Excipients certification scheme set for early 2012 launch

A long-running project to develop a third-party certification scheme for excipient suppliers is in the latter stages of development and is set for an official launch in January 2012.

The EXCiPACT project was kicked off in 2008 with the aim of developing a set of agreed certifiable quality standards - focusing on good manufacturing and distribution practices (GMP and GDP) - which could be used to identify reliable suppliers of excipients.

A key objective was a system in which third-party auditors could assess a supplier and certify that the organisation was working to the agreed standards. Thereafter, customers could approach that supplier confident that those standards were in place, without the need to conduct expensive, time consuming and often redundant audits themselves.  

The overall aim is to improve patient safety and the security of the global supply chain, in light of thankfully rare but tragic incidents involving excipients such as the fatal cases of glycerine adulteration with toxic diethylene glycol (DEG) in recent years in Nigeria, Haiti, China and Panama, and the contamination of food, beverage and some pharmaceutical products earlier this year with phthalates (see Hong Kong recalls drugs due to DEHP contamination).

"EXCiPACT has reached a critical point, and we are now working very hard on delivering the scheme for industry to begin using in the New Year," said Iain Moore of IPEC Europe, who has been intimately involved in the project since the outset. An official launch is due to take place during IPEC Europe's annual general meeting and seminar in Barcelona, Spain, January 25 To 27, 2012.

The standards are in the process of being finalised, and proofing of the EXCiPACT document is now being carried out with a view to publication in the coming weeks. Legal agreements are also being drawn up with third-party auditing operations and the first auditor training sessions are in the pipeline.

The EXCiPACT team includes representatives from IPEC Europe, IPEC Americas, the European Fine Chemicals Group (EFCG), the Pharmaceutical Quality Group (PQG) and the European Association of Chemical Distributors (FECC). The group has also forged links with other organisations - notably Rx-360 and IPEA Inc - to try to expand the use of third-party certification for excipients (see Momentum builds behind excipient certification).