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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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Addresses and Definitions

Title 21 Part 600 of the Code of Federal Regulations (CFR) addresses general biological good manufacturing practices. This is where a transfusion services laboratory can locate the addresses for notifications if and when needed, including the addresses for:
  • Center for Biologics Evaluation and Research (CBER)
    • Adverse experience reports
    • Biological product deviation reports
    • Fatality reports
  • Center for Drug Evaluation and Research (CDER)
    • Licensed products regulated by CDER (drugs)
    • Post-marketing adverse experience reporting
Definitions for the terms that are used in Part 600 are also included at the beginning of the section.