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Additionally, Yen et al

Topics The Basics Management The FutureScience The FuturePutting It Together Performance Based Monograph A PBM can include: Specified tests Identification, Assay, others Specific acceptance criteria 97%-103%, NMT 0.1%, others Criteria-based procedures with: Procedure Performance Measures (Precision, accuracy, others) Procedure Performance Acceptance Criteria (% RSD, Bias, R2, others) PPMs and PPACs USP General Chapter Validation of Compendial Procedures defines the critical validation parameters necessary to validate a procedure