USA – New USP chapter details lifecycle approach to analytical testing

The United States Pharmacopoeia (USP) has released a new chapter 1220 ahead of publication in the USP-NF that sets a lifecycle approach to analytical method development with the goal of easing the process for instituting post-approval changes for analytical methods. The chapter will become official on 1 May 2022.

The USP chapter complements efforts underway at International Council for Harmonisation to develop a Q14 guideline to make it easier for manufacturers to switch analytical methods for testing medicines.

Industry officials complained at a recent meeting that the high cost involved in securing regulatory approval for changes serves as a disincentive for making needed changes. (RELATED: Upcoming ICH guidelines should ease post-approval changes for analytical methods, Regulatory Focus, 14 July 2021)…