Transdermal Patch

GOOD VALIDATION PRACTICE (cGVP)
1

Dear Collegue.

Part of critical process for Matrix Transdermal patch is

  1. mixing,
  2. coating/lamination,
    [b]3) slit and
  3. 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?