The EMA has revised the Q&As on good manufacturing and distribution practices (GMPs/GDPs). A new question and answer on the documentation of supply chain traceability has been added to the section about EU GMP Guide Annex 16 certification by a qualified person and batch release.

The question:

How should the traceability of the supply chain of the active substance and medicinal product be documented to support the Qualified Person batch certification and release.

EMA’s response:

• To meet the certification requirements in Section 1 of EU GMP Guide Annex 16, the entire manufacturing and distribution supply chain of the medicinal product and its active substance must be documented and available to the Qualified Person.
• Supply chain records should ensure traceability, be available promptly, and support activities like quality defect investigations, product recalls, or requests from authorities.
• These records should identify all entities, including suppliers and outsourced services, involved in manufacturing each batch, as per the registered supply chain.
• Additionally, in line with Chapters 1 and 5 of EU GMP Guide Part I, supply chain traceability risks should be formally assessed, periodically reviewed, and mitigated with appropriate measures.