EU publishes final version of Chapter 6 Quality Control

European Commission has published the final version of Chapter 6 Quality Control of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use on April 3, 2014. The revised document will come into force on 1 October 2014 and then supersede the previous version of 2005. The changes will be effective and binding within Europe. The incorporation of a new section on technical transfer of testing methods and other items such as the integration of out of specification (OOS) results and trend analysis are the main changes in the document.

The new section on technical transfer of testing methods (6.37-6.41) Chapter 6 underlines that

•  the transferring site should verify that the test methods comply with the marketing authorization or the relevant    technical dossier.
•  the original validation of the test method should be compliant with current ICH/VICH requirements.
•  a gap analysis should be performed and documented prior to commencing the technical transfer process.
•  a detailed transfer protocol should be compiled and at least include:
   o the relevant test methods, any additional training requirements, standards and samples to be tested by both, the    transferring and the receiving laboratory, special transport and storage conditions required for the test items.
•  deviations from the protocol should be investigated prior to closure of the technical transfer process in order to      identify areas requiring further test method revalidation.