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Wednesday, September 3, 2008

Pharma Validation Questions Answers

Test Paper 4 – WHO GMP Training
Section – Validation




WHO GMP Training Questions and Answers Section for pharmaceutical manufacturing units :- Section Validation Test Paper 4

In this post i am giving some questions of which you may know answers or you may like to know answers ,i have given few options for you to think up on , this is a very good tool to gather knowlede these questions are provided with answers at the bottem of every page ,so enjoy solving them, you can use these questions and answer sheet to train your personnels.


1. The basic elements of validation are:

.(A) .Evidence that all aspects of a manufacturing process achieve the expected result.

.(B) .Documented evidence that all aspects of systems, facilities, equipment and manufacturing processes achieve the expected result.

.(C) .Documented evidence that the equipment used in manufacturing works as it is intended to.

.(D) .A record of how a manufacturing process works.


2. Prospective validation is carried out:

.(A) .Periodically and/or after major changes.

.(B) .For a production process that has been operating for 6 months.

.(C) .During the research and development phase.

.(D) .While a new product is being commissioned on the plant.


3. Concurrent validation is carried out:
.(A) .Periodically and/or after major changes.

.(B) .For a production process that is routinely used.

.(C) .During the development phase.

.(D) .During the normal production of a batch.


4. Retrospective validation is carried out:

.(A) .Periodically and/or after major changes.

.(B) .For a production processes that have been used on a routine basis, based on analysis of accumulated data.

.(C) .During the development phase.

.(D) .Whilst a new product is being commissioned on the plant.


5. Revalidation is carried out:

.(A) .Periodically and/or after major changes.

.(B) .For a production process that is already up and running.

.(C) .During the development phase.

.(D) .While a new product is being commissioned on the plant.


6. The purpose of design qualification is to check:

.(A) .Has it been built correctly?

.(B) .Has it been designed correctly?

.(C) .Does it produce product correctly?

.(D) .Does it work correctly?




7. The purpose of installation qualification is to check:
.(A) .Has it been built/installed correctly?

.(B) .Has it been designed correctly?

.(C) .Does it produce product correctly?

.(D) .Does it work correctly?


8. The purpose of operational qualification is to check:

.(A) .Has it been built correctly?

.(B) .Has it been designed correctly?

.(C) .Does it produce product correctly?

.(D) .The dynamic attributes of a piece of equipment and whether it works correctly?


9. The purpose of performance qualification is to check:
.(A) .Has it been built correctly?

.(B) .Has it been designed correctly?

.(C) .Does it produce product correctly?

.(D) .Does it work correctly?


10. The purpose of a validation master plan is:

.(A) .To list the tests and acceptance criteria for the entire validation programme.

.(B) .To provide an overview of the policy on validation.

.(C) .To record the results of tests carried out during validation.

.(D) .All of the above.


11. The purpose of a validation protocol is:

.(A) .To list the procedure, tests and acceptance criteria.

.(B) .To provide an overview of the whole programme.

.(C) .To record the results of tests carried out during validation.

.(D) .All of the above.


12. The purpose of a validation report is:

.(A) .To list the tests and acceptance criteria for all the validation programme.

.(B) .To provide an overview of the whole programme.

.(C) .To record and present the results of tests carried out during validation.

.(D) .All of the above.




Test Paper 4 – GMP Training

Section – Validation

Answers



.1. .B

.2. .C

.3. .D

.4. .B

.5. .A and B

.6. .B

.7. .A

.8. .D

.9. .C

.10. .B

.11. .A

.12. .C

Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing

Pharmaceutical Validation

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