Recent regulatory guidance has encouraged a lifecycle approach to pharmaceutical product development. One of the advantages of such an approach, including a Quality by Design (QbD) framework for development, is the promise of easier post-approval changes. For example, the draft ICH Q12 guideline (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) introduces the concept of established conditions, within which changes are allowed, and post-approval change management. The key to the successful implementation of a lifecycle approach to analytical methods is an effective risk management strategy, based upon sound scientific principles and knowledge of the method’s performance in routine use.
A Design of Experiments (DOE) approach to evaluating method robustness is recommended. The potential advantage of a QbD and lifecycle management approach is robust methods that produce consistent, reliable data throughout their lifecycle, with fewer method transfer failures or OOS/OOT results.
This two-day course discusses the advantages of a lifecycle approach during development, validation and transfer/verification of analytical methods. Such advantages include a better understanding of the magnitude and sources of method variability as well as a potentially easier route to post-approval method changes. The role of effective method documentation is discussed.
The course focuses on HPLC methods, but the principles of lifecycle management may be applied to any analytical method.
Course objectives
The course aims to give participants a thorough grounding in the principles of Quality by Design and lifecycle management as they apply to analytical methods. It draws on the draft guidance for analytical lifecycle management in ICH Q12, but also the more general guidance on pharmaceutical development, risk management and quality systems contained in ICH Q8, Q9 and Q10.
The course:
A Design of Experiments (DOE) approach to evaluating method robustness is recommended. The potential advantage of a QbD and lifecycle management approach is robust methods that produce consistent, reliable data throughout their lifecycle, with fewer method transfer failures or OOS/OOT results.
This two-day course discusses the advantages of a lifecycle approach during development, validation and transfer/verification of analytical methods. Such advantages include a better understanding of the magnitude and sources of method variability as well as a potentially easier route to post-approval method changes. The role of effective method documentation is discussed.
The course focuses on HPLC methods, but the principles of lifecycle management may be applied to any analytical method.
Course objectives
The course aims to give participants a thorough grounding in the principles of Quality by Design and lifecycle management as they apply to analytical methods. It draws on the draft guidance for analytical lifecycle management in ICH Q12, but also the more general guidance on pharmaceutical development, risk management and quality systems contained in ICH Q8, Q9 and Q10.
The course:
- Compares traditional and QbD/lifecycle approaches
- Shows how to apply QbD and lifecycle approaches to the development, qualification and transfer of analytical methods
- Discusses ways of controlling analytical method variability
- Shows how to save effort through the application of a risk-based approach to analytical method lifecycle management
