Do we write words prospective validation or performance qualification in preparing process validation protocols and report as per fda guideline
Yes.it has to be written,while preparing the protocol for process Validation.
Is it necessary to take validation for reprocess batches.
And what are the cases when we do cleaning verification.
Based on the product profile /nature we have to go for cleaning verification.
Like for example may I know some cases
Cleaning Verification you can perform when you will not having minimum 3 sufficient batches to manufacture. In this case you will not able to complete three cleaning validation runs to complete the validation study. Another case when your cleaning method is not yet established and you are executing trial batches there you can opt for cleaning verification.
Prospective Process performance Qualification protocol is exact terminology instead of validation protocol as per the FDA guideline.
Validation is a term which includes from process design, Process performance qualification and continuous process verification