1. Balances and other measuring equipment should be checked for effectiveness:
.(A) .On a scheduled basis.
.(B) .Before an inspector comes.
.(C) .Before the manager comes into the department.
.(D) .After the balance maintenance engineer has performed maintenance.
2. Defective equipment:
.(A) .Should be covered up until any inspector has passed by.
.(B) .May be used if the supervisor decides the defect is not too serious.
.(C) .Should, if possible, be removed from the area or clearly labelled as defective.
.(D) .May be used if production is going to be delayed providing it is repaired before the next batch.
3. Equipment must be:
.(A) .Installed where visitors can see it easily.
.(B) .Installed in such a way that risk of error or contamination is minimized.
.(C) .Selected on the basis of lowest cost only to reduce the cost of the drug bill to the nation.
.(D) .Cleaned using a method designed by the boss with no input from operators.
4. Fixed pipework:
.(A) .Should be put above ceilings so that it does not need to be marked.
.(B) .Does not need to be marked if it contains water.
.(C) .Should have only one sort of connector for flexibility.
.(D) .Should be clearly labelled to show contents and direction of flow.
5. Production equipment:
.(A) .Bearings are lubricated with vegetable oil only so that any leak doesn’t harm patients.
.(B) .Should be designed so that it can be easily and thoroughly cleaned on a scheduled basis.
.(C) .Should be maintained only when it is broken. (“If it ain’t broke don’t fix it”).
.(D) .Can be used for other purposes than designed in order to increase its value to the company.
6. Control laboratory equipment:
.(A) .Should be suited to the testing procedures to be undertaken.
.(B) .Should be calibrated once per year before any inspector comes.
.(C) .Should have interchangeable connections for all services.
.(D) .Should be located in a place where the laboratory manager can see it clearly.
7. Washing and cleaning equipment:
.(A) .Does not have to be resistant to the product.
.(B) .Does not need to have any filters.
.(C) .Should not be a source of contamination.
.(D) .If defective, does not need labelling.
8. Non-interchangeable connectors:
.(A) .Are useful to prevent staff taking any pipeline contents.
.(B) .Can prevent staff from taking the pipes for garden hoses.
.(C) .Eliminate the need to label pipes with the direction of flow and the contents.
.(D) .Provide security for the connection of supplies of dangerous gases and liquids.
9. The layout and design of equipment:
.(A) .Must aim to minimize risk of errors and permit effective cleaning.
.(B) .Can permit build-up of dirt and dust so long as it is totally enclosed.
.(C) .Can be installed as the engineers prefer, without any consideration of the effect on production.
.(D) .Can be installed exactly as production staff require without any consideration of the difficulties of maintenance.
10. Production equipment:
.(A) .Parts that come into contact with the product must not affect the quality of the product.
.(B) .Does not need to be designed for cleaning if used to make only one product.
.(C) .That is defective does not need to be labelled as such if it is the only piece of equipment in the room.
.(D) .Can have motors that cannot be cleaned if it is only ever used for one product at a time.
Test Paper 10 – GMP Training
Section – Equipment
.1. .A , (and D)
Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing
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