Quality Risk Management

Abstract

Firstly the chapter approaches risk management in a general sense, including the phases of risk assessment (risk identification, risk analysis and risk evaluation), risk control (risk reduction or mitigation, and risk acceptance), risk documentation and communication, and risk review. Then some methods for risk assessment are explored further, such as matrix type and Failure Mode Effect Analysis (FMEA) using risk priority numbers (RPN).

Quality risk management (QRM) is illustrated by practical examples about logistics, equipment, pharmaceutical care on the wards and clinical pharmacy.

QRM finds its way into medicines regulations as it is seen as a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. A structured and documented management of risks is a requirement in EU GMP as well as in the European Pharmacopoeia (Ph. Eur.). A guideline with a description of QRM elements together with appropriate tools is to be found in ICH Q9, mainly directed at manufacturing. Finally implementation of QRM in the Pharmaceutical Quality System is briefly elaborated.