System suitability

Female chemist at work in laboratory.

System and Sample Suitability – Know the Whole Story!

Within the draft ICH Q14 “Analytical Procedure Development” guidance document (here), Section 6 refers to  the Analytical Procedure Control Strategy. This should be developed prior to and confirmed via Analytical Method Validation. A key component of the Analytical Procedure Control Strategy is System Suitability (SST), but the guidance document also makes reference to sample suitability: […]

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