QA Interview Questions for Pharma Freshers: GMP, CAPA, Deviation & Change Control Explained

Quality Assurance (QA) and IPQA (In-Process Quality Assurance) roles are popular among B.Pharm and M.Pharm freshers. QA interviews focus on GMP systems and documentation rather than lab instruments. Here are the key questions and how to answer them.

GMP basics

1. What is GMP?

Good Manufacturing Practice – the minimum standards a manufacturer must follow so that products are consistently produced and controlled to quality standards. In India, GMP requirements are given in Schedule M of the Drugs and Cosmetics Rules.

2. What is cGMP?

"Current" GMP – it means companies must use up-to-date technologies and systems, not only the minimum written rules.

3. What are SOPs?

Standard Operating Procedures – approved written instructions for performing a routine activity in the same way every time.

Quality management system questions

4. What is a deviation?

Any departure from an approved procedure, specification or instruction. Deviations are classified (critical, major, minor), documented, investigated for root cause and closed with corrective actions.

5. What is CAPA?

Corrective and Preventive Action. Corrective action fixes the cause of an existing problem; preventive action stops a potential problem from happening. Effectiveness of CAPA must be checked after implementation.

6. What tools are used for root cause analysis?

5-Why analysis, Fishbone (Ishikawa) diagram, brainstorming and fault tree analysis.

7. What is change control?

A formal system to propose, evaluate, approve, implement and verify any change (equipment, process, material, document) that could affect product quality.

8. What is a market complaint and how is it handled?

A complaint from a customer about product quality. It is logged, the retained samples and batch records are reviewed, investigated, and a response with CAPA is given within a defined time.

9. What is a product recall?

Removing a distributed batch from the market because of a quality or safety problem. Recalls are classified by risk to the patient.

Documentation and IPQA

10. What is a BMR and BPR?

Batch Manufacturing Record and Batch Packing Record – documents that record every step of manufacturing and packing of a specific batch, so the full history can be traced.

11. What is line clearance?

Checking that the area and equipment are free from previous product, materials and documents before starting a new batch, to prevent mix-ups. IPQA verifies and signs it.

12. What in-process checks are done during tablet compression?

Average weight, weight variation, hardness, thickness, friability and disintegration time, at fixed intervals.

13. What is AQL?

Acceptable Quality Level – a statistical sampling plan used, for example, in packing inspection to decide whether a lot is accepted or rejected.

Validation and qualification

14. What are DQ, IQ, OQ and PQ?

Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification – stages to prove equipment is designed, installed and works correctly for its intended use.

15. What is process validation?

Documented evidence that a process consistently produces a product meeting its specifications. Traditionally, three consecutive batches are taken; modern guidance follows a lifecycle approach (design, qualification, continued verification).

16. What is cleaning validation?

Proving that a cleaning procedure removes product residues, cleaning agents and microbes from equipment to acceptable limits.

17. What is APQR?

Annual Product Quality Review – a yearly review of all batches of a product (results, deviations, changes, complaints) to check consistency and find improvements.

Data integrity and audits

18. What is data integrity?

Data must be complete, consistent and accurate throughout its life, following ALCOA+ principles.

19. What types of audits are there?

Internal (self-inspection), external by customers, and regulatory inspections such as by CDSCO, US FDA, MHRA or WHO.

20. Why do you want to work in QA?

Speak about your interest in systems, documentation and ensuring patient safety – and mention any training or project related to GMP.