Programme Day 1
Provisional timetable, the actual schedule may vary depending on the situation
09.00 – 09.10 h
Organisationals and Introduction
09.10 – 09.30 h
The Draft, the Consultation and Its Issues
09.30 – 10.00 h
- Future Sterile Manufacturing – an Authority Perspective
- Current challenges
- Regulatory developments
- Expectations
10.00 – 10.30 h
Modernisation and Implementation of Quality Risk Management (QRM) – Inspectors‘ Experiences and Expectations
10.30 – 11.00 h
Industrial Experiences in QRM in Sterile Manufacturing
- Principles of risk assessment
- Dos and don’ts
- How to apply risk assessments within contamination control
11.00 – 11.15 h Break
11.15 – 12.30 h
Authorities Expectations on Contamination Control Strategy & Monitoring
- Environment
- Personnel
- Media Fill
12.30 -13.00 h
Questions and Answers
13.00 – 14.00 h Break
14.00 - 14.45 h
Industrial Experiences on PST Regarding the Annex 1 Challenges
- The second draft: regulatory changes regarding APS
- Impact on the current media fill program at Vetter
- Industrial point of view – current experiences and discussion points
14.45 -15.30 h
Environmental Monitoring
- Principles of risk assessment
- Dos and don’ts
- How to apply risk assessments within contamination control
15.30 – 15.45 h Break
15.45 – 16.30 h
Enhanced Requirements on Facilities and Utilities
- Explicit requirements
- 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?
16.30 – 17.15 h
Annex 1 vs. US Guidance “Sterile Drug Products Produced by Aseptic Processing”
- Very brief history of the two guidances
- Main accordances
- Main differences
17.15 – 18.00 h
Question and Answers
Programme Day 2
08.30 – 09.15 h
Qualification in Sterile Manufacturing: Annex 1 and ISO 14644 – a Comparison
- Accordance and differences
- The Issue with the particle sizes
- Qualification challenges
09.15 – 09.45 h
Access & Transfer into Clean-Areas – Expectations on
- Personnel
- Material
- Airlocks
- Clothing
09.45 – 10.45 h
Cleaning and Disinfection Requirements as Part of CCS
- Regulatory requirements and industrial needs
- Elements of a robust cleaning and disinfection programme
- Selection and validation of disinfectants
- Ongoing control of effectiveness
10.45 – 11.00 h Break
11.00 – 11.45 h
Annex 1 – Developments for RABS and Isolators
- Most important changes for biopharmaceutical manufacturing - section “barrier systems”
- Regulatory comparison of Annex 1 version 2008 and new Draft
- Industrial Experiences
11.45 -12.15 h
Questions and Answers
12.15 – 13.15 h Break
13.15 – 14.15 h
Container Closure Integrity – State of the Art Testing in Context of Annex 1
- Current Requirements
- Draft Annex 1 vs new Draft Annex 1
- Personal conclusions and outlook
14.15 – 15.15 h
Sterilization & Sterile Filtration
- Definitions
- Requirements
- Validation PUPSIT
15.15 – 15.30 h Break
15.30 – 16.15 h
The Implication of a New Annex 1 for a Global Pharmaceutical company
16.15 – 17.00 h
Questions and Answers