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.
Posted by Tim Sandle
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