ASTM E 2891 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
17-08-2023
English
01-11-2013
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 14.02, 2016 Defines the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities.
| Committee |
E 55
|
| DocumentType |
Guide
|
| Pages |
6
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy |
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.
| 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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