Cognizant Pharmacovigilance Interview Questions – TCS CTS

INTERVIEW Questions FOR PHARAMACOVIGILANCE  IN CONGNIZANT TCS

Here in this article we provide you Cognizant Pharmacovigilance Interview Questions along with TCS CTS walk in for M.Pharmacy and B pharmacy Freshers. Generally the Pharmacovigilance in TCS & CTS will be conducted in the same office around 10:00 AM to 2.30 PM.

INTERVIEW PROCESS FOR PHARAMACOVIGILANCE IN CONGNIZANT

Its really good to know where about of anything you do prior. When you decide to go for an interview it is really good to know the pattern of the interview along with its process. Pharmacovigilance is the trending topic these days. I will let you know here expected rounds of interview.

1) Communication –2 min oral talking on your own topic or Group Discussion
2) Aptitude
3) Narrative writing (may be a case study related to clinical trial)
4) HR Round

These days group discussion is very important part of the interview. This is the deciding factor whether you go forward. You have to talk properly with a ear on others speech. Be alert and talk accordingly.

Aptitude is the most important task you need to practice before. Not only for this position for every job you have to give this task successfullyINTERVIEW Questions FOR PHARAMACOVIGILANCE  IN CONGNIZANT TCS

INTERVIEW Questions FOR PHARAMACOVIGILANCE  IN CONGNIZANT

Now we discuss Competency Areas for Pharmacovigilance Professionals. If you want to be a pharmacovigilance Professionals you have know all these things.

Information management skills
# Knowledge of relevant Pharmacovigilance information sources including: printed publications, unpublished sources, databases, websites, social media sites, market research, patients and healthcare professionals, investigator sponsored research and external bodies.
# Effective understanding and use of the principles of information capture, storage, searching and retrieval.
# Effective use of appropriate IT systems and programs.

Scientific knowledge
# Ability to understand in detail clinical, biomedical and scientific reports about pharmaceutical products at a level to allow appropriate capture, review and processing of safety data.

Analytical skills
# Ability to analyse and appraise safety data as part of the ongoing benefit-risk assessment of the company’s products.
# Ability to make informed decisions after finding the relevant facts.

Communication skills
# Ability to communicate information effectively and clearly in written form to allow sharing of safety data within the company and to regulatory bodies as required.

Understanding the wider context
# Knowledge of the business and of the pharmaceutical industry.
# Understanding of the external environment: the NHS, Government policy, regulatory requirements.

Understanding of relevant legal and related issues
# European and Global PV Regulations
# Medicines Act and Statutory Instruments.
# Data Protection legislation.
# Copyright.

Ethics
# Understanding of, and compliance with, company policies, legal requirements, the European
# Good Vigilance Practice Modules, ABPI Pharmacovigilance Expert Network guidance and other industry guidelines that are relevant to pharmacovigilance.
# Application of sound professional judgement to ethical issues.

Workload Management
# Ability to prioritise, plan and organise work with the appropriate sense of urgency based on regulatory requirements and business needs.

Personal skills
# Team management and leadership skills (for team leaders and managers).
# Strategic planning (especially for managers).
# Interpersonal skills.
# Understanding of the needs and priorities of regulatory bodies.
# Use of effective questioning to accurately record safety data.
# Ability to actively listen.
# Teamwork.
# Courteous manner and consideration of others’ views.

Proactivity
# Informing management of important issues as they arise which require their attention.
# Ensuring all company employees and contractors are appropriately trained to capture safety data.
# Actively increasing awareness of Pharmacovigilance requirements to colleagues and third parties in appropriate ways.

Accountability
# Compliance with regulatory requirements.
# Compliance with standard operating procedures and company policies.
# Continuous development
# Developing and improving knowledge and skills.
# Keeping abreast of developments in regulatory requirements.
# Developing the role in line with regulatory requirements and the company’s needs.
# Identifying and implementing improvements in ways of working – for self and for team/department.

PRECLINICAL SAFETY ASSESSMENT AND PHARMACOVIGILANCE 7.5 C

The past decade has seen a rise in the numbers of people working in the field of drug safety and pharmacovigilance. This trend is likely to continue and reflects a greater focus on the safety of medicines. This introductory course in Preclinical Safety Assessment and Pharmacovigilance is organized by the Department of Pharmaceutical Biosciences at Uppsala University in collaboration with the Uppsala Monitoring Centre at The World Health Organization.

This is a half-time web-based course during 10 weeks. This corresponds to 20 hours work per week and requires a commitment to engage in all assignments.
This web-based course encompasses safety aspects in all phases of drug development and drug use. We will discuss the safety of drug candidates and new pharmaceuticals based on toxicity studies as well as on clinical trials. We will also review risk / benefit assessment of drugs and the safe use of medicines. There is no need to physically attend the university for any sessions or examination and the language of instruction is English. A web-based teaching platform (the Student Portal) will be used. The course includes video lectures, five mandatory individual assignments, three mandatory group assignments and a final web-based examination.
The course is given twice a year, in the beginning of each semester. Apply online. The April admission round starts in the middle of March and ends 15 April. The October admission round starts in the middle of September and ends 15 October. The next course starts 1 September and finishes 9 November, 2014. For more detailed information about the course click here.

INTERVIEW FOR PHARAMACOVIGILANCE IN CONGNIZANT Quintiles TCS

ROUND 1: HR will ask you to speak something about yourself and he will analyze your accent and style of English .
TIP TO FACE THIS ROUND: before attending prepare SD very well without getting struck and with good accent .
ROUND 2: mostly they won’t conduct group discussion but sometimes they may conduct .it’s also bit easy just you need to open mouth and should speak something relavent to topic with good accent
ROUND 3: In this round you need to write online English ,logical Aptitude test time will be 45 mins for each set (Exam will be in the micromax Tabs)
TIP TO FACE THIS ROUND: ENGLISH APTITUDE :Prepare English Grammar ,question will be like jumbling words, passages, prepositions, vocabulary etc..(45mins)
NUMERICAL APTITUDE: coding and decoding its very simple search and find in the google how to prepare coding and decoding , small logical calculations, family relations questions etc..
ROUND 4: (HR AND TECHNICAL) ;Need to perform with good accent in English with confidant in HR round they won’t ask any technical questions ,if you have any experience they will ask about your previous work experience and company.
TECHINICAL: they don’t ask much from our core pharmacy you need to prepare pharmacovigilance topics and basic pharmacology.
NOTE: main matter to get pharmacovigilnce job in congnizant (voice process) is you have to perform with good English accent .

Hope this article provided you the information you need regarding the Cognizant Pharmacovigilance Interview Questions along with TCS CTS walk in for M.Pharmacy and B pharmacy Freshers. Generally the Pharmacovigilance in TCS & CTS will conduct interviews on a regular basis, so you need to be cautious and attentive to their announcements.

Pharmacovigilance Applying, Interview process & Tips How to Prepare

Pharmacovigilance Applying, Interview process & Tips How to preparation

As you are looking to apply Pharmacovigilance  department we are here to help you Pharmacovigilance Applying, Interview process & Tips to prepare the Pharmacovigilance Interview. Many Multinational companies like Quintiles Accenture CTS cognizant are hiring candidates in bulk for Pharmacovigilance posts. If you are fresher and trying to enter to this Pharmacovigilance thing you are at the rite place.

Pharmacovigilance applying,interview process and tips to preparation:

Know About the Pharmacovigilance companies :

Pharmacovigilance Applying, Interview process & Tips How to preparation
Quintlies CTS Accenture 

About companay : Quintiles is the worlds largest Contract Research Organizaiton(CRO) where it mainly focuses on clinical trials phase 2-4.

Apply for Pharmacovigilance Interview & Exam

You have to apply through the officaial websites. Some times few people who work can post on some facebook groups about their companies recruitment. You can follow them. Never give any one bucks to get you to the interview or to crack the job. 

