ASTM E2891-20
(Guide)Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
SIGNIFICANCE AND USE
4.1 A significant amount of data is generated during pharmaceutical development and manufacturing activities. The interpretation of such data is becoming increasingly difficult. Individual examination of the univariate process variables is relevant but can be significantly complemented by multivariate data analysis (MVDA). MVDA may be particularly appropriate for exploring and handling large sets of heterogenous data, mapping data of high dimensionality onto lower dimensional representations, exposing significant correlations among multivariate variables within a single data set or significant correlations among multivariate variables across data sets. MVDA may extract statistically significant information which may enhance process understanding, decision making in process development, process monitoring and control (including product release), product life-cycle management, and continuous improvement.
4.2 MVDA is widely used in various industries including the pharmaceutical industry. To achieve a valid outcome, an MVDA model/application should incorporate the following:
4.2.1 A predefined risk-based objective incorporating one or more relevant scientific hypotheses specific to the application;
4.2.2 Sufficient relevant data of requisite quality covering the variance space encountered during intended use, that is, pharmaceutical development, or pharmaceutical manufacturing, or both;
4.2.3 Appropriate data analysis and model utilization practices including considerations on testing, validation, and qualification of all new data prior to using a model to analyze it;
4.2.4 Appropriately trained staff;
4.2.5 Appropriate standard operating procedures; and
4.2.6 Life-cycle management.
4.3 This guide can be used to support data analysis activities associated with pharmaceutical development and manufacturing, process performance and product quality monitoring in manufacturing, as well as for troubleshooting and investigation events. Technical detai...
SCOPE
1.1 This 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 after being validated appropriately using a science and risk-based approach.
1.2 The 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:
1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status);
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers);
1.2.3 Considerations on the different types of data analysis, model testing, and validation;
1.2.4 Qualified and competent personnel; and
1.2.5 Life-cycle management of MVDA model.
1.3 This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2891 − 20
Standard Guide for
Multivariate Data Analysis in Pharmaceutical Development
1
and Manufacturing Applications
This standard is issued under the fixed designation E2891; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This guide covers the applications of multivariate data
C1174 Guide for Evaluation of Long-Term Behavior of
analysis (MVDA) to support pharmaceutical development and
Materials Used in Engineered Barrier Systems (EBS) for
manufacturing activities. MVDA is one of the key enablers for
Geological Disposal of High-Level Radioactive Waste
process understanding and decision making in pharmaceutical
E178 Practice for Dealing With Outlying Observations
development, and for the release of intermediate and final
E1355 Guide for Evaluating the Predictive Capability of
products after being validated appropriately using a science
Deterministic Fire Models
and risk-based approach.
E1655 Practices for Infrared Multivariate Quantitative
1.2 The scope of this guide is to provide general guidelines
Analysis
on the application of MVDA in the pharmaceutical industry.
E1790 Practice for Near Infrared Qualitative Analysis
While MVDA refers to typical empirical data analysis, the
E2363 Terminology Relating to Manufacturing of Pharma-
scope is limited to providing a high level guidance and not
ceutical and Biopharmaceutical Products in the Pharma-
intended to provide application-specific data analysis proce-
ceutical and Biopharmaceutical Industry
dures. This guide provides considerations on the following
E2474 Practice for Pharmaceutical Process Design Utilizing
aspects:
3
Process Analytical Technology (Withdrawn 2020)
1.2.1 Use of a risk-based approach (understanding the
E2476 Guide for Risk Assessment and Risk Control as it
objective requirements and assessing the fit-for-use status);
Impacts the Design, Development, and Operation of PAT
1.2.2 Considerations on the data collection and diagnostics
Processes for Pharmaceutical Manufacture
used for MVDA (including data preprocessing and outliers);
E2617 Practice for Validation of Empirically Derived Mul-
1.2.3 Considerations on the different types of data analysis,
tivariate Calibrations
model testing, and validation;
4
2.2 ICH Publications:
1.2.4 Qualified and competent personnel; and
ICH Q2(R1) Validation of Analytical Procedures: Text and
1.2.5 Life-cycle management of MVDA model.
Methodology
ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementa-
1.3 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the tion ICH Quality Implementation Working Group Points
to Consider (R2)
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
3. Terminology
mine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accor-
3.1 Definitions—Common term definitions can be found in
dance with internationally recognized principles on standard-
Terminology E2363 for pharmaceutical applications and some
ization established in the Decision on Principles for the
terms can be found in other standards and are cited when they
Development of International Standards, Guides and Recom-
are mentioned.
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture the ASTM website.
3
of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of The last approved version of this historical standard is referenced on
Subcommittee E55.14 on Measurement Systems and Analysis. www.astm.org.
4
Current edition approved July 1, 2020. Published July 2020. Originally approved Available from International Council for Harmonisation of Technical Require-
in 2013. Last previous edition approved in 2013 as E2891 – 13. DOI: 10.1520/ ments for Pharmaceuticals for Human Use (ICH), ICH Secretariat, Route de
E2891-20. Pré-Bois, 20, P.O Box 1894, 1215 Geneva, Switzerland, https://www.ich.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700,
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2891 − 13 E2891 − 20
Standard Guide for
Multivariate Data Analysis in Pharmaceutical Development
1
and Manufacturing Applications
This standard is issued under the fixed designation E2891; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This 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. products after being validated appropriately using a science
and risk-based approach.
1.2 The 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:
1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status),status);
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers),
outliers);
1.2.3 Considerations on the different types of data analysis and model validation,analysis, model testing, and validation;
1.2.4 Qualified and competent personnel,personnel; and
1.2.5 Life-cycle management of MVDA.MVDA model.
1.3 This 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
C1174 Guide for Evaluation of Long-Term Behavior of Materials Used in Engineered Barrier Systems (EBS) for Geological
Disposal of High-Level Radioactive Waste
E178 Practice for Dealing With Outlying Observations
E1355 Guide for Evaluating the Predictive Capability of Deterministic Fire Models
E1655 Practices for Infrared Multivariate Quantitative Analysis
E1790 Practice for Near Infrared Qualitative Analysis
E2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
3
E2474 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)
E2476 Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes
for Pharmaceutical Manufacture
E2617 Practice for Validation of Empirically Derived Multivariate Calibrations
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of
Subcommittee E55.01 on Process Understanding and PAT System Management, Implementation and Practice.
Current edition approved Nov. 1, 2013July 1, 2020. Published November 2013July 2020. Originally approved in 2013. Last previous edition approved in 2013 as E2891
– 13. DOI: 10.1520/E2891-13.10.1520/E2891-20.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’sstandard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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E2891 − 20
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2.2 ICH Standards:Publications:
ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology
ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation ICH Quality Implementation Working Group Points to Consider (R2)
ICH Q2(R1) Validation of Analytical Procedures: Text and Method
...
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