EXCiPACT's excipient certification ambitions extend well beyond Europe

By Phil Taylor

- Last updated on GMT

iStock/Mirexon
iStock/Mirexon

Related tags: European union, United states

Three years since it was set up, excipient certification organisation EXCiPACT is expanding beyond its European heartland to other areas of the world.

The next phase of its development is being spearheaded by a new president - Kevin McGlue of Colorcon - who told in-PharmaTechnologist.com​ that the organisation has started to make headway in other markets including the US, China and India.

EXCiPACT recently issued its first GMP certificate in the US​, adding to the 26 issued since it was set up. While the bulk of the certificates have been for suppliers based in Europe, others have also been issued in Canada, China, India and Saudi Arabia.

The organisation has also appointed its first certifying body in China - Bureau Veritas (BV) China - and has also recently welcomed excipient industry body IPEC China as a member of the scheme along with IPECs in other regions of the world. This should encourage further adoption of the certification scheme in what is an increasingly important excipient market.

"There is huge interest in markets such as China and India where suppliers are looking to be able to demonstrate that they meet the standards the pharmaceutical industry requires​," said McGlue.

"Having achieved our first certifications in both those countries, EXCiPACT will now be working to promote the scheme and ensure the availability of certification bodies and qualified auditors to meet the demands there​," he added.

Iain Moore of Croda, who previously served as EXCiPACT's president and was instrumental in developing the standards used by the organisation for excipient Good Manufacturing Practice (GMP) and auditor competency, is now focusing his attention on the technical aspects of EXCiPACT.

The growth of the certification scheme over the last three years has meant that there is a benefit in splitting the technical and business development roles as it gathers momentum in the EU and overseas, according to McGlue.

Moore will spearhead a revision of the EXCiPACT standards to bring them into line with the changes to ISO 17021 on certifying body requirements, as well as ISO 9001:2015.

Another important task for EXCiPACT in 2016 will be to raise the awareness of certification as a means of facilitating the EU's excipient risk-assessment guidance​. 

"Pharmaceutical companies need something to unambiguously demonstrate the GMP compliance of suppliers they may not be able to audit​," commented McGlue.

"EXCiPACT being a truly independent certification to a recognised standard fulfils those needs precisely​."

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