1. Scope
Describe standard practice and accepted methods for characterizing a processes desired process operating window (such as the design space), visualization of the process operation relative to this window and test methods for validating model describing the acceptable operating window.
This practice is intended to address the science based quality systems utilizing the design space methods described by the FDA, ICH and other pharmaceutical regulatory bodies. The design space refers to the operating space that produces good quality product and multivariate models of the process are used to describe this operating space. This practice will include methods for characterizing the process using multivariate models, visualization of process operation relative to the design space and validation of the multivariate models used.
Keywords
multivariate SPC:multivariate process monitoring:design space:process characterization
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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