Actually these cases in technical terminology called as “Perametric Release” & Acceptable by the Regulatory agencies. There are certain terms & conditions for perametric release which needs to be fulfilled before release in open market or for further processing.
Yes, concept of perametric release was introduced in early 1980’s and FDA had published CPG over the same. Several other literature on perametric release is available (APIC, EMEA, PIC/s etc) & one can refer the same.
As Mr. Prasad suggested few criteria for assessment…I will suggest prepare a assessment document for perametric release & if your conditions got fulfilled as an outcome of assessment…get rolled out a SOP & checklist for the same.
Happy Reading !