IPEC Europe is the association that brings together producers, distributors and users of pharmaceuticals excipients. IPEC Europe counts 71 full members, 4 associate members and 5 co-opted members.

Committees

Quality and Regulatory Affairs Committee

The Quality and Regulatory Affairs Committee provides a forum for members to enable discussion on relevant topics and to share best practices as they relate to various stakeholders in the pharmaceutical arena, ie makers, users and distributors of excipients.  The committee operates by:

  • Monitoring proposals by the regulatory agencies to amend legislation in our region
  • Providing consolidated feedback to those regulatory agencies
  • Monitoring trends within the pharmaceutical industry which potentially impact excipients, such as Quality by Design and the Paediatric Initiative
  • Developing and issuing position papers on relevant topics
  • Developing and promoting guidance documentation to assist both the members and outside interested parties
  • Working with other members of the IPEC organisation to achieve a global position on selected issues, such as cGMP.

Pharmacopoeial Review & Harmonisation Committee

IPEC Europe's Pharmacopoeial Review & Harmonisation Committee (PR&HC) is a working group of industry specialists involved in matters related to the (international) harmonisation procedure but also to Pharmacopoeias follow-up. The current members are supported by additional experts, who can attend the committee meetings to handle specific items.

The PR&HC is established to provide input (via IPEC Federation) to the Pharmacopoeial Discussion Group (PDG) in order to facilitate the subjects of the PDG-work programme. The PDG consists of representatives from the three pharmacopoeias (EP, USP and JP). The PR&HC contributes also to the harmonisation program of individual monographs, general methods or general chapters of the Pharmacopoeias and is involved in writing guidelines, position papers, and drafts for the Health authorities.

IPEC Europe’s PR&HC also works closely together with its counterparts in Japan, the United States and China to work actively on Pharmacopoeial review beyond harmonization topics.

Good Distribution Practices Committee

The mission of the Good Distribution Practices Committee is to contribute to drug safety by focussing on supply chain-related aspects of pharmaceutical excipients. In order to enhance excipient quality throughout the entire distribution chain from the original manufacturer onwards, the key objectives of the Committee are to:

Raise awareness of the need for Good Practices in the distribution chain

  • Contribute to the development of IPEC guides and documents
  • Act as a focal point for IPEC members' supply chain related topics (information and discussion with membership) 
  • Provide and communicate relevant information to the IPEC membership
  • Monitor and influence supply chain related activities from outside of IPEC
  • Interact with other associations and stakeholders (e.g. FECC, WHO)
  • Contribute to international harmonisation of Good Distribution Practices