Current EMEA Statements regarding the Introduction of the Harmonised Test Methods in Microbiology

GMP News
12 September 2007
 

Current EMEA Statements regarding the Introduction of the Harmonised Test Methods in Microbiology

 
In the "Questions & Answers Section" of the Quality Working Party the European Medicines Agency (EMEA) now published statements with regard to the harmonised microbiology chapters in the European Pharmacopoeia (Ph.Eur.).

The most important statements are:

  • The new test methods will become effective as reference methods on 1 January 2009, or when the respective revised monograph is published.

  • For new marketing authorisation submissions that are not covered by a monograph the QWP recommends to already apply the new methods.

  • For already licensed medicines that are not covered by a monograph, both methods defined in the Ph.Eur. can be applied until 31 December 2008. Starting on 1 January 2009 the new method will be the reference method.

  • To avoid the need for reviewing the new method's applicability for every single licensed product it is possible to choose a risk based approach for the introduction of the new methods. This procedure has to be substantiated scientifically though. For product lines it is also possible to use a "Bracketing" approach with a scientific explanation.

The statements with regard to the validation of alternative methods are also quite interesting.

The general statement is: the validation has to be conducted against the reference method.

However, can this be realised for both chapters 2.6.12 and 2.6.13?

For chapter 2.6.12 this means that until 31 December a validation has to be conducted against the "old" method, and starting with 1 January 2009 against the "new" method. However, if an alternative method was validated by applying the "old" method and approved afterwards, it is not necessary to re-validate when the "new" method becomes reference method.

This is different with chapter 2.6.13. Here the QWP already recommends validating alternative methods against the "new" method to avoid a re-validation when the "new" method turns effective as reference method.

This last sentence is in contradiction with the requirement to relate the validation to the reference method - at least until 1 January 2009, when the "new" method becomes reference method. Of course there are good reasons for following the QWP proposal. However, preferably the QWP should have explicitly provided users with the certainty that this approach will be accepted, even if - strictly interpreted - a GMP criterion is not fulfilled.

The QWP statements and more questions & answers for the application of the new microbiological Ph.Eur. methods are available at http://www.emea.europa.eu/Inspections/QWPfaq.html.
 

ECA Training Course recommendation on Microbiology:

 
Author:
Dr. Ulrich Herber
On behalf of the European Compliance Academy (ECA)
 

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