A valuable reference for professionals involved in the distribution, storage, transportation, quality systems and regulatory compliance of Active Pharmaceutical Ingredients (APIs).
The latest APIC “GDP for APIs – How to do” Document, Version 3 (June 2026) provides practical interpretation of the EU Good Distribution Practice requirements for APIs, while taking into consideration WHO guidance, ICH Q7 and relevant veterinary API requirements.
🔹 Key areas covered include:
- GDP requirements for API distribution
- Quality Management System & Quality Risk Management
- Personnel responsibilities and training
- Documentation & Data Integrity
- Supplier and service-provider qualification
- Storage and transportation controls
- Deviation, CAPA and change management
- Traceability and supply-chain controls
- Handling of non-conforming materials
- Practical implementation approaches for API distributors
The document is particularly useful for QA, QC, Regulatory Affairs, Supply Chain, Warehouse, Distribution, Compliance and Auditing professionals working with APIs.
APIC emphasizes that the document provides practical explanations and examples for implementing GDP requirements, while alternative approaches may also be acceptable when appropriately justified.
📌 Recommended reading for anyone involved in API GDP compliance and pharmaceutical supply-chain quality.
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