The European Medicines Agency (EMEA) has given useful guidance in the "Q&A
Section" of the Quality Working Party on the implementation of the
harmonised microbiology chapters 2.6.12 and 2.6.13 of the European
The most important statements are:
- For new applications for marketing authorisation not
covered by a monograph, either set of tests can be used until 31
December 2008, however use of the 2nd set is highly recommended. From 1
January 2009, the 2nd set of tests is to be used as reference method.
- For already authorised products not covered by a
monograph, either set of tests can be used until 31 December 2008. From
1 January 2009, the 2nd set of tests is to be used as reference method.
- A risk-based approach in which not all products are
tested is allowed if scientifically justified.
- Bracketing for a product line can also be used, where
The provided information on the validation of alternative
test methods is also very interesting. The general comment is: "Validation
should be performed against the reference methods."
But can this be applied to both chapters - 2.6.12 and
"For 2.6.12, this means validation against the 1st set of tests until 31
December 2008 and against the 2nd set of tests from 1 January 2009. If an
alternative method has been validated against the 1st set and subsequently
approved, no revalidation is necessary when the 2nd set becomes official."
"For 2.6.13, validation against the 2nd set is recommended to avoid
revalidation when the 2nd set becomes official."
In the opinion of the author of this GMP News the last sentence for chapter
2.6.13 contradicts the requirement to validate against the reference method
until 31 December 2008, as the 2nd set will become the reference method by 1
January 2009. Therefore, it would be helpful to receive a clear statement
from QWP that this exception from a GMP requirement is acceptable due to
very good practical reasons.
You will find the comprehensive Q&A section which also includes statements
on EP chapter 5.1.4 at
Dr Ulrich Herber
On behalf of the European Compliance Academy (ECA)