Attend the Pharmacovigilance Screening test & Interview

Written test:

English

Aptitude

Maths

Logical and reasoning 

Pharmacovigilance Interview

Pharmacovigilance Interview Phase 1

After the written test they will evaluate your papers in one or two hour. If you are qualified in the written test you will be having hr round where we can expect common hr questions like
1)tell me about yourself
2)why should i hire you?
3)why you want to join in our company?
4)what you know about our company?
Be confident while answering and prepare for these questions and practice before interview if this is your first interview. 90%they will send you for the next Technical round.

Pharmacovigilance Interview Phase 2

This is purely Technical. This is the last round where you will have more chances to eliminate but through proper preparation its easy to face.
mostly questions they ask:
1)Adverse events
2)Adverse effects
3)what is pharmacovigilance
4)what is the work we do in pharmacogivilance
5) is it important pharmacovigialnce
6)drug regulatory authorities
7)pharmacovigilance terminology,case studies.
8)some important drugs pharmacological and mechanism of action.

ALL THE BEST for your Pharmacovigilance Career and Interview. We are here to help out. Please comment if you have any doubts. Keep visiting us for more Pharmacovigilance Interview Question and answers articles. Help your friends by referring our site to crack pharma sucess.

HPLC Interview Preparation for Pharmacy & MSc Students

hplc-interview-preparation-for-pharmacy-science-msc-students

HPLC Interview Preparation for Pharmacy & Science Graduates

Have you graduated in pharmacy or science stream? Then either you must be searching for a job which gives good fetching and career growth or pursue higher studies specialization. Also, there are several corporations which offer you various job opportunities apart from your stream. Among the science and pharmacy graduates, one of the brightest fields is to opt for HPLC vacancies. High-performance liquid chromatographies (HPLC) have widespread use in Pharmaceutical Industrial and Analytical Field. In industries, the main purposes of employing HPLC are for identifying, quantifying and purifying the individual components of the mixture.

It is a chromatographic technique used to split a mixture of compounds and play an important and critical role in the fields of analytical chemistry, biochemistry and industrial. HPLC has a role of Open Access Journal too as it helps in drug formulations. Since it is used to test the products and to detect the raw ingredient used to make them i.e., qualitative and quantitative analysis there are stringent regulations established by the U.S. Food and Drug Administration (FDA). Moreover, this obligates all pharmaceutical companies to detect the quality of their products by using the HPLC before allowing them to sell it in the global market.

Specific Benefits of Using HPLC

hplc-interview-preparation-for-pharmacy-science-msc-students

The most important benefit gained from the HPLC technique in the industrial and analytical field is that it helps in structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations. These benefits gained by the utilization of HPLC are not only limited for the synthetic drugs and formulas but also include herbal medicine too. Therefore, in this regard, the open access journals shall encourage the researchers to work hard in order to clarify the importance of HPLC use in the industrial or analytical field is a very important point.

The industries look for young, dynamic and talented candidates who bring different ideas, skills and experiences to mix and ready to learn and dive into the organization. If you properly put your efforts in getting jobs of HPLC based industries then obviously you need to prepare for these interview questionnaire sessions.

 

Interview Q/A for HPLC

  1. What is the principle of HPLC?

Answer: When a mixture of compounds is passed through the HPLC column; it gets separate into its components before it exits from the column. Details on the principle of HPLC System are given on different websites. The basic principal of HPLC is the partitioning the analytes between the solid phase and the mobile phase.

  1. Why do we use HPLC?

Answer: Polar molecules in the mixture will therefore spend most of their time moving with the solvent. That means now it is the polar molecules that will travel through the column more quickly. Reversed phase HPLC is the most commonly used form of HPLC.

  1. What to Do When Back Pressure Increases?

Answer:

  • An increase in back-pressure usually suggests either a guard or analytical column problem. To find exactly where the problem lies we suggest you remove the guard column (if you are using one) and replace the old cartridge with a new one.
  • If the original pressure is restored, you solved the problem.
  • If the pressure remains high, disconnect the analytical column from the system, backflush it (do NOT connect the column to the detector while doing so) and run a few column volumes of your mobile phase through the column.
  • If the problem still persists you may have some strongly retained contaminants in your column coming from your previous injections.
  • Run the appropriate restoration procedures, as suggested by the column manufacturer, and retest the column.
  • If the initial pressure is not restored you may have to change the inlet frit or replace the column.
  • Always run your system (2 to 5 ml/min) without the guard column and the analytical column to verify that your pressure isn’t coming from another source, like a blocked in-line column prefilter, blocked/kinked tubing, particulates blocking your injector etc.
  • Always work your way from the detector back to the pump to isolate the problem.

  1. How Do I Determine The Void Volume In Hplc?

Answer: The void volume of a system is usually determined by injecting an unretained standard (Uracil in RP-HPLC) that has no or very little retention on a particular phase. Slight variations in this value are explained by the extra column dead volume of your specific system configuration and set-up.

Multiply the elution time of the unretained compound by the flow rate to get the actual void volume of the system and column. To determine the column void volume alone you would need to subtract the system void volume determined without the column attached.

  1. 5. Why Should I Use A Guard Column With My Analytical Or Preparative Column?

Answer:

  • A guard column is recommended to protect the analytical/preparative column from contamination from particulates from the injection, debris from worn pump seals/injector rotor seals or unfiltered mobile phases.
  • Filtration through a 0.22um to 0.45 um should be done in order to remove particles and help degas the mobile phase at the same time.
  • Solid Phase Extraction or Liquid Liquid Extraction also help produce a cleaner sample for direct injection.
  • Failure to use a guard column directly exposes the analytical or preparative column to contamination and therefore reduces its practical lifetime.
  • Care should be taken to use, whenever possible, the same material in the guard column as in the analytical/preparative column especially when doing method development.
  • Typical analytical guard columns are 1 or 2 cm long with either 2.0 (2.1) or 4.0 (4.6) mm depending on the column dimensions and 1cm long for 10mm, 21.2mm & 30mm column id.
  • Whether you opt for 1 or 2 cm long guard columns is tied to how harsh your mobile phase is and how messy your sample is. Ideally, in order to keep your chromatography and to avoid increasing the system pressure, you should use the shortest guard column available and use the same id as the column whenever available. Otherwise you should choose the closest smaller id guard column available.

  1. What Happens If My Sample Solvent Is Stronger Than My Mobile Phase?

Answer:

We do not recommend injecting in a stronger solvent because it usually results in peak distortion, broadening, poor sensitivity, and shortening of retention times.

This happens because some analytes will tend to travel too quickly through the column, instead of eluting in a symmetrical band.

If you absolutely must do this, keep the volume as small as possible and make sure the solvents are miscible.

  1. How Much Sample Can I Inject On My Lc Column?

Answer: Two different types are possible:

  • Mass overload (too much analyte injected on the column)
  • Volume overload (too much liquid injected on the column)

The chromatograms are somewhat different in these 2 situations.

In mass overload, the analyte molecules saturate the silica at the inlet end of the column which causes the excess molecules to move forward down the column without much interaction, reducing in turn the analyte retention time and showing a “shark fin” peak shape (fronting).

Volume overload occurs when the injected sample volume is large enough to carry analyte molecules through a significant proportion of the interstitial volume within the column and leads to shark fin type peaks as well and later elution times.

  1. What Size Threads Are On The End Fittings Of My Hplc Column?

Answer: Most fittings on your HPLC and UHPLC systems and columns have 10-32 threads. However, you will find that fittings and columns from Waters, Rheodyne and SSI (Lab Alliance) have different seating depths.

  1. What Is The Internal Diameter Of My Lc Tubing?

Answer: The internal diameter of HPLC grade stainless steel tubing is identified by the color coded band on the pre cut tubing while HPLC PEEK tubing is also colored according to its internal diameter.

