US FDA 21 CFR Parts 210/211 Amendment to the Current Good Manufacturing Practice Regulations

[Docket No. 2007N–0280] as of 4 December 2007: Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals: On 4th December 2007 the FDA published changes to the GMP regulation (21 CFR Part 210 / 211), which is the first step of a phased approach to modernize GMPs.

Link: http://www.fda.gov/cber/rules/amendcgmp.pdf

cGMP: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=211&showFR=1