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GMP News
3 May 2007

EMEA Reflection Paper on Handling Deviations

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 national jurisdiction.

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 solution?

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

You can find out more about the requirements for Qualified Persons in the course QP Education Course understand the implications of becoming a QP in Prague, Czech Republic, on 13-14 June 2007.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)


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