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ASTM E 2891 : 2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
Available format(s)

Hardcopy , PDF

Superseded date

08-17-2023

Language(s)

English

Published date

11-01-2013

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

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.

Committee
E 55
DocumentType
Guide
Pages
6
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

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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