EU GMP Annex 1 – Highlight of the new industry requirements

WEBINAR

Course description

The Annex 1 “Manufacture of Sterile Medicinal Products” of the EU GMP Guideline has gone through a major revision and has been extended from 16 to 59 pages. You will undoubtedly have many questions on these changes and will be able to send in questions on topics that are of interest to you in advance. The questions will be considered in the preparations of the presentations.

Annex 1 is not only of interest to EU participants. It has a significant global regulatory impact, not only on products regulated by the European Union, but since the same document will be adopted automatically by PIC/S which includes FDA and WHO those regulated by these authorities are likely to adopt the recommendations of this document into their own regulatory requirements.

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

• The most important news and changes in the new Annex 1 published August 25^th 2022.
• 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 implementing the new Annex 1 before September 2023.

Who should attend

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

• Manufacturing including API, sterile excipients and non-sterile high-bioburden manufacturers
• Validation
• Quality Assurance
• Quality Control
• Microbiology
• Research/Development

Prerequisites:
N/A

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