In March 2006 the European Medicines Agency (EMEA) published a so-called
Reflection Paper describing the handling of minor deviations from the
authorisation. The document is supposed to help clarify whether a batch
fulfils the requirements of the authorisation under the specified
circumstances. It illustrates certain conditions under which a Qualified
Person can release a batch which is not 100 % compliant with the details
defined in the marketing authorisation. Most important is that the QP's
release decision is based on the principles of risk management according to
the ICH Q9 guideline.
The authority expected that the Reflection Paper would be helpful in
handling the majority of doubtful cases from the past. Cases not described
in this document still have to be handled as defined in the respective
Now the EMEA Ad Hoc GMP Inspection Services Group plans on discussing the
issue with industry and interest group representatives in September 2007.
The authority has asked industry associations to provide information on
the following questions:
1. Do you find the Reflection Paper helpful?
2. Approximately, for how many batches in the last year did your QPs follow
the recommendations of the reflection paper in order to certify and thereby
allow their release?
3.1 Approximately, how many batches failed to meet the requirements of
the marketing authorisation, which in the opinion of the manufacturer were
minor deviations, but for which the reflection paper did not provide a
3.2 If any, please describe the circumstances.
4. Please provide feedback on any specific circumstances that are excluded
from the scope of the Reflection Paper that should be included?
5. Do you think incorporation of the principles outlined in the Reflection
Paper into Annex 16 of the GMP Guide would be helpful?
6. Any other comments.
The European QP Association will also conduct a survey among its members
and forward the results to EMEA. Membership in the organisation is free of
charge. To find out more about the organisation please see