Classes of documents related to the Control of Finished Product


The following classes of documents related to the Control of Finished Product are appropriate as a basis for change for a Medicinal Product - Preparation Production Chain entity:

  • Comparative table of current and proposed specifications as per B.ll.d.1#2 req.
    the automatically assigned file name "vblld1-2-table-current-proposed-specification-medprodchain.pdf"
  • Details of new analytical method and validation data as per B.ll.d.1#3 req.
    the automatically assigned file name "vblld1-3-analytical-method-validation-data-medprodchain.pdf"
  • Batch analysis data as per B.ll.d.1#4 req.
    the automatically assigned file name "vblld1-4-batch-analysis-data-medprodchain.pdf"
  • Comparative dissolution profile data as per B.ll.d.1#5 req.
    the automatically assigned file name "vblld1-5-comparative-dissolution-profile-data-medprodchain.pdf
  • Justification parameter non-significant-obsolete  as per B.ll.d.1#6 req.
    the automatically assigned file name "vblld1-6-justif-parameter-non-significant-obsolete-medprodchain.pdf""
  • Justification of new spec. parameter and limits as per B.ll.d.1#7 req.
    the automatically assigned file name "vblld1-7-justif-new-spec-parameter-limits-medprodchain.pdf"
  • Decision to change spec. outside the approved limits - as per B.ll.d.1e type ll req.
    the automatically assigned file name "vbiid1e-spec-change-outside-limits-1-type-ll-medprodchain.pdf
  • Decision to delete spec. parameter - as per B.ll.d.1f type ll req.
    the automatically assigned file name "vbiid1f-delete-spec-parameter-1-type-ll-medprodchain.pdf""
  • Validation results for current and proposed tests as per B.ll.d.2#2 req.
    the automatically assigned file name "vblld2-2-validation-results-current-proposed-tests-medprodchain.pdf"
  • Decision to delete test procedure - as per B.ll.d.2b req.
    the automatically assigned file name "vbiid2b-delete-test-procedure-medprodchain.pdf"
  • Decision on a substantial change to test method - as per B.ll.d.2c type ll req.
    the automatically assigned file name "vbiid2c-subst-change-to-test-method-1-type-ll-medprodchain.pdf"
  • Decision to update the test procedure - as per B.ll.d.2e req.
    the automatically assigned file name "vbiid2e-update-test-procedure-medprodchain.pdf
  • Decision to remove outdated test method - as per B.ll.d.2f req.
    the automatically assigned file name "vbiid2f-remove-outdated-test-method-medprodchain.pdf""
  • Introduction of real-time release - as per B.ll.d.3 type ll req.
    the automatically assigned file name "vbiid3-introduction-real-time release-1-type-ll-medprodchain.pdf"