ASTM E2891-20
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

Standard No.

ASTM E2891-20

Release Date

2020

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM E2891-20

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.

ASTM E2891-20 Referenced Document

• ASTM C1174 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 E1355 Standard Guide for Evaluating the Predictive Capability of Deterministic Fire Models
• ASTM E1655 Standard Practices for Infrared Multivariate Quantitative Analysis*， 2024-04-22 Update
• ASTM E178 Standard Practice for Dealing With Outlying Observations
• ASTM E1790 Standard Practice for Near Infrared Qualitative Analysis*， 2024-04-22 Update
• ASTM E2363 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry*， 2023-01-01 Update
• ASTM E2474 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology*， 2024-04-22 Update
• ASTM E2476 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture*， 2022-11-01 Update
• ASTM E2617 Standard Practice for Validation of Empirically Derived Multivariate Calibrations

ASTM E2891-20 history

• 2020 ASTM E2891-20 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
• 2013 ASTM E2891-13 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications