Interview questions for quality control analyst in pharma industry

Interview questions for quality control analyst in Pharma Industry

We have provided interview questions for quality control analyst here. You have to know all these question answers before attending an interview. We have already provided interview questions for quality control analyst in our previous post. This post includes some more important questions for interview. These are useful for freshers as well experienced people. Have a knowledge on all these questions before attending the interview.

interview questions for quality control analyst are as follows.

Acceptance Limit for Friability of tablets?

Ans) Acceptable tablets weight loss is 0.5 to 1.0% for 100 revolutions. Or 1-5% weight loss for 10 minutes revolution. ( Generally 6 grams of weighed and de dusted tablets place in the rotating apparatus, it revolves at a speed of 25 revolutions per minute i.e 25 rpm. Tablets freely falls from 6 inch height for every rotation. These tablets subjected to 100 rotations or for 10 minutes i.e 250 rotations (10 min*25rpm)).

Acceptance limit for uniformity of content of tablets?

Ans) There are two criterias for acceptance limit.

Take 30 randomly selected tablets. Take 10 tablets, and assay individually. 9 out of 10 tablets should be in the range of 85% to 115%. One tablet can be in the range of 75%-125%. If this criteria fits, it passes the test. If these conditions not met, remaining 20 tablets should be assayed. All of the 20 tablets should in the range of 85% to 115%.

What are different types of capsule sizes and holding capacity of smallest and largest size?

Ans) Sizes are 000, 00 , 0, 1, 2, 3, 4, 5.

Smallest size 5, It can hold at least 65 mg of drug.

Largest size 000, It can hold up to 1000 mg of drug.

What are the types of Gas Chromatography?

Ans) Two types available.

Gas Solid chromatography(GSC) : Stationary phase is solid and gas used as mobile phase.

Gas Liquid chromatography(GLC): Liquid on a thin solid support used as stationary phase and gas used as mobile phase.

Which material used as stationary phase and mobile phase in GSC and GLC ?

Ans) Granular silica, alumina or carbon used as stationary in phase in GSC. Non volatile liquid on solid base like Diatomaceous earth or kieselghar used as stationary phase in GLC. Inert gases like helium or nitrogen used as mobile phase(carrier gas) in both GSC and GLC.

which type of tablets does not require Disintegration test?

Ans) Sustained release tablets, Delayed released tablets and Chewable tablets.

interview questions for quality control analyst

What is disintegration time for Uncoated , coated, enteric coated, dispersible and soluble tablets?

Ans) Uncoated tablets – 30 min (Uses water as medium at 37+20C temperature)

Coated tablets- 30 min (Uses water as medium at 37+20C temperature)

Enteric Coated tablets- 60 min (Uses mixed phosphate buffer at 37+20C temperature) or It should no disintegration for 2 hours (Using in 0.1N Hcl as medium at 37+20C temperature)

Dispersible tablets – 3 min (Uses water as medium at 19 to 210C temperature)

Dispersible tablets – 3 min (Uses water as medium at 19 to 210C temperature)

What is disintegration time for soft gelatin and Hard gelatin capsules?

Ans)

Soft gelatin capsules- 60 min (Uses water as medium at 210C temperature)

Hard gelatin capsules – 30 min (Uses water as medium at 210C temperature)

Accuracy VS Precision:

Accuracy also known as trueness. Analytical Procedure accuracy is the closeness between the accepted reference value or conventional true value and the result value. One measurement is enough to determine the accuracy of an analytical procedure. It does not tell about the quality.

For accepted reference value is 20, you result value is 19.9 or 20.1. Then it is said as high accuracy.

In the same case, your result value is 18.7 0r 21.4. Then it is stated as low accuracy.

Precision: Analytical Procedure precision is the closeness between a number of measurements taken  from the homogenous sample multiple samplings under specified conditions. To measure the precision of an analytical procedure requires several measurements. It speaks about the quality.

