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ASTM E2474

Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

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Organization: ASTM
Publication Date: 1 April 2014
Status: inactive
Page Count: 3
ICS Code (Pharmaceutics in general): 11.120.01
scope:

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.

The term process design as used in this practice can mean:

The activities to design a process (the process design), or

The outcome of this activity (the designed process), or both.

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.

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.

Document History

ASTM E2474
April 1, 2014
Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
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...
November 1, 2006
Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
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...

References

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