WHO GMP Training Questions and Answers Section for pharmaceutical manufacturing units :- Premises

1. Which is the best answer? Premises can be situated so that:

.(A) .They are in the centre of residential areas to help staff get to work.

.(B) .With all other measures, there is a minimum risk of contamination.

.(C) .They are in an industrial estate with other industry.

.(D) .They are close together to allow staff to change jobs easily.

2. Premises should be reported for violation of GMP if:

.(A) .Rest and refreshment areas are separate from all other areas, with facilities for changing easily accessible for visitors as well as workers.

.(B) .Maintenance workshops have unobstructed access to manufacturing.

.(C) .If toilets are directly accessible to production areas.

.(D) .If animal houses in direct contact with laboratories to make it easier for staff to move easily.

3. Premises used for the manufacture of drug products:

.(A) .Should be constructed as economically as possible.

.(B) .Do not have to control entry of pests if all processes are fully enclosed.

.(C) .Only need maintenance when something breaks down.

.(D) .Should be designed and constructed to facilitate good sanitation.

4. Premises:

.(A) .Only need maintenance when something is reported as not working.

.(B) .Can have service pipes in manufacturing areas that can’t be cleaned because if the process equipment is fully enclosed.

.(C) .Should be cleaned according to detailed written procedures.

.(D) .Can have workshops and animal houses close to manufacturing or quality control areas if that makes it easy for staff to keep an eye on what is happening.

5. Rest and refreshment areas:

.(A) .Can be open to production areas if all product is enclosed.

.(B) .Can be open to production areas provided there is no smoking.

.(C) .should be separate from other areas.

.(D) .Can be open to production areas provided there is no food preparation or consumption.

6. Storage areas:

.(A) .Should be provided with a separate sampling area that prevents cross-contamination if sampling is done there.

.(B) .Can have quarantine materials put into the reject storage area for a few days if necessary.

.(C) .Should have any narcotics stored unmarked throughout the store, making it difficult for thieves to find them.

.(D) .That have printed packaging components do not need any special attention if the packing area standards are very high.

7. Weighing areas:

.(A) .Must have very accurate weigh scales but not special facilities for protection of the product.

.(B) .May belong to either storage or production areas.

.(C) .Are always within the storage or production areas.

.(D) .Do not need any written procedures for operation if controlled by a pharmacist.

8. Storage areas:

.(A) .Should provide segregation as the only acceptable method of controlling status.

.(B) .If under the control of the owner do not have any special procedures and standards.

.(C) .May provide minimal protection from the weather if that helps keep the trucks moving in and out quicker.

.(D) .Should provide segregated storage areas for rejected, recalled or returned materials.

9. Changing facilities:

.(A) .Are not required for visitors if they can change in the manager’s office.

.(B) .Should be appropriate for the number of people using them.

.(C) .Are expensive non-productive space so can be severely limited in area.

.(D) .Do not have to be easily accessible; if staff have to go outside and walk a distance, this will be good for their health.

10. Premises used for the manufacture of:

.(A) .Benzyl penicillin can be used for production of other beta-lactam products if a proper clean-down is done.

.(B) .Pesticides can normally be used for the manufacture of other pharmaceutical products as well.

.(C) .Penicillin must be dedicated and self-contained.

.(D) .Penicillin or highly active products can also be used for other products provided a campaign structure is used for the manufacturing plan.

11. The layout of the manufacturing areas:

.(A) .Can be as compact as possible because these areas are very expensive.

.(B) .Can locate machines in a position to suit the engineers who have a difficult time to maintain them otherwise.

.(C) .Can be open plan if this allows the pharmacist to see everything from his or her office.

.(D) .Should provide sufficient space to minimize risk of omission of any manufacturing or control step.

12. Production area design and installation:

.(A) .Should provide smooth, crack-free walls, floors and ceilings where product or materials are exposed to the environment.

.(B) .Should provide open-channel drains as these are easy to clean.

.(C) .Should provide a layout to suit maintenance rather than product flow.

.(D) .Does not need good lighting if there is no visual inspection required.

13. Production area design:

.(A) .For packaging areas should avoid mix-ups or cross-contamination.

.(B) .Should permit easy and effective cleaning.

.(C) .Should avoid the creation of recesses that are difficult to clean.

.(D) .Should encourage maintenance to be done from outside the areas.

.(E) .all of the above.

14. Quality control laboratories should be:

.(A) .In the production areas to be sure that there is a close overview of production.

.(B) .Should be separated from production areas.

.(C) .Kept very small because it is very expensive, non-productive space.

.(D) .All in one area because there is no risk of cross-contamination or mix-up.

15. Quality control laboratories:

.(A) .Should provide adequate storage space, with cooling if necessary, for samples, reference standards and records.

.(B) .Should provide separate areas for biological, microbiological or radioisotope testing.

.(C) .May need a separate room for instruments to protect them.

.(D) .Should take into account suitability of materials of construction, prevention of fumes and ventilation.

.(E) .All of the above.

16. Premises should be designed:

.(A) .Without considering the maintenance requirements because production must have priority.

.(B) .With minimal storage areas to keep inventory costs down.

.(C) .Providing appropriate airlocks, pressure differentials and air extraction to prevent cross-contamination.

.(D) .To avoid segregated areas that just enable people to waste time.

17. Cross-contamination should be prevented by:

.(A) .Using cleaning and decontamination procedures of known effectiveness.

.(B) .Producing every product in a segregated area.

.(C) .Relying only on status labelling of equipment.

.(D) .Preventing entry of insects or other animals.

18. Segregated areas:

.(A) .Should be available for reception of all materials.

.(B) .Are the only way of controlling the status of materials in the warehouse.

.(C) .Are the only way of ensuring that cross-contamination does not occur.

.(D) .Must be available for the production of certain highly sensitizing materials such as penicillin.

19. Ventilation of areas with temperature and humidity controlled air:
.(A) .Small companies can be exempted from this requirement by the National Health Regulator provided they make only OTCs.

.(B) .Is essential for those products that are sensitive to temperature and moisture.

.(C) .Is necessary only for the correct functioning of computers.

.(D) .Is only required in the offices where major decisions are to be taken.

20. Storage and handling of printed packaging components:

.(A) .Are considered critical, requiring special attention for safe and secure storage.

.(B) .Do not need a lot of space if they are very cheap to replace.

.(C) .Can be left to junior staff if the company has automatic bar code reading systems.

.(D) .Must be kept in the pharmacists’ office under lock and key.

Test Paper 9 – GMP Training

Section – Premises

Answers

.1. .B (be prepared to discuss why A, C and D are not the best answer or are not the responsibility of the GMP inspector)

.2. .B and C. D only if there is direct access to the manufacturing environment

.3. .D

.4. .C

.5. .C

.6. .A

.7. .B

.8. .D (A is incorrect because a validated computerized storage system is permitted)

.9. .B

.10. .A, B (possibly) and C (Be prepared to discuss B; pesticides are often used in eg head lice treatments and scabicides. The chemical can be seen as just another therapeutic to which properly validated cleaning is applied and proper cross contamination measures are taken)

.11. .D (GMP inspectors should have no objection to compact premises provided the space allows for the orderly manufacturing process)

.12. .A

.13. .E

.14. .B

.15. .E

.16. .C

.17. .A and B

.18. .D

.19. .B

.20. .A