Dr Bernhard Böhm, Boehringer Ingelheim
Dr Graham Cook, Pfizer, ICH Q12 EWG Member
Dr Hiltrud Horn, HORN Pharmaceutical Consulting
Luisa Paulo, Hovione, ICH Q12 EWG Member
Dr Jean-Louis Robert, EMA, ICH Q12 EWG Member (EU topic leader for ICH Q12)
Dr Franz Schönfeld, GMP Inspector
Conference presentations, case studies and open discussions will help participants learn more about the lifecycle management of pharmaceutical products and provide a forum for discussing ICH´s new guideline. Participants will thus have the opportunity to give feedback and ask questions directly to ICH´s Expert Working Group (EWG) members on how to move forward with the transition to and implementation of the lifecycle approach.
The meeting will also address topics such as:
- Identifying “Established Conditions” for Manufacture and Control
- How could Postapproval Change Management Protocols (“Global Comparability Protocols”) look like?
- Validation as part of lifecycle activity: What is the impact of ICH Q12 on analytical method and process transfer?
- What are the skills and interfaces a „Global Life Cycle Manager“ or „Global Change Manager“ needs?
The ICH Q12 topic was endorsed by the ICH Steering Committee in September 2014. Now progress has been made towards developing the draft ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management:
The Step 2 a/b draft document has been published for comment since December 2017.
The new guideline has been developed to complement the existing ICH Q8 to Q11 guidelines, especially to enable full realization of more flexible regulatory approaches to post-approval CMC changes. The guideline applies to pharmaceutical drug substances (i.e., active pharmaceutical ingredients, APIs) and pharmaceutical drug products, including marketed chemical, and biotechnological/biological products. The guideline also applies to drug-device combination products („Drug-delivery products“) that meet the definition of a pharmaceutical or biotechnological/biological product.
Therefore, the Q12 draft includes chapter on Established Conditions (ECs), Post Approval Change Management Protocols (PACMPs), Product Lifecycle Management (PLCM) documents, Pharmaceutical Quality System (PQS) and Change Management, categorization of post-approval CMC changes, relationship between regulatory assessment and inspection, and the application of Q12 for currently marketed products. Furthermore, the guideline describes how ECs are identified as well as what information can be designated as supportive information that would not require a regulatory submission, if changed. Guidance is also included for managing revisions of the ECs over a product’s lifecycle.
The ECA wishes to actively involve QA personnel dealing with global change management, analytical chemists, QC analysts, R&D scientists, as well as manufacturing scientists (process developers) and managers, and regulatory affairs specialists and regulators.
Update on ICH Q 12 – Current Status of the proposed document
How ICH Q8-Q12 Guidelines work together from Development to Product Realization and Continuous Improvements
Key elements of Lifecycle Management: Quality and Supply Risk Management
- What is important for Development of APIs and Drug Products in EU and US?
- What are key points of discussion for APIs and Excipients?
- How will ICH Q12 influence our future?
- What are key aspects that you should know to avoid unnecessary variations?
Key elements of Lifecycle Management: Global Change management
- Balance between quality, cost and risk
- Portfolio aspects
- Teams, processes and governance
Identifying “Established Conditions” for Manufacture and Control
Views and expectations of Inspectors
How could the utility of proposed Q12 tools of Day 1 simplify post approval changes?
- Multi-site change management: local vs. global
- Prioritisation, planning and efficiency
- Teams, processes and governance
- Change management and regulatory activities
What is the impact of ICH Q12 on analytical method and process transfer?
- Analytical methods
- Manufacturing process
- Manufacturing site
What are the skills and interfaces a „Global Life Cycle Manager“ or „Global Change Manager“ needs?
- How can you use ICH Q12 for method and process changes?
- What is the difference prior and after ICH Q12?
- How should you proceed in your daily practice?
- What should you know about CMC vs. GMP-aspects (dossier/inspections)?
- Practical examples
How could Post-approval Change Management Protocols (“Global Comparability Protocols”) look like?
Industry strategies to use ICH Q12 effectively
- Scope models: how comprehensively to manage products?
- Matrix management
- Leadership skills
- The ideal team – experience and diversity
End of Life Cycle – How to manage?
- How much the industry will benefit from the guideline
- How it will impact the post approval changes
- What type of changes will benefit
“Issues under Discussion” and Next Steps
- Portfolio analysis and pruning: selection criteria
- Divestiture and withdrawal: what to consider
- Efficient clean-up
- Concerns and implications