EMA Comments on the Role of the QP in Supply Chain Traceability

The European Medicines Agency (EMA) has published a question and answer on its website "Guidance on good manufacturing practice and good distribution practice: Questions and answers' under 'EU GMP guide annexes: Supplementary requirements: Annex 16' on the subject of documentation of the traceability of the supply chain of active substances and the medicinal product.

What is it about?

This question is about how documentation systems for the traceability of an active substance and medicinal product can be created and maintained to support the QP in fulfilling their legal obligations during batch certification and release ('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?').

What is recommended?

• Supply chain records should provide adequate traceability and be available in a timely manner
• Supply chain records should facilitate quality defect investigations and product recalls
• Records should make it possible to identify, for active substances and medicinal products, all the entities, including suppliers and outsourced activities, involved in the manufacture of a specific batch of the drug product, in line with the registered supply chain.
• Associated risks should be formally assessed and periodically reviewed with appropriate risk-mitigation measures determined to mitigate any risks identified.