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 services 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 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 have been conducted to GMP requirements and are 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.
Emergo provides Qualified Person services
We can offer the following Qualified Person (QP) support services to assist your company with both medicinal products and medicinal investigational products (IMPs) to comply with GMP requirements in the European Union (EU).
- For existing marketed products, our QPs are eligible to be named on your Manufacturing and Importation Licence (MIA) and will certify the product in accordance with the relevant marketing authorization, for example the Medicinal Products for Human Use Directive 2001/83/EC and GMP Directive 2003/94/EC.
- Provide auditing support in Supplier Qualification, as part of Supply Chain Risk Management control, in compliance with the latest European GMP regulations.
- Provision of support to ensure that the Supply Chain is secure against the introduction of counterfeit materials.
- Preparation of Technical and Quality Agreements for organizations throughout the Supply Chain.
- Certify your IMP for use in clinical trials in Europe in accordance with the Clinical Trials Directive 2001/20/EC.
- Provide Regulatory and Quality strategic guidance and support for EU product registration for medicinal products.
Consultants based in Emergo'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 on European Qualified Person services.