The new revision of Eudralex GMP Volume 4 Annex 1 regulatory standard has considerable details added compared to the last revision. This seminar will provide a valuable insight into the changes and requirement of new Annex 1 related to moist heat sterilization. This seminar will also address the commonly asked questions of how GMP manufacturing facilities can meet the requirement of new Annex 1 in these areas. In addition, past regulatory audit observations in these areas will also be discussed to enhance the understanding on the regulatory expectations related to sterilization:
The agenda for the seminar includes the following:
• An Overview of the Principles of Moist Heat Sterilization System
• Critical Design Consideration of a Steam Sterilizer
• Qualification and Maintenance according to PDA TR 48 and Annex 1
• Preventive Maintenance of a Stainless Steel Equipment : Moist Heat Sterilization System
• Sterility Assurance and Sterility Maintenance in Compliance to Annex 1

At the end of the seminar, the participants will have a better understanding on the requirement of new revision of Annex 1 and also on meeting the requirement related to sterilization. At the same time, participants will also get to know the different chemical and biological indicators required in the qualification of sterilization, and also the routine monitoring of sterile loads. The regular maintenance of the sterilizer will also be discussed to ensure the smooth and continued operation of the steam sterilizer.

moist heat sterilization, Annex 1, Critical Design Consideration, Qualification

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