Covers the scientific and technical activities used to develop and understand the commercial manufacturing process. Topics include process characterization, Design of Experiments (DOE), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), material attributes, risk assessment, operating ranges, control strategy, and design space as foundations for Process Performance Qualification.
Process characterization is the scientific work used to understand how a manufacturing process behaves before it is formally demonstrated through commercial Process Performance Qualification (PPQ). It connects product and material knowledge with unit-operation behavior, process parameters, equipment characteristics, scale effects,…
Design of Experiments (DOE) is a structured statistical approach for studying how multiple process inputs affect one or more measured outputs. In process validation, DOE is most useful during development and Stage 1 — Process Design, where it can convert…
Risk assessment is an important part of process development and validation, but it should not be used as a shortcut that mechanically “identifies CQAs and CPPs.” The correct sequence begins with product and process knowledge. A Critical Quality Attribute (CQA)…
A process control strategy translates development knowledge into the practical controls used to manufacture a product consistently at commercial scale. Within the process-validation lifecycle, this work belongs principally to Stage 1 — Process Design, after sufficient product and process understanding…