Please tell me about Gap analysis in production bulk druggie
GAP analysis is a very broad term. You need to specify more details ?
GAP analysis can be defined as difference between WHAT IS THE EXPECTATION and WHAT IS BEING DONE
Now here, you can perform gap analysis with respect to Regulations or Guidelines or SOP or batch manufacturing record and so on
The best way to perform the GAP analysis for any thing say for example “SOP for operation of centrifuge” is to convert the SOP in to a working check list and then observation of actual operation of centrifuge vis-a-vis that checklist and filling your observations against each checkpoint in the checklist. The gaps, if any, will surface out
This methodology you can extend to any GAP ANALYSIS