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ASE Pharma Solutions

On 28 March 2014, the European Commission published revised version of Chapter 6: Quality Control of the EU GMP Guide. The new chapter came into force on 1 October 2014.

Special attention should be given to current point iv. of section 6.7 and section 6.9 relating to OOS and OOT results and also to newly inserted sections 6.20 dealing with the reference standards as well as completely new chapter describing requirements for Technical transfer of testing method (sections 6.37 to 6.41).

Please download a file with the comparison between the current Chapter 6 and its old version. It helps you to verify and assess if your Quality Control Laboratory fulfils new GMP requirements.