Webinar Series Annex 1 - Sterilization and Sterile Filtration
Thursday, 28 May 2020 14.00 - 15.30 h
Course No. 18061
Speakers
Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
Important: Deadline is 12 noon on 27 May 2020You will find all webinars of this series in this overview
Background
Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment, resulting in thousands of comments. A revised version was published in February 2020 and is open for limited comment by selected stakeholders.
Target Group
This Webinar is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in
Quality Assurance and Quality Control
Inspection and Auditing
or who are involved in
Sterile/Aseptic Manufacturing
Contamination Control and Monitoring
Process Simulation/Media Fill
Programme
This webinar will inform you about the current status of the revision regarding changes and enhancements in the field of sterilization and sterile filtration. As an example, the filter test is mentioned. “The integrity of the sterilized filter should be checked before use” is stated in Annex 1. In this context, the requirement for the Pre-Use-Post-Sterilization Integrity Test (PUPSIT) is made to avoid “blinded” filter errors in the pure post-filtration test. For this purpose, it was discussed whether the risk of not using PUPSIT was lower than the risk of the integrity test negatively affecting the performance of the sterile filter. Accordingly, the webinar deals with the following topics:
Definitions
Requirements
Validation
PUPSIT - Pre-Use-Post-Sterilization Integrity Test
Testimonials