloxacin 763
35 Becloemthasone + Clotrimazole + Chloramphenicol + Gentamycin + Lignocaine Ear drops 831
36 Beclomethasone + Clotimazole + Neomycin + lodochlorohydroxyquinone 1007
37 Beclomethasone + Clotrimazole + Gentamicin + lodochlorhydroxyquinoline 1040
38 Beclomethasone Diproprionate + Neomycin + Tolnaftate + lodochlorhydroxyquinoline +
Chlorocresol 1020
39 Benfotiamine + Metformin 1044
40 Benzoxonium Chloride + Lidocaine 735
41 Betahistine + Ginkgo Biloba Extract + Vinpocetine + Piracetam 791
42 Betamethasone + Fusidic Acid + Gentamycin + Tolnaftate + lodochlorhydroxyquinoline (ICHQ) 1002
43 Betamethasone + Gentamicin + Tolnaftate + lodochlorhydroxyquinoline 1011
44 Betamethasone + Gentamycin + Zinc Sulphate + Clotrimoazole + Chlorocresol 1021
45 Betamethasone + Neomycin + Tolnaftate + lodochlorohydroxyquinoline + Cholorocresol 1015
46 Borax + Boric Acid + Naphazoline + Menthol + Camphor + Methyl Hydroxy Benzoate 1022
47 Bromhenxine + Phenylephrine + Chlorpheniramine + Paracetamol 1039
48 Bromhexine + Cetrizine + Phenylephrine IP+Guaifenesin + Menthol 990
49 Bromhexine + Dextromethorphan 1023
50 Bromhexine + Dextromethorphan + Phenylephrine + Menthol 883
51 Bromhexine + Phenylephrine + Chlorepheniramine Maleate 861
52 Caffeine + Paracetamol + Chlorpheniramine 963
53 Caffeine + Paracetamol + Phenylephrine + Cetirizine 954
54 Calcium Gluconate + Chlorpheniramine + Vitamin C 998
55 Calcium Gluconate + Levocetirizine 994
56 Cefixime + Levofloxacin 766
57 Cefixime + Linezolid 756
58 Cefpodoxime Proxetil + Levofloxacin 759
59 Cefuroxime + Linezolid 774
60 Cephalexin + Neomycin + Prednisolone 780
61 Certirizine + Phenylephrine + Paracetamol + Caffeine + Nimesulide 985
62 Cetirizine + Acetaminophen + Dextromethorphan + Phenyephrine + Zinc Gluconate 907
63 Cetirizine + Ambroxol + Guaiphenesin + Ammonium Chloride + Phenylephrine + Menthol 876
64 Cetirizine + Dextromethorphan + Ambroxol 925
65 Cetirizine + Dextromethorphan + Bromhexine + Guaifenesin 937
66 Cetirizine + Dextromethorphan + Phenylephrine + Tulsi 946
67 Cetirizine + Dextromethorphan + Phenylephrine + Zinc Gluconate + Paracetamol + Menthol 887
68 Cetirizine + Dextromethorphan + Zinc Gluconate + Menthol 910
69 Cetirizine + Diethyl Carbamazine 792
70 Cetirizine + Phenylephrine + Dextromethorphan + Menthol 903
71 Cetirizine + Phenylephrine + Paracetamol + Ambroxol + Caffeine 947
72 Cetirizine + Phenylephrine + Paracetamol + Zinc Gluconate 871
73 Cetririzine + Nimesulide + Phenylephrine 943
74 Chlopheniramine Maleate + Dextromethorphan + Guaiphensin + Phenylephrine 962
75 Chloramphenicol + Beclomethasone + Clomitrimazole + Lignocaine 825
76 Chloramphennicol + Lignocaine + Betamethasone + Clotrimazole + Ofloxacin + Antipyrine 827
77 Chlorphaniramine + Ammonium Chloride + Sodium Chloride 933
78 Chlorpheniramine + Ammonium Chloride + Chloroform + Menthol 981
79 Chlorpheniramine + Ammonium Chloride + Noscapine + Sodium Citrate 936
80 Chlorpheniramine + Codeine + Sodium Citrate + Menthol Syrup 881
81 Chlorpheniramine + Dextromethorphan + Phenylephrine + Paracetamol 890
82 Chlorpheniramine + Paracetamol + Pseudoephedrine + Caffeine 999
83 Chlorpheniramine + Phenylephrine + Caffeine 877
84 Chlorpheniramine + Phenylephrine + Dextromethophan + Menthol 894
85 Chlorpheniramine + Phenylephrine + Paracetamol + Zink Gluconate 944
86 Chlorpheniramine + Terpin + Antimony Potassium Tartrate + Ammonium Chloride + Sodium
Citrate + Menthol 966
87 Chlorpheniramine + Vasaka + Tolubalsm + Ammonium Chloride + Sodium Citrate + Menthol 989
88 Chlorpheniramine + Vitamin C 997
89 Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate 870
90 Chlorpheniramine+Ammonium Chloride + Menthol 970
91 Chlorpromazine + Trihexyphenidyl 800
92 Chromium Polynicotinate + Metformin 819
93 Cilnidipine + Metoprolol Succinate + Metoprolol Tartrate 782
94 Ciprofloxacin + Fluocinolone + Clotrimazole + Neomycin + Chlorocresol 1009
95 Ciprofloxacin + Fluticasone + Clotrimazole + Neomycin 778
96 Ciprofloxacin + Phenazopyridine 770
97 Clidinium + Paracetamol + Dicyclomine + Activated Dimethicone 843
98 Clindamycin + Clotrimazole + Lactic Acid Bacillus 854
99 Clindamycin + Telmisartan 786
100 Clobetasol + Gentamicin + Tolnaftate + lodochlorhydroxyquinone + Ketoconazole 1012
101 Clobetasol + Neomycin + Miconazole + Clotrimazole 1016
102 Clobetasol + Neomycin + Miconazole + Zinc Sulphate 1019
103 Clobetasol + Ofloxacin + Ketoconazol + Zinc Sulphate 1010
104 Clobetasol + Ofloxacin + Miconazole + Zinc Sulphate 1003
105 Clobetasol Propionate + Ofloxacin + Ornidazole + Terbinafine 1018
106 Clobetasole + Gentamicin + Miconazole + Zinc Sulphate 1004
107 Clomifene Citrate + Ubidecarenone + Zinc + Folic Acid + Methylcobalamin + Pyridoxine + Lycopene
+ Selenium + Levocarnitine Tartrate + L-Arginine 856
108 Clotrimazole + Beclomethasone + Lignocaine + Ofloxacin + Acetic Aicd + Sodium Methyl Paraben +
Propyl Paraben 1048
109 Clotrimazole + Beclomethasone + Ofloxacin + Lignocaine 830
110 Clotrimazole + Ofloxaxin + Lignocaine + Glycerine and Propylene Glycol 826
111 Codeine + Chlorpheniramine + Alcohol Syrup 920
112 Codeine + Levocetirizine + Menthol 901
113 Combikit of 3 tablets of Serratiopeptidase (enteric coated 20000 units) + Diclofenac Potassium & 2 tablets of D
114 Combikit of Azithromycin, Secnidazole and Fluconazole 760
115 Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole Tablets 769
116 Cyproheptadine + Thiamine 835
117 Dextrometharphan + Chlopheniramine + Ammonium Chloride+ Menthol 958
118 Dextrometharphan + Chlopheniramine + Ammonium + Sodium Citrate + Menthol 1026
119 Dextrometharphan + Phenylephrine + Guaiphenesin 955
120 Dextromethophan + Chlopheniramine + Bromhexine 1024
121 Dextromethorphan + Ambroxol + Ammonium Chloride + Chlorpheniramine + Menthol 991
122 Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine 902
123 Dextromethorphan + Bromhexine + Guaiphenesin 862
124 Dextromethorphan + Bromhexine + Guaiphenesin + Menthol 914
125 Dextromethorphan + Cetirizine 917
126 Dextromethorphan + Cetirizine + Guaifenesin + Ammonium Chloride 986
127 Dextromethorphan + Chlorpheniramine + Chlorpheniramine Maleate 875
