Press Release - APIC - 2nd European GMP Conference on Active Pharmaceutical Ingredients

ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE

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150 Attend 2nd European Conference on Active Pharmaceutical Ingredients

from left to right: S. Higgins, L. Hartmann, C. Pouget, N.C. Franklin, R. Gengenbach, W. Verhaegen, H. Leblanc, S. Gangkofner, L. Le Doré, O. Schmidt, C. Oldenhof, E. Rivera Martinez, B. Fellows, K. Metzger, J. Ruiz, P. Smith

Comprehensive updates were given on recent regulatory trends which will affect Good Manufacturing Practices for European Actives manufacturers. Speakers attended from EDQM, FDA and the industry. The message was brought firmly home to those who attended that the pace of change in the sector is rapid and if companies are to remain competitive they must ensure that they have effective quality management systems in place.

• The primary regulatory drivers discussed included

• The Starting Materials Directive - Henri Leblanc CEFIC/APIC

• The Internationally Harmonised Guide on GMPs (ICH Q7a) - Joyce Ramsbotham-Solvay/EFPIA

• The MRA Process - Matt Moran-CEFIC/APIC

• BACPAC/Variations - Chris Oldenhof-CEFIC/APIC

• Certificates of Suitability - Corinne Pouget-EDQM

Delegates received extensive up to the minute presentations on recent inspection trends from John Ayling , previously an inspector with the MCA , and Edwin Rivera Martinez of the US FDA.

Edwin Rivera Martinez, US FDA

Day 2 of the Conference comprised 8 parallel workshops covering topics ranging from Computer Validation (David Selby) right the way through Auditing (Lothar Hartmann) to Change Control (Chris Oldenhof).

The podium

Commenting at the end of the Conference CEFIC/APIC President , Henri Leblanc of Rhodia Chimie said,

" Overall we are very pleased with the way the event went. From a business perspective we feel that the European API sector is coming under significant pressure from 3rd countries. We are concerned that there will not be a level playing field for the industry here in Europe in terms of actual GMPs being applied. We call on upon the regulatory authorities to ensure that common standards of GMP are applied worldwide through frequent and rigorous inspections overseas. We welcome the proposed GMP Guide developed by the International Conference on Harmonisation and urge Europe to embrace the Mutual Recognition Agreement with The US FDA in any way that they can."

For further information contact:

Matt Moran
CEFIC/APIC phone 087 2073919 / fax +35316381567

Loïc Le Dore
CEFIC/APIC phone 32 2 6767212 / fax 32 2 6767301/
E mail LLE@CEFIC.BE

Karl Metzger
CONCEPT phone 49 62 21 84440 / fax 49 62 218444 84