Typical encountered colors used for 1.16” od HPLC tubing (color coded band for SS or solid color for PEEK) are:

  • Black = 0.004” ID
  • Red = 0.005” ID
  • Yellow = 0.007” ID
  • Blue/Tan = 0.010” ID
  • Orange = 0.020” ID
  • Green = 0.030” ID

Please note that these colors may differ depending on the manufacturer especially when it comes to HPLC stainless steel tubing. Please check with your tubing supplier/manufacturer to confirm tubing ID color coding. Please note that the HPLC stainless steel tubing comes in precut lengths as it is virtually impossible to produce smooth, clean, bur-free cuts without the manufacturer’s precise machinery tools. As for SS in HPLC, it also becomes extremely difficult to produce, in-house, bur-free, perfect cuts especially when using the narrower IDs (less than 0.005” ID).

  1. How Much Should I Change My Injection Volume If I Change The Size Of My Column?

Answer: Optimal injection volumes are directly related to the cylinder volume of your column and are, therefore, dependent on the cross sectional area (A=π r2) and length (L) of your column. Since that is the case, you can estimate any adjustment from an existing method for injection volume.

If you are converting to a different size ID (with packing material and length remaining the same), just multiply your current volume by the ratio of the radii squared to determine the correct volume for your new method. For example, if you are currently injecting 20 µL on a 150 x 4.6 mm column and then switch to a 150 x 3.0 mm column, you could estimate the adjusted volume by multiplying 20 x (1.52)/(2.32). Your new volume should be about 8.5 µL.

  1. How Do I Determine Total Column Volume Or Void Volume For Lc?

Answer: The term “column volume” usually refers to the void volume, which represents the volume of mobile phase that is between the silica particles. This area is referred to as the interstitial space. You can estimate void volume by multiplying the total column volume (pi x radius2 x length) by a factor that estimates the typical packing efficiency for a particular column type. For fully porous columns, the equation for void volume (in mL) is V = (0.68) pi r2 L, where V = column volume in mL, r = column radius in cm, and L = column length in cm. For superficially porous columns, such as our Raptor columns, the factor is different and the equation is V = (0.50) pi r2 L.

Void volume is more commonly estimated experimentally by injecting a standard containing an analyte that is known to have no, or negligible, retention on that particular column phase. A good example of this for reversed-phase HPLC is uracil. One should be aware that this estimation is also subject to extra column dead volume for the specific instrument that is being used, so it may vary slightly.

 

  1. Why Am I Seeing Bleed From My Biphenyl Column On My Uv But Not On My Mass Spec?

Answer: A small amount of phase bleed is inherent for all phases, including phenyl phases, and is somewhat dependent on the size and dimensions of the column. This bleed is usually negligible and does not affect retention times, but may be visible, particularly by UV detection. It can often be reduced after conditioning. Bleed may also be minimized by using an isocratic elution, a shallower gradient, and/or incorporating a gradient flush between runs.

  1. What Should I Use To Analyze Explosives (as Per Epa Method 8330b) By Hplc?

Answer: While no one LC column can provide baseline separation for all of these analytes combined, the Raptor Biphenyl and Raptor ARC-18 columns from Restek are an outstanding choice for primary and confirmation analysis. Fully porous HPLC particles, namely the Ultra C8 and Ultra Aromax columns, are also an option. Keep in mind that a variety of column phases may provide partial solutions for this method, but Restek has found these pairs to give optimal results.

  1. Is Special Conditioning Needed For The Raptor Biphenyl Column Prior To Its First Use, Or If It Has Been Sitting Idle?

Answer: For the most part, the Raptor Biphenyl column behaves just like any other reversed-phase column. However, in certain circumstances, longer equilibration times may be needed. Switching between organic solvents, such as acetonitrile and methanol, may require a 15-20 minute flush in high organic mobile phase.

 

  1. How Much Equilibration Time Is Required In Between Gradient Runs On A Raptor Biphenyl Column?

Answer: Whether you are using fully porous silica or SPP silica, some equilibration time is needed between runs if you are using a gradient and the amount of time is similar for both types of columns. Usually, the equivalent of 7 column (void) volumes is sufficient unless you are using an ion-pairing technique.

  1. 1 What Mobile Phase Solvents Are Compatible With Spp Or Raptor Columns?

Answer:

Any solvent that is commonly used for reversed-phase LC will work fine, including but not limited to water, methanol, and acetonitrile.

  1. Can I Pump Solvent Through The Raptor Biphenyl Column Backwards To Clean It?

Answer: Similar to UHPLC columns, it is not recommended to reverse the flow for these columns. However, you can still pump through a series of solvents, as long as they are miscible.

  1. 18. How Much Can I Inject Onto A Raptor Column?

Answer: Injection volume depends on a number of factors including column dimensions, sample solvents, and analysis requirements. As is always a good practice with chromatography, try to inject as little as possible and in the same or weaker solvent than your mobile phase.

  1. How Do Raptor Arc-18 Columns Differ From Ordinary C18s?

Answer: The significant difference is the ruggedness of the bonded phase. With the ARC-18, any residual silanol groups are shielded and made inert through steric protection. The result is a wider operating pH range of 1.0–8.0. The ARC-18 is particularly useful between a pH of 1.0 and 3.0, where other C18 column phases may begin to degrade under these harsh conditions. Like the Raptor Biphenyl column, the stationary phase is bonded to superficially porous silica particles (SPP).

 

  1. How Well Does The Raptor Arc-18 Column Work For Acids And Bases?

Answer: The ARC-18 provides added retention for charged bases and, in many cases, is preferred over a conventional end-capped C18. For neutral acids, it works well and is preferred over end-capped C18 phases, particularly at pH < 3. The ARC-18 also works for neutral bases and charged acids, but provides more advantages and performs best at the lower pH ranges.

  1. Can The Raptor Arc-18 Column Be Used With 100% Aqueous Mobile Phases?

Answer: No. We recommend using the Raptor ARC-18 column with at least 5% organic in the mobile phase. For applications requiring higher aqueous content, we suggest the Ultra Aqueous C18 or Pinnacle DB Aqueous C18 columns.

  1. How Do We Know That The Raptor Columns Are Rugged?

Answer:

We use frits that are less prone to clogging from sample matrices, and the column packing is less likely to be damaged by higher pressures that might develop. Added protection of a guard column is also available and recommended to extend the life of the column further.

 

  1. Which Fittings Can Be Used For Uhplc?

Answer: You can either use the stainless steel fittings that are like the ones that come with your UHPLC system or you can use EXP fittings. The EXP fittings can be used up to 20,000 psi when tightened with a wrench. In any case, always make sure you are using a fitting with zero dead volume so that the high efficiency provided by UHPLC is not compromised by extra dead volume.

 

  1. How Do I Tighten My Fittings?

Answer: Our polymer-based universal connectors and PEEK union connectors only need to be hand-tightened, whereas any of the stainless steel fittings need to be wrench-tighten.

The EXP fittings can be used either way: They are hand-tightened for use up to 8,700 psi or wrench-tightened for use up to 20,000 psi. Note that over-tightening causes galling and will destroy the threads. Fittings that need to be wrench-tightened generally require ¼-turn past hand tight to achieve a leak-tight seal. Unfortunately, there is no universal torque setting.

  1. What Injection Solvent Should I Use For Hilic Separations?

Answer: The injection solvent should be as close of a match as possible to the initial mobile phase conditions, which are high in organic content for HILIC separations. By matching the injection solvent to the initial mobile phase conditions, you get better peak shape, increased retention, and higher sensitivity.

  1. What Kind Of Ph Effects Do I Have To Be Aware Of With Hilic Separations?

Answer: The effect of pH on analyte charge state varies based on each compound’s pKa, to pH effects must be evaluated carefully during method development. With HILIC methods, the high concentration of organic solvent in the mobile phase raises the pH, and the actual eluent pH can be 1–1.5 units higher than in the aqueous portion alone. The charge state of the column itself can also be affected.

