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IPEC publishes position paper on EU Risk Assessment Guidelines for Excipients
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IPEC publishes position paper on EU Risk Assessment Guidelines for Excipients

The IPEC Federation (International Pharmaceutical Excipients Council) has published a three-page position paper concerning the risk-based approach of the EU Guidelines following the principles of Quality Risk Management according to ICH Q9. The IPEC-paper applies to the community regulated under the EU Risk Assessment Guidelines.


IPEC is convinced that the application of appropriate GMP and GDP throughout the entire pharmaceutical excipient supply chain will enhance patient safety. It is also well accepted that this can only be achieved, if the risk-based approach is scientifically sound and risks are evaluated in collaboration with all relevant parties in the supply chain. But according to IPEC, this is where the problem lies: IPEC expresses its concern that there is not enough time to complete risk assessment for all excipients by the March 2016 deadline. This could jeopardize the availability of high quality excipients that have been in use for many years. The implementation of appropriate excipient GMPs by suppliers will require more than a year, and may be difficult to achieve for manufacturers of certain substances not typically produced as pharmaceutical excipients. MAHs (Manufacturing Authorisation Holders) may need to collaboratively establish realistic timelines with their suppliers to achieve the appropriate level and timing for implementation. Therefore, the IPEC will share their views with the EC on the challenges to complying with the current compliance timeline and request collaboration with them to help establish more realistic goals and timelines.

For more detailed information we refer to the position paper of the IPEC Federation.


IPEC Americas

EU Guideline on Risk Assessment for Excipients

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