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CGMP for Phase 1 Investigational Drugs - PharmaFacts
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CGMP for Phase 1 Investigational Drugs

Guidances - FDA Guidances

This guidance lightens the load for this early clinical phase and the requirements for clinical supplies enabling companies to move more quickly through their clinical manufacturing process.  Though there still is an expectation for compliance with 21CFR Part 211 not all of it need be applied at this stage.  FDA realized that the CGMPs should not be so enforced for Phase 1 clinical supplies and this guidance is focused on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. Thus, it allows flexibility in implementing the controls needed to achieve those goals.

ucm070273.pdf 
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdf