FDA API GMP requirements –current quality guidelines

FDA API GMP requirements –current quality guidelines

The US FDA has set out Good Manufacturing Practices (GMP) requirements for a number of products. The Food, Drug and Cosmetic Act, a US law,empowers the FDA with authority to regulate a number of industries.

Accordingly, the FDA GMP requirements and guidelines exist for a clutch of products and fields. GMP’s for some of these, concerning related areas like drug products, API, excipients, devices and nutritional supplements, may appear to be linked and similar, but they are not. Their definitions, identity, application and requirements may have many common qualities, but each has unique FDA GMP requirements.

Current quality guidelines for API

There are a number of current quality guidelines for FDA GMP requirements. A few of these are:


ICH Q 7 was issued as ICH Q 7A in November 2000. It was officially accepted by the FDA as a guideline for API in August 2001.

Q 8 (R2)

Concerning pharmaceutical development, Q 8 (R2) is another of the current FDA GMP requirements. It was issued in November ’09. It has applications to GMP’s.

Q 9

The Q9, concerning Quality Risk Management, was issued in June ’06.

Q 10

The Q 10, specific to the Pharmaceutical Quality System, was issued in April ’09.

Other guidelines concerning PV for APIs

The FDA also has draft guidances for process validation. These are:

  • General Principles and Practices (November 2008)
  • Pharmaceutical Components at Risk for Melamine Contaminations(August 2009)
  • Guidance for Industry –cGMP for Phase I Investigational Drugs (June ’08)
  • CPG Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval
  • 7356.002F –Active Pharmaceutical Ingredients are other important documents.

Contact Detail


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Author: GlobalCompliancePanel-Training

GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.

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