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Pharmaceutical Interview Questions 2 contains questions about API, cGMP implementation, cGMP in Pharma industry, GMP guidelines, preventive maintenance in industry, Quality Assurance, Technology Transfer, types of different training programs, frequently asked in Pharma interview

11. What is the Technology Transfer?
12. What are the names of different countries of GMP guidelines for manufacturing of API?
13. What is preventive maintenance?
14. What do you mean by “Quality Assurance”?
15. What are the types of different training programs?
16. What is cGMP?
17. What are the requirements for the equipment used in the manufacturing of process of API?
18. How are cGMP implemented?
19. What is solvent? What are the classifications of residual solvents?
20. What is the difference between Responsibility and Accountability?

11. What is the Technology Transfer?

·         In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full scale commercialization or it is the process by which a developer of technology makes its technology available to commercial partner that will exploit the technology.

·         To assure the drug quality, it is desire to make sure 5 W’s and 1 H, that is what1, when2, and why3 information should be transferred to where4 and by whom5 and how to transfer, then share knowledge and information of the technology transfer each other between stake holders related to drug manufacturing.

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12. What are the names of different countries of GMP guidelines for manufacturing of API?

  • ·         WHO GMP - Geneva
  • ·         ICH Q7A – Europe, Japan & US
  • ·         EU GMP - Europe
  • ·         MCC – South Africa
  • ·         APIC GMP – Active Pharmaceutical Ingredient Committee (A sector group of CEFIC)
  • ·         USFDA GMP – United States of America
  • ·         PIC/S GMP- Germany
  • ·         Schedule M – Indian

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13. What is preventive maintenance?

·         It is periodic inspection and minor repairs of equipment as per schedule given in the SOP. This enables smooth operation and long life of the equipment. It also avoids major breakdown of the equipment during manufacturing of the product.

·         There are two types of maintenance.

o  Preventive maintenance: Schedule maintenance before any break down of machinery which prevents the machine break down.

o  Breakdown maintenance: Maintenance was done after stopping machine breakdown. Weekly, Monthly, Quarterly, Half yearly and Yearly preventive maintenance

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14. What do you mean by “Quality Assurance”?

The sum total of the organized arrangements made with the objects of ensuring that all APIs are of the quality required for their intended use and the quality systems are maintained.

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15. What are the types of different training programs?

1. Induction training
2. Job oriented training
3. cGMP training
4. On-going training

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16. What is cGMP?

Current Good Manufacturing Practices.

This means any procedure / system adopted by the manufacturer which proves to be necessary and important for identity, strength and purity of a product.

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17. What are the requirements for the equipment used in the manufacturing of process of API?

Material of construction used for equipment should not

·         React with component
·         Get corroded, cause rusting
·         Impart any impurities, absorb
·         Should be of appropriate design, adequate size and have smooth surface.

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18. How are cGMP implemented?

Training, compliance to SOPs, control on operations, following procedures / systems, monitoring through compliance audits.

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19. What is solvent? What are the classifications of residual solvents?

An organic or inorganic liquid used as a vehicle for the preparation of solutions or suspensions in the manufacturing of an intermediate / API.

Residual solvents are classified into three class based on the possible risk to human health:
·         Class-I (Solvents to be avoided)
·         Class-II (Solvents to be limited)
·         Class-III (Solvents with low toxic potential)
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20. What is the difference between Responsibility and Accountability?

Responsibility: Personnel directly associated with the implementation of the procedure
Accountability: Person directly associated with the implementation of the system under which the procedure falls.

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Thanks for reading - Pharmaceutical Interview Questions 2
Naitik Patel
Industrial Guide

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