When carrying out clinical trials within the European Economic Area using Investigational Medicinal Products (IMPs) that may have been manufactured outside the EU, there is a requirement for a Qualified Person (QP) to sign a QP Declaration. The QP Declaraton must state that IMPs have been manufactured according to standards of Good Manufacturing Practice (GMP) at least equivalent to those applied in the European Union (EU). This is specific requirement of EU directive 2001/20/EU and as such, applies to all EU member states.
Fisher Clinical Services can offer services for the preparation of QP Declarations for inclusion in submissions to the European authorities. Our team of QPs bring extensive experience across a wide range of dosage forms including steriles, biologicals, solids, liquids, ointments, creams, aerosols.
•Acting as auditors to provide documentary evidence to support the QP Declaration
•Providing advice on issues including expiry updating and meeting the requirements of any conditions applied by the authorities to a clinical trial approval
•Certification of individual batches of individual clinical trial materials for use at any sites within a state, following authorization by EU member state for the clinical trial to proceed
•QP Release Certificates for batch releases, as well as re-issuance of QP Release Certificates during the trial if further countries are added
All Fisher Clinical Service QPs are qualified as ISO Lead Auditors and have experience auditing facilities dealing with manufacturing, testing, packaging, chemical and microbiological analyses in both R&D and full-scale production.