EMA Clarifies Requirement Over Documentation of Active Ingredients

Drugmakers facing a European GMP inspection should be prepared to provide complete documentation of active ingredients throughout the supply chain, going back to the starting materials that were used in the synthesis of the APIs.

The European Medicines Agency clarified this requirement in a recent update in the Q&A section of its GMP Guide Part 1: Basic requirements for medicinal products: Chapter 5: Qualification of suppliers. The question was — “What are the expectations with regard to documentation and verification of the supply chain for active substances?”

According to the EMA, the entire supply chain must be documented and kept current, as should any risks associated with that supply chain. Each incoming batch of active substance should include verification that it has been received from the approved supplier and manufacturer.

Further, the entire supply chain should be verified periodically for a supplied batch to establish a documented trail going back to the starting materials. The frequency of this verification should be based on product risk, the EMA says.

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