Results of Survey on EU GMP Guide Revisions of Chapter 5 (Production) and 7 (Contract Manufacture and Analysis)

In our GMP News from 17 November 2010 and 25 November 2010, we described very precisely the changes planned to Chapter 7 (Contract Manufacture and Analysis) and Chapter 5 (Production) of the EU GMP Guide. In this context we conducted a survey to get your opinion about these changes (GMP Newsletter from 24 February and 3 March 2011).

Here are the results! 156 colleagues participated in the survey. This is an impressive number which also means that the results have an appropriate weight. This can help a lot since the results were sent to the EMA and may be integrated in the final revisions of the Chapters. For this reason, we've asked to explicitly express requests for change in the survey . Because of the large number of participants, the comments reveal very interesting information.

Author:
Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

PS: At the 4th ECA GMP Conference on 19/20 May 2011 in Heidelberg, a session will be dedicated to the topic "Contract Manufacture and Analysis". Here, the planned changes will also be discussed. Please find more information about this conference here: www.gmp-conference.org