INTERVIEW QUESTION AND ANSWER FOR PRODUCTION AREA
1. What is pharmaceutical production?
Answer:
Pharmaceutical production is the process of manufacturing medicines by following approved procedures, GMP guidelines, and quality standards to ensure safety, efficacy, and consistency.
2. What is GMP?
Answer:
GMP (Good Manufacturing Practice) is a system that ensures products are consistently produced and controlled according to quality standards. It reduces risks like contamination, mix-ups, and errors.
3. What are the responsibilities of a production officer?
Answer:
- Follow SOPs and BMR/BPR
- Ensure target production
- Maintain GMP & safety
- Coordinate with QA & QC
- Handle deviations and documentation
- Ensure proper machine operation
4. What is BMR?
Answer:
BMR (Batch Manufacturing Record) is a controlled document that records each step of manufacturing, materials used, equipment, process parameters, and signatures.
5. What is BPR?
Answer:
BPR (Batch Packing Record) records all packing activities such as carton details, batch number, expiry, reconciliation, and line clearance.
6. What is line clearance?
Answer:
Line clearance ensures that the previous product, documents, labels, and materials are completely removed before starting a new batch to avoid mix-ups.
7. What is deviation?
Answer:
A deviation is any departure from approved SOP, BMR, or process parameters. It must be documented, investigated, and approved by QA.
8. What is CAPA?
Answer:
CAPA (Corrective and Preventive Action) is taken to correct the root cause of deviations and prevent recurrence.
9. What is in-process control (IPC)?
Answer:
IPC checks are performed during production to ensure quality, such as:
- Tablet weight
- Hardness
- Thickness
- Disintegration
- Friability
10. What is granulation?
Answer:
Granulation is the process of forming granules from powder to improve flow, compressibility, and uniformity.
11. Types of granulations?
Answer:
- Wet granulation
- Dry granulation
- Direct compression
12. What is tablet coating?
Answer:
Tablet coating is the application of a polymer layer to improve appearance, stability, taste masking, or modified release.
13. What are common tablet defects?
Answer:
- Capping
- Lamination
- Sticking
- Picking
- Mottling
14. What is yield reconciliation?
Answer:
It is the comparison between theoretical yield and actual yield to identify losses during production.
15. What is change control?
Answer:
Change control is a formal system to manage any change in process, equipment, material, or document with QA approval.
16. What is cross-contamination?
Answer:
Cross-contamination occurs when one product contaminates another, which can be prevented by proper cleaning and segregation.
17. What is cleaning validation?
Answer:
It proves that cleaning procedures effectively remove residues to acceptable limits.
18. What documents are used in production?
Answer:
- SOP
- BMR
- BPR
- Logbooks
- Deviation reports
- Change control forms
19. What is OOS?
Answer:
OOS (Out of Specification) means test results that fall outside approved limits.
20. Why do you want to work in production?
Answer:
I want to work in production because it gives me hands-on experience, responsibility, and the opportunity to ensure high-quality medicines for patients.