3/4 November 2021
In Chapter 5.29 of the EU-GMP Guidelines, the requirements for the traceability of the supply chain are described, also demanding audits of API manufacturers. But it seems that companies tend to forget to audit the API distributers as well. But this is clearly required according to 5.29: "Audits should be carried out at the manufacturers and distributors of active substances to confirm that they comply with the relevant good manufacturing practice and good distribution practice requirements."
This has also been emphasised in a blog published by the U.K. Medicines and Healthcare Products Regulatory Agency MHRA. Ewan Norton, a GMDP inspector of MHRA's inspectorate, also points out that the inspectorate will have a look at this during an inspection: "When Finished Dose Form sites are inspected by the MHRA, it will be typical for the inspector to establish that there is a system in place to confirm the appropriate registrations of API Manufacturers, Distributors and Importers are in place and there is a periodic review. The compliance with the procedures would be expected to be able to be demonstrated". He is also referring to Annex 16 and the responsibility of the QP in this context. It is not enough to know where the materials and products are shipped from and shipped to; the QP needs to know appropriate controls are in place on the routes by which they are being supplied and the transport conditions, to include security measures.
For further informattion please see the MHRA Inspectorate Blog.