The making of products dependent upon small molecule Active Pharmaceutical Ingredient (API) is an area decisive in the forum of global healthcare. The manufacturing arena is subjected to challenges of different sorts. This is especially due to rising global markets, dramatically evolving regulatory, economic, social and environmental expectations.
APIs come under the adulteration provisions of Section 501(a)(2)(B) of the Act that maintains that all drugs should conform to CGMP. There is no specific distinction made between API and a finished pharmaceutical as per the Act and failure to adhere to CGMP requirements denotes violation of the Act.
The FDA stipulates building quality into the drug through the use of suitable equipment, employing trained and qualified personnel and setting up controls and written procedures to validate manufacturing processes and controls. The stipulation also holds good in final drug tests and guaranteeing drug stability during its intended period of usage.
As per FDA expectations, API manufacturers must apply CGMPs to the API process from the use of initial materials. Manufacturers are also expected to validate significant process steps impacting the purity and quality of the final API.