Dr Susanne Ding Boehringer Ingelheim, Germany
Patryk Jegorow, Takeda, Ireland
Sue Mann, Sue Mann Consultancy, U.K.
This pre-course session provides a detailed overview of the basic and specific characteristics in IMP manufacturing a QP must know to certify IMP batches for the release for clinical trials.
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 consider these particularities and the GMP/GCP interface.
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
- Different clinical phases I to IV, focus on patient safety
- Undefined processes (manufacture, fit for purpose control strategy, etc.)
- Why use risk assessments & how to apply – vital core of a IMP quality system
- Diversity: IMP manufacturers, start-ups, academia…
Specific Legal Requirements for IMPs
- Clinical Trial Regulation EU No. 536/2014 and the “old” Annex 13 and Directives 2001/20/EC and 2003/94/C
- The “new” ATMP Regulation
GMP meets Clinical Trials – Differences between IMPs and Commercial Products
- Packaging & labeling
- Blinding / placebos
- NIMPs / AMPs
- Where to apply validation activities
- The Product Specification File (PSF)
- 3rd country manufacture of IMPs: import and the QP Declaration
- IMPD, CTA, IND etc.
- Regulatory compliance and the two-step release procedure
GMP/ GDP/ GCP Interface
- Interaction with clinical sites