EU GMP Annex 1 - Highlight of the new industry requirements

WEBINAR

Course description

This webinar will give you an introduction to the most important new requirements expected in the new Annex 1. With only 6 months of expected implementation time you will need to be on top of the many new requirements already now.

The Annex 1 “Manufacture of Sterile Medicinal Products” of the EU GMP Guideline is currently being updated with the latest improvements in manufacturing science. The first draft as published in 2017 which received more that 6.000 comments and now the second draft has been released with their comments. Final version will follow immediately after this second draft version.

Once finalized, Annex 1 will have a significant global regulatory impact, not only on products regulated by the European Union, but since the same document is being review by PIC/S which includes FDA as well as WHO those regulated by these authorities are likely to adopt the recommendations of this document into their own regulatory requirements.

Remember that the FDA guidance to industry on “Sterile Drug Products Produced by Aseptic Processing” is from 2004 which is also in for an up-date. This webinar will update you on the current EU draft and give an overview of the modifications that have been implemented compared to the current 2011 version.

Course outline

• The history, evolution, and potential global regulatory impact of Annex 1
• Scope and the expantion to include non-sterile low bioburden API intermediates
• Contamination control strategy, Risk assessments and Quality Risk Management associated with sterile product manufacture
• Cleanroom classification and qualification
• Water systems and expecation of microbiome flora determination
• Isolator decontamination and environmental monitoring approaches and requirements
• Sterile filtration considerations and filter integrity test requirements – PUPSIT
• Aseptic Process Simulation
• Quality Control – sampling for sterility test and testing

Agenda

Learning objectives

• Updates to the February 2020 version of Annex 1 and the next steps in the revision and implementation process.
• The integration of Quality Risk Management and the development of a contamination control strategy for sterile product manufacturing processes.
• Assess your level of preparedness for meeting current Annex 1 requirements.

Who should attend

The following individuals or disciplines will benefit from attending this Webinar:

• Manufacturing including API
• Validation
• Quality Assurance
• Quality Control
• Microbiology
• Research/Development

Prerequisites:
N/A

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