QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1

By Magnus Stering is senior product manager, Integrity Testing Solutions, Sartorius

Quality risk management (QRM) is a systematic process for assessment, control, communication, and review of risks to the quality of a pharmaceutical product across its lifecycle. Although QRM is not new (1), the regulatory focus on QRM will increase with the arrival of the European Medicines Agency’s (EMA’s) Annex 1 (2), which was reviewed by the US Food and Drug Administration (FDA), the World Health Organization (WHO), and the Pharmaceutical Inspection Convention Scheme (PIC/S). Integrity testing of sterilizing-grade filters is a key focus of QRM because it is a fundamental element of sterility assurance.

The following discussion points out the insufficiency of traditional QRM for filter-integrity testing and advocates for a comprehensive approach. Such a method offers thorough identification of possible failure modes, ways to prevent failure, and improved detectability through use of program-specific parameters for automatic detection of abnormal conditions.