Technical Update of Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors

Recommendation

15/16 October 2024

Bioburden - Live Online Training
Regulatory Expectations and Practical Experiences

In October 2012, the US FDA implemented the Compliance Program Guidance Manual, Chapter 42 - Blood and Blood Products "Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001". Now this document  was technically updated.

This program represents a continuing compliance and surveillance activity that began in 1972. The program objective is to ensure that blood and blood components for human use are safe, pure, effective, and are appropriately labeled. The inspection of a blood establishment is supposed to ensure that manufacturers are making products that:

• Meet the standards described in applicable provisions of the regulations, including those specifically intended to protect donors. These include regulations in Title 21, Code of Federal Regulations (21 CFR) Parts 600, 601, 606, 607, 610 and 640, process and production controls, equipment regulations and quality control in 21 CFR Part 211 and other applicable standards, and
• Meet any additional conditions of licensure incorporated in the establishment's approved Biologic License Application (BLA), if manufacturing a licensed product.

The following types of establishments are covered by this program:

• Blood Bank (foreign and domestic)
• Blood and/or Plasma Broker
• Component Preparation Facility
• Contractor
• Distribution Center or Depot
• Donor (collection) Center
• Hospital Transfusion Service
• Indian Health Service Hospital
• Military Blood Banks and Transfusion Service
• Testing Laboratory
• Veteran's Health Administration Medical Center
• Other Blood Establishment

For more detailed information please see the complete "Compliance Program Guidance Manual - Chapter 42 - Blood and Blood Products".