Quality assurance interview questions in Pharma

These are the most frequently asked interview questions in the Quality Assurance Department if you are a fresher looking for a job opportunity, in quality assurance then these are basic questions that are asked.

1.  Define SOP?

Answer:  SOP – Standard operating procedure, these are detailed written step-by-step instructions for operations that are routinely performed.        In simple terms, SOP contains detailed written step-by-step procedures for accomplishing a specific task in the pharmaceutical industry

Examples – SOP for weighing balance calibration which contains detailed steps to accomplish calibration of weighing balance.

2. What is API and how it differs from intermediate

Answer: An API abbreviated as Active Pharmaceutical Ingredient also called a biologically active molecule responsible for therapeutic response which can derived from a natural source or manufactured synthetically. whereas an intermediate is a chemical compound that undergoes further      chemical reactions to form API, simply intermediates are precursor molecules

3. Difference between a drug substance and a drug product?

Drug substance (API): Any substance or mixture of substances intended to be used in the manufacture of a drug product, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to get pharmacological activity or another direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
Drug product: The dosage form in the final immediate packaging intended for marketing. Reference ICHQ7A

4. What are ICH guidelines?

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines are the collection of standards and recommendations made by discussions between industry experts and regulatory authorities. The Primary goal of ICH guidelines is to bring harmonization in the regulatory requirements and to ensure safe, effective high-quality medicines are developed registered and maintained.

5. What are the different ICH guidelines?

Answer: These are Q, S, E, M:  – Quality Guidelines – safety guidelines – efficacy guidelines – Multidisciplinary Guidelines.

6. Outline the Quality Guidelines.

Answer:

Q1A-Q1F  Stability

Q2 –  Analytical Validation

Q3A-Q3E Impurities

Q4A –Q4B Pharmacopoeias

Q5A-Q5E Quality of Biotechnology Products

Q6A-Q6B Specifications

Q7 Good Manufacturing Practices

Q8 Pharmaceutical Development

Q9 Quality risk management

Q10 Pharmaceutical Quality System

Q11 Development & Manufacture of drug substances

Q12 Lifecycle Management

Q13 “Continuous” manufacturing of drug substances and drug products

Q12 Analytical Procedure Development

7. What is Quality Assurance?

Answer: Quality assurance” is a diverse concept covering all concepts that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of required quality for their intended use.

8. What is OOT? and explain it with an example
Answer: “OOT” stands for Out of Trend. It means any test results obtained for a particular batch that significantly differs from the previous batches obtained through same validated method. for example, the yield in compression stage for X product is 91 but the OOT limit is Not less than 92.

9. What are Good Manufacturing Practices?

Answer:  According to WHO, Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.

10. Differentiate   Qualification and Validation?
Answer: Qualification is equipment or instrument oriented, but validation is process oriented.