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ASTM E 2475 : 2010 : R2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date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

10-08-2023

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).

1.1The 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 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.

1.2Process 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:

“…a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in process materials and processes, with the goal of ensuring final product quality. It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner. The goal of PAT is to enhance understanding and control the manufacturing process…” (U.S. FDA PAT)

1.3This 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.

Committee
E 55
DocumentType
Guide
Pages
7
ProductNote
Reconfirmed 2016
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM E 3326 : 2022 Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
ASTM E 2968 : 2023 Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry
ASTM E 2474 : 2014 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)
ASTM E 2968 : 2014 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry
ASTM E 2500 : 2013 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ASTM E 2617 : 2009 : REV A Standard Practice for Validation of Empirically Derived Multivariate Calibrations
ASTM E 456 : 2002 Standard Terminology for Relating to Quality and Statistics
ASTM E 456 : 2013 : REV A : R2022 Standard Terminology Relating to Quality and Statistics
ASTM E 2281 : 2015 Standard Practice for Process Capability and Performance Measurement
ASTM E 2281 : 2003 Standard Practice for Process and Measurement Capability Indices
ASTM E 2617 : 2008 Standard Practice for Validation of Empirically Derived Multivariate Calibrations
ASTM E 2474 : 2014 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)
ASTM E 456 : 2013 : REV A : R2017 : EDT 5 Standard Terminology Relating to Quality and Statistics
ASTM E 2281 : 2008 Standard Practice for Process and Measurement Capability Indices
ASTM E 2617 : 2008 : REV A Standard Practice for Validation of Empirically Derived Multivariate Calibrations
ASTM E 2281 : 2015 : REDLINE Standard Practice for Process Capability and Performance Measurement
ASTM E 2474 : 2006 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
ASTM E 2617 : 2017 Standard Practice for Validation of Empirically Derived Multivariate Calibrations
ASTM E 2617 : 2010 Standard Practice for Validation of Empirically Derived Multivariate Calibrations
ASTM E 2617 : 2008 : REV A : EDT 1 Standard Practice for Validation of Empirically Derived Multivariate Calibrations
ASTM E 2281 : 2008 : REV A Standard Practice for Process and Measurement Capability Indices
ASTM E 2474 : 2014 : REDLINE Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
ASTM E 456 : 2013 : REV A : R2017 : EDT 4 Standard Terminology Relating to Quality and Statistics
ASTM E 456 : 2013 : REV A : R2017 : EDT 6 Standard Terminology Relating to Quality and Statistics
ASTM E 2281 : 2008 : REV A : R2012 : EDT 1 Standard Practice for Process and Measurement Capability Indices

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