Dr Rainer Gnibl, GMP Inspector
Dr Ulrich Kissel, Chair of the EQPA
Dr Maren Kopp, Boehringer Ingelheim
Dr Jennifer Maguire, FDA
Dr Lisa Matzen, Boehringer Ingelheim
Luisa Paulo, Hovione
Dr Jean-Louis Robert, ICH Q12 EU topic lead
The ICH Q12 topic was endorsed by the ICH Steering Committee in September 2014 and the draft ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management was published for comment in December 2017. The final ICH Q12 Post-Approval Changes Guideline including two Annexes has been adopted in November 2019. The guideline aims to promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of global supply chain adjustments.
The next phase will be the implementation of ICH Q12 across the ICH regions. However, especially in the EU, revision of local regulations (e.g. the EU Variations Regulation) will have to be performed to fully implement the concepts of Q12.
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 and products (both chemical and biological). The guideline also applies to drug-device combination products that meet the definition of a pharmaceutical or biological product and to analytical methods.
In order to ensure a standardized approach, the guidance defines the categorization of Post-Approval CMC changes, Established Conditions (ECs), Post-Approval Change Management Protocols (PACMPs), and Product Lifecycle Management (PLCM) concepts. In particular, the guideline emphasizes the relationship between Regulatory Assessment and GMP Inspection.
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.
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 Q12 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:
- What are “Established Conditions” for Manufacture and Control?
- How could Postapproval Change Management Protocols look like?
- What is the impact of ICH Q12 on analytical method and process validation and transfer?
- What are the views and expectations of assessors and inspectors?
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.
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Programme Day 1
09.00 – 09.15 h Welcome and Introduction
09.15 – 10.30 h
Update on ICH Q 12 – Current Status of the Final Document
- Current status
- Timelines for Implementation
- Application of Q12 tools on post approval changes for:
- Analytical methods
- Manufacturing process
- Manufacturing site
10.30 – 10.45 h Coffee Break
10.45 – 11.45 h
Key elements of Lifecycle Management and implications from ICH Q12
- Quality (and Supply) Risk Management
- Multi-site Change Management
- Prioritization, planning, processes and governance
11.45 – 12.15 h Q&A Session 1
12.15 – 13.15 h Lunch
13.15 – 14.15 h
Change Implementation Control now and with ICH Q12
- How we control change implementation today
- How will ICH Q12 influence our future?
- Simplification or new complexity?
- QP considerations
14.15 – 15.15 h
How Quality Systems have to support the ICH Q12 vision
- ICH Q10 Pharmaceutical Quality System (PQS)
- Importance of Quality Metrics
- Interplay between the PQS and Regulatory Affairs
- QP experience
15.15 – 15.30 h Coffee Break
15.30 – 16.45 h
Established Conditions Pilot (U.S.)
- Case studies for process and product
- Innovative analytic approaches
- Lessons learned
16.45 – 17.15 h Q&A Session 2
Programme Day 2
08.30 – 09.15 h
How could Postapproval Change Management Protocols (PACMPs) look like?
- What is a PACMP?
09.15 – 10.00 h
Post-approval CMC Changes - How to Use ICH Q12 effectively
- Global Regulatory Complexity
- Classification of Changes
- Established Conditions
10.00 – 10.15 h Coffee Break
10.15 – 11.30 h
Views and Expectations of Inspectors
- Interfaces between ICH Q12 & GMP
- Intentions, preconditions & the Inspector´s expectations
11.30 – 12.00 h Q&A Session 3
12.00 h End of conference