21 CFR Parts 210 and 211
Learn About FDA's Quality Systems Approach, Pharmaceutical GMP Inspection Tips, and How to Automate Paper-based Quality Processes to Ensure Compliance with FDA 21 CFR Part 210-211
In 1962, the U.S. Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP) which should be compliant to FDA 21 CFR Part 210-211. The move was in response to concerns about substandard drug manufacturing practices at the time, such as the use of thalidomide, a drug used in Europe to treat morning sickness, which was found to cause birth defects. The 1962 Drug Amendments brought modern quality assurance and control principles to drug manufacturing. The word "current" was later added to make it "CGMP" (or cGMP) to imply that the regulation allows for changing technology in attaining GMP.
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