Qualified Person (QP) for Medicinal Products
Companies that intend to manufacture or import medicinal products or intermediate products, for use in clinical trials or for market within the EU, must appoint the service of a Qualified Person (QP), in order to comply with EU Good Manufacturing Practice Standards.
What is the Role of a Qualified Person?
The primary legal responsibility of the Qualified Person (QP) in the European Union (EU) is to certify that batches of medicinal products have been manufactured or assembled and checked in compliance with Member State law and in accordance with their Marketing Authorization, prior to use in a clinical trial (human medicines only), or prior to release for sale and placing on the market (human and veterinary medicinal products).
The QP is a specialist role and is essential to the safe control of medicines and has had extensive training and in-depth critical understanding of all aspects associated with pharmaceutical manufacture. For each batch of medicinal product manufactured, the QP has a duty to ensure that the production and testing has been conducted to GMP requirements and is fully in compliance with the rules Governing Medicinal Products in the European Community Volume 4 Medicinal products for human and veterinary use: Good Manufacturing Practice along with the associated annex for Investigational Medicinal Products.
The legal functions of the Qualified Person (QP) are as stated in Article 51 of Directive 2001/83/EC - Community Code Relating to Medicinal Products for Human Use and article 55 of Directive 2001/82/EC Community Code Relating to Veterinary Medicinal Products. The QP works to a recognized Code of Practice established by his or her professional society.
Consultants based in Emergo Group's UK office are able to provide Qualified Person assistance and also have significant experience with clinical trial management and medical device regulatory approvals.
Please contact us for more information or a free proposal on European Qualified Person services.
