Thursday, 17 July 2014

EU GMP Chapter 6: Quality Control

The new version of chapter 6 of the EU GMP Guide comes into effect on 1st October 2014.

“Quality Control is concerned with sampling, specifications and testing as well as the organisation, documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. Quality Control is not confined to laboratory operations, but must be involved in all decisions which may concern the quality of the product. The independence of Quality Control from Production is considered fundamental to the satisfactory operation of Quality Control.”


The final version includes of a new section on technical transfer of testing methods and other items such as Out Of Specification results. There is also a new section on the technical transfer of analytical methods.

To view the final version, see Eudralex

Posted by Tim Sandle