QP role discussion

As we proceed in Europe with the implementation of the Clinical Trials Directive and also continue towards the implementation date of the Future Medicines Legislation (FML) Directive, the role of the Qualified Person is becoming ever more crucial (that's not to say that it wasn't always crucial!) to the effective functioning of the manufacturing side of industry. Yet there are still a number of areas where the exact role of the QP is not totally clear in the newer legislation.

In respect of clinical trials we have ongoing questions about the role and responsibilities of the QP in confirmation of the GMP status of suppliers in non-EU countries where there is no effective Mutual Recognition Agreement, and similar concerns about the import of comparators from those states.

With regard to the FML, we will have a requirement for Active Pharmaceutical Ingredients (APIs) and certain, as yet unspecified, excipients to be manufactured in compliance with GMP in accordance with annex 18 of the EU GMP guide. Again, the extent of the role of the QP in verifying this process is far from clear.

In the CT Directive there is also the question of transitional arrangements for people performing the role of a QP but not eligible for QP status and who were in post pre-legislation. In the UK legislation is very explicit on this point, requiring six months in post pre-legislation. However, application of this provision may vary between member states.

It is to be hoped that things will become clearer in the coming months through guidance and statements from the various regulatory authorities.