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.
During this Live Online Training elements and methodologies associated with ICH Q8 will be discussed. All this will be illustrated with examples and case studies.
Background
The impact of ICH Q8, Q9, Q10, and Q11 is changing both the regulatory expectations and the strategies of Pharmaceutical Development. This impact will continue to grow, especially in view of the 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 patients’ 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 are 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 ICH 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 Live Online Training addresses 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 Elements.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Drug product development at a glance – from first in man to marketing authorization
Pharmaceutical QbD: Quo vadis?
Application of QbD principles to drug product development
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
Quality Risk Management and Control Strategy
Objectives of Quality Risk Assessment (QRA) as part of development
Overview on risk assessment tools
Introduction to Process Risk Map
Introduction of risk-based control strategy development
Q&A Session 1
Case Study DoE
Why we use DoE in the pharmaceutical development
Example: DoE for formulation selection / optimization
Example: DoE for manufacturing process optimization
DoE vs “traditional” approach – when to use which
QbD Toolbox: DoE, PAT, Basic Statistics
Value-added use of QbD tools – generic approaches and tailored Solutions
Examples for different unit operations and variable problems
Q&A Session 2
Programme Day 2
Reports and Documentation
Development Reports
Transfer protocols and reports
Control Strategy and link to the submission dossier
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)
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
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
Q&A Session 3
This course is part of the GMP Certification Programme "ECA Certified Pharmaceutical Development Manager" Learn more
Testimonials
Seminar Programme as PDF