By Bruce McDuffee
Q. What are the parameters I need to map?
A. The parameters you choose to map in drug development and processing will depend upon your particular situation. Typical parameters for mapping are temperature, humidity, pressure, light and vibration. You must first determine the environmental parameter(s) critical to your system, process, and product. Assuming you are operating in a regulated environment, the critical parameters are most likely already documented in your cGMP files.