GMP News No. 12
"1st European GMP Conference on Active Pharmaceutical Ingredients", 9-11 September 1998, Brussels
|GMP on Active Pharmaceutical Ingredients Manufacturing|
|The latest developments were discussed from September 9 to 11 in Brussels|
|140 attend inaugural European
GMP Conference on Active Pharmaceutical Ingredients
140 delegates from the European Active Pharmaceutical Ingredient and intermediate industry and a range of national and European regulatory authorities attended the inaugural GMP Conference on Active Pharmaceutical Ingredients in Brussels from Wednesday 9th September to Friday 11th September. The Conference was run by 'The Active Pharmaceutical Ingredients Committee (APIC) of CEFIC (The European Chemical Industries Council) in association with Concept Heidelberg.
Conference delegates discussed a number of breaking issues currently effecting the European actives industry including
The delegates who came from over 20 countries, inside and outside Europe learnt of the rapidly changing regulatory environment as it effects GMPs within the Actives industry. The importance of Europe possessing an inspection regime which will complement and facilitate the successful completion of the MRA with the U.S.A. was emphasized. Companies were advised of the need to be ready and prepared to adhere to the proposed EU Directive on Starting Materials and the supporting ICH Guideline on GMPs for actives.
Speaking after the Conference APIC Chairman, Dr. Henri Leblanc (Rhodia-Chimie) said:
'European actives industry, through CEFIC-APIC is highly supportive of the current ICH process aimed at producing a global GMP guide for the industry. I am optimistic that the consences being sought on this by the ICH partners will produce a guide of great benefit to the industry'.
He went on to say:
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