ASTM E 2474 : 2014 : REDLINE
Current
The latest, up-to-date edition.
Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
English
04-01-2014
Important note : All end users must be registered with an Account prior to user licenses being assigned.CONTAINED IN VOL. 13.01, 2017 Defines process design, which is integral to process development as well as post-development process optimization.
| Committee |
E 55
|
| DocumentType |
Redline
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| Pages |
4
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Current
|
1.1This practice covers process design, which is integral to process development as well as post-development process optimization. It is focused on practical implementation and experimental development of process understanding.
1.2The term process design as used in this practice can mean:
1.2.1The activities to design a process (the process design), or
1.2.2The outcome of this activity (the designed process), or both.
1.3The principles in this practice are applicable to both drug substance and drug product processes. For drug products, formulation development and process development are interrelated and therefore the process design will incorporate knowledge from the formulation development.
1.4The principles in this practice apply during development of a new process or the improvement or redesign of an existing one, or both.
1.5This 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.
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| ASTM E 2476 : 2016 : REDLINE | Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture |
| ASTM E 2475 : 2010 | Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control |
| ASTM E 2500 : 2013 : REDLINE | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| ASTM E 2475 : 2010 : R2016 | Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control |
| ASTM E 2629 : 2011 | Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems |
| ASTM E 2476 : 2016 : REDLINE | Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture |
| ASTM E 2587 : 2016 : REDLINE | Standard Practice for Use of Control Charts in Statistical Process Control |
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