Validation in the pharmaceutical context is a critical process that entails the establishment of documented evidence proving that any system, process, equipment, method, or product reliably achieves outcomes that meet predefined specifications and quality attributes. This comprehensive approach, which encompasses equipment validation, process validation, and analytical method validation, is geared towards ensuring consistent performance and output within specified tolerances. Essential across various sectors, including pharmaceuticals, healthcare, and manufacturing, validation serves as a cornerstone for quality assurance, safety, and adherence to regulatory standards, through systematic testing, qualification, and verification activities.
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