BIT 155 80 Quality Control and GMP's Mid-Term

Name _______ Date

1. The FDA is given authority to inspect and regulate drug manufacturer’s according to the

b. Pure Food and Drug Act

2. Harvey Washington Wiley was

b. The first commissioner of the Bureau of Chemistry

3. A drug must have certain characteristics so as to meet the requirements of the “Act”. What are these characteristics?

Identity, Quality, Strength, purity.
Method development
Stability testing
Quality pharmaceuticals.

4. What is the significance of the Park’s decision?

Is a desition making process. Discussion between people about the drugs, and is quality. comprehasive logical decisions.

5. What is an adulterated drug?

A drug that may be filthy, or has discomposed substance. A contaminated drug. This drug is held in insanitary condition and later becomes contaminated.

6. If no observations are found, during an FDA inspection, it will be stated in the form 483. True

7. If an FDA investigator asks a question you don’t know; take your best guess. False

8. Phase I, II and III are animal studies. True

9. FDA can take action against drug manufacturer’s but not individuals in the firm. True or False

10. Matching

___E__ FD-483 a. Drug which caused birth defects

___D__CDER b. FDA group that controls devices

J__Phase I c. Document from FDA which requires a response, within 15 days, or other action will be taken

___F__CBER d. FDA group that controls drugs

__H___Phase III e. Notice of Inspection Observations

___B__CDRH f. FDA Group that controls biologics

___I__GLP’s g. Drug which contained poisonous substance which eventually led to deaths

___C__Warning Letter h. Where efficacy is determined

___A__Thalidomide i. Initial safety studies

___G__Sulfanilamide j. Regulation governing preclinical testing

11. __________ is the practice used to prevent mix-ups of labeling, drug product containers, closures, components, etc.

b. Segregation

12. Areas for storage of untested components are

d. Quarantine Areas

13. Cleaning and sanitizing solutions used to prevent contamination must be included in

d. All of the above

14. Each person responsible for supervising the manufacture of drug product shall have ______Education_____ , ______Training , and ______Experience________ or any combination thereof.

15. Once a person has successfully completed GMP training, no further training is necessary until regulations are changed.

True

16. If a person is a temporary worker, the regulations state that they need to be trained in the particular operations they perform. Since they are short term, training in the particular operations is adequate and GMP training need not be performed.

False

17. The major source of contamination in clean rooms comes from:

Airborne Particles, lack of adequate space.

18. The Quality Unit should not report to the Manufacturing organization.

False

19. Cleaning and Sanitation procedures require.

a. All the above

20. The Manufacturing Unit can not approve components for use.

True

21. The Manufacturing Supervisor can make a temporary change to a procedure as long as it is documented.

True

22. B Equipment must be A. Reactive, additive, absorptive

23. A Surfaces that may B. Cleaned, maintained, sanitized alter the drug product

24. C Done to prevent C. Appropriate design, adequate malfunction or size, suitably spaced contamination

25. When sampling components, samples should be taken

d. from the top, middle, and bottom of the containers sampled

26. Rejected components, drug product containers or closures shall be identified and controlled under a _________ system to prevent their use in manufacturing or processing operations for which they are unsuitable.

c. quarantine

27. Components need to be stored, in shipping boxes, on the floor in the quarantine area until tested and released.

True

28. What statement best describes the requirement for use of stock materials?

a. First in first out

29. A certificate of testing may be accepted from the outside supplier if the following is true. (Circle all that apply)

a. you conduct at least a visual examination

b. establish the reliability of the supplier

c. have the suppliers test procedure qualified and on file

30. When we talk about containers and closures what are we referring. Describe what their functions are and list at least 2 examples of each.

Shall not be reactive, Addictive, and Adsorptive. Shall be clean where indicated, and sterilized to remove bacteria protegens. Specification test method, and processing should be written, follow.

31.What information is required on the sample containers submitted for testing?

32. Drug product batches are formulated to provide not less than ______ of the labeled or established active ingredient. a. 95 - 105% b. 90 - 100% c. 100% d. 99.9995%

33. Outdated or obsolete labels, labeling, or other packaging materials must be a. reprinted b. destroyed c. returned d. filed

34. The GMP's require a second check for some operations. What specific operations require a second check? (Give 3 examples)

35. The GMP's require identification of major pieces of equipment in the batch record. Why? This information is used in the event of:

36 In your own words, why would you have time limitations on production? And what do you think would be the major concern if the drug or biologic was a parenteral?

37. When a component is placed in a new container, what pieces of identification are necessary on the new container?

38. What expiration dating is required for a lyophilized product and how is it determined?

39. In-process specifications are derived from previous acceptable process averages and are slightly less stringent than the final specifications

True or False

40. Area or line clearance refers to: a. authorization to enter the restricted area where labeling materials are stored b. an area free from trash or contamination c. security of an area between operations d. inspection before and after use.