CGMP

From WikiBioPharm

CGMP = Current Good Manufacturing Practices. One of the "GxPs". Created by 21 CFR Part 210 and 21 CFR Part 211, they govern the environment in which drug product.... should be manufactured. ... the "Current" refers to the notion that the practices are ever-evolving. There is a recent movement to use a capital "C" in the acronym as to signify its importance. (This is is more of a place holder, and less of a real article on CGMP.)

Also affecting CGMPs are:

• 21 CFR Part 820 (Quality System Regulations)
• 21 CFR Part 11 (Electronic Records; Electronic Signatures)
• 21 CFR Part 600 (Biological Products: General)
• 21 CFR Part 610 (Genreal Biological Products Standards)