ICH Q2 validation of Analytical Procedures describes the current concepts of validation, verification and transfer of procedures. This approach addresses portions of the analytical lifecycle but also has a number of downsides.
The Analytical Lifecycle
The Analytical Lifecycle based on ICH Q2: Validation of Analytical Procedures.
Downsides of this approach
Validation is regularly treated as a check-box exercise where analysts compare the validation results to (default) validation criteria to satisfy compliance objectives. The rationale behind the used criteria is not always transparent.
The used indicators do not necessarily provide a direct measure of the quality or the error(s) associated with the results the procedure generates
Analytical Target Profile (ATP)
As an alternative to this approach, predefined criteria can be established in the form of an Analytical Target Profile (ATP).
ATP defines the desired performance criteria for the measurement of the attribute(s), impurities, API content, potency,…
The ATP defines the appropriate performance criteria for the analytical result and is method- independant.
ATP considers analytical validation, verification and transfer to be closely interrelated, whereas the current model approaches these as separate activities.
Traditional criteria compared to ATP
ATP describes method performance criteria and provides more confidence & control on the method result, based on a probability of result being within a given range from the “true value”.
Enhanced method understanding and robustness
Understand, reduce and control sources of variability
Method aligned with processes
Better understanding and control of method variability enables better understanding and
control of process variability
Facilitates continuous improvement
Performance criteria is independent of analytical technique
ATP can reduce product variability and defects, thereby enhancing patient efficacy and safety. It can enhance the product and process development depth and understanding, which can improve the efficiency and help to effectively manage the post approval changes.
Finally, product and process capability is continually reviewed and improved post approval during product lifecycle management.