Food and Drug (Pharmaceuticals) related Regulations

US Food and Drug Administration (FDA)

All topics connected with the US Food and Drug Administration (FDA), a division of the United States Department of Health and Human Services covering CDER, CBER, CDRH, CFSAN, CVM, NCTR, ORA and OC divisions.
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shimonv
Design input

Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations)

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J
What kind of cleaning should be required after HEPA filter testing (with use of PAO 4 reagent)?

Qualification and Validation (including 21 CFR Part 11)

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Semoi
Equipment Qualification sample size - attribute data
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