ICH Q8 / ICH Q11 AND ICH Q12 - Live Online

23-25 November 2021

Seminar-Nr. 18880

Note: All times mentioned are CET.


ICH Q8 / ICH Q11
Dr Carmen Boix Bernardini, Almirall
Dr Steffen Groß, PEI
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Dr Line Lundsberg-Nielsen, Lundsberg Consulting

Dr Joachim Ermer, Ermer Quality Consulting
Dr Steffen Groß, PEI
Dr Ulrich Kissel, Chair of the EQPA
Dr Lisa Matzen, Boehringer Ingelheim
Luisa Paulo, Hovione, Member of the ICH Q12 IWG
Dr Ramesh Raghavachari, FDA


ICH Q8 / ICH Q11
You will be updated on the latest regulatory developments and learn how to apply the respective paradigms in Pharmaceutical Development to be better able to design strategies for the implementation of Quality by Design (QbD) according to ICH Q8 and ICH Q11.
During this Live Online Training elements and methodologies associated with ICH Q8 and ICH Q11 will be discussed. All this will be illustrated with examples and case studies.
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 (e.g.: the PACMP can currently be used in the US and in the EU, whereas the ECs are not yet used in the EU).
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.
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.
Participants will thus have the opportunity to give Feedback and ask questions directly to ICH´s Q12 Implementation Working Group (IWG) 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 andControl?
  • 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 impact of ICH Q8, Q9, Q10, and Q11 is changing both the regulatory expectations and the strategies of Pharmaceutical Development, and this impact will continue to grow, especially in view of the emerging ICH Q12 Guideline.
The QbD concept described in ICH Q8 and ICH Q11 have to be seen as an overarching paradigm and an interdisciplinary Approach across the product lifecycle. It also systematically emphasises enhanced product and process understanding throughout the product lifecycle.
Ideally, application of ICH Q8 and ICH Q11 elements already starts in the early design phase of a drug product where both Patient needs and process design are considered. The QbD concept requires a comprehensive understanding of the chemical and physical nature of the individual active substance(s) and excipients, and of the way their attributes interact in the formulation and how they bare impacted by the manufacturing process. During the design phase, it is important to establish the Quality Target Product Profile (QTPP), determine the Critical Quality Attributes (CQAs), identify Critical Process Parameters (CPPs) and Material Attributes (material CQAs) and to understand how the process parameters and material attributes affect the CQAs. The relationship between process inputs (material attributes and process parameters) and the CQAs is described in the Design Space and ensured during manufacturing with an enhanced control strategy, leading to improved process understanding, greater operational flexibility and opportunities for more efficient life cycle management activities.
ICH Q8 combined with the new Q12 will open the door to a powerful era of refined, modern and efficient pharmaceutical development and optimization for those companies who are ready to invest in this new paradigm.


ICH Q8 / ICH Q11
This Live Online Training is designed for all scientists, engineers, managers and executives from Pharmaceutical and Biotech Development units and support functions to Manufacturing, including Quality Assurance and Technical/CMC Regulatory Affairs, who are involved in the implementation of ICH Q8/Q11 elements.
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.

Technical Requirements

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ICH Q8 / ICH Q11
Provisional timetable, the actual schedule may vary depending on the Situation.
Programm Day 1

Welcome and Introduction 09.00 - 09.15 h

09.15 - 10.15 h
QbD for Drug Products: Background and Practical Aspects
  • Essentials to know about QbD
  • Steps for defining QTPP/CQA/CPP
  • Benefits of the QbD Approach
  • Practical Examples
10.15 - 11.00 h
QBD for Drug Products
  • QTPP – CQA – CPP for different kinds of formulations, e.g. Oral formulations (Tablets, vs. Biotech vs. Vaccines)
Break 11.00 - 11.15 h

11.15 - 12.15 h
QbD - Regulatory Perspective
  • Current state of PAT & QbD implementation and regulatory challenges
  • Quality by on-line (PAT) measurements
  • Real time release testing: general considerations
  • Going forward: ICH Q12 / Q13 / Q14
12.15 - 12.45 h
Q&A Session 1