For example: in a Raptor HILIC-Si column, the bare silica has a pKa between 3.8 and 4.5, so the mobile phase pH changes the charge of the silica surface, making it neutral in very acidic conditions and ionized (negatively charged) as the pH begins to approach 3.8 and above. For this reason, if your analyte has one or more protonated amine or quaternary amine groups, it’s a good candidate for analysis on a Raptor HILIC-Si column.

  1. Can I Use Buffers For Hilic Separations? What Kind and What Concentration?

Answer: Many HILIC separations use a mass spectrometer for the detector, so volatile buffers like ammonium formate and ammonium acetate are very common. However, the high organic content of the mobile phase can cause buffer salts to precipitate, which can lead to downtime for instrument maintenance. In addition, high buffer concentrations can impact chromatography by reducing analyte retention.

To avoid these effects, method optimization is required and 10 mM is a good starting point for buffer concentration. Both the A and B mobile phases should be buffered equally in order to keep the ionic strength constant during a gradient for the most consistent MS detector response. Check with your MS vendor for the maximum buffer concentration they recommend for your ESI source.

  1. What Should I Use To Analyze Explosives (as Per Epa Method 8330b) By Hplc?

Answer: While no one LC column can provide baseline separation for all of these analytes combined, the Raptor Biphenyl and Raptor ARC-18 columns from Restek are an outstanding choice for primary and confirmation analysis. Fully porous HPLC particles, namely the Ultra C8 and Ultra Aromax columns, are also an option. Keep in mind that a variety of column phases may provide partial solutions for this method, but Restek has found these pairs to give optimal results.

30.Can I Get A Sharper Peak By Injecting My Sample In A Weaker Injection Solvent?

Answer:

  • In this scenario, the sample is initially concentrated onto the head of the column and moves through the column in a tight band.
  • This technique is sometimes used to minimize band broadening for a larger volume sample injection.
  • Keep in mind that your sample components must be soluble in the mobile phase as well, in order for this to work.

Interview Preparation for Regulatory Affairs Role IPR Question & Answers

Interview Preparation for Regulatory Affairs Role IPR

Interview Preparation for Regulatory Affairs Role: In the Pharmaceutical industry, Regulatory Affairs is a profession, acting as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products prior to their marketing for respective countries. The goals of Regulatory Affairs Professionals are Protection of human health, Ensuring safety, efficacy and quality of drugs with appropriateness and accuracy of product information

Depending on the type of regulatory affairs role you are going for, you are to answer different questions. Therefore the first recommendation for the preparation is to take a look at the job description and try to practice the probable questions. Also, match your CV against the job profile such as the criteria of where and where have you demonstrated the skills, characteristics and experience the interviewer is looking for…

Let’s find out the Roles of Regulatory Affairs professionals

  1. Act as a liaison with regulatory agencies. For translating regulatory requirements into practical workable plans they provide expertise and regulatory intelligence
  2. Organize and prepare scientifically valid NDA, ANDA, INDA, MAA, DMF submissions
  • Adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws
  1. Adviser to the companies on regulatory aspects and climate that would affect their proposed activities

There are various other roles which Regulatory Affairs professionals play so you must be well aware of what preparation is apt to you.

Interview Preparation for Regulatory Affairs Role IPR

Generally, the main questions during an interview include the following:

  • The interview will go around regulatory authorities or agencies if you have dealt with any.
  • Electronic submissions have evolved as a big part of regulatory affairs work nowadays. You can expect questions on it and your experience to date.
  • If the regulatory affairs job offers to work for a UK affiliate, be prepared to be asked about your experience of dealing with MRHA.
  • Often, in the interview of regulatory affairs job, you will be given the companies that tend to operate on a global level, who are doing global submissions. Since experience matters, in most cases, you can prepare yourself to answer questions about your experience of team working on a global level. It’s better to collect data about the times when you have worked as part of a team on a global level, and the impact you made.

Interview Preparation for Regulatory Affairs Role IPR

Here are some Interview questions and answers:

  1. What is an Investigational New Drug (IND) application?

Ans- It is an application which is filled with FDA to get approval for legally testing an experimental drug on human subjects in the USA.

  1. What is CTD?

Ans-The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.

  1. 3. What are the modules in CTD?

Ans- The Common Technical Document is divided into five modules:

Module 1. Administrative information and prescribing information

Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5)

Module 3. Quality

Module 4. Nonclinical Study Reports (toxicology studies)

Module 5. Clinical Study Reports (clinical studies)

  1. 4. What are the chemical classification codes for NDA?

Ans-

NumberMeaning
1New molecular entity (NME)
2New ester, new salt, or other noncovalent derivative
3New formulation
4New combination
5New manufacturer
6New indication
7Drug already marketed, but without an approved NDA
8OTC (over-the-counter) switch
  1. What is a New Drug Application?

Ans- The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.  The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDA

In simple words, “It is an application which is filed with FDA to market a new Pharmaceutical for sale in USA”

  1. What is an Abbreviated New Drug Application (ANDA)?

Ans- It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug.

In simple words, “It is an application for the approval of Generic Drugs “

  1. What is a Generic Drug Product?

Ans- A generic drug product is the one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.

  1. What is a DMF?

Ans- A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

Important facts regarding DMFs

  • It is submitted to FDA to provide confidential information
  • Its submission is not required by law or regulations
  • It is neither approved nor disapproved
  • It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these
  • It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420
  • It is not required when applicant references its own information
  1. What are the types of DMF’s?

Ans-

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information (FDA discourages its use)

  1. What is a 505 (b)(2) application ?

Ans- 505 (b)(2) application is a type of NDA for which one or more investigations relied on by applicant for approval were not conducted by/for applicant and for which applicant has not obtained a right of reference.

  1. What kind of application can be submitted as a 505(b)(2) application?

Ans-

  • New chemical entity (NCE)/new molecular entity (NME)
  • Changes to previously approved drugs
  1. What are the examples of changes to approved drug products for which 505(b)(2) application should be submitted ?

Ans-

  • Change in dosage form.
  • Change in strength
  • Change in route of administration
  • Substitution of an active ingredient in a formulation product
  • Change in formulation
  • Change in dosing regimen
  • Change in active ingredient
  •  New combination Product
  • New indication
  • Change from prescription indication to OTC indication
  • Naturally derived or recombinant active ingredient
  • Bioinequivalence
  1. What is Hatch-Waxman act?

Ans-It is the popular name for Drug Price Competition and Patent Term Restoration Act, 1984. It is considered as the landmark legislation which established the modern system of generic drugs in USA. Hatch-Waxman amendment of the federal food, drug and cosmetics act established the process by which, would be marketers of generic drugs can file Abbreviated New Drug Application (ANDA) to seek FDA approval of generic drugs. Paragraph IV of the act, allows 180 day exclusivity to companies that are the “first-to-file” an ANDA against holders of patents for branded counterparts.

In simple words “Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics”

  1. What are the patent certifications under Hatch-Waxman act?

Ans-As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants should include certifications in their applications for each patent listed in the “Orange Book” for the innovator drug. This certification must state one of the following:

(I) that the required patent information relating to such patent has not been filed (Para I certification);

(II) that such patent has expired (Para II certification);

(III) that the patent will expire on a particular date (Para III certification); or

(IV) that such patent is invalid or will not be infringed by the drug, for which approval is being sought(Para IV certification).

A certification under paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved when the patent expires.

  1. What is meant by 180 day exclusivity?

Ans-The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit.

180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of Lipitor ( Atorvastatin calcium).

Interview Preparation for Regulatory Affairs Role IPR Question and Answers

  1. What are the procedures for Approval of Drug in EU?

Centralised Procedure (CP)

Decentralised Procedure (DCP)

Mutual Recognition Procedure (MRP)

National Procedure (NP)

  1. What is the Full form of abbreviation, CEP?

Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs

It is also informally referred to as Certificate of Suitability (COS)

  1. What is a CEP?

It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.

  1. What is ICH?

Ans-International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.

