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Pharmaceutical Interview Questions 3 contains interview questions about different countries regulatory body, expiry date, MSDs, quality audit, re-test date, reprocess, rework, types of cleanings frequently asked in pharma industry

21. Write the names of the different countries regulatory body (Like for India, USA, UK, Australia, South Africa, Brazil, Hungary, Germany, Philippines etc.)
22. What is the abbreviation of MSDS and how many contents are mentioned & what are those?
23. What is the static electricity?
24. What is the different types of Qualifications and write its flow?
25. What is audit/inspection and Why quality audit? Write different types of aud...

21. Write the names of the different countries regulatory body (Like for India, USA, UK, Australia, South Africa, Brazil, Hungary, Germany, Philippines etc.)

  • India – Schedule M
  • United Status of America – USFDA (United States Food and Drug Administration)
  • Australia – TGA (Therapeutic Goods Administration)
  • United Kingdom – MHRA (Medicines & Health care products Regulatory Agency)
  • South Africa – MCC (Medicine Control Council)
  • Brazil – ANVISA (Brazilian Health Surveillance Agency or National Sanitary Surveillance Agency)
  • Hungary - PIC/S (Pharmaceutical Inspection Convention or Pharmaceutical Inspection Cooperation Scheme)
  • Germany – NIP (National Institute of Pharmacy)
  • Philippines – BFAD (Beaureu of Food & Drug)
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22. What is the abbreviation of MSDS and how many contents are mentioned & what are those?

MSDS means Material Safety Data Sheet and it contains 16 contents. Those are given below:

1. Product Identification
2. Composition / Information on Ingredients
3. Hazards identification
4. First Aid measures
5. Firefighting measures
6. Accidental release measures
7. Handling & storage
8. Exposure controls / Personal protection
9. Physical & Chemical properties
10. Stability & Reactivity
11. Toxicological information
12. Ecological information
13. Disposal consideration
14. Transport information
15. Regulatory information
16. Other information

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23. What is the static electricity?

Denoting / pertaining to electricity which is at rest. The electricity which is present on surface of a non-conductive body, where it is trapped from escaping, is called static electricity.

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24. What is the different types of Qualifications and write its flow?

Qualifications are as follows:

  1. Design Qualification, 
  2. Installation Qualification, 
  3. Operational Qualification, and 
  4. Performance Qualification.


URS/DS -----FAT-----SAT-----DQ-----IQ-----OQ-----PQ

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25. What is audit/inspection and Why quality audit? Write different types of audits/inspection?

A planned and systematic examination and check of a system, procedure or operation in order to monitor compliance with and the effectiveness of established standards and to allow for improvement and corrective measures where required.

Quality audit because of:

  • To assess the effectiveness of the quality management system
  • Assessing conformance
  • Investigating problems
  • Continual improvement of performance
  • Assessing for Registration
  • Reducing cost of operation
  • Legal requirement

Types:

1. Study/test based inspection
2. Facility based inspection
3. Process based inspection



 

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