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

• Product and process development studies as per B.ll.g.1#1 req.
  the automatically assigned file name "vbiig1-1-product-process-development-studies-medprodchain.pdf
• Description of the design space in tabular format as per B.ll.g.1#2 req.
  the automatically assigned file name "vbiig1-2-descript-design-space-tabl-medprodchain.pdf
• Detailed description for the proposed change as per B.ll.g.2#1 req.
  the automatically assigned file name "vbiig2-1-detailed-descript-proposed-change-medprodchain.pdf
• Change management protocol for MP as per B.ll.g.2#2 req.
  the automatically assigned file name "vbiig2-2-change-management-protocol-med-prod-medprodchain.pdf
• Justification for the proposed deletion as per B.ll.g.3#1 req.
  the automatically assigned file name "vbiig3-1-justift-for-proposed-deletion-medprodchain.pdf
• Declaration change within approved limits as per B.ll.g.4#1 req.
  the automatically assigned file name "vbiig4-1-declar-change-within-app-limits-medprodchain.pdf
• Change to an approved change management protocol - as per B.ll.g.4 type ll req.
  the automatically assigned file name "vbiif1-change-to-change-manage-protocol-type-ll-medprodchain.pdf"
• Reference to the app. change management protocol as per B.ll.g.5#1 req.
  the automatically assigned file name "vbiig5-1-ref-to-app-change-manag-protocol-medprodchain.pdf
• Declaration change in accord. with the app. change management as per B.ll.g.5#2 req.
  the automatically assigned file name "vbiig5-2-declar-change-in-accord-with-protocol-medprodchain.pdf
• Results of the studies as per B.ll.g.5#3 req.
  the automatically assigned file name "vbiig5-3-results-of-studies-medprodchain.pdf