1st Conference in 1998

November 1998

GMP on Active Pharmaceutical Ingredients Manufacturing

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 latest draft of the EU Directive on starting materials-presented by Beatrice Hughes, European Commission DG III
  • The Internationally Harmonised Guide on GMP for Active Pharmaceutical Ingredients - presented and discussed by Bernhard Scherz (IKS) and Gordon Munro (MCA)
  • Ph. Eur. Certificates of Suitability and European Drug Master Files - presented by Agnes Artiges, European Pharmacopoeia
  • The current status of the Mutual Recognition Agreement (MRA) with the U.S.A. and Canada presented by Matt Moran, vice-chairman CEFIC-APIC.

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: 'When consens is achieved it is vital that a level playing field in GMP is applied inside and outside the trading zone covered by the MRA agreement. The European Actives industry remains commited to high quality and protection of the ultimate consumer, the patient. However with quality comes lost and the European Industry would be disappointed if sub standard materials are imported into this area. Disadvantaging the European industry area ultimately jeoparding the patient.'

Dr. Leblanc called for regulatory agencies within the ICH area to be extra vigilant in this regard. Gordon Munro, MCA informed the Conference delegates that the next ICH meeting on the global GMP Guide was scheduled to take place in January of 1999. It now seems likely that the transition phase of the MRA with the USA will commence in November of 1998 at the earliest.

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