Current Good Manufacturing Practice (cGMP): An Overview for the Analytical Chemist: Good Manufacturing Practice (GMP) is the most significant regulation impacting the pharmaceutical industry and requires substantial investment in resources and time commitments. This paper provides a high-level overview of Current Good Manufacturing Practice (cGMP) regulations and related public quality standards. It discusses GMP compliance requirements and practices, emphasizing those relevant to the analytical chemist in development and quality control

The original cGMP regulations published in 1978 in Codes of Federal Regulations (CFR), 21 CFR 210 and 211 (1,2), contain requirements for methods, facilities, and controls for manufacturing, processing, packaging, [...]