Application of Continued Process Verification (CPV) to New Products – PDF download

Manostaxx - Industrial Management Consulting
Manostaxx – Industrial Management Consulting

http://www.manostaxx.com

Validation in General
Planning and Knowledge are EVERYTHING
 Documenting the established approaches and terms, process
monitoring, testing methods, acceptance criteria, etc. prior to
initiating validation studies is absolutely required.
 Demonstrating true understanding of the systems, equipment and
processes is key to Success.

Process control is key in producing a quality product
Pharmaceutical companies should plan and execute a system for the monitoring of process
performance and product quality to ensure a state of control is maintained. An effective
monitoring system provides assurance of the continued capability of processes and controls
to produce a product of desired quality and to identify areas for continual improvement.
• Quality risk management to establish the control strategy
• Measure and assess parameters and attributes identified in the control strategy
• Verify continued operation within a state of control
• Identify sources of variation
• Provide knowledge to enhance process understanding

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