Members Area Login

Go to the login page

Want to be a Member?

Click here
Contact us
FAQ

IPEC Europe

Supporting the interests of pharmaceutical excipient developers, producers, distributors and users.

Objectives

Objectives of the Certification Project

 

Excipients are not yet fully regulated (in comparison to APIs) but there are legal proposals on both sides of the Atlantic to address this, which will lead to many more audits being required.

 

The Excipient Certification scheme (Excipact) proposes an independant certfication of manufacturers including a classification of excipients based on risk. This is a means of ensuring patient safety, improving assurance of supplier quality, while minimising the overall supply chain costs. To deliver the scheme IPEC Europe has partenered with IPEC-Americas, the UK Pharmaceutical Quality Group (PQG), the Federation of European Chemical Distributors (FECC) and the European Fine Chemical Group (EFCG).

 

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.

 

The key deliverables of Excipact are:

  • GMP and GDP standards suitable for 3rd party auditing;
  • Auditor competency schemes;
  • Certification scheme rules for 3rd party audit organisations;
  • Publication, communication and ongoing maintenance of the schemes, standards and guides developed.

 

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.

 

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

Newsletter Subscription

Sign up for our subscriber newsletter!