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Description of ASTM-E2474 2014ASTM E2474-14Withdrawn Standard: Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)ASTM E2474Scope 1.1 This practice covers process design, which is integral to process development as well as post-development process optimization. It is focused on practical implementation and experimental development of process understanding. 1.2 The term process design as used in this practice can mean: 1.2.1 The activities to design a process (the process design), or 1.2.2 The outcome of this activity (the designed process), or both. 1.3 The principles in this practice are applicable to both drug substance and drug product processes. For drug products, formulation development and process development are interrelated and therefore the process design will incorporate knowledge from the formulation development. 1.4 The principles in this practice apply during development of a new process or the improvement or redesign of an existing one, or both. 1.5 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 design space; desired state; manufacturing; PAT; pharmaceutical process design; process analytical technology; process understanding; quality risk management ICS Code ICS Number Code 11.120.01 (Pharmaceutics in general) DOI: 10.1520/E2474-14 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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