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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 audits/inspection?
26. Why nitrogen gas used in the manufacturing area at room temperature and why not other gas?
 27. What are the different types of cleanings?
28. What is blending?
29. What is expiry date & re-test date?
30. What is difference between reprocess & rework?

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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26. Why nitrogen gas used in the manufacturing area at room temperature and why not other gas?

Because of nitrogen is chemically less reactive and does not react with other elements at ordinary temperature. It is due to strong bonding in its molecule.

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27. What are the different types of cleanings?

There are three types of cleanings:

  • Batch to Batch cleaning
  • Periodically cleaning
  • Product change over cleaning

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28. What is blending?

Blending is defined as the process of combining materials within the same specification to produce a homogeneous intermediate or API.

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29. What is expiry date & re-test date?

Expiry date


·         The date place on the container / labels of an API designated the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions and after which it should not be used.

Re-test date


·         The date when a material should be re-examined to ensure that it is still suitable for use. The period of time during which the drug substance is expected to remain within its specifications and therefore, can be used in the manufacturing of the drug product, provided that drug substance has been stored under the defined conditions.

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30. What is difference between reprocess & rework?

 Reprocess:


·         Introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, and milling) that are part of the established manufacturing process.

·         Continuation of a process step after an in-process control test has shown that the step is incomplete, is considered to be part of the normal process, and is not reprocessing.

Reworking:


·         Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent).

Thanks for reading - Pharmaceutical Interview Questions 3
Naitik Patel
Industrial Guide

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