ASTM-E2475 2010

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E2475-10 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

Published By	Publication Date	Number of Pages
ASTM	2010	6

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Categories: 11.120.01 - Pharmaceutics in general, ASTM

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Description

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:

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PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Process Understanding
3	Process Knowledge FIG. 1
5	FIG. 2
6	Risk and Uncertainty in the Context of Process Understanding, Predictability, Control, and Product Quality Requirements Keywords

Additional information

Standard Title	E2475-10 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
Published Code	ASTM
Publication Date	2010
Pages Count	6
ICS Codes	11.120.01 - Pharmaceutics in general

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ASTM-E2475 2010

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