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
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.
A video conference with Dr. Kopp-Kübel
of WHO (World Health Organization), Geneva, who spoke on the problems of
starting materials from the Third World, rounded off the first day of the
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?
Social Event on Wednesday evening.
After a visit to the port of Hamburg and the famous 'Speicherstadt'
(warehouse district) we had a traditional evening meal in a pub
brewery in downtown Hamburg.
By the way:
Those of you who were unable to attend
the conference can obtain the conference documentation from CONCEPT
HEIDELBERG for DM 300.00 plus value-added tax and postage and mailing
Dr. Barbara Jentges, CONCEPT HEIDELBERG