USP Intent To Publish - General Chapter 'Prospectus': <1221> Ongoing Procedure Performance Verification

Date

October 25, 2024

Category

US Regulations

Description

The United States Pharmacopeia (USP) is preparing to introduce a new general chapter, numbered above 1000, that provides best practice/aid to compliance and data trending tools to support performance monitoring of analytical procedures throughout their lifecycle, with a focus on the USP <1220> Ongoing Procedure Performance Verification (OPPV) stage 3 -. This chapter aims to establish a guide for implementing risk-based approaches to support the review of the performance of analytical procedures to assure they remain fit for their intended purpose. The outlined approach aligns with current ICH Q14 guideline concepts, providing clear directions for implementing OPPV.

Anticipated proposed design phase activities: USP is requesting early input from stakeholders on this potential proposed General Chapter <1221> which is anticipated to be published for comment in the Pharmacopeial Forum (PF) in 2025.

Comments are due 27 October 2024.