128 Dextromethorphan + Chlorpheniramine + Guaiphenesin 896
129 Dextromethorphan + Levocetirizine + Phenylephrine + Zinc 859
130 Dextromethorphan + Paracetamol + Cetirizine + Phenylephrine 965
131 Dextromethorphan + Phenylephrine + Ammonium Chloride + Menthol 913
132 Dextromethorphan + Phenylephrine + Bromhexine + Guaifenesin + Chlorpheniramine 974
133 Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + Caffeine 929
134 Dextromethorphan + Phenylephrine + Cetirizine + Zinc + Menthol 992
135 Dextromethorphan + Phenylephrine + Guaifenesin + Certirizine + Acetaminophen 979
136 Dextromethorphan + Phenylephrine + Guaifenesin + Triprolidine 921
137 Dextromethorphan + Phenylephrine + Tripolidine + Menthol 972
138 Dextromethorphan + Phenylephrine + Zinc Gluconate + Menthol 880
139 Dextromethorphan + Tripolidine + Phenylephirine 898
140 Dextromethorphan + Triprolidine + Phenylephrine 878
141 Dextromethorphen + Bromhexine + Chlorpheniramine Maleate + Guaiphenesin 873
142 Dextromethorphen + Promethazine 891
143 Diclofenac + paracetamol + chlorpheniramine maleate + mgnesium Trisillicate 725
144 Diclofenac + Paracetamol + Chlorzoxazone + Famotidine 715
145 Diclofenac + paracetamol + magnesium Trisilicate 738
146 Diclofenac + Paracetamol injection 751
147 Diclofenac + Tramadol + Chlorzoxazone 710
148 Diclofenac + Tramadol + Paracetamol 714
149 Diclofenac + Zinc Carnosine 724
150 Dicyclomine + Paracetamol + Domperidone 711
151 Diethyl Carbamazine + Chlorpheniramine + Guaifenesin 938
152 Diethylcabamazine Citrate + Cetirizine + Guaiphenesin 892
153 Diethylcarbamazine + Cetirizine + Ambroxol 923
154 Diphenhydramine + Guaifenesin + Bromhexine + Ammonium Chloride + Menthol 908
155 Diphenhydramine + Guaiphenesin + Ammonium Chloride + Bromhexine 889
156 Diphenhydramine + Terpine + Ammonium Chloride + Sodium Chloride + Menthol 866
157 Diphenoxylate + Atropine + Furazolidonee 768
158 Disodium Hydrogen Citrate + Paracetamol 748
159 Doxycycline + Serratiopeptidase 765
160 Doxylamine + Pyridoxine + Mefenamic Acid + Paracetamol 793
161 Dried Alumnium Hydroxie Gel + Prophantheline + Diazepam 1038
162 Drotaverine + Clidinium + Chlordiazepoxide 794
163 Enrofloxacin + Bromhexin 882
164 Ergotamine Tartrate + Belladona Dry Extarct+Caffeine + Paracetamol 1027
165 Ethylmorphine + Noscapine + Chlorpheniramine 924
166 Famotidine + Oxytacaine + Magaldrate 840
167 Flunarizine + Paracetamole + Domperidone 832
168 Flupentixol + Escitalopram 796
169 Furazolidone + Metronidazole + Loperamide 844
170 Gabapentin + Mecobalamin + Pyridoxine + Thiamine 798
171 Gentamicin Sulphate + Clotrimazole + Betamethasone + Lignocaine 829
172 Gentamycin + Dexamethasone + Chloramphenicol + Tobramycin + Ofloxacin 858
173 Glibenclamide + Metformin (SR)+ Pioglitazone 822
174 Gliclazide 40mg + Metformin 400mg 1029
175 Gliclazide 80 mg + Metformin 325 mg 803
176 Glimepiride + Pioglitazone + Metformin 815
177 Glimepiride 1mg/2mg/3mg + Pioglitazone 15mg/15mg/15mg + Metformin 1000mg/1000mg/1000mg 806
178 Glimepiride 1mg/2mg+ Pioglitazone 15mg/15mg + Metformin 850mg/850mg 807
179 Glipizide 2.5mg + Metformin 400 mg 816
180 Glucosamine + Methyl Sullfonyl Methane + Vitamin D3 + Manganese + Boron + Copper + Zinc 732
181 Guaifenesin + Bromhexine + Chlorpheniramine + Paracetamol 980
182 Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol + Serratiopeptidase
(as enteric coated granules) 10000 SP Units 1000
183 Guaifenesin + Dextromethorphan 948
184 Guaifenesin + Diphenhydramine + Bromhexine + Phenylephrine 1037
185 Heparin + Diclofenac 731
186 Imipramine + Chlordiazepoxide + Trifluoperazine + Trihexyphenidyl 799
187 Ketoconazole + Tea Tree oil + Allantion + Zinc Oxide + Aloe Vera + Jojoba oil +
Lavander oil + Soa noodels 1017
188 Ketotifen + Cetirizine 939
189 Ketotifen + Levocetrizine 951
190 Ketotifen + Theophylline 941
191 L-5-Methyltetrahydrofolate Calcium + Escitalopram 788
192 L-Arginine + Sildenafil 783
193 Levocetirizine + Ambroxol + Phenylephrine + Guaiphenesin 874
194 Levocetirizine + Ambroxol + Phenylephrine + Paracetamol 1005
195 Levocetirizine + Dextromethorphan + Zinc 931
196 Levocetirizine + Montelukast + Acebrophylline 912
197 Levocetirizine + Paracetamol + Phenylephirine + Caffeine 949
198 Levocetirizine + Phenylephrine + Ambroxol + Guaiphenesin + Paracetamol 886
199 Levocetirizine + Ranitidine 885
200 Levofloxacin + Bromhexine 884
201 Levofloxacin + Ornidazole + Alpha Tocopherol Acetate 761
202 Levothyroxine + Phyridoxine + Nicotinamide 1043
203 Lignocaine + Clotrimazole + Ofloxacin + Beclomethasone 773
204 Lornoxicam + Paracetamol + serratiopeptidase 737
205 Lornoxicam + paracetamol + Tramadol 736
206 Lornoxicam + paracetamol + trypsin 728
207 Magaldrate + Famotidine + Simethicone 834
208 Magaldrate + Papain + Fungul Diastase + Simethicone 838
209 Magaldrate + Ranitidine + Pancreatin + Domperidone 836
210 Mebeverine & Inner HPMC capsule (Streptococcus Faecalis + Clostridium butyricum + Bacillus
mesentricus + Lactic Acid Bacillus) 853
211 Menthol + Anesthetic Ether 1025
212 Metformin (SR) 500mg + Pioglitazone 5mg 824
213 Metformin (Sustainded Release) 500mg + Pioglitazone 15 mg + Glimepiride 3mg 823
214 Metformin + Atorvastatin 785
215 Metformin + Bromocriptine 812
216 Metformin + Gliclazide + Chromium Polynicotinate 821
217 Metformin + Gliclazide + Piogllitazone + Chromium Polynicotinate 820
218 Metformin + Glimepiride + Methylcobalamin 813
219 Metformin 1000/1000/500/500mg + Pioglitazone 7.5/7.5/7.5/7.5mg + Glimepiride 1/2/1/2mg 802
220 Metformin 500mg/500mg+Gliclazide SR 30mg/60mg + Pioglitazone 7.5mg/7.5mg 810
221 Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 1mg 809
222 Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 2mg 808
223 Metformin ER + Gliclazide MR + Voglibose 818
224 Metronidazole + Norfloxacin 776
225 Metronidazole + Tetracycline 779
226 N-Acetyl Cysteine + Ambroxol + Phenylephrine + Levocertirizine 971
227 Naphazoline + Carboxy Methyl Cellulose + Menthol + Camphor + Phenylephrine 916
228 Naphazoline + Chlorpheniramine + Zinc Sulphate + Boric Acid + Sodium Chloride + Chlorobutol 976
229 Naproxen + Paracetamol 716

Banned  drugs list

230 Neomycin + Doxycycline 1008
231 Nimesulide + Certirizine + Phenylephrine 975
232 Nimesulide + Cetrizine + Caffeine 707
233 Nimesulide + Diclofenac 706
234 Nimesulide + Dicyclomine 730
235 Nimesulide + Loratadine + Phenylephrine + Ambroxol 860
236 Nimesulide + Paracetamol + Cetirizine + Phenylephrine 867
237 Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine 918
238 Nimesulide + paracetamol Injection 721
239 Nimesulide + Paracetamol Suspension 743
240 Nimesulide + Phenylephrine + Caffeine + Levocetirizine 864
241 Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol 719
242 Nimesulide + Serratiopeptidase 717
243 Nimesulide + Tizanidine 708
244 Nimorazole + Ofloxacin 762
245 Norfloxacin+ Metronidazole + Zinc Acetate 847
246 Oflaxacin + Ornidazole Suspension 1031
247 Ofloxacin + Clotrimazole + Betamethasone + Lignocaine 828
248 Ofloxacin + Metronidazole + Zinc Acetate 767
249 Ofloxacin + Nitazoxanide 758

List of Banned FDC drugs

250 Ofloxacin + Ornidazole + Zinc Bisglycinate 775
251 Olmesartan + Hydrochlorothiazide + Chlorthalidone 787
252 Omepraozle + Paracetmaol+ Diclofenac 720
253 Oxetacaine + Magaldrate + Famotidine 849
254 Pantoprazole (as Enteric Coated Tablet) + Zinc Carnosine (as Film Coated Tablets 850
255 Paracetamol + Ambroxol + Phenylephrine + Chlorpheniramine 1030
256 Paracetamol + Caffeine + Codeine 749
257 Paracetamol + Caffine + Phenylephrine + Chlorpheniramine 959
258 Paracetamol + Cetrizine + Caffeine 709
259 Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + Phenylephrine 988
260 Paracetamol + Codeine + Chlorpheniramine 968
261 Paracetamol + Dextromethorphan + Bromhexine + Phenylephrine + Diphenhydramine 934
262 Paracetamol + Dextromethorphan + Chlorpheniramine 899
263 Paracetamol + Diclofenac + famotidine 718
264 Paracetamol + Disodium Hydrogen Citrate + Caffeine 746
265 Paracetamol + DL Methionine 747
266 Paracetamol + domperidone + Caffeine 739

Prohibited Medicines 2018 list

267 Paracetamol + Levocetirizine + Phenylephirine + Zink Gluconate 952
268 Paracetamol + Levocetirizine + Pseudoephedrine 995
269 Paracetamol + Loratadine + Dextromethophan + Pseudoepheridine + Caffeine 868
270 Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + Caffeine 863
271 Paracetamol + mefenamic Acid + ranitidine + Dicyclomine 729
272 Paracetamol + Pheniramine 1001
273 Paracetamol + Phenylephrine + Chlorpheneramine + Dextromethorphan + caffeine 723
274 Paracetamol + Phenylephrine + Chlorpheniramine + Zinc Gluconate 928
275 Paracetamol + Phenylephrine + Desloratadine + Zinc Gluconate + Ambroxol 911
276 Paracetamol + Phenylephrine + Levocetirizine + Caffeine 932
277 Paracetamol + Phenylephrine + Triprolidine 905
278 Paracetamol + Phenylephrine + Triprolidine + Caffeine 953
279 Paracetamol + Prochloperazine 797
280 Paracetamol + Prochlorperazine Maleate 741
281 Paracetamol + Promethazine 790
282 Paracetamol + Propyphenazone + Caffeine 1036
283 Paracetamol + Pseudoephedrine + Cetrizine 726
284 Paracetamol + Pseudoephedrine + Dextromethorphan + Cetirizine 888
285 Paracetamol + Tapentadol 733
286 Paracetamol+Phenylephrine+Levocetirizine+Sodium Citrate 1035
287 Paracetamol+Pseudoephedrine+Certirizine+Caffeine 969
288 Permethrin + Cetrimide + Menthol 1006
289 phenylbutazone + sodium salicylate 727
290 Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + Caffeine 1047
291 Pholcodine + Phenylephrine + Promethazine 900
292 Pioglitazone 15mg + Metformin 850 mg 817
293 Pioglitazone 30 mg + Metformin 500 mg 814
294 Pioglitazone 7.5/7.5mg + Metformin 500/1000mg 805
295 Pseudoephedrine + Bromhexine 984
296 Pseudoephedrine + Cetirizine 957
297 Pseudoephedrine + Dextromethorphan + Cetirizine 893
298 Rabeprazole + Diclofenac + Paracetamol 845
299 Rabeprazole + Zinc + Domperidone 839
300 Rabeprazole + Zinc Carnosine 833
301 Ranitidine + Domperidone + Simethicone 841
302 Ranitidine + Magaldrate 846
303 Ranitidine + Magaldrate + Simethicone 837
304 Roxithromycin + Serratiopeptidase 904
305 Salbutamol + Aminophylline + Guaiphensin 960
306 Salbutamol + Bromhexine + Guaiphenesin + Menthol 935
307 Salbutamol + Certirizine + Ambroxol 973
308 Salbutamol + Choline Theophylinate + Ambroxol 982
309 Salbutamol + Choline Theophylinate + Carbocisteine 996
310 Salbutamol + Theophylline + Bromhexine 961

Banned Medicines 2018 list

311 Salbutamol+Hydroxyethyltheophylline (Etofylline) + Bromhexine 1034
312 Sildenafil + Estradiol Valerate 855
313 Tamsulosin + Diclofenac 722
314 Telmisartan + Metformin 1041
315 Terbutaline + Ambroxol + Guaiphenesin + Zinc + Menthol 919
316 Terbutaline + Bromhexine + Etofylline 940
317 Terbutaline + Bromhexine + Guaiphenesin + Dextromethorphan 897
318 Terbutaline + Etofylline + Ambroxol 967
319 Terbutaline + N-Acetyl L-Cysteine + Guaifenesin 993
320 Terpinhydrate + Dextromethorphan + Menthol 879
321 Thyroid + Thiamine + Riboflavin + Phyridoxine + Calcium Pantothenate + Tocopheryl Acetate +
322 Thyroxine + Pyridoxine + Folic Acid 857
323 Tranexamic Acid + Proanthocyanidin 734
324 Ursodeoxycholic Acid + Silymarin 801
325 Voglibose + Pioglitazone + Metformin 811
326 Voglibose+ Metformin + Chromium Picolinate 804
327 Zinc Carnosine + Magnesium Hydroxide + Dried Aluminium Hydroxide + Simethicone 851
328 Zinc Carnosine + Oxetacaine 848
329 Zinc Carnosine + Sucralfate 852



Banned medicines drug combination latest list in news 4

Hope this article helped you in getting what you are looking for.

Here in this article you have found list of banned drugs in India 2018, Latest news on banned drugs in india 2018, banned drugs list in India 2018 with reason,LIST OF DRUGS BANNED IN INDIA PDF – 2018 || 329 Full list Recently Banned Drugs Ban on medicines in India


How to Write a Pharmacy Progress Note ? When to Write ? Procedure ?

How to Write a Pharmacy Progress Note ? When to Write ? Procedure ?

Hello readers. Today here we discuss about What is a Pharmacy Progress Note ? How to Write a Pharmacy Progress Note ? When to Write Pharmacy Progress Note ? Pharmacy Progress Note Procedure.

When to Write a Pharmacy Progress Note -Procedure

What is a Pharmacy Progress note?

When it comes to documentation of pharmacy services and whenever there is something to communicate to the entire medical team, note(s) is written in response to a formal consult in case of pain management, antibiotic monitoring, medication reconciliation, etc… E.g.: “Would consider changing Synthroid 10 mg po daily to 100 mcg po daily”

When to write a progress note?

There are 3 main ways to communicate with other members of the medical team. Not all communication is apt for a progress note. According to the urgency of the case, the communication types are chosen.

  1. Progress notes (about the consultation/documentation process)
  2. Sticky notes (or other communication not part of the medical record, helps build a relationship with the team.)
  3. Verbal communication (in person or on the phone; if there is a grossly ridiculous issue going on)How to Write a Pharmacy Progress Note ? When to Write ? Procedure ?

How to write a pharmacy progress note?

  • Write to the point being brief– No one wants to read a long note with mostly ‘fluff’ in it. Physicians haveto read each note. If you can express what is needed in a single sentence, do it. If you suggest a pneumococcal vaccine, in the middle of a 3-page note the physician doesn’t read it, and the patient goes on to develop pneumonia. A physician’s mind is being sued when they are reading a lengthy progress note.
  • Use non-judgmental language– It is easy to be misinterpreted because you can’t use body-language or intonation to show that you are genuinely trying to help take better care of a patient, so make sure you avoid using judgmental language, such as the word “obviously” or the phrase “should have”. Use non-judgmental words like “consider”, “suppose” with your recommendation.
  • Prepare an alternative to SOAP – Physicians write SOAP (subjective, objective, assessment, plan) notes because the format lends itself well to problem-based care. TITRS (title, introduction, text, recommendation, and signature) format helps to find communicate the information such as:

The Title-Introduction reveals the basic questions “Who am I? My purpose? Who is/are the patient? Their needs”. Text must support your clear and complete recommendations with subjective & objective information. It should be followed by your signature and how you can be reached.

Decide prudently when to communicate verbally, or with a sticky note or a progress note. It can cost a patient’s life.

