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.
This project does not envisage mandatory certification of excipients nor additional legislative or regulatory burden. However, should regulatory agencies require 3rd party certification or a mandatory GMP for excipients, industry will be ready with a consistent, harmonised science and risk based approach to the subject.

For more information please contact EXCiPACT Secretariat at This email address is being protected from spambots. You need JavaScript enabled to view it.

Useful Information

Next EXCiPACTTM Training Courses in Europe – 7-8 Oct – Brussels

USA Launch of EXCiPACTTM on 29 April, 2013

BASF ExACT article

2nd EXCiPACT Auditor Training Programme

Comparison of Audit and Certification Programs

EXCiPACTTM - The New Iinternational GMP and GDP Certification for Pharmaceutical Excipients is Launched

White Paper - International Excipients Certification Project: Minimize risks - Maximize benefits

Auditor Training Course, 18 & 19 January, 2012, Paris

EXCiPACTTM Launch Event, 25 January, 2012,  Barcelona