ASTM E 2898 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
03-06-2020
English
01-06-2014
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Superseded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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