On January 24, 2024, the United States Food and Drug Administration’s (“FDA’s”) Center for Veterinary Medicine (“CVM”) issued a draft guidance for industry (Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products). The purpose of the draft guidance is to provide recommendations regarding Good Manufacturing Practice (“GMP”) for the manufacturing of active pharmaceutical ingredients (“APIs”) for use in veterinary medicinal products and to help ensure that such APIs meet the quality and purity characteristics that they are represented to possess. The draft guidance also is intended to facilitate harmonization of a single set of international standards for GMP inspections of facilities that manufacture APIs for use in veterinary medicines as well as starting materials for such products.
Background
FDA has supported scientifically based harmonized technical procedures for pharmaceutical development through participation in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”). The ICH is a council that works to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. Harmonization allows for the identification and reduction of differences in technical requirements for drug development among regulatory agencies across countries. The ICH has published Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients Guidance for Industry, which provides guidance on the GMP for APIs used in human drug products.
FDA also has participated in the parallel initiative for veterinary medicinal products, the International Cooperation on Harmonisation of Technical requirements for Registration of Veterinary Products (“VICH”), which seeks to develop harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory bodies and industry representatives. The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA’s CVM; U.S. Department of Agriculture (“USDA”) Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association.
2024 Draft Guidance
The 2024 draft guidance adopts guidance first published by the VICH in September 2023 and generally mirrors the ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients Guidance for Industry.
The 2024 guidance is organized into 21 sections including quality management; personnel; buildings and facilities; process equipment; documentation and records; material 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; agents, brokers, trader, distributors, re-packers and re-labelers; specific guidance for APIs manufactured by cell culture/fermentation; and APIs for use in clinical trials.
FDA is accepting comments on the report until March 25, 2024 through FDA’s docket (No. FDA-2023-D-4761).
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
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