Excipient makers could save up to 200 man hours with a new industry-driven, third-party audit certification scheme set to launch next week.
The scheme - known as Excipact - will be unveiled at the International Pharmaceutical Excipients Council Europe’s (IPEC - Europe) 20th anniversary celebrations in Barcelona, Spain on January 25, 2012 by representatives of the IPEC, IPEC-Americas, the EFCG, the FECC and the PQD.
Project director Ian Moore, a QA specialist at specialty chemicals firm Croda, told in-Pharmatechnologist.com that Excipact was created to improve the quality of drug excipients in a way that minimizes supply chain costs for stakeholders.
"The development of Excipact followed the process used by IPEC in the development of its guides," he said, explaining that an expert committee drafted the standards which were then peered-reviewed by organisations involved in the scheme before being put before manufactureres, suppliers and users for consultation.
"The feedback was very positive and constructive with no-one coming back and indicating that the draft was unacceptable," Moore continued adding that "we have also had some feedback from regulatory authorities in Europe and the US which again has been very encouraging."
Moore also set out how excipient suppliers and their drug industry customers that join the scheme stand to benefit in terms of both cost and quality.
“For a very modest investment – we expect Excipact certification will cost between €15K and €20K over a three-year audit cycle – they could easily gain between 100 and 200 man days that they would otherwise have spent being audited.”
Excipact uses ISO 9001 as a framework and consists of two annexes covering good manufacturing and distribution practice (GMP/GDP) that can be used to assess excipient suppliers and distributors.
In addition it also covers the competency and quality requirements for third party auditors, based on ISO guidelines 19011 and 17021.