The International Pharmaceutical Excipients Council Europe

3/12/2009

Certification Project Update

All members have received the request to review the excipient classification and GMP
annex that is build around it and the IPECPQG GMP Guide.

Members' input and considerations now are critical to the project. IPEC Europe members are invited to provide their views about the risks identified that would drive the need for enhanced GMPs for excipients. In particular the coordinator, Iain Moore, would like to address the following questions: O Are these risks ever seen in practice? Does the additional GMP specified match up with the risks so that they are controlled?

Are there things in the GMP Annex that you now have to do that you do not do now? - have we raised the bar? The development team will be meeting in Cannes on 27 January, so please have your comments sent in well before so that that can consider them.

Feel free to contact the coordinator or the Classification and GMP team leaders. We hope to be issuing the GDP Annex for review very shortly in the same manner. Also the Auditor Competency team and scheme teams are making good progress, and their outputs will be available for review in the first quarter of 2010.


This is a critical part of the development of these standards. Your broader experience and  knowledge will be absolutely invaluable in setting a standard that is achievable and which delivers the benefits we all want to see. Meantime the authorities on both sides of the Atlantic and Rx-360 look at our progress in eager anticipation that we can deliver a scheme that moves the whole industry forward.

For all team members and those of you who have provided comments and a review, the coordinator would like to express his sincere thanks for your contribution, wishing to all of you a very happy and relaxing holiday season.