On 15 February, the EU Parliament accepted with a large majority the amendmends to the EU directive 2001/83/EC regarding the prevention of the entry of counterfeit medicines into the legal supply chain of medicinal products. The revisions to the directive concern different fields of drug manufacture; especially the securing of quality of pharmaceutical APIs and excipients are concerned.
The new guidance for APIs includes the following:
Considering pharmaceutical APIs, the following new provisions are applicable:
The amended directive will come into force on the 20iest day after the publication in the Official Journal of the European Union. Further changes or a withdrawal of the tightened regulations won't be expectable any longer after the EU Parliament has adopted the revision. After the directive has become operative, the EU Member States will have a 18 month time period to implement the new regulations into their national laws.
The courses on "ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis/Cell Culture/Fermentation" taking place in Vienna, Austria, from 27-29 June 2011 will cover in detail the topic of GMP for APIs. The final "ICH Q7 Auditor Training Course" also in Vienna from 29 June - 1 July 2011 (which will be repeated on 26 - 28.10.2011 in Heidelberg) will provide excellent knowledge about the techniques to be used during an audit.
During the course "GMPs for pharmaceutical Excipients" in Barcelona, Spain, from 27-28 September 2011, you will have access to first-hand information about the possibilities to verify the GMP compliance of APIs.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)