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ASTM E 2474 : 2014

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)
Available format(s)

Hardcopy , PDF

Withdrawn date

07-07-2020

Language(s)

English

Published date

01-04-2014

Publisher

American Society for Testing and Materials

This practice covers process design, which is integral to process development as well as post-development process optimization

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.

Committee
E 55
DocumentType
Standard Practice
Pages
3
PublisherName
American Society for Testing and Materials
Status
Withdrawn
Supersedes

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 2500 : 2013 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 2891 : 2013 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
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 1325 : 2002 : R2008 Standard Terminology Relating to Design of Experiments
ASTM E 2629 : 2019 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E 2587 : 2016 Standard Practice for Use of Control Charts in Statistical Process Control
ASTM E 1325 : 2016 Standard Terminology Relating to Design of Experiments
ASTM E 2587 : 2014 Standard Practice for Use of Control Charts in Statistical Process Control
ASTM E 1325 : 1991 : R1997 Standard Terminology Relating to Design of Experiments
ASTM E 2476 : 2009 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 : 2007 : EDT 1 Standard Practice for Use of Control Charts in Statistical Process Control
ASTM E 2587 : 2015 Standard Practice for Use of Control Charts in Statistical Process Control
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 1325 : 2015 Standard Terminology Relating to Design of Experiments
ASTM E 2587 : 2010 Standard Practice for Use of Control Charts in Statistical Process Control
ASTM E 1325 : 2002 Standard Terminology Relating to Design of Experiments
ASTM E 2475 : 2010 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
ASTM E 2587 : 2012 Standard Practice for Use of Control Charts in Statistical Process Control
ASTM E 2475 : 2010 : R2016 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
ASTM E 2587 : 2014 : EDT 1 Standard Practice for Use of Control Charts in Statistical Process Control

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