An NSF International Company Revised EU GMP Chapter 2
Tuesday the 10th September 2013
The Commission has issued the final version of the revised EU GMP Chapter 2. The revised Chapter becomes effective from 16 February 2014.
The main changes in the revised version are:
- New references to the responsibilities of Senior Management, which are consistent with Chapter 1 and ICH Q10.
- The recognition that a separate Head of Quality Assurance or Head of the Quality Unit may be appointed.
- The addition of new requirements for consultants (which are virtually identical to US 21 CFR 211.34) to have adequate education, training, and experience to advise on the subject for which they are retained and to have adequate records of consultants used.
Further details will be provided on our Legal Update courses on 9 October in Manchester, UK and on 15 October in Milan, Italy.
