Stevanato Group Investor Presentation
Adoption of RTU Containers by Biopharma Manufacturers Helps
Simplify Compliance and Reduce Burden of EU-GMP Annex 1 Regulation
Revised Principles And Main Impacts By ANNEX 1
Impacted by RTU containers
Premises and Barriers Systems
Out-of-scope for RTU containers
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Quality Risk Management (QRM)
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RTU containers simplify compliance to ANNEX 1
Optimized investments to align existing filling lines
with new regulation
Reduced risk of particle generation during F&F process
Contamination Control Strategy (CCS)
Pre-use Post-Sterilization Integrity Testing
Container Closure Integrity Testing
Source: https://www.pda.org/pda-letter-portal/home/full-article/pda-annex-1-workshop-six-key-takeaways-from-the-final-annex-1
SG, Stevanato Group
Stevanato Group Investor Presentation, March 2024
Simplifying QRM; RTU containers prevent contamination
Externalizing part of the Contamination Control
Strategy (CCS) responsibilities to RTU suppliers
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