Qualified Person (QP) Declaration in Clinical Trials.
When developing a new drug, it is critical to ensure that it is safe and effective for use in humans. Clinical trials are an essential step in this process, and regulatory authorities within the European Union (EU) require that the Investigational Medicinal Product (IMP) used in clinical trials is manufactured in compliance with EU Good Manufacturing Practice (GMP) standards. Therefore, to ensure that Product(s) manufactured outside the EU in third countries comply with this requirement an audit of the facilities is required by the QP. If suitable a QP declaration is then provided.
Third-party audit reports can be provided but these must be detailed enough that the QP can determine the suitability of the site. The CV of the auditor must also be provided. As the QP takes personal responsibility for the declaration a review of the audit report may result in it being deemed unacceptable to produce a QP declaration.
What is an IMP QP declaration?
An IMP QP declaration is a statement made by a Qualified Person (QP) that provides assurance to regulatory authorities that the IMP used in the clinical trial has been manufactured, tested, and released in the third country in compliance with GMP standards equivalent to EU GMP. The QP signing the declaration is responsible for verifying that the manufacturing process, release testing, stability, labelling and packaging sites are appropriate, and meet the requirements of EU GMP. The QP signing the declaration must be named on an MIA (IMP) licence within the EU.
Why is a QP declaration necessary?
A QP declaration is required to be submitted as part of the Clinical Trial Application (CTA) process, if an application is submitted without this document then the Regulatory Authority within the EU will request it.
What is included in a QP declaration?
The QP declaration must name all the sites that are located outside the EU involved in manufacturing steps starting with the conversion of the API into the dosage form and including primary and secondary packing and also any contract laboratories involved with release or stability testing.
The date of the audit and the auditing body must be listed on the QP declaration, with the audit period being no more than 3 years since the last audit. However, the expectation is that audits are performed on a risk-based approach so the frequency of the audit should be based on these principles e.g., a sterile site may have a frequency of 12 – 18 months, but with no audit being greater than 3 years without a suitable justification.
Note: Import of finished IMPs that have been QP certified in an EEA country into Great Britain that undergoes the QP oversight process under the supervision of a UK MIA(IMP) holder does not require a UK QP Declaration. (Source MHRA website Manufacture of Investigational Medicinal Products – Frequently Asked Questions).
For information a different type of QP declaration is required for commercial products and this will be discussed in a separate post.