.(A) .Released for use immediately if needed urgently for a life-saving product.
.(B) .Quarantined immediately after receipt until released for use or distribution.
.(C) .Used if they were delivered inadvertently to your factory.
.(D) .Purchased according to a specification developed by the finance department to save money.
2. Starting materials purchasing:
.(A) .Should be left to financial staff since they are the only ones who can take that type of decision.
.(B) .Is very important and thus should be taken only by the owner of the company.
.(C) .Can best be dealt with by contacting traders who can get supplies at very reasonable prices.
.(D) .Is an important activity that should involve staff who have detailed knowledge of products and suppliers.
3. On receipt; starting materials:
.(A) .Should be checked to ensure that the consignment corresponds to the order.
.(B) .If found to have broken seals, can be accepted so long as the delivery driver states that all is well.
.(C) .If made up of different batches of the same material, can be sampled as though they are all one batch.
.(D) .Do not need to be labeled until passed by the quality control department.
4. Starting materials may be used:
.(A) .Once they have been sampled by the quality control department.
.(B) .Immediately after they have been labeled with all the details about receipt.
.(C) .Only when released by the quality control department and within their shelf-life.
.(D) .Immediately after the purchasing section has paid the supplier’s invoice.
5. Materials dispensed for a batch:
.(A) .Can be dispensed by one person with no checks if that person is a pharmacist.
.(B) .Should be kept together and clearly labeled as such.
.(C) .Can be sent item by item to the production department, as it wants them.
.(D) .Do not need to be labeled if they are going to an area that only ever makes one product.
6. Printed packaging components:
.(A) .Do not need any special precautions because they are so cheap.
.(B) .If obsolete, can be given to the waste disposal contractor in complete packs with no need to destroy them.
.(C) .Do not need to be handled like other starting materials because they are so cheap and therefore less important.
.(D) .Should be issued for use only by designated personnel using an approved and documented procedure.
7. Materials for recovery:
.(A) .Can be added into a new batch until the mixer cannot hold any more.
.(B) .Do not need to be recorded in the batch document unless the quality control department specifically requests it.
.(C) .Should be added in accordance with a defined procedure after evaluation of the risks involved.
.(D) .Should be kept out of sight so that an inspector doesn’t see them.
8. Reprocessing of rejected materials:
.(A) .Is quite normal and to be expected so long as it is done following an approved procedure.
.(B) .Can be done on whole batches only using the original batch number.
.(C) .Should be exceptional and is permitted only when quality of final product is not affected.
.(D) .Can be done without limit so long as the same procedure is followed.
9. Returned goods:
.(A) .Should not be considered for reissue or reuse if there is any doubt over the quality of the product.
.(B) .May be sent out for resale if they are not sterile products.
.(C) .May be considered for resale if assessed critically by the finance department.
.(D) .May be sold to staff if local legislation permits.
.(A) .Made up by quality control personnel do not need checking since they must be right.
.(B) .Should be labeled with information about the concentration, standardization factor, shelf-life, re-standardization due dates and storage conditions.
.(C) .Should have only positive controls applied to verify their suitability.
.(D) .Do not need to be recorded on manufacture because they are personal to each laboratory operator.
11. Reference standards:
.(A) .Should be stored and used in a manner that will not adversely affect their quality.
.(B) .Can be made freely available to any one who wants them.
.(C) .If produced in-house, do not need to be compared with official standards.
.(D) .If official, can be used for all testing not just those in the monograph.
12. Waste materials:
.(A) .Should be allowed to accumulate until these are sufficient to attract a cheap deal for removal.
.(B) .Can be quietly buried so long as no one knows.
.(C) .Should be collected in the cheapest containers possible so that removal is kept cheap.
.(D) .Should not be allowed to accumulate; and should be disposed of safely.
.(A) .Can be sprayed in production areas without taking care of the prevention of contaminating containers.
.(B) .Can be sprayed lightly into the air in the dispensing department so long as there is only one product or material exposed.
.(C) .Should not be permitted to contaminate any equipment or material.
.(D) .Can come into contact with products or materials so long as they are available in a formulation, that is safe for humans.
14. Starting material labels:
.(A) .Are not needed if a computer storage system is used.
.(B) .Should bear information including the name of the product or material and an internal code reference.
.(C) .Need only be applied after the quality assurance department has rejected the material.
.(D) .With a status of quarantine can have that status changed by warehouse people applying the approved labels.
.(E) .All of the above.
15. Incoming materials:
.(A) .Should be stored under the appropriate conditions and in an orderly fashion.
.(B) .Should be bought using an agreement established by the managing director with the supplier’s managing director.
.(C) .Do not need to be rotated first in, first out if the materials are cheap or have a long shelf-life.
.(D) .Can be dispensed without waiting for approval if the department manager does it.
Test Paper 11 – GMP Training
Section – Materials
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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