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Process Validation 1987 Vs 2011 – What You Need To Know!
In January 2011 USFDA issued new guidance for industry on process validation with Life...
Quality Risk Management within the Pharmaceutical Industry
Every product or process has associated risks. Zero risk reduction is not a realistic...
Scope Of Risk Management For The Pharmaceutical Industry
Protection of patient by managing risk in the quality systems and manufacturing process is...
Out Of Trend Results – OOT’s
An out-of-trend (OOT) result that does not follow the expected trend, either in comparison...