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.
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Change in container closure system must needed process validation as it’s stability result indicating change as barrier property differ for different container closure system.
If scientific rational for positive change i.e. incremental gsm change & proper risk assessment documents help us to skip process Validation. It’s must for us we have not nagative change w.r.t. barrier properties, vendor & sealing indicating critical process attribute ( HSL gsm, forming & sealing temp).
If IH SOP & quality team not allow to do , continue for process validation path.
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