Validation of manual packinging pharmaceutical products

Our small pharmaceutical company has a problem:

We want to validate or packinging process.

what do we have:

1 corton box
1 leaflet
1 blister

this makes our end product

The goods are packed manually.

We do a reconciliation on the carton boxes, leaflet and blisters.
Only for the quantity of leaflets we do not know the exact quantity of the incoming leaflets.

The leaflets are packed per 300 -+ 5.

So for the reconciliation we can never be 100 % shure if the operator didn’t forget to put a leaflet in each box. Also the goverment in belgium states that the reconciliation of leaflets must be 0%.

Do other companys also have this problem? We have searched for manufacteres of leaflets that can guaranty a certain amount of leaflets in a box but that doesnt excist in Belgium.

And becouse of the reconsiliation problem we can not validate the packaging process.

Thanks in advance,

Sigurd Staelens

It sounds like you need to error-proof rather than validate.

Since you say leaflet insertion is a manual process, you can never rely on validation for guaranteeing the boxes are properly packed.

I would think you’d want, then, to minimize the risk. Some ideas that come to mind would be an extra set of eyes confirming a leaflet in each box (100% inspection), more frequent reconciliation counts, etc. I wouldn’t think weighing a packed box would be able to discern whether or not a leaflet (or > 1) was packed but in the spirit of brainstorming, I’m mentioning it.

Thanks for the reply,

We have also tought of weighing a packed box, but the leaflets don’t weigh enough to make a descission on the total box wether there is one in it or not.

Now we manually count the leaflets in the beginning of the packaging process (per 100) and then do a reconciliation per 100 sealed boxes.
But we don’t know if in one box there are 2 leaflets and in a other box none.
That can only be checked with an eye.