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ASTM E2475-10

Historical Revision

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

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1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992; FDA/ICH Q8). The framework is applicable to both active pharmaceutical ingredient (API) and to drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continuous process improvement efforts.

1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:


SDO ASTM: ASTM International
Document Number E2475
Publication Date April 15, 2010
Language en - English
Page Count 7
Revision Level 10
Supercedes
Committee E55.01
Publish Date Document Id Type View
Nov. 15, 2023 E2475-23 Revision
April 15, 2010 E2475-10 Revision
Sept. 1, 2016 E2475-10R16 Reaffirmation