Monthly Archives: November 2016

Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 11)

Figure: Aseptic filling operation  Assessment made based on the FDA 2004 Aseptic guidance: 1.       Initial clean room qualification includes, in part, an assessment of air quality under as-built, static conditions. A.      True                               B. False 2.       Air in the immediate … Continue reading

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Use of Nitrogen gas in lyophilizer during media fill

Process simulation studies (media fills) are simulating the whole process in order to evaluate the sterility confidence of the process. Process simulation studies include formulation (compounding), filtration and filling with suitable media. Simulations are made to ensure that the regular … Continue reading

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