ASTM E2898 - 14 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications


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    D3764 Practice for Validation of the Performance of Process Stream Analyzer Systems

    D6122 Practice for Validation of the Performance of Multivariate Online, At-Line, and Laboratory Infrared Spectrophotometer Based Analyzer Systems

    E1655 Practices for Infrared Multivariate Quantitative Analysis

    E1790 Practice for Near Infrared Qualitative Analysis

    E2056 Practice for Qualifying Spectrometers and Spectrophotometers for Use in Multivariate Analyses, Calibrated Using Surrogate Mixtures

    E2476 Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

    E2500 Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

    E2617 Practice for Validation of Empirically Derived Multivariate Calibrations

    E2629 Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems