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Function: This type of validation is important for new processes, services, or merchandise, guaranteeing their readiness for steady and compliant production. It is actually carried out on at least three consecutive creation-dimension batches to substantiate reproducibility and compliance with regulatory benchmarks.In terms of the value of process v
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The presentation elaborates over the technologies transfer taking place in production period. Production stage mainly fears with validation scientific studies and scale-up. Validation studies including performance qualification, cleaning validation and system validation is performed by R&D Section. Scale-up includes using benefits received from lab