For ex: From a homogenous sample, you have measured multiple samples, the values you obtain is

A. 19.2, 19.4, 19.3, 19.2, 19.1

B. 10.2, 10.4, 10.3, 10.2, 10.1

C. 19.2, 22.4, 16.6, 17.1, 16.9

In the above options, Result “A”& “B” said as High precision, Result “C” said as Low precision. Here the consideration is series of measurement values for a particular homogenous sample. There is no reference value in the concept of precision.

Differentiate between relative humidity and absolute humidity?

Ans) Absolute humidity also called as Humidity. Simply defined as amount of water vapour (moisture) present in a volume of air. Unit expressed as gram/m3.

“Relative” humidity: “Relative” nothing but comparison or ratio. So it is expressed in percentage(%). It is the ratio of air current water vapour/moisture/humidity to highest possible water vapour /moisture/ humidity. This highest possible humidity depends upon the current specific air temperature.

Ex: Current air contains 1 gram/m3 of water vapour (humidity), For that air it can hold up to 4 gram/m3 of water vapour (humidity) (It depends on temperature).

Relative humidity = ¼*100 = 25%

LOD:

Limit of Detection: Also known as Detection Limit. For a particular analytical procedure, Upto how much lowest amount of component or analyte  in a sample can be detected. That is the detection limit for that individual or particular analytical procedure. It does not mean that it should able to quantitate that analyte.  It should able to detect that analyte, that’s it.

LOQ: Limit of Quantitation: Also known as Quantitation Limit. For a particular analytical procedure, up to how much lowest of analyte in sample can be quantitated with suitable accuracy and precision. LOQ come into picture in quantitative assays to determine the degraded products or impurities in the samples.

Related: QA interview questions and answers 

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Pharmacovigilance interview questions and answers-Part 2:

Pharmacovigilance interview questions and answers-Part 2:

Pharmacovigilance interview questions are prepared here in two parts. Part 1 covers most of pharmacovigilance interview questions from technical point of view. Part 2 contains technical as well as physiology, medical terms and computer questions.

These are remaining questions continuation to the pharmacovigilance interview questions part 1.

  • What do you know about aggregate reporting?

Ans) It is a procedure that collects all the cumulative safety data of a medicinal product on a periodic basis from a wide variety of sources. These data is submitted to regulatory authorites.

As long as If the company medicinal product is in market of any where in the world.  Aggregate safety reports of that medicinal product should be submitted to regulatory authorities.

pharmacovigilance interview questions pharmaclub

  • Explain about Interventional studies and Non interventional studies?

Ans) Interventional study: This is a type of clinical trail. Treatment/Intervention is assigned to one or more groups in the clinical study. Another group may not receive the treatment (if it is a Control group otherwise If it is active control group, this group also receive the medication). All these details will be mentioned in the study protocol in advance and evaluates the medicinal product effect on health related outcome.

Non-interventional study: Also known as Observational study. Participants in this study receives medicinal product in usual manner. These studies helpful to determine various aspects of medicinal product use. In these studies Treatment strategy is not decided advance in the protocol. Any additional diagnostic methods are not used (only clinical samples are collected as the part of their regular normal clinical practice) to measure efficacy. Usually questionnaires, interviews used to collect the data.

Related: Job opportunities after M pharm Pharmcology

  • What do you know about signal and its types?

Ans) Signal is a reported information based on a causal relationship. This information may be not known till now or incompletely reported previously. For generating a signal, 2 or more than 2 reports are required.

Three types of signals are available.

  1. Confirmed signals
  2. False signals
  3. Unconfirmed signal: need further information.
  • What do you know about causality and mention causality assessing methods?

Ans) Causality is all about relatedness or relationship between a set of factors mainly of drug and adverse event. For assessing the causality, several methods are available.

e.g: WHO assessment scale, European ABO system, Kramer scale etc.

Note: These pharmacovigilance interview questions and answers helpful mainly for freshers also some of the questions  for experienced people.  While attending a pharmacovigilance interview, you may asked different questions which are related to PV and other working point of view (like basic computer questions. E.g You have to use computer while, so these questions as well questions from your personal education background may also be expected).

If you are trying to attend a pharmacovigilance interview , you should aware of all these pharmacovigilance interview questions and answers. We hope that this pharmacovigilance interview questions will assist you face the interview successfully.

