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  • ASTM E 2891 : 2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

    Available format(s):  Hardcopy, PDF

    Superseded date:  17-08-2023

    Language(s):  English

    Published date:  01-11-2013

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 14.02, 2016 Defines the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities.

    Scope - (Show below) - (Hide below)

    1.1This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products.

    1.2The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:

    1.2.1Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status),

    1.2.2Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers),

    1.2.3Considerations on the different types of data analysis and model validation,

    1.2.4Qualified and competent personnel, and

    1.2.5Life-cycle management of MVDA.

    1.3This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

    General Product Information - (Show below) - (Hide below)

    Committee E 55
    Document Type Guide
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM E 2363 : 2005 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
    ASTM E 2363 : 2014 : REDLINE Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
    ASTM E 2617 : 2009 : REV A Standard Practice for Validation of Empirically Derived Multivariate Calibrations
    ASTM E 2363 : 2005 : REV B Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
    ASTM C 1174 : 1997 Standard Practice for Prediction of the Long-Term Behavior of Waste Package Materials Including Waste Forms Used in the Geologic Disposal of High-Level Nuclear Waste
    ASTM E 1790 : 2004 Standard Practice for Near Infrared Qualitative Analysis
    ASTM E 2476 : 2009 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
    ASTM E 1655 : 2004 Standard Practices for Infrared Multivariate Quantitative Analysis
    ASTM E 2617 : 2008 Standard Practice for Validation of Empirically Derived Multivariate Calibrations
    ASTM C 1174 : 2004 Standard Practice for Prediction of the Long-Term Behavior of Materials, Including Waste Forms, Used in Engineered Barrier Systems (EBS) for Geological Disposal of High-Level Radioactive Waste
    ASTM C 1174 : 2017 Standard Practice for Evaluation of the Long-Term Behavior of Materials Used in Engineered Barrier Systems (EBS) for Geological Disposal of High-Level Radioactive Waste
    ASTM E 2474 : 2014 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)
    ASTM E 2476 : 2016 : REDLINE Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
    ASTM C 1174 : 2007 Standard Practice for Prediction of the Long-Term Behavior of Materials, Including Waste Forms, Used in Engineered Barrier Systems (EBS) for Geological Disposal of High-Level Radioactive Waste
    ASTM E 2363 : 2004 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
    ASTM E 2617 : 2008 : REV A Standard Practice for Validation of Empirically Derived Multivariate Calibrations
    ASTM E 2476 : 2016 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
    ASTM E 2363 : 2006 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
    ASTM E 1790 : 2004 : R2010 Standard Practice for Near Infrared Qualitative Analysis
    ASTM E 2474 : 2006 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
    ASTM E 1355 : 1997 Standard Guide for Evaluating the Predictive Capability of Deterministic Fire Models
    ASTM E 1355 : 2004 : REV A Standard Guide for Evaluating the Predictive Capability of Deterministic Fire Models
    ASTM E 1355 : 2012 Standard Guide for Evaluating the Predictive Capability of Deterministic Fire Models
    ASTM E 1655 : 2017 Standard Practices for Infrared Multivariate Quantitative Analysis
    ASTM E 2617 : 2017 Standard Practice for Validation of Empirically Derived Multivariate Calibrations
    ASTM E 1355 : 2005 : REV A Standard Guide for Evaluating the Predictive Capability of Deterministic Fire Models
    ASTM E 1790 : 2004 : R2016 : EDT 1 Standard Practice for Near Infrared Qualitative Analysis
    ASTM E 1655 : 2000 Standard Practices for Infrared Multivariate Quantitative Analysis
    ASTM E 1655 : 2005 Standard Practices for Infrared Multivariate Quantitative Analysis
    ASTM E 2617 : 2010 Standard Practice for Validation of Empirically Derived Multivariate Calibrations
    ASTM E 1790 : 2000 Standard Practice for Near Infrared Qualitative Analysis
    ASTM E 2363 : 2004 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
    ASTM E 2617 : 2008 : REV A : EDT 1 Standard Practice for Validation of Empirically Derived Multivariate Calibrations
    ASTM C 1174 : 2017 : REDLINE Standard Practice for Evaluation of the Long-Term Behavior of Materials Used in Engineered Barrier Systems (EBS) for Geological Disposal of High-Level Radioactive Waste
    ASTM E 2474 : 2014 : REDLINE Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
    ASTM E 2363 : 2005 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
    ASTM E 2363 : 2006 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
    ASTM E 1655 : 2005 : R2012 Standard Practices for Infrared Multivariate Quantitative Analysis
    ASTM E 1355 : 2012 : R2018 Standard Guide for Evaluating the Predictive Capability of Deterministic Fire Models
    ASTM C 1174 : 2007 : R2013 Standard Practice for Prediction of the Long-Term Behavior of Materials, Including Waste Forms, Used in Engineered Barrier Systems (EBS) for Geological Disposal of High-Level Radioactive Waste
    ASTM E 2363 : 2014 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
    ASTM C 1174 : 2020 Standard Guide for Evaluation of Long-Term Behavior of Materials Used in Engineered Barrier Systems (EBS) for Geological Disposal of High-Level Radioactive Waste
    ASTM E 1355 : 2011 Standard Guide for Evaluating the Predictive Capability of Deterministic Fire Models
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