EMA interprets and comments on the role of the QP in supply chain traceability

The European Medicines Agency (EMA) has updated the question and answer session good manufacturing practice (GMP) and distribution (GDP) on on its website “Guidance on good manufacturing practice and good distribution practice: Questions and answers”, regarding section “EU GMP guide annexes: Supplementary requirements: Annex 16”.

The question focuses on the method to be adopted to create and maintain a reliable documentation system to ensure the traceability of an active substance and a medicinal product useful to support the QP in fulfilling their legal obligations during batch certification and release.

Recommendations

• Supply chain records should provide adequate traceability and be available in a timely manner, to facilitate quality defect investigations and product recalls, or requests of competent authorities.
• 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.

SOURCES:

Guidance on good manufacturing practice and good distribution practice: Questions and answers | European Medicines Agency (EMA)