The FDA’s Current Good Manufacturing Practices

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Manufacturing Practices

In addition to serving as president of commercial operations for San Antonio-based Mission Pharmacal Company (“Mission”), Terrell “Terry” Herring is the of Alamo Pharma Services in Doylestown, Pennsylvania. Herring’s duties at Mission revolve around producing pharmaceuticals in full compliance with all US Food and Drug Administration (FDA) Current Good Manufacturing Practices (CGMP).

Concerned with all aspects of drug manufacturing, processing, and packaging, CGMP regulations demand on-site inspections of pharmaceutical facilities and the examination of the methodology and controls that each pharmaceutical facility has in place. The FDA demands CGMP compliance reviews as part of its approval process for all new drug and generic drug marketing applications.

In order to encourage the use of modern technologies and drive industry innovation, CGMP requirements are designed to be somewhat flexible. This flexibility allows each manufacturer to achieve higher quality through continual improvement. As long as manufacturers employ scientifically sound operational principles, they have a great deal of leeway when developing facility processing structure and testing procedures.