20/21 November 2019
GMP News No. 935: EMEA Reflection Paper on Handling Deviations
EMEA Reflection Paper on Handling Deviations
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 www.qp-association.eu.
|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.|