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The surface area of particular ingredients in a formulation may be considered a Critical Quality Attribute (CQA) that, when performing Risk Assessment (under the guidance of ICH Q9), will place added importance on this parameter and may become part of your overall control strategy.
Supporting instruments from all major vendors, Genedata Expressionist reduces data analysis times by factors of ten or more to accelerate the identification and quantification of critical quality attributes of biopharmaceuticals.
By monitoring physical and chemical properties, the manufacturer can also define a set of variable CPP-dependent variables known as Critical Quality Attributes (CQAs) at various stages of the process, allowing the manufacturer to better understand and control the entire process.
Critical quality attributes (CQAs), determined with the patient in mind, have been built into the development process to help ensure quality, safety and efficacy throughout a drug product's lifecycle.
A risk-based, scientifically sound submission would be expected to include the following: Quality target product profile (QTPP), critical quality attributes (CQAs) of the drug product, product design and understanding including identification of critical attributes of excipients, drug substance(s), and/or container closure systems, process design and understanding including identification of critical process parameters and in-process material attributes control strategy and justification.
A process risk assessment is a very effective way to connect the product design, process unit operation and final product performance critical quality attributes (CQAs).
A factorial sequence with replicates that evaluates machine factors such as agitator bar tip speed, vessel tip speed and vessel slope with respect to a critical quality attribute such as mix uniformity, thereby proving a proven acceptable range, may be accomplished in one day of testing.
A sufficient cause-and-effect model that links Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).