The FDA issued the final version of this guidance on Sept. 29, 2006. It is meant to bridge the gap between the
1978 Current Good Manufacturing Practice (CGMP) regulations and current quality systems and risk management
approaches. The guidance aims to help manufacturers operate modern quality systems that are fully compliant
with CGMP― specifically 21 CFR Parts 210 and 211― and to harmonize CGMP with other quality standards, such
as ISO 9000, non-U.S. pharmaceutical quality management requirements, and FDA’s own medical device Quality
System Regulations (QSR).
