Susanne Ding, Boehringer Ingelheim, Germany Sue Mann, Sue Mann Consultancy, U.K. Brenda Van Assche, Janssen, Belgium
This pre-course session provides a detailed overview of the 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 take into account 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