ICH Q12 - Product Life Cycle Management
Berlin, Germany
Course No 17113
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Speakers
Dr Rainer Gnibl, GMP Inspector
Dr Ulrich Kissel, Chair of the EQPA
Dr Maren Kopp, Boehringer Ingelheim
Dr Lisa Matzen, Boehringer Ingelheim
Luisa Paulo, Hovione
Dr Jean-Louis Robert, ICH Q12 EU topic lead
FDA Speaker (invited)
Dr Ulrich Kissel, Chair of the EQPA
Dr Maren Kopp, Boehringer Ingelheim
Dr Lisa Matzen, Boehringer Ingelheim
Luisa Paulo, Hovione
Dr Jean-Louis Robert, ICH Q12 EU topic lead
FDA Speaker (invited)
Objectives
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.
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:
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?
Target Group
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.
Important information
You will reveive a USB Memo stick with the presentations when you Register in Berlin.
Note: there will be no print-Outs available during the conference.
Programme
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
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