EXCiPACT

Regulators require excipient users to qualify their suppliers based on GMP/GDP & GWP audits and they have indicated that third party auditing of suppliers is acceptable if a creditable certification body issues certificates and audit reports by employing qualified auditors who are demonstrably credible in suitable GMP/GDP & GWP  standards and in the needs of the pharmaceutical industry. EXCiPACT asbl is a non-profit organisation that owns and manages oversight of such an independent, high quality, third party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.

IPEC Europe

Initially created in 1992, IPEC Europe, the International Pharmaceutical Excipients Council Europe, is the only European association bringing together producers, distributors and users of pharmaceutical excipients. IPEC Europe offers a unique forum for members to exchange good practices and to develop harmonised standards for pharmaceutical excipients. It strives to continuously promote and achieve worldwide acceptance and use of the IPEC developed guidelines as a means of improving and ensuring quality, safety, and functionality of excipients. Since 2010, together with its sister associations, IPEC Americas, IPEC Japan, IPEC China and IPEC India, IPEC Europe is a member of IPEC Federation whose global membership extends to more than 200 companies. In 2008, IPEC Europe initiated with other industry experts the development of a certification scheme for excipients suppliers that has become in January 2014 the free-standing association EXCiPACT®.