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

• Table of current and proposed in-process tests as per B.ll.b.5#2 req.
  the automatically assigned file name "vbllb5-2-table-current-proposed-in-process-tests-substprodchain.pdf"
• Details of new analytical method and validation data as per B.ll.b.5#3 req.
  the automatically assigned file name "vbllb5-3-analytical-method-validation-data-medprodchain.pdf"
• Batch analysis data as per B.ll.b.5#4 req.
  the automatically assigned file name "vbllb5-4-batch-analysis-data-medprodchain.pdf"
• Comparative dissolution profile data as per B.ll.b.5#5 req.
  the automatically assigned file name "vbllb5-5-comparative-dissolution-profile-data-medprodchain.pdf"
• Justification in-process test non-significant-obsolete  as per B.ll.b.5#6 req.
  the automatically assigned file name "vbllb5-6-justif-in-process-test-non-significant-obsolete-medprodchain.pdf"
• Justification of new in-process test and limits as per B.ll.b.5#7 req.
  the automatically assigned file name "vbllb5-7-justif-new-in-process-test-limits-medprodchain.pdf"
• Tests/limits change - as per B.ll.b.5 type ll req.
  the automatically assigned file name "vbllb5-tests-limits-change-1-type-ll-var.pdf"