Packaging validation

Can someone provide guidance that PV required or not if there are increase in HTF foil GSM for blister pack

Yes, please. Process Validation is required w r to only for packaging operation because there is a change in the specification of HTF foil of blister packing. There could be changes in the “Critical process parameters” in the blister packing operations such as the temperature of sealing, speed of blistering etc.

Moreover, the stability study of the product with change in the blister foil is also very important to establish the stability of the product until its expiry (Shelf life) with revised blister packing.

1 Like