Pharma Queues Up for QPs

The EU Clinical Trials Directive implemented on 1st May, 2004 stated that a QP needs to have a personal knowledge and understanding of the manufacturing process, usually via site audit. For QP teams, this has resulted in a great deal of overseas travel, but also has been an excellent way to ensure that other clients can benefit from the experience and examples of best practice gained during these visits. However, there is a need to balance this extensive on-site role with pre- and post-audit support, presenting an interesting yet challenging situation.

The EU Clinical Trial Directive means that all medicines imported into the EU for use in clinical trials must be released by a QP and receive specialised handling, labelling, packaging and distribution. The UK is a relatively attractive route into the EU due to the proactive and communicative way that the UK MHRA has approached the introduction of the new legislation. At the same time as the introduction of the Clinical Trials Directive, the EU expanded by 10 member states. Access to this expanded population of clinical subjects, coupled with the added data security and patient safety brought by the new controls, further enhanced the EU as a good option for sponsors wishing to conduct clinical trials.

THE ROLE OF THE QP

The Code of Practice and Annex 16 to the EU guide to GMP clearly defines the role of the QP. The production processes for commercial products are fixed and validated and must therefore be applied rigidly. Any changes would need approval by the regulatory authority, either as a permanent variation or as a ‘single batch variation’ and would be assessed on data submitted.