GDP for APIs: APIC Publishes Updated "How to Do" Document

Version 3 (June 2026) of “GDP for APIs: How to do” has been published on the website of the Active Pharmaceutical Ingredients Committee (APIC). It provides practical guidance on the implementation of Good Distribution Practice for active substances.

Following an introduction to the objectives and regulatory background, the guide covers Scope and General Considerations. The central Chapter 4 (Good Distribution Practices for API) provides practical guidance on the applicable GDP requirements.

The main section is structured in tables, comparing the requirements of the EU GDP Guideline with the corresponding provisions of the WHO guideline on Good Trade and Distribution Practices for Pharmaceutical Starting Materials. It also includes APIC’s explanations and practical recommendations, as well as references to ICH Q7 and other relevant regulatory requirements.

The guide addresses topics including:

• quality management and quality risk management;
• personnel responsibilities, competence and training;
• documentation, procedures and records;
• premises, equipment, maintenance and calibration;
• operations, including orders, receipt, storage, transportation and delivery;
• quarantine, rejected materials and the handling of deviations;
• returns, complaints and recalls;
• self inspections.

The document concludes with a Glossary of Terms.

Compared with Version 2 of March 2019, Version 3 has been expanded to cover active substances used as starting materials in veterinary medicinal products. In particular, it takes into account the requirements of Regulation (EU) 2021/1280 on good distribution practice for active substances used as starting materials in veterinary medicinal products.

The regulatory background has also been updated. In addition, the scope and numerous explanatory sections have been revised to reflect the parallel application of the requirements to active substances for human and veterinary medicinal products. Intermediates remain outside the scope.

The updated version is available here.