Abstract

Analytical Procedure Lifecycle - USP <1220>

Mrunal Jaywant, Senior Director, USP India Private Limited

An analytical procedure must be demonstrated to be fit for its intended purpose. Reportable values generated using qualified analytical procedures provide the basis for key decisions regarding compliance of a test article with regulatory, compendial and manufacturing limits.

Thus Analytical procedure must be able to provide data of constant quality.

It is useful to consider the entire lifecycle of an analytical procedure, i.e., its design, development, qualification and continued verification. The current concepts of validation, verification and transfer of procedures, address portions of the lifecycle but do not consider it holistically.

USP has proposed new general chapter “<1220> The Analytical Procedure Lifecycle” to address the entire procedure lifecycle and to define concepts. This general chapter is consistent with the concept of quality by design (QbD) as described in International Council for Harmonization (ICH) Q8-R2, Q9, Q10, and Q11.

Application of lifecycle management concepts to analytical procedures provides an opportunity to use the knowledge gained from the application of scientific approaches to the reportable values generated while using that procedure. This risk based approach helps to understand and control sources of variability, to ensure that measurement uncertainty is aligned with the decisions that will be made using results generated by an analytical procedure.

To control an analytical procedure throughout its lifecycle, one can use a three-stage concept process validation terminology: (1) Procedure Design and Development, (2) Procedure Performance Qualification, (3) Continued Procedure Performance Verification.

This new general chapter <1220> will provide guidance to facilitate the management of post-approval changes in a more predictable and efficient manner across the product life cycle and it will promote innovation and continual improvement, and strengthen quality assurance and reliable supply of a product.