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# API GMP Guidance Answers
- URL: https://www.fdaweb.com/api-gmp-guidance-answers/
- Published: 2018-04-19T12:00:00.000Z
- Updated: 2026-09-14T23:59:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141265

FDA has published an International Council for Harmonization guidance, *Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients—Questions and Answers*, to clarify uncertainties due to interpretation of certain sections of the ICH Q7 guidance on good manufacturing practice for active pharmaceutical ingredients (API). The document says the Q7 guidance should be read in its entirety regardless of the nature of the manufacturing activities being conducted to fully understand the linkages between certain sections and successfully implement appropriate good manufacturing practices at all stages of the API supply chain, including distribution.