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ASTM E 2898 : 2014 : REDLINE

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
Available format(s)

PDF

Superseded date

08-24-2020

Language(s)

English

Published date

06-01-2014

CONTAINED IN VOL. 14.02, 2016 Gives an overview to the risk-based validation of process analytical methods under a process analytical technology (PAT) paradigm for pharmaceuticals and biopharmaceuticals and as such includes guidance on assessing risk to product quality from inappropriate method validation.

1.1This guide provides an overview to the risk-based validation of process analytical methods under a process analytical technology (PAT) paradigm for pharmaceuticals and biopharmaceuticals and as such includes guidance on assessing risk to product quality from inappropriate method validation.

1.2This guide builds on existing standards on the topic of validation concentrating on applying such standards to analytical methods for on-line analysis. In particular, it addresses the validation of at-line, on-line, or in-line PAT measurements and covers both API and Drug Product (DP) measurements.

1.3The definitions of International Conference on Harmonization (ICH) validation parameters (such as specificity, precision, repeatability, etc.) apply; however, the method of demonstrating the validation parameters may vary from that described in ICH and is discussed.

1.4As consistent with the U.S. Food and Drug Administration (FDA) process validation guidance, this document also briefly covers ongoing assurance that the method remains in a validated state during routine use.

1.5Equipment and instrument qualification are out of the scope of this guide but will be referenced as inputs to validation of analytical methods for PAT applications.

1.6The validation of multivariate prediction models is out of scope but will be referenced as inputs to validation of analytical methods for PAT applications.

1.7Microbiological methods are out of scope.

1.8This 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.

Committee
E 55
DocumentType
Redline
Pages
8
PublisherName
American Society for Testing and Materials
Status
Superseded

ASTM E 2968 : 2014 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry

ASTM E 2629 : 2011 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASME BPE : 2016 BIOPROCESSING EQUIPMENT
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
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
ASTM D 6122 : 2016-02 PRACTICE FOR VALIDATION OF THE PERFORMANCE OF MULTIVARIATE ONLINE, AT-LINE, AND LABORATORY INFRARED SPECTROPHOTOMETER BASED ANALYZER SYSTEMS
ASTM E 2500 : 2013 : REDLINE Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 15839:2003 Water quality On-line sensors/analysing equipment for water Specifications and performance tests

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