Hope you got the answers for What is a Pharmacy Progress Note ? How to Write a Pharmacy Progress Note ? When to Write Pharmacy Progress Note ? Pharmacy Progress Note Procedure ? 

Pharma QA Job Interview Guide |+| Quality Assurance Interview Questions – Pharmaceutical Industry

Pharma QA Job Interview Guide Quality Assurance Interview Questions - Pharmaceutical Industry

Pharma QA Interview Question And Answer are here presented for you to help you to crack Quality Assurance Interview in Pharmaceutical manufacturing companies. Definition Of Quality Assurance along with its use In Pharma Industry are listed here below.

Quality Assurance Pharma Interview Questions – Part 1

Sample QA Interview Question:  Define quality assurance
Ans) QA is a broad range of concept contains all the matters that individually or collectively effect the quality of a product. QA mainly concentrated on planning and documenting the procedures to assure the quality of the product.

Sample QA Interview Question: What needs to be checked during inprocess QA checks?
a.) Environmental Monitoring
b.) Measured values obtained from the process equipment (ex:temperature,RPM etc.)
c.) Measured values obtained from persons (ex:timmings,entries etc.)
d.) Process attributes (Ex:weight,hardness,friability etc.)

Sample QA Interview Question: What precautions shall be taken while collecting inprocess samples ?
A. While collecting inprocess samples, avoid contamination of the product being sampled (Don’t collect samples with bare hands) & avoid contamination of sample taken.

Sample QA Interview Question: In a tablet manufacturing facility ‘positive’ pressure is maintained in processing area or service corridors?
A. In tablet manufacturing facilities, pressure gradients are maintained to avoid cross contamination of products through air. Usually processing areas are maintained under positive pressure with respect to service corridors.

Sample QA Interview Question: If sticking observed during tablet compression what may the probable reason for the same?
1.If the granules are not dried properly sticking can
2.Too little or improper lubrication can also leads to
3.Sticking can occur because of too much binder or
hygroscopic granular.

Sample QA Interview Question: What checks shall be carried out, while calibrating DT apparatus?
A. While calibrating DT apparatus, following checks shall be performed.
1.) Number of strokes per minute (Limit:29-32 cycles/min)
2.) Temperature by probe & standard thermometer
(Limit: 37 ± 1 OC).
3). Distance travelled by basket (Limit:53 -57mm)

Explain the difference between QC and QA?

Ans) QA provides the confidence that a product will full fill the quality requirements. QC determines and measures the product quality level.

QA Interview Question: . Expand cGMP and what is the difference between GMP and cGMP?

Ans) cGMP known as Current Good Manufacturing Practices. It is a USFDA regulations to assure proper design , manufacturing and control of manufacturing processes and services.

GMP-Good Manufacturing Practices. These are the standard guidelines given by Food and Drug administration to make sure that a product is manufactured with safety and quality. c in cGMP means current. It refers to recent and advance updates to these standard guidelines. cGMP is up to date standard reference guidelines.

Pharma QA Job Interview Guide |+| Quality Assurance Interview Questions – Pharmaceutical Industry

Pharma QA Job Interview Guide Quality Assurance Interview Questions - Pharmaceutical Industry

Pharma QA Job Interview Q&A:  Tell me any five countries with their regulatory authorities?
Ans) India – Central Drugs Standard Control Organisation (CDSCO)

USA – United States Food and Drug Administation (USFDA)

UK – Medicines and Healthcare products Regulatory Agency (MHRA)

Japan- Ministry of Health Labour and Welfare (MHLW)

Australia- Therapeutics Goods Administration (TGA)

Sample QA Interview Question: What is In process checks?
A. In process checks are checks performed during an activity,In order to monitor and,if necessary,to adjust the process to ensure that product confirms to its specification.

Sample QA Interview Question: What is the difference between disintegration and dissolution?
A. Disintegration is a disaggregation process, in which an oral dosage form falls apart in to smaller aggregates.(Disintegration time is the ‘break up’ time of a solid dosage form).

Where as dissolution is a process by which solid substance enters in the solvent to yield a solution.It is controlled by the affinity between the solid substance and the solvent.

In other word disintegration is a subset of dissolution.

Sample QA Interview Question: Why do we calibrate a qualified equipment/instrument on definite intervals?
A. An equipment or instrument can ‘drift’ out of accuracy between the time of qualification and actual use.So it is recommended to calibrate and recalibrate the measuring devices and instruments on predetermined time intervals, to gain confidence on the accuracy of the data.

Pharma Quality Assurance Interview Q&A: What is room temperature?

Ans) 25 degree centigrade

Pharma Quality Assurance Interview Q&A:  What is the Ultraviolet(UV) and visible spectroscopy range?

Ans) UV spectroscopy range 200-400 nm, Visible spectroscopy range 400 nm to 800nm.

Pharma Quality Assurance Interview Q&A: What is the use of UV Spectroscopy?

Ans) Spectroscopy used for detecting the functional groups, impurities. Qualitative and quantitative analysis can be done.

Pharma QA Job Interview Guide Part 2

Sample QA Interview Question:  What is the difference between qualitative and quantitative analysis?

Ans) Qualitative analysis involves identification of the compound or chemical based on their chemical(absorption, emission )or physical properties(e.g Melting point, boiling point).

Quantitative analysis involves estimation or determination of concentration or amount of the chemical compounds or components.

Q5) Explain the principle of Ultraviolet spectroscopy?

Ans) UV spectroscopy uses light in the UV part of electromagnetic spectrum. UV absorption spectra arises in which molecule or atoms outer electrons absorb energy, undergoes transition from lower energy level to higher energy level. For each molecule, absorbance at wavelength is specific.

Q6) Explain about Beer Lamberts law?

Ans) It states that the intensity of monochromatic light absorbed by a substance dissolved in a fully transmitting solvent is directly proportional to the substance concentration and the path length of the light through the solution.

Q7) Explain the Infrared spectroscopy principle?

Ans) When a molecule absorbs the Infrared radiation, it vibrates and gives rise to packed Infrared(IR) absorption spectrum. This IR spectrum is specific for every different molecule absorbing the IR radiation, useful for its identification.

Q8) What is the body temperature?

Ans) 37 oCelsius or 98.6 oF

v Define pH? What is the pH of blood?
Ans) pH -Negative logarithm of hydrogen ion concentration. Blood pH-7.35 to 7.45.

