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II. 8 Quality risk management as part of…. Industry. Packaging and labeling. Competent Authorities. QRM as part of packaging and labelling. Design of packages Design the secondary package for the protection of primary packaged product Ensure product authenticity Label legibility

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ii 8 quality risk management as part of
II. 8 Quality risk management as part of…

Industry

Packaging and labeling

Competent Authorities

qrm as part of packaging and labelling
QRM as part of packaging and labelling
  • Design of packages
    • Design the secondary package for the protection of primary packaged product
      • Ensure product authenticity
      • Label legibility
  • Selection of container closure system
    • Determine the critical parametersof the container closure system

ICH Q9

qrm as part of packaging and labelling3
QRM as part of packaging and labelling
  • Label controls
    • Design label control procedures based on the potential for mix-ups
      • Involving different product labels
      • Including different versions of the same label

ICH Q9