Current Good Manufacturing Practice in Manufacture, Processing, PackIng, or Holding

FEDERAL REGISTER, VOL. 43, NO. 190 – FRIDAY, SEPTEMBER 29, 1978

AGENCY: Food and Drug Administration.

ACTION: Final rule.

This document amends the FDA regulations that set forth current good manufacturing practice (CGMP) for human and veterinary drug products. The amendments update present regulations in light of current technology for drug manufacturing and delineate requirements more specifically than do the present regulations. Although some of the provisions in these amendments represent requirements not specifically included in the existing CGMP regulations, in many instances the revisions are practices that have been considered implic­it in the regulations or are at least considered by most manufacturers to be desirable- requirements for their own operations.

Under the Federal Food. Drug, and Cosmetic Act, a drug is deemed to be adulterated unless the methods used in its manufacture, processing. packing. and holding, and the facilities and controls used therefor, conform to current good manufacturing practice so that the drug meets the safety requirements of the act and has the identity and strength and meets the quality and purity characteristics that it is represented to have. The regulations are being updated and made more explicit, and therefore less subject to varying interpretations, to assure that all members of the drug industry are made aware of the level of performance expected of them to be in compliance with the act.

EFFECTIVE DATE: March 28.1979.

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Last Updated: 2016-04-12

CGMP Final Rule for Human and Veterinary Drugs
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