  1. What is a Marketing Authorization Application?

Ans- It is an application filed with the relevant authority in the Europe (typically, the UK’s MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine.

As per UK’s MHRA-

Applications for new active substances are described as ‘full applications’.

Applications for medicines containing existing active substances are described as ‘abbreviated’ or ‘abridged applications’.

PHARMACIST Exam Books Preparation PDF – RRB +Government Pharmacist Material

PHARMACIST Exam Books Preparation PDF - RRB +Government Pharmacist Material

PHARMACIST Exam : Every year government conduct exams for PHARMACIST to fill out the vacant post in various hospital and other departments under government. Do you want to crack  Government Pharmacist & RRB Pharmacist examination. Then First find your own deep and compelling reason to successfully learn your subject and pass your exams. This really is the most important of the study tips I shall share with you here because your success will be deeply rooted in your motivation to learn. Many kids at school do not want to be there and can’t be bothered to try which is often why they fail. It does not mean that they are unable to learn, it just means that they have not applied themselves to the work at hand. I know that this is often true because I have met literally hundreds of people who “failed” at school by conventional standards yet later in life made the decision to go back to studying a subject because they wanted to do it. And because of their motivation to succeed the did.
So what does that mean to you? Well understand that you are driven by emotional needs and not necessarily logical ones. If we were driven by logic, the world would be a much better place. So you have to find a deep emotional reason for achieving success as a student. And if you can dig deep and find that reason then nothing will stop you because you will find a way.

Government PHARMACIST Exam Pattern:

Now can discuss about general Exam Pattern of Government Pharmacist & RRB Pharmacist. Pharmacist exam paper contains 200 Multiple Choice Questions each question carrying 1 marks, with a duration of 2 hour.
Question type: MCQ’s
Questions : 200
Marks: 200
Duration: 2 hours
Sr.No. Test Components No.of Questions
i) General Awareness — 20
ii) Gen. Intelligence and reasoning Ability — 20
iii) Arithmetical and Numerical Ability — 20
iv) Test of General Science — 20
v) Test of Language English/Hindi — 20
vi) Subject-related questions — 100

General Awareness: Students should be updated with all the current affairs and general knowledge topics.

General knowledge by Arihant 

Partiyogita Darpan

NCERT Text books from class 6 to 10

Economics by ramesh singh

Geography Of india by khullar

Science and technology by spectrum

Polity for UPSC by laximikant

Arithmetic: This section is very scoring since the only concern with this section is practice. If students practice hard for this section they can surely score high. S Chand Arithmetic:

Pharmacy: This section includes questions from technical courses which students opted for.

Reasoning: You can scorte more than your competitors ion this session if you practice more. Time is main factor in this. Practice Verbal & nonverbal Reasoning R.S. Aggarwal . Students should go according to syllabus while preparing and practicing RRB mock test.

PHARMACIST Exam  Preparation Books

Pharmacology

I think you know the importance of this subject in our Pharmaceutical sciences. If  you prepare well and thorough in this subject I assure you will definitely clear 50 60 percent of the subject. So concenterate more on this subject. You will cover pharmaceutical chemistry along with these. 

Study these Pharmacology books:

Essentials o f medical Pharmacology by KD Tripathi , Pharmacology by Rang and Dale : Let me tell you what to study here and how to study. 

Prepare important chapters first. Like CVS drugs, antibiotics, anticancer, CNS DRUGS, Hypoglycemic drugs ,  hypnotics, NSAIDs, hypertension.

Concentrate on classifications and mechanism of action. Antidotes, specific severe side effects, vaccines should never be left unstudied.
Don’t forget Drug interactions.

List of Important topics for RRB Pharmacist 2019 exam

1. Cardiac drugs
2. Antihypertensive drugs
3. Antiarrhythmic agents
4. Drugs affecting The Central Nervous system
5. Centrally acting skeletal muscle relaxants
6. Narcotic Analgesics & Antagonists
7. Non-narcotic Analgesics & Antipyretics
8. Antirheumatic & Nonsteroidal Anti-inflammatory Agents
9. Anti-gout Agents
10. Drugs Affecting the Autonomic Nervous system
11. Adrenergic blocking (sympatholytic) Agents
12. Cholinergic Blocking (Parasympatholytic) Drugs
13. Drugs affecting the respiratory system
14. Antihistamines
15. Drugs affecting the G.I.T.
16. Hormones & Hormone Antagonists
17. Oral Contraceptives
18. Diuretics

 Next Study these Pharmaceutics books:

Pharmaceutics cooper and gun

Pharmaceugical engineering by cvs subrahmaniam

Biopharmaceutics & Pharmacokinetics by Brahmankar 

Physical Pharmaceutics by CVS subrahmaniam

Theory and Practice of Industrial Pharmacy –Lieberman & Lachman

What to study in pharmaceutis for Railway Pharmacist exam 2019?

Tablets

Capsules

Emulsions

Packaging

Prescription abbrevations

dissolution tests

contraindications, adverse drug reactions, available dosage forms

Compounding and dispensing of following prescriptions

Enlarging and reducing formula, displacement value

Preparations of formulations involving allegation, alcohol dilution, isotonic solution

Dentifrices, desensitizing agents, & anticaries agents

Pharmaceutical Impurities

Isotopes

Monographs

Tablets

Parenteral – product requiring sterile packaging

Suspensions

Emulsions

Suppositories

Stability of formulated products

Prolonged Action Pharmaceuticals

Novel Drug delivery system

GMP and Validation

Semisolids

Allopathic dosage form

Crude extract

Allergenic extract
Drying

Size reduction and size separation

Extraction

Mixing

Crystallization

,Capsules

Liquids(solutions, syrups, elixirs, spirits, aromatic water, liquid for external uses)

Pharmaceutical Aerosols

 

PHARMACIST Exam Books Preparation PDF - RRB +Government Pharmacist Material

Pharmacognosy

Toxic drugs

Enzymes

Natural pesticides and insecticides

Adulteration and evaluation of crude drugs

Quantitative microscopy

Factors influencing quality of crude drugs
Biogenetic pathways

Carbohydrates & lipids

Tannins

Volatile oils

Resinous drugs

Glycosides

Alkaloids

Extraction and Isolation Techniques

Phytopharmaceuticals

Pharmacognosy by C.K Kokathe, purohit and gokhale


Pharmaceutical Jurisprudence- RRB Jurisprudence Guide

A Textbook of Forensic Pharmacy – B M Mithal 
Concentrate mainly on SCHEDULES.

Next important are YEARS.
TOPICS TO COVER FOR RRB in JURISPRUDENCE

(Dont take more time for this subject but have a clear idea on all the years and numbers 

Narcotic Drugs and Psychotropic substances Act, and Rules there under

Factory Act

Shops and Establishment Act

Introduction to Intellectual Property Rights and Indian Patent Act 1970

Prevention of Food Adulteration Act 1954 and Rules

Industrial Development and Regulation act 1951

Drugs and Magic Remedies (Objectionable Advertisements) Act 1954

Historical background Drug legislation

The Pharmacy Act 1948

Drugs and Cosmetics Act 1940, Rules 1945, including New Drug applications

Consumer Protection Act

Indian Pharmaceutical Industry- An Overview

Drug (Price Control) Order

RRB Government Pharmacist EXAM Material:

Read and practice good competitive exam books ion the market without fail. Gpat books will help you more . Previous exam papers should be solved without any haste. 

You can now read Piyush GPAT books and Inamdar guide for GPAT for subject paper preparation. This will help you to identify important topics and questions as you give a one time reading. Next turn you will understand what to be stressed more.

RRB Previous Papers for Central Government Pharmacist Exam Material

As every one know Previous papers will help you a lot in your successful exam. You need to do all the years RRB Pharmacist Previous papers along with other government pharmacist exams at this time. This is peak time and you should know how to work smart here. You can now download RRB Pharmacist previous questions papers along with answers PDF as solved RRB pharmacist exam. 

