Quality Risk Management - an ICH Q9 Training Course
Im Auftrag der ECA Academy

The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH). To achieve the quality objective, “there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice, Quality Control and Quality Risk Management.” [EU-GMP Guidelines, Part 1, Chapter 1].

QRM was formally introduced to the pharmaceutical industry with the ICH Q9 Guideline, which has been incorporated in the EU-GMP Guidelines, Part 3. In the course of implementing ICH Q9, risk-based approaches increasingly gained in importance. Before that, it was often the case that processes were defined, implemented and documented to the latest detail. Now, based on risk assessments, more flexibility is possible, allowing implementing and controlling processes more efficiently. Decisions can be made based on evaluated risks. Unfortunately many companies limit their whole QRM system to the implementation of the FMEA method only. But it is much more than this and QRM can support the pharmaceutical industry in improving their processes and performance.