ASTM E 2891:2020

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.

11.120.01, 35.240.80