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ASTM International - ASTM E2475-10

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

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Organization: ASTM International
Publication Date: 15 April 2010
Status: inactive
Page Count: 7
ICS Code (Pharmaceutics in general): 11.120.01
scope:

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:

Document History

September 1, 2016
Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
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;2 FDA/ICH Q8). The...
ASTM E2475-10
April 15, 2010
Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
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...
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