The European Medicines Agency (EMA) has updated its EU GMP/GDP FAQ under EU GMP Guide Annexes: Supplementary Requirements:Annex 16.
This update aims to clarify documentation standards to ensure the traceability of the supply chain for active substances and medicinal products, supporting Qualified Persons (QPs) in batch certification and release.

Key Recommendations:
•   Maintain timely and adequate supply chain records for traceability.
•   Facilitate quality defect investigations and product recalls.
•   Ensure traceability across all entities involved in a batch’s manufacture.
•   Conduct formal risk assessments, with periodic reviews and the implementation of risk mitigation measures.

You are kindly invited to explore other FAQs on EU GMP/GDP available for further guidance on related topics.