21 22. An air break or other mechanical device to prevent Part 210 CL CESSING, P

Question

21 22. An air break or other mechanical device to prevent Part 210 CL CESSING, PA back-siphonage is required for a. the air fiältration systems b. MANUF the humidity and temperature systems ins connected a sewer s are provided only for those personnel working in the sterile tedilisies CURRENT SING, PACK a. True b. False 24. Wri itten sanitatlon procedures are required only for the sterile fadilisies a. True b. False or current good bility of curren 25. It is against CGMP regulations to use suitable rodentiddes, insecticides, fungicides, fumigating agents, and cleaning and sanitation agents in any manufactaring area. a. True False Secs. 201. 50 b. . 352, 355, 45076, or et forth 26. Any building used in the manufacture, processing. packing or holding of a drug prodact shal be maintained in such a manner to have at least four exit doors a. b. c. d. in a good state of repair at least 250 feet from other buildings all of the above ice for 27. Equipment used in manufacturing shall be th and a. b. c. used for its designed purpose of the latest possible design of the most efficient and cost effective model ly with suc 28. Under no circumstances can lubricants or coolants, although they are non-reactive, come into contact with components, drug product containers, closures, in-process materials or drug products. of c part as t nle a. True b. False 29. All surfaces of equipment utilized in any phase of the manufacturing operation must not react with the drug product in any way a. True b. False 30. Written cleaning procedures are not required for portable equipment such as utensils a. True b. False 31. The inspection and approval of equipment cleaning should come: immediately after the equipment is cleaned immediately before use only after QC approval a. b. c. 32. Broad general guidelines for the cleaning of equipment must be maintained a. True b. False

Explanation / Answer

22- (a) the air filtration system

23- True

24- False

25- True

26- (b) in a good state of repair

27- (c) of the most efficient and cost effective model

28- True

29- True

30- False

31- (a)

32- True

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