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# Animal Drug API GMP Guidance
- URL: https://www.fdaweb.com/animal-drug-api-gmp-guidance/
- Published: 2024-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:21:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156199

FDA has published a Veterinary International Conference on Harmonization guidance, *Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products*, to give guidance regarding good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. The [document](https://www.fda.gov/media/175603/download?ref=fdaweb.com) says it also is intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.

The guidance includes an Introduction; Quality Management; Personnel; Buildings and Facilities; Process Equipment; Documentation and Records; Materials Management; Production and In-Process Controls; Packaging and Identification Labeling of APIs and Intermediates; Storage and Distribution; Laboratory Controls; Validation; Change Control; Rejection and Re-use of Materials; Complaints and Recalls; Contract Manufacturers (Including Laboratories); Agents, Brokers, Traders, Distributors, Repackers, and Relabelers; Specific Guidance for APIs Manufactured by Cell Culture/Fermentation; APIs for Use in Clinical Trials; Glossary; and References.