Break 12.45 - 13.45 h

13.45 - 15.15 h
DoE Examples for API Development
  • DoE theory:
    • Resolution and confounding
    • Overview of available DoE designs
    • Basic statistics – understanding my software Analysis
    • Intuitive interpretation of the design: mapping
  • Practical approach to DoE aimed to reduce the number of experiments:
    • Risk assessment: Fishbone (Ishikawa) diagram; FMEA (failure Mode Effect Analysis) and RPN analysis (Risk Priority Number)
    • Choosing the design
    • Practical tips for execution
Break 15.15 - 15.30 h

15.30 - 16.30 h
Development of the Drug Substance/Drug Product (incl. Biotech)
  • Strategies to consider for development
  • Key points and potential pitfalls
  • Ways to success for the submission of the dossier
  • Typical questions from regulators
16.30 - 17.00 h
Q&A Session 2
Programme Day 2

09.00 - 10.00 h
QbD for Drug Products
  • Typical Points of Discussions within Teams
  • Keypoints and potential pitfalls
  • Ways to success for the submission of the dossier
  • Typical questions from regulators
10.00 - 11.00 h
How the QbD derived Control Strategy defines Process Validation
  • QbD and PAT as an enabler for gaining Process Understanding and designing the process and the control strategy, PV stage 1 (establishing the control strategy)
  • Different approaches to PV/PPQ depending on the type of control strategy, PV stage 2 (traditional, continuous process verification or hybrid approach used to verify the control strategy)
  • Ongoing/Continued Process verification, PV stage 3 (verifying the validity and robustness of the control strategy)
Break 11.00 - 11.15 h

11.15 - 12.15 h
Process Validation - Case Study (Small Molecule Drug Product)
Case study related to the previous presentation (PV stage 1 and 2)
  • Case example of a solid dosage form process enabled by a QbD approach
  • Establishing the control strategy: Examples of the application of PAT/RTRT
  • Validation of the process – verification of the control strategy
12.15 - 13.00 h
Ongoing Process Verification and Lifecycle Approach of a Process established from QbD Principles
  • Continuous process verification versus continued/ongoing process verification (PV stage 3)
  • Case study – the continuation of the example from above (PV stage 3)
  • ICH Q12, performance-based control and the link to PAT
  • Life cycle management of the product, process and control strategy opportunities for a product developed using of a QbD principles
12.30 - 13.30 h
Q&A Session 3
Provisional timetable, the actual schedule may vary depending on the situation.

Welcome and Introduction 09.00 - 09.15 h

09.15 - 10.00 h
PACMP - Postapproval Change Management Protocol
  • What is a PACMP?
  • Structure
  • Examples
10.00 - 10.45 h
Views and Expectations of Assessors (EU)
  • Current Status
  • Implementation in Europe
  • Application of Q12 tools on post approval changes: Case Studies
  • Lessons learned
Break 10.45 - 11.00 h

11.00 - 12.00 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
12.00 – 12.30 h
Q&A Session 1

Break 12.30 - 13.30 h

13.30 - 14.30 h
Analytical Lifecycle Management
  • Overview on EFPIA/PhRMA Paper and the draft USP Chapter <1220>Alignment with manufacturing process
  • Analytical Target Profile (ATP)
  • Continuous improvement and regulatory flexibility
  • ICH Q12, Q2(revision), Q14
14.30 - 15.15 h
Post-approval CMC Changes -How to Use ICH Q12 effectively
  • Global Regulatory Complexity
  • Agile post-approval change management within ICH Q12 including examples for
    • Classification of changes
    • Established Conditions / PACMPs / PLCM
Break 15.15 - 15.30 h

15.30 - 16.30 h
Drug Product Lifecycle and ICH Q12 - FDA Perspective
  • Current Status
  • Implementation in US
  • Application of Q12 tools on post approval changes:
    • PACMP
    • EC
  • Lessons learned
16.30 – 17.00 h
Q&A Session 2

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