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GMP-News Nr. 48
|GMP News Nr. 48|
12. November 1999
ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE
+++++Press Release++++++ Press Release ++++++
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.
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.
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).
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:
Loïc Le Dore