I am currently looking into validating the packaging of new products on our existing packaging line. My query relates to the classical validation 3 lot approach. In this instance, my bulk lot is 500k tablets but my packaging runs are small, varying in blister and carton sizes. Some of the first packaging lots are as small as 4000 tablets.
Therefore we have had a rethink about our approach. Classically, we would pack the full bulk lot, 3 times, thus giving us a validation study of 3 full lots. in this instance, with small runs, i dont have this option.
I am currently looking at bracketing the smaller lots together. My blister size is the same over 4 smaller runs, therefore i intend validate by grouping these lots together as one lot and taking representative samples (based on military tables) across all the lots to validate my packaging operation. Has anyone any experience of validating in such a manner.
In a way, i am verifying the packaging operation operates as intended, but not classically validating the line in full. Is there an issue with this? From a risk point of view if i can show continous good pacakging over the smaller runs then can i validate the line in this manner?
Any pointers on another approach would be appreciated.