The Regulatory Environment of Filter Integrity Testing
The filter integrity test result is one of the key foundations for drug lot release and any external element that may have an impact on the reliability of the integrity test result must be seen upon as extremely critical.
The new Annex 1 (expected in 2020), written by EMA and reviewed by US FDA, WHO and PIC/s, will align most regulatory authorities, not only on when to perform filter integrity testing but also on Quality Risk Management (QRM) throughout the whole pharmaceutical process, including QRM for filter integrity testing. False passed and false failed integrity test results must be avoided by all means.
Test Data Integrity must not be seen as only an IT problem but as a global business risk that could, if not fulfilled to the highest standards, jeopardize the drug manufacturing company’s activities, and more critically, patient health. Devastating malware incidents and the continuing threat of computer-related virus infections have created an urgent need for data protection and security. The increasing number of 483 warning letters related to Data Integrity illustrates the regulatory focus.
- Get an overview of the regulatory requirements for filter integrity testing (FIT)
- Get background for Data Integrity, Quality Risk Management and HSE related to FIT
- Learn how the Sartocheck® 5 Plus Filter Tester contributes to your regulatory compliance
Meet Our Expert
Magnus Stering
Senior Product Manager
Magnus Stering is the Senior Product Manager for all topics related to filter integrity testing at Sartorius. He holds a degree in microbiology, business economy and analytical chemistry from Stockholm University, Sweden. As an official expert at Sartorius, he regularly holds seminars worldwide on filtration, integrity testing and the drafting of Annex 1. Magnus holds 7 patents and patent applications, all relating to filter integrity tests and bag testing. He has also authored and co-authored several articles in scientific publications.