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ASTM E 2898 : 2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

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

Available format(s)

Hardcopy , PDF

Superseded date

03-06-2020

Superseded by

ASTM E 2898 : 2020

Language(s)

English

Published date

01-06-2014

€67.30
Excluding VAT

Committee
E 55
DocumentType
Guide
Pages
7
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

1.1This guide provides an overview to the risk-based validation of process analytical methods under a process analytical technology (PAT) paradigm for pharmaceuticals and biopharmaceuticals and as such includes guidance on assessing risk to product quality from inappropriate method validation.

1.2This guide builds on existing standards on the topic of validation concentrating on applying such standards to analytical methods for on-line analysis. In particular, it addresses the validation of at-line, on-line, or in-line PAT measurements and covers both API and Drug Product (DP) measurements.

1.3The definitions of International Conference on Harmonization (ICH) validation parameters (such as specificity, precision, repeatability, etc.) apply; however, the method of demonstrating the validation parameters may vary from that described in ICH and is discussed.

1.4As consistent with the U.S. Food and Drug Administration (FDA) process validation guidance, this document also briefly covers ongoing assurance that the method remains in a validated state during routine use.

1.5Equipment and instrument qualification are out of the scope of this guide but will be referenced as inputs to validation of analytical methods for PAT applications.

1.6The validation of multivariate prediction models is out of scope but will be referenced as inputs to validation of analytical methods for PAT applications.

1.7Microbiological methods are out of scope.

1.8This 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.

ASTM E 2629 : 2019 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E 2968 : 2014 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry

ASTM E 2629 : 2011 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E 2629 : 2019 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM D 6122 : 2010 Standard Practice for Validation of the Performance of Multivariate Online, At-Line, and Laboratory Infrared Spectrophotometer Based Analyzer Systems
ASTM E 2617 : 2009 : REV A Standard Practice for Validation of Empirically Derived Multivariate Calibrations
ASTM D 3764 : 2013 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
ASTM D 6122 : 2013 Standard Practice for Validation of the Performance of Multivariate Online, At-Line, and Laboratory Infrared Spectrophotometer Based Analyzer Systems
ASTM E 1790 : 2004 Standard Practice for Near Infrared Qualitative Analysis
ASTM D 6122 : 2006 Standard Practice for Validation of the Performance of Multivariate Process Infrared Spectrophotometers
ASTM D 3764 : 2015 : EDT 1 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
ASTM E 2500 : 2007 : R2012 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM D 3764 : 2001 Standard Practice for Validation of Process Stream Analyzer Systems
ASTM E 2056 : 2004 Standard Practice for Qualifying Spectrometers and Spectrophotometers for Use in Multivariate Analyses, Calibrated Using Surrogate Mixtures
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 2500 : 2007 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM D 3764 : 2006 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
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 D 6122 : 2015 Standard Practice for Validation of the Performance of Multivariate Online, At-Line, and Laboratory Infrared Spectrophotometer Based Analyzer Systems
ASTM E 2656 : 2016 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
ASTM D 3764 : 1992 : R1998 Standard Practice for Validation of Process Stream Analyzer Systems
ASTM D 6122 : 2001 Standard Practice for Validation of Multivariate Process Infrared Spectrophotometers
ASTM D 6122 : 2019 : REV A Standard Practice for Validation of the Performance of Multivariate Online, At-Line, and Laboratory Infrared Spectrophotometer Based Analyzer Systems
ASTM D 6122 : 2018 Standard Practice for Validation of the Performance of Multivariate Online, At-Line, and Laboratory Infrared Spectrophotometer Based Analyzer Systems
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 1790 : 2004 : R2010 Standard Practice for Near Infrared Qualitative Analysis
ASTM E 2656 : 2010 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
ASTM E 2500 : 2013 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 1655 : 2017 Standard Practices for Infrared Multivariate Quantitative Analysis
ASTM D 3764 : 2015 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
ASTM E 2617 : 2017 Standard Practice for Validation of Empirically Derived Multivariate Calibrations
ASTM E 1790 : 2004 : R2016 : EDT 1 Standard Practice for Near Infrared Qualitative Analysis
ASTM D 3764 : 2009 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
ASTM D 6122 : 2019 Standard Practice for Validation of the Performance of Multivariate Online, At-Line, and Laboratory Infrared Spectrophotometer Based Analyzer Systems
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 D 6122 : 2006 : EDT 1 Standard Practice for Validation of the Performance of Multivariate Process Infrared Spectrophotometers
ASTM E 2617 : 2008 : REV A : EDT 1 Standard Practice for Validation of Empirically Derived Multivariate Calibrations
ASTM D 6122 : 1999 Standard Practice for Validation of Multivariate Process Infrared Spectrophotometers
ASTM E 2056 : 2004 : R2016 Standard Practice for Qualifying Spectrometers and Spectrophotometers for Use in Multivariate Analyses, Calibrated Using Surrogate Mixtures
ASTM E 2056 : 2004 : R2010 Standard Practice for Qualifying Spectrometers and Spectrophotometers for Use in Multivariate Analyses, Calibrated Using Surrogate Mixtures
ASTM E 1655 : 2005 : R2012 Standard Practices for Infrared Multivariate Quantitative Analysis
ASTM E 2056 : 2000 Standard Practice for Qualifying Spectrometers and Spectrophotometers for Use in Multivariate Analyses, Calibrated Using Surrogate Mixtures
ASTM D 6122 : 2009 Standard Practice for Validation of the Performance of Multivariate Process Infrared Spectrophotometers

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