Although QRM is not new (cf. CHQ9 - 2005), the regulatory focus on QRM will increase with the arrival of the European Medicines Agency’s Annex 1, which was reviewed by the US Food and Drug Administration, the World Health Organization, and the Pharmaceutical Inspection Convention Scheme. Integrity testing of sterilizing-grade filters is a key focus of QRM because it is a fundamental element of sterility assurance.The following presentation 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 failures, and improved detectability through use of program-specific parameters for automatic detection of abnormal conditions, thus avoiding false passed and false failed test results.
Abo Magnus Stering is the senior product manager for all filter integrity testing related topics at Sartorius Stedim Biotech.He holds a degree from the University of Stockholm Sweden in microbiology, business economy and analytical chemistry. For several years he was heading the South European team of Application Specialists. He makes regular seminars around the world on filtration, integrity testing and the draft version of Annex 1 as the official Sartorius subject matter expert. He has also given trainings at conferences of the Parenteral Drug Association (PDA) and is familiar with the PDA Technical Reports and texts of regulatory bodies and is a member of the BPOG PDA interest group Sterile Filtration Quality Risk Management (SFQRM). In addition to that he has a long experience of customer audits and trainings, process improvements, troubleshooting related to filter integrity testing, gas and liquid filtration applications and SIP/CIP in the US, Asia, Europe and North Africa.