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Question Status:   Open

what is validation?



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Author: veerendra_nath2010: Add as a Colleague
Posted: 11/11/2011  11:38:55 PM EST
Tags: pharma

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View Profileanandsharma.90@rediffmail.com: Add as a ColleagueAdd as a Colleague
12/11/2011 8:10:11 AM EST

FDA-guidelines: Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. EU-guidelines Action of proving, in accordance with GMP-principles that any procedure, process, equipment, material, activity or system actually leads to the expected results.
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View Profiletharunsarella: Add as a ColleagueAdd as a Colleague
11/17/2011 9:30:08 AM EST

validation is the documented avidence that the procedure or system or equipment that we are selected will give the reproducable result.
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