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

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 process for commercial batches repeatedly and reliably produces the finished product of the required quality. However, each process simulation trial is unique and so it is not possible to extrapolate these results directly to actual production contamination rates.