RRB PHARMACIST General PAPER BEST BOOKS 

Discussed in the first section of this article please refer.

.

Crack Government Pharmacist Exam with our Support – You must read this to get success

1. Find your own deep and compelling reason to successfully learn your subject and pass your exams.
This really is the most important of the study tips I shall share with you here because your success will be deeply rooted in your motivation to learn. Many kids at school do not want to be there and can’t be bothered to try which is often why they fail. It does not mean that they are unable to learn, it just means that they have not applied themselves to the work at hand. I know that this is often true because I have met literally hundreds of people who “failed” at school by conventional standards yet later in life made the decision to go back to studying a subject because they wanted to do it. And because of their motivation to succeed the did.
So what does that mean to you? Well understand that you are driven by emotional needs and not necessarily logical ones. If we were driven by logic, the world would be a much better place. So you have to find a deep emotional reason for achieving success as a student. And if you can dig deep and find that reason then nothing will stop you because you will find a way.
2. Plan your time to include study, revision and social commitments – a balance of having fun, taking breaks and studying is vital.
Balance is very important to have a successful and rewarding life and the same is true when you are a student. OK you could spend every waking hour reading every book you could find and learning everything you could and yes you would pass your exams provided you had not burnt out. But it would not be fun, you would have no friends and you would definitely be out of balance.
Taking appropriate breaks and giving yourself little rewards when you have finished an essay or learnt something new for your exams is vital for your success. This is because it keeps you in balance and gives you a degree of variety that keeps you fresh and alert. Yes having a night out with your friends is good for you – but only if it is as a reward for doing good work and is as part of your overall plan.
3. Use multi-coloured Mind Maps for your notes.
My friend and mentor Tony Buzan developed the most powerful thinking tool ever (and I am not exaggerating here) when he invented the Mind Map. Imagine being able to get the key facts from an entire book on a single page in a way that was not only easy to remember but would stay in your memory for as long as you wanted it.
Imagine having a thinking tool that allowed you to prepare essays and assignments in a fraction of the time than you do at the moment AND have them much better. Imagine being able to give a powerful hour long presentation from a single page of colourful notes that you put together in about 10 minutes.
Well all these are possible with the Mind Map. It is an amazing tool that combines the power of association, the fact that we have a very strong visual processing mechanism and that it combines right and left brain processing.
I have seen what Mind Maps can do for students of all ages and all abilities and if I had my way it would be a compulsory tool taught to kids from a very young age.
4. Review your notes regularly to reinforce your new-found knowledge.
This is another very simple but extremely powerful tip for you. The experience of most students is that the learning that takes place in the classroom is really an information gathering exercise. When it comes to revising for their exams at the end of the year they go to their notes and often can’t remember ever seeing that information before. They know they must have because the notes are in their handwriting but they can’t remember anything! So the preparation for exams becomes a re-learning exercise.
This study tip is so simple and powerful yet most will not bother. If at the end of every day, every week and every month you quickly scanned what you have learnt, made a few key word notes and then reviewed those ultra-condensed notes regularly, you would be amazed at how much you could remember. This only need take 10 minutes at the end of the day, half an hour at the end of the week and maybe an hour or two at the end of the month.
Each time you review what you have learnt, even in condensed key word format, it is more deeply engrained in your memory.
5. Swiftly skim through your text books and course material before you read them in depth to give you an overview of your subject.
Now there is not enough space here to explain why this tip is important because it is a fundamental part of learning how to read faster and absorb more information. Just trust me on this one and before you start reading, skim through your book (no more than 10 minutes) to get a feel for the contents.
As you read in greater depth later on, some of what you have got from the quick scan will help put into context that information and allow you to make the necessary links in your mind and memory.
Doing this will often stop you from getting stuck at any point because you will have a flavour of what is to come later in the book and this added preview can help the understanding of earlier information.
6. Learn how to remember lists of things by linking each item to a location on a journey or route you are familiar with around your town. You could even use your own home.
At some point, once you have understood your subject, you will need to be able to memorise it. Many people think that just understanding it is enough to learn it but unfortunately that is not the case and so some memorization is necessary.
The most powerful way of doing this is to create a “filing system” in your mind. One way to do this is to create a little journey in your imagination (it can be a real place or you can make it up). See for example the chair, the bed, the TV, the door and the window in your bedroom. If you wanted to remember a sequence of items you would link an outrageous (and therefore memorable) picture to each location.
To recall the information, simply revisit the journey in your own mind and “see” the information in the silly pictures you have created.
7. Before you do any revision, warm up by doing some gentle exercise to relieve any tension in your body and to get a rush of healthy oxygen flowing to your brain.
There is a saying – “a healthy body, a healthy mind” – and nowhere is this more true than when it comes to learning. Two things happen when you physically warm up before studying. First of all you get rid of any physical tension that will create stress in the body and mind (not good for learning) and secondly you will get a rush of oxygen to the brain which will help you think more clearly (definitely good for learning).
8. Do past papers under thorough exam conditions as often as possible to familiarize yourself with the format and the pressures of working under exam conditions.
If you are training in a sport or practicing a musical instrument, you will practice the plays or rehearse the pieces for the big day. It would not make sense to spend months doing push ups and then turn up on the big day and expect to play soccer really well. It would also be unwise to only practice scales on your instrument and then when the big performance comes up expect a perfect recital.
So the same is true of exams. Fortunately these days you can get hold of past exam papers from previous years. Do these, under the same exam conditions, over and over again so that when the big day comes you will have exam experience under your belt.
Doing this will give you more confidence, much better exam techniqe and an insight into how the examiners for your subject think. Remember practice makes perfect.
9. In an exam, make sure you read the question completely and fully understand what the examiner wants before you allocate your time and begin answering the questions.
This is commonsense but you would be amazed at how many people do not do this. Take your time, plan what you are going to write and then write it.
10. If you are faced with a mental block breathe deeply, relax and ask yourself “If I did know the answer to this question, what would it be?”
This might sound silly but if you do it with a positive expectation that your very powerful subconcious will give you the answer, then you will be amazed at what comes to mind. The combination of the breathing, relaxation and expectation is the key. Of course you have had to have done the preparation beforehand because this won’t work with information that you have not previously learnt or covered in class.
So there you have my top 10 tips. Each are very powerful and just doing one of them will make a big difference to your success…but if you do all 10…Wow!

Pharma Interview Questions And Answers For Fresher’s Pdf Free Download – QA QC MR Pharmacist Interview

Pharma interview questions and answers for freshers pdf free download QA QC MR PHARMACIST

At one time or another most of us will have to go through a formal interview with a company that has a job opportunity we are interested in. Pharma Interview Questions And Answers For Fresher’s Pdf Free Download – QA QC MR Pharmacist Interview. The interview is probably the most difficult part for most people because there is always apprehension about what questions will be asked and how they should respond.

The way in which applicants answer job interview questions will greatly determine if they get the job or not. Applicants should be confident in their responses and project professionalism throughout the interview, and answer job interview questions truthfully and respectfully, not to say that some personality should not be projected, but should be kept inline with that of the interviewer.

Pharmaceutical Interview Questions And Answers in pdf

What Is Warfarin And What Are Some Of The Drugs It Interacts And Should Be Avoided?

Answer :

Warfarin is a drug used as anti-coagulant, and it is used in patient who is at high risk of heart attack due to blood clot.

Some of the drugs with which it interacts and should be avoided in combination with

Aspirin
Clopidogrel
Danaproid
Dipyridamole
LMWHs
NSAIDs
Ticlopidine
Unfractionated heparin

What Is Nabp?

Answer :

NABP is the Electronic Licensure Transfer Program allows licensed pharmacists to transfer their existing pharmacist license easily from one state to another.

Explain How Pharmacist Can Help The Patient With Asthma?

