Saturday, 14 September 2013

EU GMP update

A new version of chapter 2 of the EU GMP guide ('Personnel') has been published by the European Commission (16th August 2013). The chapter is effective as of February 2014, according to the ECA.

The new chapter incorporates ICH Q10 'Pharmaceutical Quality System'.

The revised chapter describes the roles and responsibilities of senior management, the need to ensure that consultants are suitably qualified, the key aspects of a quality management system, and there is the addition of the position 'Head of Quality Assurance' for the first time.

The revised chapter can be found here: GMP 2

Posted by Tim Sandle

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