Blue Sky Approach - Down to Earth Solutions
QbD and Lifecycle Management for Analytical Methods
A QbD approach and lifecycle management approach to analytical method development and qualification will result in a better understanding and fewer failures of analytical methods due to more robust methods which produce consistent, reliable, quality data throughout the lifecycle. This, in turn, will lead to less method transfer failures, OOS results and method “incidents” when used in the routine environment. As the industry is moving towards applying Quality by Design (QbD) to process development - Is this also the way forward to improve and standardise our approach to method qualification?
This course relates QbD approach and the lifecycle management to analytical methods.
This two day workshop presents a brief overview of method validation according to ICHQ2 (R1) and discusses the limitations of this approach in terms of its contribution to failure of methods with regards to method transfer and generation of OOS results later in the method lifecycle. The course then introduces the concept of QbD and works through the application of it in relation to analytical methods and focuses on the application of a three stage approach of QbD and lifecycle management. Finally a comparison of the current approach (ICHQ2) and the benefits of a QbD approach are presented.
The course focuses on HPLC methods, therefore experience in developing, validations and transferring analytical HPLC methods would be an advantage to participants.
The course material is presented by means of slides, handouts and participation of the attendees through discussion, case studies and hands on group exercises.
Questions and answers will be taken throughout the duration of the course.
Course objectives
This course is designed to provide training in how to apply Quality by Design and lifecycle management to the development and qualification of analytical methods. It aims to highlight the limitations of the current approach to method validation (ICHQ2) and the benefits to using the QbD approach.
Although the QbD and Lifecycle management approach is not yet officially recognised for analytical methods, the course is based on the approach used for manufacturing processes and products as described in ICH Q8, Q9 and Q10. The course emphasises practical issues such as:
Ø Comparison of the traditional approach and QbD/lifecycle approach to analytical methods
Ø Applying the QbD and lifecycle approach to development and qualification of analytical methods
Ø Exploring and controlling variables of analytical methods
This course will deliver the tools to enable you to
· Consider a QbD and lifecycle management approach to analytical methods
· Define an Analytical Target Profile
· Recognise the importance of understanding method variables of individual methods
· Develop more robust analytical methods