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ASTM E 2475 : 2010

ASTM E 2475 : 2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

Available format(s)

Hardcopy , PDF

Superseded date

07-12-2023

Language(s)

English

Published date

15-04-2010

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 14.02, 2016 Aims to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992; FDA/ICH Q8).

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:

Committee
E 55
DocumentType
Guide
Pages
7
ProductNote
Reconfirmed 2010
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM E 2474 : 2014 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)
ASTM E 2500 : 2013 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 2968 : 2014 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry

ASTM E 2281 : 2015 : REDLINE Standard Practice for Process Capability and Performance Measurement
ASTM E 2474 : 2014 : REDLINE Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

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Hardcopy - English
PDF - English
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