Part of critical process for Matrix Transdermal patch is
[b]3) slit and
- pouching or packaging[/b]
Let say the final product have 4 different patch sizes and each patch was packed in alu sachet. If, mixing and coating/lamination have been validated accordingly. Can we skip process validation on the ‘slit’ & ‘pouching’ process by considering both are stable and un-critical process?
Honestly, I really don’t think it is necessary because it is a mechanical process which use moulded knife. And the validation pouching process can be skip because we have conduct stability study.
Am I correct?