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URS and FDS for equipment
Hi all, I would really appreciate some feedback on the following: What is the approach pharmaceutical companies are taking with respect to URS and FDS for equipment on site? Is a URS required for all pieces of equipment e.g from Filling Line to Incubator to HPLC? In addition, when is an FDS required and in what format is it received from the suppliers? Is there a QA/Head of QC sign-off on it? Thanking you in advance for your help, Regards, Ger Russell gerrussell@hotmail.com |
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