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Qualification: A documented testing that demonstrates with a high degree of assurance that a specific process will meet its pre-determined acceptance criteria. Validation: A documented testing, performed under highly controlled conditions, which demonstrates a process consistently produces a result meeting pre- determined acceptance criteria While qualification is used to provide a high degree of assurance that a process is replicable under anticipated variable ranges, validation is used to describe how a system will perform under highly controlled conditions. Based on the definitions above, it is easy to see how these definitions are interchanged. However, the key difference is determined by whether or not the process under review operates under 'highly controlled' conditions. Answerd By S.K. Karimullah PharmEvo, Karachi, Pakistan
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∙ 15y ago
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