As required by the Clinical Trial Directive 2001/20/EC and Annex 13 to the European GMP Guide, all Investigational Medicinal Products (IMPs) must be certified by a Qualified Person (QP) prior to release for use in a Clinical Trial. A QP is required to have qualifications in Chemistry, Pharmacy or Microbiology and have wide ranging technical knowledge and experience within the pharmaceutical industry. Each QP named on the Manufacturer’s and Importer’s License takes personal responsibility for the quality of the IMP being released to the clinical protocol.
Widely known and respected, our QPs have experience across a wide range of product types and dosage forms. We also have an experienced support team who are able to assist you in the release of IMPs for use in clinical trials, including importation into the EU when necessary.
Supporting you at every step:
- Provide you with easy to follow release procedures which provide a consistent, secure, structured approach that has been repeatedly reviewed during MHRA inspections
- Ensure you have the latest information regarding current regulatory guidance and expectations – proactively ensuring continued compliance
- Global auditing of third party manufacturing, testing, packaging and labelling facilities as required in support of QP declarations for import into the EU
- If required, available support from our Sciences Business Unit
- On-site services are available if you require a deeper level of understanding of the QP release process or if you need to supplement existing internal resources. Information relating to the applicable European Directives Good Manufacturing Practice and requirements for Clinical Trials is available within Eudralex Volumes 1, 4 and 10 respectively.
QP Facilitation Program
Simplifying the QP process
Our QP Facilitation Program is designed to provide the necessary background information on how the QP release process occurs. The program happens on-site and enables us to gather much of the documentation required for the import and release of investigational medicinal products into the EU.
An experienced Quality Compliance Manager will work side by side with you for approximately 2-3 days. This process, which normally takes place via email or phone over an extended number of weeks, is simplified and expedited with our on-site guidance. Achievable goals and contact points will be agreed upon in advance of the trip, with a performance status report issued upon leaving the site.
Key benefits you will receive:
- Step-by-step review of the QP process
- Review of why QP release is required
- Open forum to answer any questions around QP release
- Collection of relevant documentation
- Early completion of necessary forms
- Establish relationships with relevant personnel
Onsite services help to improve understanding of your processes, as well as allows us to supplement any lack of internal resources. Your documentation is completed early, ultimately removing the preparation for QP release from the critical path prior to IMP distribution.
View Almac’s webinar on our ‘QP Facilitation Programme’
QP Facilitation Programme from Almac Group on Vimeo.