Pharmacist can help the patient with Asthma by educating them and give information on it

Trigger management
Role of controller medications
Role of Rescue medications
Early detection of disease

Pharma interview questions and answers for freshers pdf free download QA QC MR PHARMACIST

Interview questions for quality assurance in pharmaceutical industry

Tell me about Validation

Prospective validation: Conducted prior to process implementation to assuring that process is performs as intended on the basis of pre-planned plans.
Concurrent validation: Conducted during the product routine production.
Retrospective validation: Conducted on some products , those products which are already on commercial market. The intention is to establish the long term compliance of that product.
Re-validation: This is nothing but repetition of validation. Conducted to assuring that the changes/modifications done in equipment/process in according to the change control procedures. Those changes are not effecting the equipment/process and their produced products adversely.

Pharma Interview Questions And Answers For Fresher’s Pdf Free Download – QA QC MR Pharmacist Interview

Medical representative interview questions and answers for freshers pdf free download

How can you become a successful pharmaceutical representative?
Pharmaceutical sales is a high turnover business and to get its foot into it requires
• Positive Approach
• Good Network and Focussing on Sales call
• Good communication skills
• Good product knowledge
• Understanding market value of your product
• Good research on competitors and their sales target

• Explain why pharma sales is different than other sales?
• Pharmaceutical sales is an indirect sales role
• Pharmaceutical sales have no order to close or contract to sign
• It serves for an expert physician promoting product through education and awareness

Quality control interview questions and answers pdf

Q/A
What does 6 Sigma represent?
Six Sigma represents the six standard deviations from the mean toward the upper specification limit in a normally distributed sample where an average of 3.4 defects per million is reported to live.
Differentiate between product quality and process quality.
Product quality deals with the given specification of an individual product whereas the process quality deals with the process capability of the process that how much it can be effective to produce the quality products.
What is the maximum Acceptable Tolerance Limit for any product?
It is a TOLERANCE limit which is set by CONSUMER for acceptable any lot, parts, etc, generally within +/-5%
How do you track bug and report through Quality Control dept?
• Tracking by sampling process, through
• FIR (Final Inspection Report)
• FOI (First off Approval Inspection Report)
• Patrol Inspection Report

PHARMACEUTICAL QUALITY ASSURANCE INTERVIEW QUESTIONS & ANSWERS

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.

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.

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

Pharmaceutical Industrial Interview Questions and Answer — QC & QA

What is the difference between quality assurance and quality control?
Quality control is the process of identifying the defect and quality assurance is a process of improvement Quality control is reactive Action quality assurance is a protective action QC is a set of actions. Quality control takes CORRECTIVE ACTION during production,
Quality Assurance takes PREVENTIVE ACTION during development or after production (for completely prevention, if any defect arises)

QA Pharma interview questions and answers for freshers pdf free download

How are filters be used?
Filters are used to sort the test results. A tester can easily find all pass or fail results using a filter.
What is the Test Lab?
The Quality Centre Test Lab where tests are executed. Tests from the test plan can be added to test trees that run in various test cycles.
How can the defect management cycle be tailored in Quality Center?
Once all of the defect attributes that will be tracked (i.e. version, details, etc.) are determined, use the “Modify Options” feature of Quality Center to customize.

What is the difference between Quality Assurance, Quality Control and Audit Function?
Quality assurance is a set of activities involved in the processes and Quality control is set of activities involved in product and audit function is nothing but the periodic inspection in the quality system.

TOP QC INTERVIEW QUESTIONS AND ANSWERS PDF

When do we use a c-chart?
C chart is used when the item is too complex to analyse the product for confirming or not- confirming and subgroup size is same. It is used to monitor the number of defects per unit
What is meant by risk? How can you avoid the risks?
A risk is the possibility that an unfavourable event may occur. It may be predictable or unpredictable. A risk may have 3 components:
• The event that could occur;
• The probability that the event will occur;
• The impact/consequences of the event that if it occurs.

Pharmacist Interview Questions And Answers For Fresher’s Pdf Free Download 

 What Is The Responsibility Of A Pharmacist?

The responsibility of a pharmacist is to

Manage a drug store
Advising patients and physicians
Verifying accuracy of prescription
Reviewing possible side effects
Assigning correct dosage
Recommending most appropriate non-prescription drug
Give information to the patient about drug interaction
Question 2. What Are The Three Qualities A Professional Pharmacist Should Have?

Answer :

Drug Management
Customer Management
Staff Management
Question 3. What Are The Record Keeping Procedures That A Pharmacist Have To Do?

Answer :

The record keeping procedures that a pharmacist have to do

Storing pharmacy files
Patient records
Inventories and update system files
Registries of poisons and controlled drugs
Question 4. What Are The Side Effects Of Methadone?

Answer :

The side effects of methadone are:

Feeling anxious, nervous or restless
Insomnia ( Sleeping disorder )
Feeling drowsy and weak
Nausea, vomiting, diarrhoea, constipation, loss of appetite, dry mouth
Impotence
Question 5. Classify The Controlled Drug? What Is The Storage Procedure For Controlled Drug?

Answer :

Controlled drug is classified into five, Schedule type 1, Schedule type 2, Schedule type 3, Schedule type 4 and Schedule 5.

For CD drug, it should be stored into a closed cabinet made up of metal and with a lock on it. Moreover, only authorized person should have an access to it and only he can administer the CD drug to the patient. For home visit doctor should carry in a lockable bag.Phatmacist.

 Is Pharmacist Allowed To Give A Copy Of Prescription?

Yes, pharmacist is allowed to give a copy of prescription but they can only use a copy of prescription for an informational purpose only. A pharmacist cannot dispense a drug from a copy of a prescription. They can contact your doctor to provide you with a new prescription in case you lost your prescription based on the information on the Copy of prescription.

Final Words

Whether it is your first job after graduation or a well-considered career move, you always need to be well prepared for the interview. Ensure that your resume is well written. To stand out from the crowd, a professionally written resume is a wise investment. A well-written resume and cover letter will ensure that you are called for a job interview. The process of interviews intimidates many, but you should look at it as a discussion to determine if you are suitable for the job and if this company is right for you. Keep in mind that being well prepared for an interview is as important as the interview itself.The best advice you can get is to remain true to yourself, relax and be calm throughout the entire interviewing process. Our pharmawiki site have great suggestions on the subject of interviewing and how to come out on top!  

Hope you liked this article Pharma Interview Questions And Answers For Fresher’s Pdf Free Download – QA QC MR Pharmacist Interview.Good Luck!!

Thank You Notes for Pharmacy Residency Interviews

Thank you notes for Pharmacy residency interviews

Here is the Thank you notes for Pharmacy residency interviews provided for you to make it easy when you really need them.

You might have involved a lot much into preparing for your residency interview and performing well throughout the interview day, isn’t it? But the work is not yet over after the interview because the right thing to do is Thank You Letter writing; it is an important gesture that demonstrates your dedication, determination, and lasting interest in the program. Also, when it comes to ranking, it leaves a program’s impression of you, raising your standard amongst the other candidates after you have parted. Does it impact you after the interview is over? Why bother? Just do the needful.

What to do After the Interview?

Naturally exhausted after your interview, you need to follow some steps that can make your job of writing the Thank You Letter easier and stronger. Once you have settled down for some time, take some notes while recapitulating the events you have gone through the whole day.

Ponder Upon:

“Overall impression of the program?”

“Mostly spent time/made a connection with?”

“About the facilities/any special mention?”

If these details are written down while they are still fresh it will help you personalize your Letter and reveal that you were paying attention throughout the day.

Thank you notes for Pharmacy residency interviews

 Whom & When to send the Thank You Letter?

You should send a Thank You Letter to the Program Director. Always address to RPD in inclusion or exclusion of other interview committee members (you can always ask RPD to extend your thanks to them if you didn’t get a chance to really get to know them).
However, you may also send a brief letter or note to anyone who spent enough time with you for you to feel as though you made a connection.  Remember that the Program Coordinators deserves their own Thank You Letter if they have helped you out a lot during the interview process.

