International Pharmaceutical Excipients Certification Project
EXCiPACTTM is a new, voluntary, international scheme that provides for the high quality, independent certification of manufacturers and suppliers of pharmaceutical excipients to prescribed cGMP and cGDP standards, as a means of ensuring patient safety through supplier quality, while minimising the overall supply chain costs.
Fecc has partenered with IPEC Europe, IPEC-Americas, the UK Pharmaceutical Quality Group (PQG), and the European Fine Chemical Group (EFCG) to develop this project.
The key project principles are:
- "International": An excipient manufacturer's certfication should have the same acceptance and value anywhere in the world.
- "Inclusivity": The scheme should provide quality standards and be applicable to as many excipients as possible.
- "Accessibility": The scheme should be accessible from as many 3rd party organisations as possible.
- "Evolution not revolution": Existing best practices, guides and standards should be utilised and adapted wherever possible.
- "Simplicity": The overall scheme should be as simple as possible.