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h Past: Applied same standard to all drugs that
were be administered to humans
h July 2008: The manufacture of most
investigational new drugs (IND) used in phase 1
clinical trials are exempt from complying with 21
CFR part 211
h Improve the quality of phase 1 investigational
drugs and facilitate the initiate of clinical trials in
humans
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h ïther guidance from FDA:
h ´INDs---Approaches
´INDs--- Approaches to Complying with CGMP
During Phase 1µ dated January 2006 is being issued
concurrently with a final rule that specifies that 21
CFR part 211 no longer applies for most
investigational products, including exploratory
products that are manufactured for use in phase 1
h Preamble to 21 CFR 210 and 211
h Distribution records
h QC Function Plan
h Component records
h Complaints
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h Procedures used
h Record of changes