APIC: Publishes Updated “How to Do” Document for GDP for Active Pharmaceutical Ingredients
The Active Pharmaceutical Ingredients Committee (APIC) has published Version 3 of the document “GDP for APIs: How to Do” (June 2026) on its website. The document provides practical guidance on implementing Good Distribution Practice for active pharmaceutical ingredients.
One change compared with Version 2 of March 2019 is the extension to active pharmaceutical ingredients for veterinary medicinal products. In particular, the document takes into account the requirements of Regulation (EU) 2021/1280 (Good Distribution Practice for Active Pharmaceutical Ingredients used as starting materials for veterinary medicinal products). Furthermore, the regulatory framework has been updated. The scope and numerous explanatory notes have been adapted to allow for the parallel consideration of active substances for human and veterinary medicinal products. Intermediates remain excluded from the scope.
In the main section of the document, which is structured in tabular form, the requirements of the EU GDP Guidelines are compared with the corresponding provisions from the WHO guideline on Good Trade and Distribution Practices for Pharmaceutical Starting Materials, as well as supplementary explanations and practical guidance from APIC. In addition, references are made to ICH Q7 and other relevant guidelines.
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