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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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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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