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Description of ASTM-E2898 2013ASTM E2898-13Historical Standard: Standard Guide for Risk-Based Validation of Analytical Methods for PAT ApplicationsASTM E2898Scope 1.1 This 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. 1.2 This 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. 1.3 The 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. 1.4 As 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. 1.5 Equipment 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. 1.6 The validation of multivariate prediction models is out of scope but will be referenced as inputs to validation of analytical methods for PAT applications. 1.7 Microbiological methods are out of scope. 1.8 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 and health practices and determine the applicability of regulatory limitations prior to use. Keywords at-line; in-line; in-process measurements; method development; method verification; multivariate modeling; off-line; on-line; particle characterization; PAT; process analytical; process analytical technology; process analytics; process analyzers; qualification; risk assessment; sampling; validation; vibrational spectroscopy ICS Code ICS Number Code 11.120.99 (Other standards related to pharmaceutics) DOI: 10.1520/E2898-13 The following editions for this book are also available...This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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