Q10) Expand LCMS, HPLC,UPLC, TLC and GC?

Ans) LCMS- Liquid Chromatography

HPLC- High Performance Liquid Chromatography,

UPLC- Ultra High Performance Liquid Chomatography,

TLC- Thin Layer Chomatography,

GC- Gas Chromatography.

qc pharma interview questions for freshers

Q11) What is the HPLC principle?

Ans) It is a technique used for separating the mixture of components into individual components based on adsorption, partition, ion exchange and size exclusion principles. Stationary phase and mobile phase used in it. HPLC used for identification, quantification and purification of components form a mixture.

Q12) Explain HPLC instrumentation?

Ans) It involves solvent system, pump, Sample injector, HPLC columns, Detectors and Recorder. Firstly, solvent(mobile phase) is degassed for eliminating the bubbles. It is passed through the pump with a uniform pressure. The liquid sample is injected into the mobile phase flow stream. It passes through the stationary phase identified by the detectors and recorded.

Q13) In reverse phase HPLC, which type of stationary phase is used and give example?

Ans) Non polar stationary phase used

Ex: Silica gel C-18

Q14) What are the detectors used in HPLC?

Ans) UV detector, IR detector, Fluorescence detector, Mass spectroscopy, LC MS etc.

Q15) How to calculate Retention factor in paper chromatography?
Ans) Rf = Distance travelled by solute/ Distance travelled by solvent.

Q16) Define molarity?

Ans) Number of moles of solute per litre solution. Denoted with “M”

Quality Assurance Pharma Interview Questions – Part 2

Q17) Define Molality?

Ans) Number of moles of solute per kilogram solvent. Denoted with “m”

Q18) Define Normality?

Ans) Number of Number of moles equivalent per litre solution.


Q19) Molecular weight of oxygen?

Ans) 16

Difference between humidity and relative humidity?

Ans) Humidity – Measure of amount of water vapour present in the atmosphere.

Relative humidity- Water vapour amount exists in air expressed as a percentage of the amount needed for saturation at the same temperature.

Sample QA Interview Question: Why do we consider three consecutive runs/batches for process validation? Why not two or four?
A. The number of batches produced in the validation exercise should be sufficient to allow the normal extent of variation and trends to be established and to provide sufficient data for evaluation and reproducibility.
· First batch quality is accidental (co-incidental),
· Second batch quality is regular (accidental),
· Third batch quality is validation(conformation).
In 2 batch we cannot assure the reproducibility of data,4 batches can be taken but the time and cost are involved.

Sample QA Interview Question: Explain about revalidation criteria of AHU system?
A. AHU system shall be revalidated periodically as mentioned in the regulatory standards. AHU shall be revalidated in following cases also.
· When basic design of AHU is changed,
· When clean room volume is changed,
· When new equipment is installed
· When a construction is carried out, that calls for reconstruction of AHU system.

Sample QA Interview Question: What needs to be checked during AHU validation?
A. During AHU validation, following tests shall be carried out
· Filter efficiency test,
· Air velocity & number of air changes,
· Air flow pattern (visualization)
· Differential pressure, temperature and RH
· Static condition area qualification
· Dynamic condition qualification
· Non-viable count
· Microbial monitoring
· Area recovery and power failure study.

Sample QA Interview Question: Position of oblong tablets to be placed in hardness tester to determine the hardness? Lengthwise / widthwise?
A. Position of oblong tablets should be length wise because the probability of breakage is more in this position.

Sample QA Interview Question: Explain in detail about qualification of pharmaceutical water system?
A. Qualification of pharmaceutical water system involves three phases
· Phase -1
· Phase -2
· Phase -3
Phase -1
A test period of 2-4 weeks should be spent for monitoring the system intensively. During this period the system should operate continuously without failure or performance deviation.Water cannot be used for pharmaceutical manufacturing in this phase.The following should be included in testing approach.
· Under take chemical & microbiological testing in accordance with a defined plan.
· Sample incoming feed water daily to verify its quality.
· Sample each step of purification process daily.
· Sample each point of use daily.
· Develop appropriate operating ranges.
· Demonstrate production and delivery of product water of required quantity and quality.
· Use and refine the SOP’s for operation,maintenance,sanitization and trouble shooting.
· Verify provisional alert and action levels.
· Develop and refine test failure procedure.

Phase -2
A further test period of 2-4 weeks. Sampling scheme will be same as Phase – 1.Water can be used for manufacturing process in this phase.
Approach should also
· Demonstrate consistent operation within established ranges.
· Demonstrate consistent production & delivery of water of required quality and quantity.

Phase – 3
Phase 3 runs for one year after satisfactory completion of phase-2.Water can be used for manufacturing process during this process.

Objectives & Features of Phase -3
· Demonstrate extensive reliable performance.
· Ensure that seasonal variations are evaluated.
· The sample locations, sampling frequencies and test should be reduced to the normal routine pattern based on established procedures proven during Phase -1 & phase – 2.

Sample QA Interview Question: What are the recommended environmental monitoring limits for microbial contamination?

Sample QA Interview Question: What is the difference between calibration and Validation?
A. Calibration is a demonstration that, a particular
Instrument or device produces results with in specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.

Where as Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.

In calibration performance of an instrument or device is comparing against a reference standard. But in validation such reference standard is not using.

Calibration ensures that instrument or measuring devices producing accurate results. Whereas validation demonstrates that a process, equipment, method or system produces consistent results (in other words, it ensures that uniforms batches are produced).

Sample QA Interview Question: Briefly explain about ICH climatic zones for stability testing & long term storage conditions?
Type of Climate
Zone I
Temperate zone
Zone II
Mediterranean/subtropical zone
Zone III
Hot dry zone
Zone IVa
Hot humid/tropical zone
Zone IVb
ASEAN testing conditions hot/higher humidity

Long term Storage condition
Climatic Zone
Minimum Duration
Zone I
21ºC ± 2ºC
45% rH ± 5% rH
12 Months
Zone II
25ºC ± 2ºC
60% rH ± 5% rH
12 Months
Zone III
30ºC ± 2ºC
35% rH ± 5% rH
12 Months
Zone IV
30ºC ± 2ºC
65% rH ± 5% rH
12 Months
Zone IVb
30ºC ± 2ºC
75% rH ± 5% rH
12 Months
5ºC ± 3ºC
No Humidity
12 Months
-15ºC ± 5ºC
No Humidity
12 Months

Sample QA Interview Question: What is bracketing & matrixing in stability testing?
A.Both Matrixing & Bracketing’s are reduced stability testing designs
The design of a stability schedule, such that only samples of extremes of certain design factors (ex:strength,package size) are tested at all time points as in full design.The designs assumes that the stability of any intermediate level is represented by the stability of extremes tested.
The design of a stability schedule, such that a selected subset of possible samples for all factor combinations is tested at a specified time point.At a subsequent time point another subset of samples for all factor combination is tested.The design assumes that the stability of each subset samples tested represents the stability of all samples at a given time point.
There for a given time point other than initial & final ones not every batch on stability needs to be tested.

Sample QA Interview Question:What are the common variables in the manufacturing of tablets?
· Particle size of the drug substance
· Bulk density of drug substance/excipients
· Powder load in granulator
· Amount & concentration of binder
· Mixer speed & mixing timings
· Granulation moisture content
· Milling conditions
· Lubricant blending times
· Tablet hardness
· Coating solution spray rate

Sample QA Interview Question: Whether bracketing & validation concept can be applied in process validation?
A.Both Matrixing & Bracketing’s can be applied in validation studies.
Different strength of same product
Different size of same equipment
Bracketting – Evaluating extremes
Largest and smallest fill volumes
Fastest and slowest operating speeds

1. What is an SOP ?

A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step outline form how to perform a particular task or operation. Everyone in a company must follow the same procedures to assure that tasks are performed consistently and correctly. Most companies have a wide variety of SOPs that describe how to do different tasks. In many companies technicians and operators are trained in how to follow individual SOPs and their training record specifies which SOPs they are trained on and are authorized to use.

2. What is 21 CFR part 11 ?

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records

 What are user requirements ?

User Requirements Specification describes what users require from the System. User requirement specifications are written early in the validation process, typically before the system is created. It is written by the System Owner and End Users, with input from Quality Assurance. Requirements outlined in the URS are usually tested in the Performance Qualification. User Requirements Specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirements outlined in the URS.

4. What is a validation plan ?

Validation Plans define the scope and goals of a validation project. Validation plans are written before a validation project and are specific to a single validation project. Validation Plans can include:

Deliverables (Documents) to be generated during the validation process
Resources/Departments/Personnel to participate in the validation project
Time-Line for completing the validation project

5. What is an IQ document ?

Installation Qualifications are a collection of test cases used to verify the proper installation of a System. The requirement to properly install the system was defined in the Design Specification. Installation Qualifications must be performed before completing Operational Qualification or Performance Qualification.

6. What is an OQ Document ?

Operational Qualifications are a collection of test cases used to verify the proper functioning of a System. The operational qualification tests requirements defined in the Functional Requirements. Operational Qualifications are usually performed before the system is released for use.

7. What is a PQ Document ?

Performance Qualifications are a collection of test cases used to verify that a System performs as expected under simulated real-world conditions. The performance qualification tests requirements that were defined in the User Requirement Specification (or possibly the Functional Requirements). Due to the nature of performance qualifications, these tests are sometime conducted with power users as the system is being released.

8. What is a Validation Summary Report ?

Validation Summary Reports provide an overview of the entire validation project. When regulatory auditors review validation projects, they typically begin by reviewing the summary report. The validation summary report should include:

A description of the validation project
All test cases performed, including if those test cases passed without issue
All deviations reported, including how those deviations were resolved

9. What is a Change Request ?

Change Control is a general term describing the process of managing how changes are introduced into a controlled System. In validation, this means how changes are made to the validated system. Change control is required to demonstrate to regulatory authorities that validated systems remain under control after system changes. Change Control systems are a favorite target of regulatory auditors because they vividly demonstrate an organization capacity to control its systems.

Sample QA Interview Question: Why water for pharmaceutical use is always kept in close loop in continuous circulation ?
A. Water is a best medium for many microorganisms, microorganism can be a highly pathogenic which causes serious diseases(many diseases are water born), these pathogens infect after consumption of contaminated water, microorganisms tend to settle on a surface if water is allowed to stand in a stagnant position for few hours, these settled microorganism form a film over the surface of vessel and piping, such film formed by microorganisms is also called as biofilm, biofilms are very difficult of remove, once a biofilm is formed at a particular point then that point may form a biofilm again even after cleaning very easily as seed from this point is may not completely get removed effectively.

Biofilms then can become a source of microbial contaminations; therefore purified water after collection in a distribution system is always kept in a closed loop in a continuous circulation.
A continuous circulation is also not enough at some points, therefore it is aided with high temperature range from 65 °C to 80°C, a minimum temperature of 65 °C is considered a self sanitizing, but better assurance is obtained with a temperature of 80°C .

Purified water collected should be stored in a stainless still vessel which must facilitate distribution to the point of use in a closed loop of continuous circulation, tank should be made of corrosion free material of construction, and must facilitate sanitization and easy cleaning.

Quality Assurance Pharma Interview Questions – Part 3

Sample QA Interview Question: Water for pharmaceutical use shall be free cations,anions and other impurities why ?

A.Water for pharmaceutical must be free from inorganic as well as organic impurities, minerals, and heavy metals. Some impurities like calcium, magnesium, ferrous are responsible for degradation of drug molecule, many cations like ferrous and calcium magnesium act as catalysts in degradation reaction of drug molecule, anions like chloride are highly active they participate in nucliophylic substitution reactions, where in they break a double bond between -C=C- in to a single bond as CL –CH-CH2- , which a reason why we observe that color dies tend to fed in presence of chlorine as most of the dies used are diazo compounds which has plenty of places for nucliophylic substitution reactions, which is also a reason why stability of drug is drastically affected in presence of cations and anions from mineral origin present in water.

Sample QA Interview Question: Water for pharmaceutical use shall be free heavy metals why ?
A. Heavy metals like lead and arsenic are highly cumulative neurotoxic metals, heavy metals are not eliminated out of our body easily like other drugs and molecules but heavy metals bind with proteins and tend to get accumulated in fatty tissues, nerve tissue is most likely to get damaged by heavy metals, heavy metal causes nervous tissue damage there for water must be free from heavy metals.

Sample QA Interview Question: Brazil falls under which climatic zone ?
A. Zone IVB (30 degree celsius and 75% relative humidity)

Sample QA Interview Question: Change in the size or shape of the original container requires any stability study?
A. Change in the size or shape of the original container may not necessitate the initiation of new stability study.

