Future Sterile Manufacturing – Some Thoughts about the Annex 1 Changes
QRM in Sterile Manufacturing – Industrial Experience
- Strengths and limitations of an EM program
- Trending: detecting changes
- Use of modern technologies
- Response to level excursions
Quality Risk Management - Inspector’s Experiences
- QRM in Annex 1, more than CCS
- Inspector‘s expectations on implementation of QRM principle
- Best and worst case examples
Contamination Control Strategy - Inspector’s View on an Overarching Strategy
- Requirements
- Expectations & interpretations
The ECA CCS Guide – a Brief Overview
- Guide scope and purpose
- Structure & content overview
Ready to Present your CCS
- How to develop the strategy
- How to have your documents available and accessible
Process Simulation – Annex 1 Requirements
- Requirements
- Expectations & interpretations
Aseptic Process Simulation (APS /Media Fill) –
- Industrial Point of View
- Different Designs / Simulation long filling times
- Risk-based approach for interventions
Will the new Annex 1 Change Batch Certification?
- How QPs involve in batch certification of sterile products
- Explicit requirements
- Sterile products, complex supply chains, and imports
Annex 1 vs. ISO 14644-1
Requirements from a Technical Point of View
- Accordance and differences
- The Issue with the particle sizes
- Qualification challenges
Cleaning and Disinfection in the Light of Annex 1
- How QPs involve in batch certification of sterile products
- Explicit requirements
- Sterile products, complex supply chains, and imports
Sterile Filtration & Container Closure - Annex 1 Requirements
- Sterile filtration requirements
- Pre-Use-Post-Sterilization-Integrity-Testing (PUPSIT) of sterile filters
- Container Closure Integrity Testing (CCIT)
- Visual inspection process
CCIT and PUPSIT - New Requirements from the Draft Annex, but also Deeper Insight into Methods and Practice
- PUPSIT: Risk Assessment for PUPSIT and Considerations of Associated Risks in Established Processes
Environmental & Process Monitoring - Inspector’s View
- Summary of requirements from entire Annex 1
- Essentials for inspection
Environmental Monitoring – Current Methodology and Experiences
- Strengths and limitations of an EM program
- Trending: detecting changes
- Use of modern technologies
- Response to level excursions
Barrier Systems – the Current Way
- What makes a real barrier?
- What are the limitations of isolators, of RABS?
- Are Isolators less “performant” than RABS?
Isolators and Monitoring - The Challenge of Modern Systems
Authorities‘ Point of View on RABS and Isolators
- Requirements for barrier systems in new Annex
- Major changes compared to previous Version (Annex 1, 2008)
- Inspector’s comments on changed requirements
Enhanced Requirements on Facilities and Utilities
- Facilities: airlocks and pass-boxes ; insertion of barrier technologies
- Utilities: water, steam and gases
- Implicit requirements
- Lyophilisation facilities
- Media-fill rooms
- Equipment for barrier technologies?
Personnel - Behaviour and Access into Cleanrooms
- Requirements for personnel in new Annex 1
- Developments since version 2008 of Annex 1
- Comments of inspector on implementation
New Requirements on a Cleanroom Garment System as an Essential Element of the Contamination Control Strategy
- The „new“ Annex 1
- Contamination control strategy for garments
- Risk Management
Comparison of Annex 1 with Other Relevant
- Documents
- Clean room grades
- Gowning
- Monitoring
- Trending