Ans: Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing :
Current Good Manufacturing Process
6). A. national institute of occupational safety and health
b. hazardous drugs list
Ans: A. Acronym: NIOSH
B. Used for: __________
7). Hepa & ulpa filters
Ans: IEST-RP-CC001.5
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, 8). Unidirectional-flow & clean-air devices
Ans: IEST-RP-CC002.3
9). Testing cleanrooms
Ans: IEST-RP-CC006.3
10). Calibration procedures and guidelines for select equipment used in testing cleanrooms
and other controlled environments
Ans: IEST-RP-CC013.2
11). Hepa and ulpa filter leak tests
Ans: IEST-RP-CC034.3
12). Cleanroom and associated controlled environments - classification of air cleanliness by
particle concentration
Ans: ISO 14644-1
13). Cleanroom and associated controlled environments - monitoring to provide evidence of
cleanroom performance related to air cleanliness by particle concentration
Ans: ISO 14644-2
14). Cleanroom and associated controlled environments - test methods
Ans: ISO 14644-3
15). Cleanroom and associated controlled environments - design, construction and start-up
Ans: ISO 14644-4
16). International organization of standards
Ans: ISO
17). Controlled environment testing association
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, Ans: CETA
18). Certification application guide
Ans: CAG
19). Institute of environmental sciences and technology
Ans: IEST
20). United states pharmacopeia
Ans: USP
21). Food and drug administration
Ans: FDA
22). High efficiency particulate air
Ans: HEPA
23). Primary engineering control
Ans: PEC
24). Direct compounding area
Ans: DCA
25). Standard operating procedure
Ans: SOP
26). Laminar air flow workbench
Ans: LAFW
27). Colony-forming unit(s)
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