EXCiPACTTM was initiated by a group of industry experts from the European Fine Chemical Group (EFCG), International Pharmaceutical Excipients Council (IPEC) Europe, IPEC Americas, European Association of Chemical Distributors (FECC), and the Pharmaceutical Quality Group (PQG) who worked together on the development of an international certification scheme for excipients suppliers.

EXCiPACTTM Excipient GMP standard

An EXCiPACTTMcertification scheme was developed and made available for comment in June 2011.  An explanatory slide show of the scheme and its use is available for download.

EXCiPACTTMwas established as a not-for-profit organisation (end 2011), initially as part of the IPEC Federation, and a dedicated website was launched in January 2012.

EXCiPACTTM has agreed that Rx-360 can use the EXCiPACTTM GMP standard for pharmaceutical excipients for their shared auditing scheme. Collaboration between EXCiPACTTM and Rx-360 is the subject of an announcement.

In parallel a new ANSI Excipient GMP standard is being developed by NSF with input from Excipact and others. This will enable certification of suppliers who do not wish to take up certification to ISO 9001:2008.

The EXCiPACTTM certification scheme was launched on January 25th, 2012.

The EXCiPACTTM standard can be accessed from the Go to Excipact standard download location

NSF 363 – new standard for excipients available for comment

This new American standard is based on the Excipact draft Excipient GMP standard (which has been developed from the IPEC/PQG Excipients GMP guide 2006). Whereas the Excipact standard assumes the supplier already holds certification to ISO 9001, or will be assessed simultaneously, the NSF 363 also includes the quality system requirements. Thus NSF 363 would be suitable for suppliers not wishing to hold certification to ISO 9001, as is common in the US.

The document was open for comments until August 2011.

To access the NSF 363 draft standard Click here.

Links to websites of Excipact, EFCG, FECC, IPEC FED, & Rx360 may be found on our Links page