Classes of documents related to the Stability of the Medicinal Product 


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

  • Revised product information as per B.ll.f.1#2 req.
    the automatically assigned file name "vbiif1-2-revised-product-information-medprodchain.pdf"
  • Approved end of shelf life spec as per B.ll.f.1#3 req.
    the automatically assigned file name "vbiif1-3-approved-end-of-shelf-life-spec-medprodchain.pdf"
  • Justification for the proposed changes as per B.ll.f.1#4 req.
    the automatically assigned file name "vbiif1-4-justif-proposed-changes-medprodchain.pdf"
  • Change in the shelf life or storage conditions - as per B.ll.f.1 type ll req.
    the automatically assigned file name "vbiif1-change-shelf-life-storage-cond-type-ll-medprodchain.pdf"