3rd European GMP Conference on Active Pharmaceutical Ingredients - Review -

During the period from September 6 - 8, 2000 the 3rd European GMP Conference on Active Pharmaceutical Ingredients of APIC, a subgroup CEFIC, took place in Hamburg.

A total of 23 speakers from industry (e.g. Rhodia Chimie, France, F. Hoffmann-La Roche, Switzerland, SST Corporation, USA, etc.), authorities (Medical Products Agency, Sweden; MCA, UK, Laboratoire National de Sante, Luxembourg) and associations (EDQM, France; WHO, Switzerland) informed the participants from a total of 17 different European countries as well as the USA, Egypt and India about the latest GMP trends in the manufacture of active pharmaceutical ingredients. Focal topics of the first day of the conference were the EC Directive on Starting Materials, new developments concerning the MRA and the ICH Q7A Guideline, which was released for consultation at Step 2 of the ICH Process on July 19 of this year as well as problems concerning the falsification of active ingredients from the point of view of the industry. Topics of relevance for marketing authorization such as certificates of suitability, post-approval changes and variations as well as new developments at BACPAC filled the afternoon. Another focal topic concerned the GMP requirements for research and development.

The second day of the conference was devoted to selected special topics such as validation in fermentation, retrospective qualification and validation, handling of out-of-specification test results, definition of specifications particularly as regards impurities and stability. Furthermore, the requirements as regards computer validation and the requirements to be placed on paper-free documentation, particularly as regards electronic signatures, were described.

On the third day of the conference the participants had the opportunity to discuss selected topics such as preparation for inspections, SAP in active ingredient production, application of the ICH Q7A Guideline, type II variations, stability tests, etc. with the experts in small groups.

The conference was generally a great success, and the participants made use of the opportunity for an exchange by means of intensive discussion in the plenary session. The conference was rounded off by a sightseeing tour of Hamburg, the most important transshipment port for APIs imported for the European market.

And nevertheless the question occupying the minds of the participants still remains unanswered: Quo vadis EC Directive on Starting Materials?

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