System Suitability for USP Chromatographic Methods

System Suitability for USP Chromatographic Methods
How should system suitability tests (SSTs) be structured for USP monographs? More about USP experts group’s recommendations on the parameters and acceptance criteria for SSTs and the essential aspects of this new approach can be found in this News.

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http://www.gmp-compliance.org/enews_4539_System-Suitability-for-USP-Chromatographic-Methods_9150,8369,8488,Z-QCM_n.html

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…