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  • What are sources of Adverse Event Reports?

Ans) Adverse events reported by following sources.

  • Spontaneous reporting by healthcare professionals (Physicians/ Pharmacists/Nurse etc.)
  • Solicited reports from Clinical trails
  • Stimulated reports through patient support programs, marketing surveys, patient registries, disease management and medical chart reviews etc.

Apart from these questions, Usually pharmacology questions asked in interviews generally. Questions and answers as follows.

These are the common physiology and pharmacology question and answers you should know before attending the pharmacovigilance interview.

  • What are life threatening diseases? and explain it?

Ans) These are the dangerous diseases which are able to cause death.  Usually these diseases are chronic diseases and most of these diseases/medical conditions don’t have proper curable treatment. E.g HIV/AIDS, Diabetes, Hypertension, Cancer, Neurological conditions etc.

  • What do you know about diabetes and mention the drugs used for its treatment?

Ans) Diabetes is a metabolic disorder. There are two types of diabetes.

  • Type 1 diabetes: In this type, insulin is not produced from the pancreas. Insulin produced cells may be damaged due to several reasons like due to immunity disorders or infections etc. Direct insulin injections are used in this disorder.
  • Type 2 diabetes: In this type, Insulin produced in the body, Type 2 DM patients unable to use this insulin properly. This is the most common diabetes.

Most commonly used are Metformin, Gliclazide, Glimperimide, simvastatin etc.

  • Gestational diabetes: This is disorder occur in pregnancy.
  • What is the normal blood pressure and explain about Hypertension?

Ans) 120/80 considered as normal blood pressure. 120 indicates systolic blood pressure and 80 diastolic blood pressure.

High blood pressure(Hypertenstion) is a long term medical disorder. If pressure of the blood is high enough i.e 140/90 on arteries, it is called as hypertension. Excess salt, excess body weight, smoking and alcohol are the risk factors for high BP.

  • Expand ECG, COPD disease,EEG, FSH harmone, OGTT test, HIV, ICU and NIDDM?

Ans) ECG-  Electrocardiogram

COPD- Chronic Obstructive Pulmonary Disease

EEG- Electroencephalogram

OGTT- Oral Glucose Tolerance Test

HIV- Human Immunovirus

ICU- Intensive Care Unit

NIDDM- Non Insulin Dependent Diabetes Melletus.

  • Tell me about various parenteral routes of administration?

Ans) Intravenous (IV) route – Drug delivered directly into a vein.

Intramuscular (IM) route- Drug  injected into the muscle.

Subcutaneous (SC) route- Drug delivered through the subcutaneous layer located the below the dermis and epidermis layer of the skin.

Intra arterial (IA) route-  Drug injected through artery which specific for a particular organ.

Intra articular route: Drug injected in joint space avoiding the systemic circulation.

Intrathecal route: Drug injected in to the spinal canal or subarachnoid space .

Intradermal route: Medicine injected through the skin dermis layer.

  • Explain the functions of Liver, lungs and kidney?

Ans) Liver: It plays key metabolic functions in the body like carbohydrates, fats and protein metabolism. It detoxify the blood chemicals. It stores the minerals, vitamins and glycogen. Liver produces the bile salts for breaking down the fats in the small intestine.

Lungs: The main function of the lungs is to exchange the gases during the respiration. It provides the oxygen to the blood (RBC) and removes carbon dioxide from the blood (RBC).

Kidneys: It plays a key role in balancing the water fluids level. It continuously filter the blood and do excretion or retention of the minerals depend upon the body requirement.

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Apart from these questions, you are may be asked about basics of computer short cuts

  • Mention a few keyboard shortcuts except cut, copy and paste?

Ans) Ctrl +A : Select all, Ctrl + B: Bold,  Ctrl + D: Go to Font, Ctrl + E: Align the line or selected text to the center, Ctrl + F: Find, Ctrl + G: Go to, Ctrl + H: Replace, Ctrl + I: Italics,  Ctrl + N: New document, Ctrl + P: Print,

Windows+ D : Go to desktop

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