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# FDA Posts ICH Guidance on API GMPs
- URL: https://www.fdaweb.com/fda-posts-ich-guidance-on-api-gmps/
- Published: 2016-09-30T12:00:00.000Z
- Updated: 2026-09-14T21:36:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136956

FDA has released an International Conference on Harmonization [guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073497.pdf?ref=fdaweb.com) on “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs).” The document is intended to “help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess,” the agency says. It defines the term “manufacturing” to include all operations in receiving materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage and distribution of APIs and the related controls.

The guidance does not cover safety aspects for the personnel engaged in manufacturing, nor aspects related to protecting the environment. These controls are inherent responsibilities of the manufacturer and are governed by national laws, the agency says. . It describes an API “starting material” as a “raw material, an intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API starting material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API starting materials normally have defined chemical properties and structure.”

The guidance also says that firms should designate and document the rationale for the point at which production of the API begins. “For synthetic processes, this is known as the point at which API starting materials are entered into the process,” it says. “For other processes (e.g., fermentation, extraction, purification), this rationale should be established on a case-by-case basis... From this point on, appropriate GMP as defined in this guidance should be applied to these intermediate and/or API manufacturing steps. This would include the validation of critical process steps determined to impact the quality of the API. However, it should be noted that the fact that a company chooses to validate a process step does not necessarily define that step as critical.”