Based on the legislatively defined sets of "basis for change" documents, changes in the definition of a Medicinal Product - Preparation Production Chain related to the In-process Quality Control of the Medicinal Product initiate the following variations that have to be reported to the competent Health Authorities:

• B.II.b.5 Change to in-process tests or limits applied during the manufacture of the finished product

  • a) Tightening of in-process limits

  • b) Addition of a new test(s) and limits

  • c) Deletion of a non-significant in-process test

  • d) Deletion of an in-process test which may have a significant effect on the overall quality of the finished product

  • e) Widening of the approved IPC limits, which may have a significant effect on overall quality of the finished product

  • f) Addition or replacement of an in-process test as a result of a safety or quality issue