Classes of documents related to the Marketed Substance Container Closure System


related to the Marketed Substance Container Closure System are appropriate as a basis for change for a Marketed Substance - Production Chain entity:

  • Packaging data compliance with Pharmacop. req. as per B.I.c.1#2 req.
    the automatically assigned file name "vbIc1-2-pack-data-compl-with-pharmacop-substprodchain.pdf"
  • Proof of non-interaction content - packaging as per B.I.c.1#3 req.
    the automatically assigned file name "vbIc1-3-proof-non-interaction-content-packg-substprodchain.pdf"
  • Statement concerning satisfactory stability data as per B.I.c.1#4 req.
    the automatically assigned file name "vbIc1-4-state-concerning-satisf-stability-data-substprodchain.pdf"
  • Stability study results of at least two batches as per B.I.c.1#5 req.
    the automatically assigned file name "vbIc1-5-stability-study-results-substprodchain.pdf"
  • Comparison of current and proposed imd. pack. as per B.I.c.1#6 req.
    the automatically assigned file name "vbIc1-6-compar-current-proposed-imd-pack-substprodchain.pdf"
  • Table of current and proposed specification as per B.I.c.2#2 req.
    the automatically assigned file name "vbIc2-2-tbl-current-proposed-spec-substprodchain.pdf"
  • New analytical method details as per B.I.c.2#3 req.
    the automatically assigned file name "vbIc2-3-new-analytical-method-details-substprodchain.pdf"
  • Batch analysis data as per B.I.c.2#4 req.
    the automatically assigned file name "vbIc2-4-batch-analysis-data-substprodchain.pdf"
  • Justification for deletion of spec. parameter as per B.I.c.2#5  req.
    the automatically assigned file name "vbIc2-5-justif-deletion-spec-prmt-substprodchain.pdf"
  • Justification for the new spec. parameter and limits as per B.I.c.2#6 req.
    the automatically assigned file name "vbIc2-6-justif-new-spec-prmt-limits-substprodchain.pdf"
  • Comparative results of new and current tests as per B.I.c.3#2 req.
    the automatically assigned file name "vbIc3-2compar-results-new-current-tests-substprodchain.pdf"
  • Composition change - as per B.I.c.1 type ll req.
    the automatically assigned file name "vbic1-composition-change-1-type-ll-var.pdf"
  • Specification change - as per B.I.c.2 type ll req.
    the automatically assigned file name "vbic2-specification-change-1-type-ll-var.pdf"