Section – Documentation
WHO GMP Training Questions and Answers Section for pharmaceutical manufacturing units :- Documentation
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 knowledge these questions are provided with answers at the bottom of every page ,so enjoy solving them, you can use these questions and answer sheet to train your personnel.
1. Which of the following is a GMP requirement for documentation:
(A) To put the pharmacopoeia specifications for raw materials into a company authorized document.
(B) To tell people what to do and when.
(C) To make sure the process operators have something to do while waiting for a manufacturing step to finish.
(D) To provide an audit trail in the case of a justified customer complaint.
2. Master copies of documents should be signed by:
(A) The author alone.
(B) The QC manager.
(C) The technical director.
(D) The author plus appropriate authorization signatories.
3. Approval signatures on electronic documents:
(A) Can be electronic or hard copy as appropriate.
(B) Must always be written by hand.
(C) Are not required at all.
(D) Must always be electronic.
4. Review of master documents:(A) Should take place every 6 months.
(B) Should take place every 12 months.
(C)Is not necessary once they have been approved.
(D) Should take place according to a pre-defined schedule.
5. Mistakes made in filling in documentation:
(A) Should be neatly covered by white correcting fluid.
(B) Should be completely covered over with a dark black pen.
(C) Should be crossed through with a single line and initialed or signed, dated, and if appropriate, the reason recorded.
(D) Should be reported to the supervisor at once.
6. Within a factory, labels are required for:
(A) All material containers.
(B) All equipment used in production.
(C) Processing areas such as packing lines.
(D) All of the above.
7. In order to sell a product, the company must have:
(A) Material specifications.
(B) Specifications, master formula, packaging instructions and batch processing records.
(C) Master formula and packaging instructions.
(D) Batch processing records.
8. Colour coding for labels is useful because:
(A) It reduces the need for writing on the label.
(B) It prevents mistakes being made due to incorrect information on the label.
(C)It provides additional security that the information is correct.
(D) It prevents people from needing to read the label.
9. Which of the following must be found on the company’s raw material approved status label:
(A) Company standard name for the raw material.
(B) Unique inwards goods number.
(C) Manufacturer’s batch number.
(D) Expiry or review date.
10. A specification will need to be amended:
(A) Every 12 months.
(B) If there is a change in a related national compendium.
(C) Every 24 months.
11. A specification is required for an intermediate:
(A) If the material is bought in by the company.
(B)If the material is sold on by the company.
(C) If the results are used in the final evaluation of the product.
(D)All of the above.
12. Which of the following is required in a master formula:
(A) Full list of materials with theoretical weights.
(B) Space to record the actual weights used.
(C) Stepwise processing instructions.
(D) Storage requirements and special precautions.
13. Packaging instructions will normally be found:
(A) In the technical director’s office.
(B) In the QC laboratory.
(C) In the engineering workshop.
(D) Wherever they are used as reference documents.
14. Document audit of batch processing records is carried out:
(A)Before the next batch is commenced.
(B)Whenever the QC department has time to do it.
(C) Prior to batch release.
(D) Whenever production management has time to do it.
15. Which of the following must be found on a batch processing record:
(A) Expiry date of each raw material used.
(B) Name of product and batch number.
(C) Date and time of key steps.
(D) Reconciliation of final yield.
16. Which of the following must be found on a batch packaging record:
(A) Expiry date of finished product.
(B)Reconciliation of bulk product against finished packs.
(C)List of active ingredients used with reference codes.
(D) Reconciliation of packaging materials used.
17. Which of the following information should SOPs carry on every page not just one of the pages to meet GMP:
(A)Page number and document reference number.
(C) Review date.
(D) Authorizing signatures.
18. Standard Operating Procedures (SOPs) are written:
(A)To make sure that the inspector is happy.
(B) To give production managers something to do.
(C) Because GMP require it.
(D) To make sure people know what to do and when.
19. Stock control documents are required:
(A) To ensure that the company knows how much material it has.
(B) To make sure the material can be found when it is needed.
(C) To make sure the material is used in the right order.
(D) All of the above.
20. Distribution records are critical for product recalls because:
(A) The company can find the material that must be recalled as quickly as possible.
(B) The company can give the customer the choice of returning material or not.
(C)The company only needs to warn its most important customers.
(D) The recall can be carried out without notifying the authorities.
Test Paper 12 – GMP TrainingSection – Documentation
1. A, B and D. There may be some debate as to whether A really is a requirement.
9. A, B and D (the manufacturer’s batch or lot number must be traceable through other company records but does not need to go on the approved label)
12. A, C and D (B is not required on the master but will be required on the process record)
15. B, C and D
16. A, B and D
17. A and D
18. C 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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