The manufacture of investigational medicinal products (IMPs), including labelling, packaging, testing and certification, is carried out in accordance with the applicable GMP regulations. However, this is not a routine process, since, among other things, manufacturing and packaging procedures might be different for each and every clinical trial. The Qualified Person (QP) must therefore take into account these particularities and the GMP/GCP interface. Currently, the provisions for IMP QPs are also given in Annex 16 to the EU-GMP Guide (Certification by a Qualified Person and Batch Release). But because of the nature of pharmaceutical development work and the manufacturing of clinical trial batches, not all requirements can be transferred one to one.
The U.K. Medicines and Healthcare Products Regulatory Agency MHRA discussed these particularities and exceptions in a recent blog. And indeed, these are questions, IMP QPs are struggling with, for example:
- Do API GDP-Guidelines apply to IMPs?
- May an importer of IMPs rely on the results of analysis from a non-EU laboratory? Or does testing on import to the EU need to be repeated?
- Are API import registration requirements and GMP for excipients applicable to IMPs?
- How much validation is required?
- What are the valid specifications for batch release testing?
- How should supply chain mapping been done?
- Are the document retention times for IMPs the same as for licensed products?
- What are the requirements for Deviation Handling and Change Management?
- Is an IMP shipment "under quarantine" possible?
Please see the MHRA Inspectorate Blog "Annex 16 QP Certification and Batch Release - Frequently Asked Questions - part 2 for more detailed information.