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