02 Oct Is proficiency/competency assessed on every approved process? If not, how are appropriate processes selected?
It is generally not feasible to assess all processes for manufacturing. Instead, we recommend selecting representative processes that are either common between multiple processes, frequently performed, or particularly difficult, and using these processes as indicators. For Quality Control proficiency on analytical tests, it may be more reasonable to assess all assays.
“Competency is assessed by performing two procedures under review. One procedure should include aseptic technique. The two procedures assessed shall be different than those chose the previous year.”