History of FDA GMP requirements

History of FDA GMP requirements

The FDA has Good Manufacturing Practices (GMP) requirements for a range of items. One of them is Active Pharmaceutical Ingredients (API). FDA GMP requirements are established under the FDA Act. In Sec. 501 (a) (2) (B) of the Act (21U.S.C. 351(a) (2) (B)); the FDA seeks to establish API as a drug. It makes a drug subject to GMP. This is a culmination of a series of regulations on drugs and food that dates all the way to 1906, the year in which the Food and Drugs Act of 1906 was promulgated. A major landmark was the Food, Drug and Cosmetic Act of 1938.


Since they are important regulations, the finer aspects of GMP requirements need to be understood. Sec. 501 (a) (2) (B) of the FD & C Act requires that drugs be manufactured, processed, packed and held according to current good manufacturing practice (cGMP). GMP for API thus has a starting point in this legislation.

One of the important points relating to GMP is that FDA makes no distinction between API and finished pharmaceuticals, and failure of either to comply with cGMP constitutes a failure to comply with the requirements of the Act.

Historic guidances

Important regulations were passed in 1978 and 1998, and other guidances were established in PHRMA BPC Guidance, WHO Guidance and CEFIC Guidance. All of these were effectively replaced by the ICH Q7A of November 2000. It was accepted as an official guidance by the FDA the following year. Q9 Quality Risk Management was issued in 2006; Q10 Pharmaceutical Quality System was issued in April 2009, and the Q8 (R2) pharmaceutical development in November 2009. All these are essentially guidances on what a pharma company needs to do with regard to API.


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