QP Release

PPD provides Qualified Person (QP) services and assists in the release of investigational medicinal products (IMP) manufactured outside the European Union (EU) for use in European trials. The QP is responsible for the compliance of the imported IMPs with European cGMP regulations and guidelines.

Definition and Responsibilities

The EU Clinical Trials Directive 2001/20/EC dictates that all IMPs manufactured outside the EU have to be imported into a licensed facility and released by a QP upon entry into the EU. A QP:

• Is qualified in chemistry, pharmacy or microbiology
• Has extensive pharmaceutical experience and is required to keep current with developments in quality and regulatory areas
• Is listed in a register
• Is named with respect to a manufacturer’s or dealer’s license
• Takes personal responsibility for product quality

Release Services:

The QP facilitates the smooth transition through the regulatory process for release. Services include:

• Easy to follow release procedures
• Upfront consultancy to streamline the process
• Advice on EU Good Manufacturing Practices (GMP) compliance, particularly related to investigational medicinal products
• Auditing of third parties (if required)

The QP also ensures that each batch has been manufactured in accordance with current EU GMP guidelines and its clinical trial authorization. If a recall is required, the QP has access to relevant records.

Benefits

PPD offers proven experience in QP release services. Our QPs provide effective communication and transition management with external contractors, ensuring smooth IMP release.

By utilizing QP release with services offered by our clinical supply management team, we ensure a direct pathway between the importation of medicinal products into the EU and timely shipment to the clinical trial sites.