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.
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