Analytical Procedure Lifecycle under ICH Q14 and Q2 (R2): A Regulatory Review of the Development and Validation of Analytical Procedures
Year: 2026
Type: article
Abstract: Analytical procedures determine whether medicines are released, remain stable and can be changed. In November 2023 the International Council for Harmonisation (ICH) adopted a complete revision of its validation guideline, Q2 (R2), together with a new guideline, Q14, on analytical procedure development. This narrative regulatory review explains how ICH analytical guidance evolved from 1993 to the current pair of guidelines, describes the main elements of Q14 (analytical target profile, minimal and enhanced development approaches, robustness, control strategy and lifecycle management) and summarises what Q2 (R2) changed, including coverage of spectroscopic and multivariate procedures, reuse of development data as validation data and the handling of limited specificity. It links the guidelines to analytical quality by design, compares them with other validation guidance including that of the Indian Pharmacopoeia Commission, and considers greenness assessment as an additional design criterion. A workflow, a checklist and an illustrative HPLC example are proposed. Nineteen verified sources were used, and the review identifies as gaps the limited number of application studies and the lack of information on how Indian regulators apply the new guidelines. The main message is that validation is now one stage in a lifecycle that starts with a defined analytical target profile and continues after approval.
Institution: Vikas College of Engineering and Technology
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W7225323330