The qualified person and GMP for IMPs – key guidance.
Legal basis – European union (and still applicable for Northern Ireland).
Within the European Union there are two key pieces of legislation relating to role of the QP in a clinical trial:
1) “The clinical trials regulation” - Regulation (EU) No 536/2014 - on clinical trials on medicinal products for human use.
- Specifically, Article 62 (Responsibilities of the qualified person) and Article 63 (manufacturing and Import)
2) Regulation (EU) No 1569/2017 - supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections.
- Specifically, Article 12 – (Responsibilities of the Qualified Person). This is broadly analogous to the three key responsibilities listed for a QP in general (compliance to PSF, compliance to quality guidance/GMP and recording in a maintained register.
These repealed the original “Clinical Trials Directive” 2001/20/EC which is still listed in the UK QP study guide as of 2022 – just to make sure you are confused.
Additional EU centric documents.
There is also a specific guidance annex in EudraLex Volume 4. Annex 13 – Manufacture of Investigational Medicinal Products.
There is a standard IMP batch certificate - Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
Legal basis – Great Britain (and mostly applicable for Northern Ireland).
Brexit, and the associated departure of the UK from the EU has added a layer of (much loved) complexity to the picture. As of January 2021, the EU and UK function as separate legal and regulatory jurisdictions, and drug products must meet the relevant requirements for the market in which they will be sold.
The key legislation for the UK remains.
1) The Medicines For Human Use (Clinical Trials) regulations 2004 (SI 2004/1031) as amended
2) The Human Medicines regulations 2012 (SI2012/1916)
A key consideration is that SI 2004/1031 implements 2001/20/EC (the Clinical Trials Directive) which has since been repealed by the EU in the time period post the Brexit vote.
While the UK’s (current) trade agreement with the EU does provide for the mutual recognition of GMP inspections of drug product manufacturing facilities, the agreement does not stipulate mutual recognition for QP certification and batch release or for product batch release testing and this includes IMPs.
Within the UK batch testing and QP certification is accepted if it is conducted in an approved country—currently the European Economic Area (EEA)
Recent changes
Additional guidance has been published in 2022 which is in effect from 1st January 2023 – “Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice”.
This guidance adds additional detail for three areas.
1) The two stage IMP release procedure
2) Shipment
3) Contractual/technical Agreements