ASTM E 2474 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
Hardcopy , PDF
11-11-2014
English
01-11-2006
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
E 55
|
| DocumentType |
Standard Practice
|
| Pages |
3
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy |
1.1 This 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.
1.2 The term process design as used in this practice can mean:
1.2.1 The activities to design a process (the process design), and/or
1.2.2 The outcome of this activity (the designed process).
1.3 The 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.
1.4 The principles in this practice apply during development of a new process or the improvement or redesign of an existing one, or both.
This 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 2500 : 2013 | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| ASTM E 2476 : 2016 | 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 : R2016 | Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control |
| ASTM E 2891 : 2013 | Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.