Generally, you prepare the Thank You Letter written within 48 hours of the interview. Deliver the letter so that it arrives within a week after the interview.

Mode of sending the Thank You Letter:

The two main methods of sending a Thank You Letter are email and Postcard. If you have more time to work with, send a letter or card in the mail. You may handwrite the letter, but if your handwriting is questionable or hard to read, type out the letter and hand sign it. You may choose to send a letter on regular paper, or use paper with a header or even a card. If you choose to send a card, make sure it is conservative with a minimal design with little or no use of colour.

If the program has mentioned they will be making their decisions shortly, consider email. Emails reach faster yet run the risk of getting ignored within the emails tides programs receive or get lost in the Spam/Junk folder. After the interview, choose an appropriate moment, and ask the Program Coordinator for the best way to send Thank You Letters to get noticed. Some programs have a preference, others do not.

 What to say in the Thank You Letter?

The letter should be short, generally, around 2 to 3 paragraphs. Write in your own words, it should open with your thanks and a reaffirmation that you are hoping to see them again.

Some potential topics are:

  • What you saw
  • Whom you met
  • Good experiences

Avoid to Say

  • Complaints and criticism about the program
  • Advantages and provisions including vacation time, pay, lower hours etc
  • Remarks like, “I will be ranking you #1 in my list” in the Thank You Letter.

A Thank You Letter is the correct and best way to pay vote of thanks as well as follow up an interview experience. Here you can express your thoughts about the program based on your honesty, be enthusiastic and grateful and remain hopeful that you will get the right message across. We hope The Thank you notes for Pharmacy residency interviews provided  you great help.

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.
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?
A.
1.If the granules are not dried properly sticking can
occur.
2.Too little or improper lubrication can also leads to
sticking.
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?
A.ICH STABILITY ZONES
Zone
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
Temperature
Humidity
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
Refrigerated
5ºC ± 3ºC
No Humidity
12 Months
Frozen
-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
Bracketing
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.
Matrixing
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?
A.
· 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.
Matrixing
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?
A.Brazil,Cuba,China,Brunei,Cambodia,Indonesia,Malaysia,Myanmar,Philippines,Singapore,Thailand

 

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?
A.
1. A 5% change in assay for initial value.

2. Any degradation products exceeds its acceptance
criterion.

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

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 ?
A.
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?
A.
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.
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

IP/BP
Limit
USP
80 mg or less
10%
130mg or less
More than 80mg or Less than 250mg
7.5%
130mg to 324mg
250mg or more
5%
More than 324mg

Weight Variation limits for Capsules
IP
Limit
Less than 300mg
10%
300mg or More
7.5%

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Pharmacy Jobs – Pharma Recruitment 2018 Freshers/ Experience -HYD BNGLR Chennai

pharma related jobs walkin freshers

 Here we provide Pharma related jobs and vacancies in different parts of our country line Bangalore Hyderabad Mumbai Chennai Thane New Delhi. Pharmaceutical Jobs Vacancies information for B.Pharm, M.Pharm, B.Sc, M.Sc, Ph.D candidates. Pharma Jobs, Pharma vacancies, pharmacist job in India,
Pharma job vacancies with job description, apply to suitable job Pharmacy Jobs – Pharma Recruitment 2018 Freshers/ Experience -HYD BNGLR Chennai Pharma Jobs in Bangalore Pharma Industry jobs available in Whitefield, Bengaluru, Karnataka Quality Assurance Analyst, Practice Manager, Production department jobs, Pharmacovigilance, pharma.

Pharmacy Jobs 

Urgent requirement for QA dept.
Only for fresher’s male candidate
Intrested candidate.
Contact ; 9640003863
Location ; hyderabad
Bhanavath Sai Nayak
July 3

Pharmacy Jobs in Mumbai -Medical Writing

June 26
at 2:33 PM
Vacancy in Glenmark for Medical writing…

Experience: 3-5 yrs
Qualifications: M.Pharm or MSc clinical research
Position: senior associate
Location: Mahape, Navi Mumbai

Send resumes at : [email protected]

Pharma Recruitment 2018 Freshers/ Experience – Bangalore:

Looking for medical writers (freshers/experienced) for a startup company based in bangalore close to Bannerghatta. Would prefer full time canditates with attitude to learn and excel in their future.
https://www.facebook.com/sunilinpharm

SAS Programmer Vacancy Bangalore

Walk in drive for #SAS Programmer (SDTM) at Bangalore.

Qualification: Graduate/post graduate with 2-10 years experience in SAS/SDTM, ADAM, TLF

Interview & Job location: #Bangalore

Interview date: #7th July 2018 at
11AM – 1PM

pharmacy jobs walkin freshers

Pharma jobs in Production dept

July 5th

Required Sr.officer and executive level in Injectable Production having experience of 3-4 yrs. Who can handle production activities and online documents.

Send cv along with current CTC on
[email protected]

Call on 9426995153..

Pharma jobs in Hyderabad Production dept

Production

Required a candidate for production dept.
Fresher’s (male)
Contact : 9640003863
Location : Hyderabad

Urgently required.
Fresher’s {female} for QC dept.
Intrested candidate
Contact : 9640003863
Location ; Hyderabad

medical representative jobs
medical representative jobs

 

 

pharma related jobs walkin freshers hyderabad bangalore chennai
pharma related jobs walkin freshers hyderabad bangalore chennai
pharma related jobs walkin freshers
pharma related jobs walkin freshers

pharmacy jobs walkin freshers

Anyone looking to start career in Remote Site Monitoring, Please ping me personally
Company Name: IQVIA (Quintiles IMS)- Thane
Only for freshers

Contact Person: shubham
9867991527

Opening for Executive/Sr. Executive (formulation research Development Department) in Panacea Biotec based at Mumbai. Candidate must be M Pharm and should have 3-6 years of experience. Interested candidates please share your resume on [email protected]

PharmD Jobs

Dear PharmD Candidtaes,

If you are looking for challenging job roles in critical field of Oncology, this is your chance to hone your skills with real time patients. You can learn while you earn and a certificate too.

Cancer Herbalist is World’s first ever most successful, result oriented institute for providing Hope When There is No Hope for Cancer Patients. Patients of all ages, stages, cancers are regressed successfully.

Position: Internship
Duration: 3 Months
Stipend: Rs. 10,000 per month
Qualification: PharmD, M.Pharm, M.Sc

Requirements:
1. Patience
2. Sympathetic to patients
3. Documentation skills
4. Good communication
5. Multi lingual
6. Knowledge of computer, internet, email, MS Office, is essential

Internship Program includes

1. Orientation
2. Cloud based registration
3. Case sheet preparation
4. Case review & Counselling
5. Case followup
6. Tele counselling
7. Drug interactions of all types
8. ADR Documentation & Reporting
9. Understanding Diagnostic reports
10. Writing case studies etc.

Pharma Jobs Freshers

After successful completion of training, you will get a certificate and if your performance is excellent, then can be employed.

R​​egards​​,
​For Cancer Herbalist, ​​​

Deepa
​Front Office

CANCER HERBALIST,
6, DVG Road, Basavanagudi,
Bangalore – 560004
LL: 080 41718877
M: 8884588835
www.cancerherbalist.com
F: www.facebook.com/cancerherbalist

MetLife (in India known as PNB MetLife) looking for Medical Insurance underwriter.
Experience: Fresher/0-2 years
Qualifications: B.Pharmacy/M.Pharmacy (any specialization)
Position: Executive/Sr. Executive
Location: Mumbai
Contact ID: m[email protected]

REQUIRED IMMEDIATELY A FRESHER PHARMACIST IN LUCKNOW.
CONTACT :

+91-83189 73785

+91-63902 12474

July 3 at 7:10 PM
HETERO LABS LIMITED – Walk-In Interview for QC / Production / Warehouse / Packing on 7th July, 2018 @ Hyderabad.

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

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.