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

• Validation study batches or validation protocol as per B.ll.b.1#2 req.
  the automatically assigned file name "vbllb1-2-validation-study-batches-validation-protocol-medprodchain.pdf"
• Approved release and end-of-shelf life specifications as per B.ll.b.1#4 req.
  the automatically assigned file name "vbllb1-4-approved-release-end-of-shelf-life-specif-medprodchain.pdf"
• Batch analysis data as per B.ll.b.1#5 req.
  the automatically assigned file name "vbllb1-5-batch-analysis-data-medprodchain.pdf"
• Microscopic imaging of particle size distrib. and morphology as per B.ll.b.1#6 req.
  the automatically assigned file name "vbllb1-6-microscopic-imaging-particle-size-distribution-medprodchain.pdf"
• The substance manufacturing process - Statement as per B.ll.b.1#7i req.
  the automatically assigned file name "vbllb1-7i-batch-release-qp-subst-manuf-process-statement-medprodchain.pdf"
• The substance manufacturing process - Statement as per B.ll.b.1#7ll req.
  the automatically assigned file name "vbllb1-7ll-manuf-site-qp-subst-manuf-process-statement-medprodchain.pdf"
• Bulk Medicinal Product transport and storage conditions as per B.ll.b.1#9 req.
  the automatically assigned file name "vbllb1-9-balk-med-prod-transport-storage-conditions-medprodchain.pdf"
• The substance manufacturing process - Statement as per B.ll.b.2#4 req.
  the automatically assigned file name "vbllb2-4-batch-release-qp-subst-manuf-process-statement-medprodchain.pdf"
• Microscopic imaging of particle size distrib. and morphology as per B.ll.b.3#2 req.
  the automatically assigned file name "vbllb3-2-microscopic-imaging-particle-size-distribution-medprodchain.pdf"
• Comparative dissol. profile on pilot batches as per B.ll.b.3.#3 req.
  the automatically assigned file name "vbllb3-3-dissol-profile-on-pilot-batch-medprodchain.pdf"
  (optional, for solid dosage forms only)
• Justification for not submitting bioequivalence study as per B.ll.b.3.#4 req.
  the automatically assigned file name "vbllb3-4-justif-not-submitting-bioequivalence-study-medprodchain.pdf"
• Declaration for changes of process parameters as per B.ll.b.3.#5 req.
  the automatically assigned file name "vbllb3-5-declaration-changes-process-parameters-medprodchain.pdf"
• Approved release and end-of-shelf life specifications as per B.ll.b.3#6 req.
  the automatically assigned file name "vbllb3-6-approved-release-end-of-shelf-life-specif-medprodchain.pdf"
• Batch analysis data as per B.ll.b.3#7 req.
  the automatically assigned file name "vbllb3-7-batch-analysis-data-medprodchain.pdf"
• Declaration relevant stability studies started as per B.ll.b.3#8 req.
  the automatically assigned file name "vbllb3-8-declaration-stability-stud-started-medprodchain.pdf"
• Batch analysis data as per B.ll.b.4#2 req.
  the automatically assigned file name "vbllb4-2-batch-analysis-data-medprodchain.pdf"
• Approved release and end-of-shelf life specifications as per B.ll.b.4#3 req.
  the automatically assigned file name "vbllb4-3-approved-release-end-of-shelf-life-specif-medprodchain.pdf"
• Validation study batches or validation protocol as per B.ll.b.4#4 req.
  the automatically assigned file name "vbllb4-4-validation-study-batches-or-validation-protocol-medprodchain.pdf"
• Validation study results as per B.ll.b.4#5 req.
  the automatically assigned file name "vbllb4-5-validation-study-results-medprodchain.pdf"
• Stability studies results as per B.ll.b.4#6 req.
  the automatically assigned file name "vbllb4-6-stability-studies-results-medprodchain.pdf"
• Change in manufacturer - as per B.ll.b.1 type ll req.
  the automatically assigned file name "vbllb1-change-in-manufacturer-1-type-ll-var.pdf"
• Change in importer/batch release - as per B.ll.b.2 type ll req.
  the automatically assigned file name "vbllb2-change-in-importer-batch-release-1-type-ll-var.pdf"
• Change in the manufacturing process - as per B.ll.b.3 type ll req.
  the automatically assigned file name "vbllb3-change-in-manuf-process-1-type-ll-var.pdf"
• Change in batch size - as per B.Il.b.4 type ll req.
  the automatically assigned file name "vbllb4-change-in-batch-size-1-type-ll-var.pdf"