Pharma GMP Questions and Answers Personnel

1. Establishment and maintenance of a satisfactory system of quality assurance:

.(A) .Relies upon people.

.(B) .Needs good systems with just a few good people in charge.

.(C) .Just needs one or two good people at the top.

.(D) .Can be done by one good person.

2. The manufacturer:

.(A) .Can make one individual responsible for all GMP issues.

.(B) .Need have only a limited number of people who look after all GMP matters.

.(C) .Should have an adequate number of people who are well qualified but may lack pharmaceutical manufacturing experience.

.(D) .Should have an adequate number of people who have both the necessary qualifications and experience.

3. The manufacturer should have:

.(A) .A few people who are able to delegate their jobs to junior staff.

.(B) .People who are motivated by the threat of dismissal if they don’t perform their duties responsibly.

.(C) .An organization chart and written job descriptions for all staff.

.(D) .Consultants, if it is a small company, who work part time in key posts when necessary.

4. Personnel, when recruited:

.(A) .Should already be aware of GMP requirements to reduce training.

.(B) .Receive initial and continuing training relevant to their needs.

.(C) .Need to be flexible enough to take on any task management gives to them.

.(D) .Should be made aware that if they make a mistake the supervisor is paid extra to detect and correct it.

5. Access to production, storage and quality control areas:

.(A) .Can be given to everyone wearing the appropriate clothing.

.(B) .Should be controlled to prevent unauthorized people from entering.

.(C) .Can be given to office staff if they need to get to the warehouse at the back, provided they are properly trained in GMP and are wearing appropriate clothing.

.(D) .Is acceptable for GMP inspectors even though they may not have suitable factory clothing, providing they are with senior management.

6. Key personnel include:

.(A) .Head of production.

.(B) .Head of quality control.

.(C) .Head of sales and distribution.

.(D) .Authorized person.

.(E) .All of the above.

7. Key personnel:

.(A) .Have to have appropriate qualifications and experience irrespective of the size of the company.

.(B) .Can delegate the most difficult decisions to the owner.

.(C) .If they have a lot of experience, do not need academic qualifications.

.(D) .Should have scientific education and practical experience to exercise professional judgement.

8. Heads of production and quality control:

.(A) .May share some responsibilities depending on national regulations.

.(B) .Can never share responsibilities.

.(C) .May report to one another depending on who is the most senior person.

.(D) .Have no role in managing contract manufacture or analysis.

9. The head of production:

.(A) .Has the responsibility to approve or reject packaging materials.

.(B) .Has the responsibility for the maintenance of all equipment in all departments including quality control.

.(C) .Ensures that products are produced and stored according to the appropriate documentation.

.(D) .Ensures the training of all personnel apart from in GMP.

10. Training should be provided:

.(A) .By GMP Inspectors for small companies.

.(B) .By the manufacturer in accordance with a written programme.

.(C) .Only for senior management in charge of quality control and production.

.(D) .For all senior and top managers as well as other staff employed in the factory.

11. People who work in specialized areas, such as sterile areas:

.(A) .Should be paid extra money for all the problems that arise.

.(B) .Should be kept to a minimum to minimize the training costs.

.(C) .Don’t need any special or extra training because they have to be specialists by law.

(D) Should be given specific training relevant to the special needs of that area.

12. When sudden orders appear, the company is permitted by the GMP guidelines to:

.(A) .Take temporary staff on provided they do not work directly with the product.

.(B) .Take on temporary staff and just tell them exactly what they have to do.

.(C) .Provide any temporary staff with all the training that full time staff should receive before they do anything that can affect product quality.

.(D) .Offer existing staff overtime to prevent having to take on any temporary staff.

13. When GMP inspectors arrive, the company should:

.(A) .Give them information in advance particularly about hygiene and the wearing of appropriate protective clothing. The visitors must be closely supervised.

.(B) .Permit them go where they like in production so long as they are closely supervised by a company escort.

.(C) .Encourage them to pick up products to check its quality.

.(D) .Encourage them to talk to operators to see for themselves how things are actually done.

14. The Minister for Health arrives for a factory visit and refuses to wear hair covering because it may look silly in photographs. What should the company do?

.(A) .If he fails to be persuaded, production stops and all the production that was exposed to him is rejected.

.(B) .He is refused entry to the production areas.

.(C) .Factory staff have already planned for this eventuality. No production is planned for the day.

.(D) .Any of the above.

15. Key personnel in production should possess a qualification in:

.(A) .Business studies so they understand commercial realities.

.(B) .Personnel sciences because of the importance of people to production.

.(C) .Life, because experience of the real world is the best qualification.

.(D) .An appropriate combination of sciences with relevant practical experience.

16. In small companies:

.(A) .The GMP inspectorate can exempt them from the need to have key personnel.

.(B) .They should have independent people responsible for quality control and production, both of them preferably full-time.

.(C) .They can have one part-time person who does all the key personnel work.

.(D) .They can carry on working when the qualified people and their delegates are sick or on holiday provided that they save up all batch releases until they return.

17. Process validation:

.(A) .Is only done by large companies who can afford to do it.

.(B) .Is extremely complicated and needs special consultants to make it happen.

.(C) .May be a shared responsibility of production and quality control staff.

(D) Is the sole responsibility of the quality control manager.

18. Personnel policies should be prepared:

.(A) .Which motivate all personnel to high quality standards.

.(B) .Which disciplines people if they do not follow procedures.

.(C) .Which show clearly that if people have a wound or lesion they will be put on leave.

.(D) .Which allows flexible job descriptions since these may change with the introduction of ISO9000.

Test Paper 8 – WHO GMP Training

Section – Personnel

Answers

.1. .A

.2. .D

.3. .C

.4. .B

.5. .B, and maybe C, depending on the circumstances. Be prepared to accept a good case.

.6. .E

.7. .A

.8. .A

.9. .C

.10. .B and D

.11. .D

.12. .C and D, or C or D

.13. .A

.14. .B

.15. .D

.16. .B

.17. .C

.18. .A, maybe B. Be prepared to discuss this since harsh punishment procedures may make a culture of covering up mistakes rather than reveal them. On the other hand some discipline is warranted if the culprit continues to make mistakes.