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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Section Summary

Key Points
  1. The Quality Control Unit’s function is to approve or reject components, procedures, productions records, and QC data.
  2. Personnel must be adequate in number, qualified, trained, and have and use appropriate PPE.
  3. Facilities must be adequate in size, clean, safe, and organized.
  4. Equipment must be calibrated and maintained before use, as defined by the manufacturer, and after repair.
  5. The equipment used to prepare blood components must be validated.
  6. Reagents and blood components must be tested to ensure quality as defined in the CFR.
  7. Processes must be validated and designed to ensure that donors, reagents, and materials used can be traced.
  8. Labeling of components must be controlled to ensure that the label on the component is correct.
  9. Records of all significant steps in a process must be maintained and identify the date (time if appropriate) and personnel involved.
  10. A file of complaints and errors should include an investigation of the cause and recommendations for prevention of a recurrence.
  11. The final disposition of blood components, unsatisfactory reagents, and supplies must be maintained.