Pharma interview questions and answers – For Formulation production and R&D jobs:

Pharma interview notes:

We have already provided department wise pharma interview question and answers. Also provided qualifying exam papers for interview. Here we covered some more interview Q&A. these notes are also useful for interview. We are dedicated to provide some more interview questions as shown below in the near future. We also provide departmental wise interview notes continuously. Following Q&A are belongs to pharmaceutics which are useful for the production and R&D jobs.

What is corrosion?

It is a metal deterioration process. Due to chemical or chemical reactions or environmental interactions with surface metal, metal surface is gradually destructed. It is an unwanted process. Corrosion leads to machinery damage, product contamination and replacement of damaged machinery increase economic burden to the plant. Corrosion should be avoided by taking preventive measures.

What is passivation?

It is a procedure which makes the stainless steel more rust resistant by reducing the chemical reactivity of surface. Usually citric acid or nitric acid is used to do this process. It removes the free iron from the stainless steel surface. A protective oxide layer will be formed with inert in nature. This layer will less likely react with chemicals or air in the environment. If more layer is formed It will more resistant to corrosion less reactivity with chemicals.

What is the difference between dry bulb and wet bulb temperatures?

These are the temperatures useful to find the state of humid air.

The dry bulb temperature and wet bulb temperature is known as “air temperature” and “adiabatic saturation temperature” respectively.

Dry bulb temperature measured using a thermometer, bulb of the thermometer will be exposed freely in the air. While measuring the wet bulb temperature, bulb will be wrapped in a wet muslin cloth.

Pharma interview notes

What are azeotropes?

Azeotropes are also known as constant boiling mixtures. It is a mixture of liquids that act as a pure liquid having a constant boiling point. The boiling point may be higher or lower than individual component in the mixture’s boiling point. Azeotropes contains same composition of components in both liquid and vapour phase.

For eg:

water boiling temperature : 100 0C,

Ethanol boiling point : 78.3 0C

When a mixture of liquid composed 95% water and 5% ethanol by volume. This azeotrophic mixture will constantly boil at 78.2 0C. By using boiling method or simple distillation, we can not separate water and ethanol from this azeotrophic mixture.

If the mixture contains two liquids, is known as binary azeotropes. If it contains three liquids, it is known as ternary azeotropes.

Mention a few methods to enhance the solubility of poorly soluble drugs?

Various methods are used to enhance the drug solubility are as follows

– Particle size reduction

– Drug salt formation

– Solid dispersion

– Preparing Nano suspension

– Using surfactants

What is lyophilisation?

It is also known as freeze drying technique. In involves following steps

– Freezing: In this step, sterilised partially stoppered containers (drug+ excipients+ solvent) placed in the  freeze drying chamber.

-Primary drying(Sublimation): To sublimate water, pressure is reduced and heat increased. Ice crystals directly converted to vapour bypassing the liquid state. 95% water removed in this phase.

-Secondary drying (Desorption): Remaining bounded water removed in this phase. Temperature is increased more than the primary drying temperature. Then the vacuum is broken and filled with inert gas and sealed.   

This technique is used to preserve the biodegradable materials.

pharma interview notes which are not covered in the previous posts.
What is annealing?

Annealing is also known as slow freezing. When some compounds (ex. Amorphous compounds like mannitol) will not complete crystals. In this case, annealing is used. After forming the crystals, temperature is cycled. (Like -50 C to -30 C for few hours then back to -50 C). This process helps to form larger crystals.

What is osmosis?

It is a phenomenon. When dilute solution and concentrated solution separated by a semipermeable membrane. The  solvent passes from dilute solution to concentrated solution. This pressure is known as osmotic pressure.

Any fluid is injected into the body should be isotonic in nature. If hypertonic fluid injected into the body, it crenation of blood cells. If hypotonic fluid injected into the body, solvent passes in to blood cells causes haemolysis.

Mention a few solubility terms?

Very soluble- 1 part of solute soluble in less than 1 part of solvent

Freely soluble  -1 part of solute soluble in 1-10 parts of solvent

Soluble – 1 part of solute soluble in 10-30 parts of solvent

Sparingly soluble – 1 part of solute soluble in 30-100 parts of solvent

Slightly soluble – 1 part of solute soluble in 100 -1000 parts of solvent

Very slightly soluble – 1 part of solute soluble in 1000-10000 parts of solvent

Practically insoluble – 1 part of solute soluble in more than 10000 parts of solvent

Related: Clinical trials overview

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Quality assurance interview questions in pharma industry

Quality assurance interview questions in the pharma industry:

Before knowing the interview questions for  QA job, you have to know the situation in interview pattern. Here we have provided the question and answers according to Quality assurance department point of view. But in actual times there is no rule to ask these type of questions only. Because you are a fresher and you have all the subjects in your B pharmacy like pharmaceutical analysis, pharmaceutics and medicinal chemistry etc.

They may expect answers form you for other HPLC, UV  etc principles methodology also.  For your understanding about QA job and knowledge required for this job, we have provided QA job oriented knowledge related questions here.

You have to know the Quality control interview questions also before attending an interview for getting success.

Quality assurance interview questions in pharma industry are as follows

1. 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.

2. 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.

3. 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.

4) 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)

Brazil- ANVISA

5) Expand ICH? Tell me about ICH Guidelines?

ICH known as The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. It brings the regulatory authorities and pharmaceutical companies together to discuss the drug registration technical aspects.

The aim of the ICH is to enhance the harmonisation world wide to make sure that  safe, high quality and effective drugs are developed and registered in the most efficient manner.

ICH provides guidelines on 4 aspects that is quality , safety , Efficacy and Multidisciplinary guidelines.

6) What is SOP?

SOP known as Standard Operating Procedure.

7)Expand IQ OQ PQ DQ

IQ- Installation Qualification

OQ-Operational Qualification

PQ-Performance Qualification

DQ-Design Qualification

8) Difference between validation and calibration

Validation produces the documented evidence assuring a specific procedure/procedure or activity consistently develops a product with predetermined specifications and quality credits. It is performed according to validation protocol.

Calibration denotes that an equipment produces the values in specified limits by comparing the values produced by a standard. It is done according the calibration standard operating procedure.

9) Expand BMR and BPR?

Ans) BMR – Batch Manufacturing Record , is prepared as a written file during the manufacturing a product  by writing. Step by step manufacturing process and details about batch recorded here.

BPR Batch Packaging Record, is kept for every BMR. BPR is depends on packaging operation.

10) What do you know about stability studies?

Ans) These are necessary for developing the pharmaceutical products. It helps to evaluate the effect of environmental factors (e.g Light, Humidity, Temperature etc) on Active Pharmaceutical Ingredient(API) or Pharmaceutical formulation.

11) What is the time period required for long term and accelerated stability studies?

Ans) Long term 12 months, Accelerated studies- 6 months

12) What are types of climatic zones? India belongs to which climatic zone?

Ans) India belongs to Zone III(Hot dry zone) and Zone IVb(Hot/Higher humidity)


Quality assurance interview questions
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I have also prepared some more important questions for you from QA of point view. You can view QA interview questions in pharmaceutical industry here.

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