1. Scope
These practices cover a guide for multivariate analysis (MVA) related to process analytical technology (PAT) in the pharmaceutical industry. These practices are applicable to all stages of model creation and use and post-process data mining from process parameters. These practices provide a procedural outline for the validation and implementation of MVA models, including quantitative and qualitative models.
No such standard presnetly exists.
Keywords
pharmaceutical manufacturing; process model; control model; data-based model; rule-based model; qualitative analysis; quantitative analysis
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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