Recording Webinar: Annex 1 - Sterilization and Sterile Filtration

Recording Webinar: Annex 1 - Sterilization and Sterile Filtration


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Dr Rainer Gnibl, GMP-Inspector for EMA and local Government, Germany


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


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

Recording from 28.05.2020

Duration of recording: 1,5 h.

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