Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 7)

GMP Question and Answers


Why is GMP important?
Poor quality medicines are not only a health hazard, but a waste of MONEYfor both governments and individual consumers.

Few qualification facts of Sterilization and Depyrogenation tunnel

Dry heat is used for sterilization instead of the much more efficient moist heat because some materials are sensitive to moisture. Dry heat is often used to ensure that glass and other laboratory equipment is free of pyrogenic material. The process of sterilization within a chamber or hot air tunnel is a critical process and there is a regulatory requirement for validation of the process in most countries. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the dry heat sterilization process has been and will be consistently effective. Dry heat sterilizer validation consists of accurately measuring the temperature at critical points within the sterilization chamber throughout the process. Dry heat process generally employs a temperature between 250°C and 400°C for varying time. The sterilizer is required to heat all parts of its load up to the specified temperature for a specified period long enough to achieve the desired sterility.