Based on the legislatively defined set of some of the above specified "basis for change" documents, changes in the definition of a Marketed Substance - Production Chain initiate following variations that have to be reported to the competent Health Authorities:

• B.I.a.4 Change to in-process tests or limits applied during the manufacture of the active substance

  • a) Tightening of in-process limits

  • b) Addition of a new in-process test and limits

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

  • d) Widening of the approved in-process test limits, which may have a significant effect on the overall quality of the active substance

  • e) Deletion of an in-process test which may have a significant effect on the overall quality of the active substance

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