ASTM E 2475 : 2010 : R2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
Hardcopy , PDF
07-12-2023
English
10-08-2023
Important note : Users cannot be edited or removed once added to your Multi user PDF.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).
| Committee |
E 55
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| DocumentType |
Guide
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| Pages |
7
|
| ProductNote |
Reconfirmed 2016
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| 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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