Analytical System Suitability: Criteria, Examples & Regulatory Expectations Mastering Analytical System Suitability in Pharma: Criteria, Examples & Regulatory Expectations System Suitability Testing (SST) is a critical checkpoint in pharmaceutical analytical methods, ensuring that the chromatographic or spectroscopic system performs adequately before sample analysis. SST is a regulatory requirement and a part of method validation and routine analysis governed by standards such as USP , ICH Q2(R1), and FDA guidance documents. This tutorial-style guide walks through the essential parameters, calculations, regulatory guidelines, real examples, and documentation tips for establishing a robust system suitability program in a GxP-compliant pharmaceutical environment. 1. What…