European Commission Publishes Draft of GMP Directive on Certain Excipients

European Commission Publishes Draft of GMP Directive on Certain Excipients

GMP News
03 April 2007

European Commission Publishes Draft of GMP Directive on Certain Excipients

On 22 March 2007 the European Commission published a draft of the designated GMP requirements for certain excipients on its website. It is entitled „Specific Conditions of the Application of the Principles and Guidelines of GMP for Certain Excipients". This draft from 21 December 2006 is the first publicly accessible EU Commission draft on GMP requirements for excipients manufacturing. So far there were only internal discussion papers.

The publication of GMP requirements for manufacturing certain excipients is a milestone in the development of GMP Directives. Their impact (after finalisation) will be comprehensive, because not only excipient manufacturers will have to implement them. Medicinal product manufacturers (and especially the Qualified Person) also have to examine whether the used excipients were manufactured in compliance with the GMP regulations. Similar to the GMP compliant manufacture of APIs it is now a question of verification. For APIs this question has been resolved by now. The medicinal product manufacturer has to verify the GMP status with an audit.

Together with the draft the European Commission also posted various documents, among them questionnaires for excipient manufacturers and users (medicinal product manufacturers) and an instruction note from 16 March 2007.

The commission’s goal is to collect information regarding the possible impacts of the future GMP Directive for certain excipients. Therefore excipient and medicinal product manufacturers – and specifically midsized and small companies – are asked to participate in the online consultation and to answer the questions by 30 July 2007.

It is also possible to comment the draft of the GMP Directive – for that purpose a form „submission of comments" is attached at the end of the instruction note.

The draft of the GMP requirements for excipients and the questionnaires of the EU Commission are available on the European Commission Website.


GMP for excipients – cutting edge information from the EU Commission in Berlin on 24/25 May 2007

Find out more about the current GMP requirements for excipients and APIs – at the 2. Pharma Business Conference of the EFCG in Berlin on 24/25 May 2007. You will get first hand information from the decision makers, and you will have the opportunity to discuss potential consequences. Sabine Atzor from the EU Commission will present the latest developments. Other speakers at the conference include Emer Cooke, EMEA, and Jean Marimbert, AFSSAPS as well as other representatives of the Head of Agencies. You will find the conference programme at

Wolfgang Heimes
On behalf of the European Compliance Academy (ECA)

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