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Packaging and Label Control

Title 21 Part 211 labeling requirements include:
  • Use of approved labels only
  • Visual inspection of labels
  • Record keeping of label shipments
  • Destruction of labels that are no longer needed
  • Procedures specific to labeling must be followed.
Section 606.120 also requires control and inspection of labels and destruction of obsolete labels. Additional requirements are that labeling functions be separated physical or spatially from other functions and that labels be clear and legible. Additional specific requirements for blood component labels will be reviewed in the cGMP for Blood and Blood Components section of this course.