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
Monday, August 18, 2008
Prerequisites for Successful Validation
Journal:
Journal of Validation Technology, May 2003 • Volume 9, Number 3
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