EMEA Reflection Paper on PAT

GMP News No. 770

GMP News
9 August 2006
 

EMEA Reflection Paper on PAT

 
On 20 March 2006, EMEA published the Reflection Paper: "Chemical, pharmaceutical and biological information to be included in dossiers when Process Analytical Technology (PAT) is employed".

EMEA's PAT Team worked out this document in order to formulate preliminary recommendations on how to hand in PAT-related information in applications for or variations to Marketing Authorisations. Here, it is important to the PAT Team not to build up unnecessary barriers. This Reflection Paper is meant to provide guidance to those companies that plan a PAT-based submission. The industry is called to comment on the content of this paper, mainly since this working document is meant to be developed further.

In general, the paper recommends to those firms intending to hand in an application or variation containing PAT elements to enter into discussion with the competent authorities at an early stage, well before preparing the documents.

The complete Reflection Paper can be found here.
  

At the University of Heidelberg PAT Conference 2006 the topic "PAT from a European Perspective" will be presented by Christina Graffner from Sweden, a member of EMEA's PAT Team. And with Dr Chris Watts, there will also be a speaker from FDA. The comprehensive PAT Conference takes place in Heidelberg, Germany, from 27 to 29 September 2006.

 
Author:
Dr Günter Brendelberger
On behalf of the European Compliance Academy
  

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