ASTM E 2475 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
Hardcopy , PDF
07-12-2023
English
15-04-2010
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
|
| DocumentType |
Guide
|
| Pages |
7
|
| ProductNote |
Reconfirmed 2010
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy |
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:
| ASTM E 2474 : 2014 | Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020) |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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