Dr Joachim Ermer, Ermer Quality Consulting, Germany
Dr Rainer Gnibl, GMP Inspector for EMA and Local Government, Germany
Dr Steffen Groß, PEI, Germany
Dr Ulrich Kissel, Chair of the EQPA, Germany
Dr Lisa Matzen, Boehringer Ingelheim, Germany
Dr Bianca Omasreiter, Roche, Germany
Luisa Paulo, Hovione, Member of the ICH Q12 IWG, Portugal
Dr Ramesh Raghavachari, FDA, USA
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 (i.e. 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 (with reference to ICH Q14).
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) documents. 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.
Presentations, case studies and open discussions will help participants learn more about the lifecycle management of pharmaceutical products / analytical methods and provide a forum for discussing ICH´s new Guideline.
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.