This procedure is applicable to planned and unplanned deviations that occur within GMP-related activities, procedures, processes, systems and operations that support manufacturing, testing, packaging, labeling, storage and shipping of regulated products.
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The Validation Master Plan includes all activities related to equipment, utilities, and processes that directly affect the validation operation, its content and outcome.
The objective of the OQ is to establish, through documented testing, that all critical components and systems are capable of operating within established limits and tolerances.
This document summarizes the OQ manually executed validation activities
The objective of the Performance Qualification (PQ) is to establish, through documented testing, that all critical components and equipment are capable of performing within established limits and tolerances over an extended period of time.
This document summarizes the PQ manually executed validation activities.
Describe the scope of the VMP; What does this apply to? What does this exclude?