Validation of packaging new product

GOOD VALIDATION PRACTICE (cGVP)
1

All,
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.

2

I think the objective of process validation is to ensure that your process operates as intended with a high degree of assurance as to that fact (and documented evidence). So if your process is to operate short runs, with turnaround between different formats, then I would look to validate exactly that.

Bracketing products into families also works - I would advocate thinking whether any particular families, run sizes or formats are “worst case” and concentrating the validation on these - with a reasonable assumption that easier cases would need less effort (if any). We typically package different sizes of the same product down one packaging machine (eg a 5cmx5cm size smallest and a 25cmx25cm largest) so would validate these with the reasonable assumption and confidence that sizes in between are less challenging to the process.

I think that provided you document your approach, and the reasons why you are justified in taking it, together with a risk assessment, then you are doing the right things.

Hope that helps.