The new EU GMP Annex 1 (Series) : Sterilisation and Sterile Filtration

Thursday, May 28, 2020 10:30 a.m. - 12:00 p.m.

speaker

Dr. Rainer Gnibl, GMP inspector for the EMA and local authorities, Germany

background

Annex 1 "Manufacture of sterile medicinal products" of the EU GMP guidelines is currently being revised. A first draft of the revised version was published in 2017 and released for public comment, which led to thousands of comments. A revised version was published in February 2020 and is open to limited commentary by selected interest groups.

target group

This webinar is aimed at employees of pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibility in

• Quality assurance and quality control
• Inspections and audits

or who are active in the

• Sterile / aseptic manufacturing
• Contamination control and monitoring
• Process simulation / media fill

Technical requirements

We use Cisco WebEx, one of the leading providers for online meetings, for our webinars. At https://www.webex.com/de/test-meeting.html you can check whether your system meets the necessary requirements for attending WebEx meetings and whether the required plug-in can be installed immediately. Simply enter your name and email address for the test. If the installation is not possible due to your rights in the IT system, please contact your IT department. WebEx is now a standard and the necessary facilities are quick and easy to do.

program

This webinar informs you about the current status of the revision with regard to changes and extensions in the area of ​​sterilization and sterile filtration. The filter test is an example. "The integrity of the sterilized filter should be checked before use" is stated in Annex 1. In this context, the pre-use post-sterilization integrity test (PUPSIT) is called for "blinded" filter errors in the pure test after To avoid filtration. In this context, there was controversy as to whether the risk would not be lower if PUPSIT were not used.

Accordingly, the webinar deals with the following topics:

• Definitions
• conditions
• Validation
• PUPSIT - Pre-Use-Post-Sterilization Integrity Test