New European guidelines for excipients and APIs

The 21st of March saw publication in the Official EU journal of two new guidelines

2015/C 95/01Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use and 2015/C 95/02Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.

For the first time this requires that manufacturer and distributors of APIs must show full traceability throughout the supply chain, including temperature records. A full quality system is required in line with that for finished medicines, and the requirements for GDP detailed in the guidelines of 5th November 2013 will apply. There is a six month transition period and compliance is required from 21st September. Excipients are subject to a full risk assessment to ensure that they are suitable for use in medicinal products in accordance with paragraph 2 of article 46(f) of directive 2001/83/EC from 21st March 2016.

We welcome these requirements, and we are ready to support companies by providing transport records for current and future shipments.