16-18 November 2021
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate has published a set of Question and Answers on the manufacture of Investigational Medicinal Products (IMPs) in a blog. Quite a few questions are dealing with the import of IMPs and the associated QP Declarations which accompany clinical trial (CT) applications.
Here is an overview:
"All sites 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" should appear on the QP declarations.
Regulatory inspection instead of own audit:
"The starting point for a QP declaration of EU GMP should be an audit conducted by or on behalf of the importing company. (…). A regulatory inspection cannot be used unconditionally to remove the need for your own audit."
Audit by QP or not:
"An audit does not need to be done by the QP, however the QP needs to be satisfied that it has been done correctly by an appropriately trained individual as the QP will be taking final responsibility."
Recognition of Certification by Swiss QP (Responsible Person, RP)
"Although there is a Mutual Recognition Agreement (MRA) between the EU and Switzerland, it remains a third country therefore the IMP would need to be imported into the EU by an MIA(IMP) holder. (…) and the IMP would need to be certified by a (EU) QP upon import prior to release for use in the clinical trial."
QP statements for APIs used in IMPs
"There is no requirement for APIs used in IMPs to comply with EU GMP Part II but there remains a responsibility for IMP manufacturers to assure themselves that the API is of an appropriate quality."
Further details and more frequently asked questions can be found in the MHRA Inspectorate Blog.