Yes, quality risk management (QRM) is a requirement of Chapter 1 of the EU GMP Guide Part I and Annex 20. All manufacturing authorisation holders, third country manufacturing sites, blood establishments, blood banks and active pharmaceutical ingredient manufacturers must have a system for QRM. Inspectors will review the QRM system as part of the Quality Systems section of the inspection (along with complaints, recalls, deviations, and product quality reviews etc). Additionally, inspectors may review specific risk assessments when encountered during inspection. Inspectors will allocate time commensurate with their perceived significance of the risk and if necessary request the company to produce a formal summary of the risk assessment, key decisions and conclusions or take copies of risk assessments for further consideration outside the inspection.
