Basically, yes. Again, you’re going to have to do a very good investigation on this. You need to
look at why did your reprocessing or reworking not work the first time. There is no limit in Q7A to
the number of times that something can be reprocessed or reworked
The key is to have an adequate investigation of why you’re repeating a rework or reprocess
because it does bring into question some of your other GMP issues at the plant as to whether you
have adequate control. Reworking or reprocessing would usually improve final quality.
