If a new product haven’t stability, how can we assign retest and expriy date to them??
And a product Mfg presses same for Usp, Ep & ip… But we have 5 yr stability data in Usp… Shall we able to use the same 5yr retest to Ep & Ip, is it’s acceptable??
How to assign Retest date to new products, on which basis
Retest Dates are assigned to products for which long term shelf life has not been fully established and to neat reference materials to ensure the continued collection of data.
Retest dates are assigned to new products and to products which are continuing on stability testing.
The retest date is assigned during product design, at the time of initial production, or at a stability testing interval.
As a general rule, all new products will be assigned a Retest Date until sufficient data is gathered to establish a shelf life of 36 to 60 months (more for some neat materials).
Ok, thq for Ur information… If we have 5 yrs retest in usp grand, then can we use it for IP, EP, and JP??
