System Suitability for USP Chromatographic Methods

Recommendation
13-15 May 2025
Vienna, Austria
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory
An interesting article from the USP experts group "Small Molecules" has been published in the Pharmacopoeial Forum 39(5). It deals with USP's future requirements regarding system suitability tests (SST).
SSTs are performed each time an analytical method is used. Together with instruments qualification and methods validation, the SST ensures the quality of analytical test results. The SST shows that a procedure and an instrumental system are performing as they did when the procedure was validated and that the method is thus "fit for purpose" for the intended use.
General requirements can be found in the USP Chapter <621> Chromatography which also contains provisions and acceptance criteria for individual parameters of the SST. Nevertheless, parameters and acceptance criteria laid down in specific monographs always take priority over the general provisions provided in General Chapter <621>.
In the article, the USP Expert Committee has noted that because of many different sponsors who have submitted a number of various monographs to the USP, inconsistencies with regard to SSTs in the USP have arisen.
That's why the USP Expert Committee has described in this article which data are required on SSTs for new monographs or monographs to be updated. The following descriptions are provided:
- Assay
- Impurities
- Dissolution
- Content Uniformity
You can find all information on the USP website of the Pharmacopeial Forums (PF).
Source: USP
Related GMP News
12.02.2025USP Announces Corrections to General Chapter <1132.1> on Residual Host Cell Protein Measurement
12.02.2025FDA Warning Letter: Focus on Quality Control of APIs and Excipients
29.01.2025Revision of USP <1032> Design and Development of Biological Assays
23.01.2025English Translation of Supplement II to the Japanese Pharmacopoeia (JP18) Published
23.01.2025How to keep Analytical Systems Current and Compliant
23.01.2025FDA 483s due to Deficiencies in the Stability Program: Evaluation of Fiscal Year 2024