ICH Q8 / ICH Q11 Training Course - From QbD to Process Validation

ICH Q8 / ICH Q11 Training Course - From QbD to Process Validation

Hamburg, Germany

Course No 16860


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Dr Hiltrud Horn, Horn Pharmaceutical Consulting

Dr Lorenz Liesum, Novartis Pharma AG

Dr Jobst Limberg, BfArM (Federal Institute for Drugs and Medical Devices, Germany)

Dr Antonio Peinado Amores, Novartis Pharma AG

Dr Hubertus Rehbaum, Dr. Rehbaum Technology Consulting


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.

In workshops, you will discuss elements and methodologies associated with ICH Q8 and ICH Q11. All this will be illustrated with examples and case studies.


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 coming 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.

Target Group

This training course 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.


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
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
Interactive Sessions: QBD for Drug Products
  • QTPP – CQA – CPP for different kinds of formulations, e.g. Oral formulations (Tablets, vs. Biotech vs. Vaccines)
  • Typical points of discussions within teams
Development of the Drug Substance (Focus on Biotech)
  • Strategies to consider for development
  • Key points and potential pitfalls
  • Ways to success for the submission of the dossier
  • Typical questions from regulators
Development and launch of a QbD process (Drug Product)
  • Lab and pilot phase investigations for criticality assessments and design space definition
  • Verification of the design space and the RTRT methods at full scale
  • Post approval activities and the use of a post approval change management protocol

From the design board to the implementation in the manufacturing plant:
Practical examples of PAT in small and large molecules

  • PAT Toolbox
  • PAT as an enabler of Process Understanding and Quality Assurance
  • Main milestones in the implementation of PAT for RTRT: Example in small molecules
  • The big opportunities lurking around: Examples of development of PAT solutions for large molecules

Case examples: Control strategy options for a QbD process

  • Case example for solid dosage form process with Real Time Release Testing (RTRT) enabled by PAT and a Design Space approach
  • Case example for an small molecule API manufacturing process with PAT and SPC (Statistical Process Control) elements
  • The PAT toolbox for pharmaceutical manufacturing and launches
Linking QbD and PAT towards improved process control (RTRT)
  • PAT projects and the challenges with equipment manufacturers
  • Technical solutions to implement the Design Space into the Control Strategy
Real Applications of PAT in Primary and Secondary Manufacturing
  • Examples for Biotech Products
Continuous Process Verification and lifecycle approach of a QbD process
  • Differences to the traditional validation approach
  • Case example of an NDA using the alternative validation approach
  • Draft ICH Q12: Life cycle management of a QbD process in the framework of ongoing process verification

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