Ten years of IPEC Federation

The association marked its 10 years of existence.

Creation of IPEC India

A fifth regional IPEC is created in India to play a greater role in the evolution and development of the excipient industry in this country.

Creation of EXCiPACT

IPEC Europe is a founding member of and an active contributor to EXCiPACT, a not-for-profit organisation that develops and manages a 3rd party certification scheme for manufacturers, suppliers and distributors of pharmaceutical excipients.

Creation of IPEC Federation

The TriPEC structure evolves into the IPEC Federation, a global association consisting of regional associations organised to promote quality in excipients and legally registered in Belgium.

Creation of IPEC-China

Inaugurated in Hong Kong, IPEC China is the association representing the excipient industry in the People’s Republic of China.

First publication of joint IPEC-PQG Good Manufacturing Practices Audit Guideline

IPEC Europe, IPEC-Americas and PQG publish the first Good Manufacturing Practices Audit Guideline.

First publication of IPEC Europe Good Distribution Practices Audit Guideline

IPEC Europe publishes the first Good Distribution Practices Audit Guideline.

Publication of the first Good Manufacturing Practices Guide with PQG

The first guide to produce appropriate standards for the manufacturing of excipients for pharmaceutical use aligned with ISO:9001 is jointly published by IPEC Europe, IPEC-Americas and the PQG in January.

First WHO Good Trade and Distribution Practice guideline

IPEC Europe provides expertise on excipients during the development of the first edition of the World Health Organisation (WHO) Good Trade and Distribution Practice for Pharmaceutical Starting Materials guideline.

Collaboration with the Pharmaceutical Quality Group

IPEC Europe and IPEC-Americas enter into an arrangement with the Pharmaceutical Quality Group (PQG), an organisational unit of the UK-based Institute of Quality Assurance.

Publication of first GMP Audit Guideline

IPEC publishes the first Good Manufacturing Practices Audit Guideline for Distributors of Bulk Pharmaceutical Excipients.

IPEC website

IPEC Europe launches its first website, jumping in the world wide web.

Publication of Guidelines for Safety Evaluation of Excipients

The Safety Committee elaborated the Guidelines for Safety Evaluation of Excipients, published in European Pharmaceutical Review

Publication of the first Guide on GMP for Bulk Pharmaceutical Excipients

IPEC Europe and IPEC-Americas jointly adopt, publish and implement industry-developed Good Manufacturing Practices (GMP) for Bulk Pharmaceutical Excipients. An updated version of this guidance has been adopted by the World Health Organisation and by the United States Pharmacopoeia.

Creation of TriPEC

IPEC Europe, together with IPEC Japan and IPEC-Americas, creates the TriPEC group as a forum to discuss global excipient harmonisation.

Creation of IPEC Europe and IPEC Japan

IPEC Europe is officially created on 7 April 1992 in France. The founding members of IPEC Europe are Colorcon, Dow Corning, Ciba Geigy, Seppic, Aqualon, Smith Kline Beecham. Mr John Hogan, Colorcon is appointed as the first Chairman. In parallel, another regional IPEC is founded in Japan as JPEC in February.

First IPEC Europe event

A one-day seminar is organised in Paris during the spring.

Creation of the International Pharmaceutical Excipients Council

The IPEC (later IPEC-Americas) is created in the U.S. with four basic goals:

• Harmonisation of compendial standards for excipients;
• Harmonisation and appropriate GMP guideline to ensure excipient quality and uniformity since no formal regulatory review and approval process exists for pharmaceutical excipients;
• Harmonisation and appropriate safety evaluation guideline for new excipients;
• Effective communication and cooperation with producers, excipient users, pharmacopeia officials and government regulators.