Validation was hinted in the 1960s, almost four decades ago. What has changed over the last 30 o 40 years? Has the overall understanding of the term improved? Have all responsible firms truly embraced validation? Are they doing everything within their power to make validations a success? Unfortunately not. While validation is a very necessary element of any firm that falls under the scrutiny of the governing regulatory agencies – both United States and foreign – it has not received the recognition it deserves.
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Validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes
Showing posts with label Prerequisites for Successful Validation. Show all posts
Showing posts with label Prerequisites for Successful Validation. Show all posts
Monday, August 18, 2008
Prerequisites for Successful Validation
Journal:
Journal of Validation Technology, May 2003 • Volume 9, Number 3
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