Update on ICH Q 12 – Current Status of the Final Document
- Current status
- Timelines for Implementation
Change Implementation Control now and with ICH Q12
- How we control change implementation today
- How will ICH Q12 influence our future?
- Where do we need to develop our systems to
- Simplification or new complexity?
- Practical considerations
Key Elements of Lifecycle Management: Quality and Supply Risk Management
- Balance between quality, cost and risk
- Portfolio aspects
- Teams, processes and governance
Key Elements of Lifecycle Management: Global Change Management
- Multi-site change management: local vs. global
- Prioritisation, planning and efficiency
- Teams, processes and governance
- Change management and regulatory activities
Views and Expectations of Assessors
- Intentions, preconditions & the Assessor´s expectations
- Identifying “Established Conditions” for Manufacture and Control
- Challenges
Views and Expectations of Inspectors
- Interfaces between ICH Q12 & GMP
- Intentions, preconditions & the Inspector´s expectations
- Challenges
How Could the Utility of Proposed Q12 Tools of Day 1 Simplify Post Approval Changes
- Analytical methods
- Manufacturing process
- Manufacturing site
How Quality Systems Have to Support the ICH Q12 Vision
- ICH Q10 Pharmaceutical Quality Systems have to support ICH Q12 vision
- New importance of Quality metrics
- Stronger interface of Pharmaceutical Quality System with Regulatory
- ICH Q12 and reliable project management capabilities
- Practical experience
How could Postapproval Change Management Protocols (PACMPs) look like?
- What is a PACMP?
- Structure
- Examples
Post-approval CMC Changes -How to Use ICH Q12 effectively
- Agile Post-Approval Change Management within ICH Q12
- PACM Protocols & Classification of Changes
- Established Conditions
- Regulatory Flexibility & Robustness of Current Pharmaceutical Quality Systems