Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-10-2023

Publisher

American Society for Testing and Materials

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 after being validated appropriately using a science and risk-based approach.

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, model testing, and validation;

1.2.4Qualified and competent personnel; and

1.2.5Life-cycle management of MVDA model.

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4This 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.

Committee	E 55
DocumentType	Guide
Pages	7
PublisherName	American Society for Testing and Materials
Status	Current
Supersedes	ASTM E 2891 : 2013

ASTM D 8431 : 2022	Standard Test Method for Detection of Water-soluble Petroleum Oils by A-TEEM Optical Spectroscopy and Multivariate Analysis
ASTM E 2898 : 2020 : REV A	Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

ASTM E 2363 : 2023	Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
ASTM E 178 : 2016 : REV A	Standard Practice for Dealing With Outlying Observations
ASTM E 178 : 2021	Standard Practice for Dealing With Outlying Observations
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 178 : 2000	Standard Practice for Dealing With Outlying Observations
ASTM E 178 : 1994	Standard Practice for Dealing With Outlying Observations
ASTM E 1355 : 2023	Standard Guide for Evaluating the Predictive Capability of Deterministic Fire Models
ASTM E 2476 : 2022	Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
ASTM E 1355 : 2012 : R2018	Standard Guide for Evaluating the Predictive Capability of Deterministic Fire Models
ASTM E 2363 : 2014	Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry