Labelmill Spezifikation

Listing Results Labelmill Spezifikation

Frequently Asked Questions

• What are the specifications for labeling?

  Labeling specifications are: engineering drawing and/or artwork for each label, appropriate inspection or control procedures, and appropriate procedures for attaching the labels. All procedures, drawings, and artwork must have the name of the preparer, an approval signature, and a date.

• What is adequate labeling for medical devices?

  Adequate labeling for a medical device requires proper design and procurement of the labels and labeling. Design includes labeling content that meets the requirement of the QS regulation as well as the needs of the customer.

• What are the labeling requirements for in process sterile goods?

  The requirements for the labeling of in process sterile goods in transit to the contract sterilizer are addressed in detail by 21 CFR 801.150, and covered under Other Labeling Exemptions. Care must be taken in this situation to eliminate the possibility of an unsterilized product being mistaken for a sterilized product.

• How flexible is the quality system regulation on labeling control?

  When reviewing or auditing labeling operations, it is wise to keep in mind that the Quality System regulation contains flexible requirements and thus allows flexibility in a quality assurance program. The degree of labeling control needed to satisfy the Quality System regulation varies considerably for different devices and operations.