EU QP guidance update planned to reflect realities of globalised pharma - 17 Dec 2012
EU guidance on Qualified Person (QP) requirements is undergoing some important revisions aimed at bringing it in line with current practices in a dynamic and globalised pharmaceutical industry.
The revised guideline will provide greater clarity on issues such as different types of activities that QPs can delegate to other parties; address issues on the use of third-party contractors by QPs for various activities, e.g. foreign audits and the acceptance of audits from companies in a third country.
The revision is driven by the increasing complexities in the globalised pharmaceutical industry, for instance, the supply chains are much more complicated, a lot of work is contracted out as various companies have developed expertise in specific activities and there is much more cross-border activity. Specifically, the guideline is being revised to:
- provide greater clarity on sampling and testing of batches entering the EU;
- highlight the differences between certification and release;
- clarify the activities that can be delegated by a QP, especially if the manufacturing is taking place in a third country (for instance, what level of interest or awareness should a QP show in a factory outside the EU);
- Clarify importation practices and
- to ensure greater consistency of QP practices across all EU member states.
However, the revised QP guideline is not expected to address contract QPs, even though QPs are increasingly hired on a contract basis and have the same legal responsibilities as QPs that are permanent company employees. In addition, the revised guideline will not address real time release testing as this is already done elsewhere (working group on revision of Annex 17 of the EU GMP Guide).