In 1962, 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 210 211. The move was in response to concerns about thalidomide – The drug used in Europe to treat morning sickness and later found to cause birth defects.
This tragic incident brought about 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.
Consequences of not meeting 21 CFR 210 and 211:
21 CFR 210.1 (b) also states that as a result of non-compliance both the drug and the person responsible for the company’s failure to comply with regulation requirements are subject to regulatory action.
This is the reason that Warning Letters issued by the Food and Drug Administration (FDA) are sent to the company’s President or Chief Executive Officer (CEO). FDA holds these individuals accountable for regulatory compliance failures.
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Additional Articles on 21 CFR 210 211