Sample QA Interview Question: Forced degradation(stress testing) and accelerated stability testing are same?
A. Forced degradation and stress testing are not same. Stress testing is likely to be carried out on a single batch of the drug substance. The testing should include the effect of temperatures (in 10°C increments (e.g., 50°C, 60°C) above that for accelerated testing), humidity (e.g., 75 percent relative humidity or greater) where appropriate, oxidation, and photolysis on the drug substance. The testing should also evaluate the susceptibility of the drug substance to hydrolysis across a wide range of pH values when in solution or suspension. Photo stability testing should be an integral part of stress testing.

Sample QA Interview Question: According to WHO guidelines what is the storage condition of climatic zone IVa and zone IVb?
A. Zone IV a: 30°C and 65% RH (hot and humid countries)
Zone IV b: 30°C and 75% RH (hot and very humid countries

Sample QA Interview Question: Countries comes under climatic zone IVb?


Pharmaceutical Industry Interview Questions pdf

Sample QA Interview Question: What is the purpose of stress testing in stability studies?
A. Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.

Sample QA Interview Question: What is the formula for calculating number of air changes in an area?
A. Number of air changes/hour in an area is

= Total Room Airflow In CFM x 60
Total Volume of room in cubic feet
For calculating Total Room Airflow in CFM, first calculate air flow of individual filter. Formula is given below.

Air flow (in cfm) = Avg.air velocity in feet/Minute x Effective area of filter

Then find Total air flow. Formula is
Total Air flow = Sum of air flow of individual filter.

Air flow Velocity can be measured with the help of Anemometer.

Sample QA Interview Question: What is dead leg?
A. A dead leg is defined as an area in a piping system where liquid can become stagnant and not be exchanged during flushing.

Sample QA Interview Question: What is the recommended bio burden limits of purified water & WFI?
A. Purified water has a recommended bioburden limit of 100 CFU/mL, and water for injection (WFI) has a recommended bio burden limit of 10 CFU/100 mL.
Sample QA Interview Question: Brief about ICH stabilty guidelines?
A. Q1A- Stability testing of new drug substance & products
Q1B- Photo stability testing of new drug substances & products
Q1C-Stability testing of new dosage forms
Q1D-Bracketing & Matrixing designs for testing of new drug substances and products
Q1E-Evaluation of stability data
Q1F-Stability data package for registration applications in climatic zone III & IV (Withdrawed)

Sample QA Interview Question: What is significant changes in stability testing?
1. A 5% change in assay for initial value.

2. Any degradation products exceeds its acceptance

3. Failure to meet acceptance criterion for
appearance,physical artributes and functionality

4. Failure to meet acceptance criteria for dissolution
for 12 units.

Sample QA Interview Question: If leak test fail during in process checks what needs to be done ?
Immediately stop packing process and check for
1.Sealing temperature
2.Verify for any possible changes like foil width,knurling etc.
3.Check & quarantine the isolated quantity of packed goods from last passed inprocess.
4.Collect random samples & do retest.
5.Blisters from the leak test passed containers shall allow to go further and rest must be deblistered/defoiled accordingly.

Sample QA Interview Question: How many Tablets shall be taken for checking friability?
A. For tablets with unit mass equal or less than 650 mg, take sample of whole tablets corresponding to 6.5g.For tablets with unit mass more than 650mg,take a sample of 10 whole tablets.

Sample QA Interview Question: What is the formula for calculating weight loss during friability test?
A. %Weight loss = Initial Weight – Final Weight X 100
Initial Weight

Sample QA Interview Question: What is the pass or fail criteria for friability test?
A. Generally the test is run for once.If any cracked,cleaved or broken tablets present in the tablet sample after tumbling,the tablets fails the test.If the results are doubtful,or weight loss is grater than the targeted value,the test should be repeated twice and the mean of the three tests determined.A mean weight loss from the three samples of not more than 1.0% is considered acceptable for most of the products.

Sample QA Interview Question: What is the standard number of rotations used for friability test?
A. 100 rotations

Sample QA Interview Question: What is the fall height of the tablets in the friabilator during friability testing?
A. 6 inches.Tablets falls from 6 inches eight in each turn within the apparatus.

Sample QA Interview Question: Why do we check hardness during inprocess checks?
A. To determine need for the pressure adjustments on the tableting machine. Hardness can affect the disintegration time.If tablet is too hard, it may not disintegrate in the required period of time. And if tablet is too soft it will not withstand handling and subsequent processing such as coating,packing etc.

Sample QA Interview Question: What are the factors which influence tablet hardness?
1.compression force
2.Binder quantity(More binder more hardness)
3.Moisture content

Sample QA Interview Question: Which type of tablets are exempted from Disintegration testing?
A. Chewable Tablets

Sample QA Interview Question: Which capsule is bigger in size – size ‘0’ or size ‘1’?
A. ‘0’ size

Sample QA Interview Question: What is the recommended temperature for checking DT of a dispersible tablet?
A. 25 ±10C (IP) & 15 – 250C (BP)

Sample QA Interview Question: What is mesh aperture of DT apparatus ?
A. 1.8 -2.2mm (#10)

Sample QA Interview Question: What is the pass/fail criteria for disintegration test?

A. If one or two tablets/capsules fails to disintegrate completely, repeat the test on another 12 additional dosage units. The requirement is meet if not fewer than 16 out of 18 tablets/capsules tested are disintegrated completely.

Sample QA Interview Question: What is the recommended storage conditions for empty hard gelatin capsules?
A. 15 – 250C & 35 -55% RH

Sample QA Interview Question: Which method is employed for checking “Uniformity of dosage unit”?
A.)Content uniformity
B.) Weight Variation
Weight variation is applicable for following dosage forms;Hard gelatin capsules,uncoated or film coated tablets,containing 25mg or more of a drug substance comprising 25% or more by weight of dosage unit.

Sample QA Interview Question: What is the recommended upward and downward movement frequency of a basket-rack assembly in a DT apparatus?
A. 28 – 32 cycles per minute.

Sample QA Interview Question: When performing the ‘uniformity of weight’ of the dosage unit, how many tablet/capsule can deviate the established limit?
A. Not more than two of the individual weights can deviates from the average weight by more than the percentage given in the pharmacopeia,and none can deviates more than twice that percentage.
Weight Variation limits for Tablets

80 mg or less
130mg or less
More than 80mg or Less than 250mg
130mg to 324mg
250mg or more
More than 324mg

Weight Variation limits for Capsules
Less than 300mg
300mg or More

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