Master Plan or Protocol for Process Capability Design and Testing

Master Plan or Protocol for Process Capability Design and Testing

Objective Process capability design and testing
Types of process Batch, intermittent, continuous
Typical processes Chemical, pharmaceutical, biochemical
Process definition Flow diagram, in-process, finished product
Definition of process output Potency, yield, physical parameters
Definition of test methods Instrumentation, procedures, precision, and accuracy
Process analysis Process variables, matrix design, factorial design analysis
Pilot batch trials Define sampling and testing, stable, extended runs
Pilot batch replication Different days, different materials, different equipment
Process redefinition Reclassification of process variables
Process capability evaluation Stability and variability of process output, economic limits
Final report Recommended SOP, specifications, and process limits

Source & Reference-Drug and Pharmaceuticals sciences (Volume 129)

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