Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

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PDF

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English

Published date

01-04-2014

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2017 Defines 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	Redline
Pages	4
PublisherName	American Society for Testing and Materials
Status	Current

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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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ASTM E 2474 : 2014 : REDLINE

Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

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