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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