The idea is that detailing all third-party quality control, process testing, milling and sterilisation services providers as well as intermediates sources on certificates of suitability to the European Pharmacopoeia (CEP) will enhance traceability and quality.
The European Directorate for the Quality of Medicines and Healthcare (EDQM) told in-Pharmatechnologist.com “This information has always been part of the application. The change is that now it will be reported on CEPs, which was not the case before when only the holder and the final manufacturer were mentioned.
“The change brought to CEPs does not affect the content of the applications, but the information on the CEPs themselves.”
The EDQM also told us that, while it has not yet happened “theoretically, an applicant that fails to provide this information risks to have its application rejected and no CEP issued.”
Holders of CEPs issued before the July 15 are required to communicate details of the additional manufacturing sites to customers.
Whether CEP holders that fail to do this risk losing certification is unclear as the EDQM told us that: “This is something that is outside of our control.”
Rule change
The revision is the first major change to the CEPs since 2011 when the EDQM asked active pharmaceutical ingredient (API) manufacturers to provide the precise locations of their plants using Google Earth.
Details of the manufacturing facilities can be either a DUNS number – which is a system devised by Dun & Bradstreet that assigns a unique digit numeric identifier to each plant – or a set of global positioning satellite (GPS) co-ordinates.
The new requirement will follow just weeks after new laws requiring all APIs shipped to the European Union (EU) be accompanied by written confirmation from local regulators they were made to the same standards as those produced in Europe.