Master Plan or Protocol for Process Capability Design and Testing

January 15, 2018February 2, 2023 Pharmaceutical Guidanace

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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