Current Good Manufacturing Practices for Transfusion Services

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Author: Suzanne H. Butch, MA, MLS(ASCP)CM, SBB, DLM
Reviewer: Rory Huschka, M.Ed., MT(ASCP) and Sheri Goertzen, MT(ASCP)BB, CLS, CQA(ASQ)

Good manufacturing practices lead to final products or services that consistently meet appropriate specifications and compliance with defined regulations. The main goal of good manufacturing practices is to prevent adulterated products from entering the market place.

This course focuses on transfusion services and the practices related to the manufacturing of blood and blood components. These practices are correlated to the Food and Drug Administration's (FDA's) current good manufacturing practices (cGMP) that are discussed in Title 21 of the US Code of Federal Regulations.

Laboratory personnel who review the cGMP sections of the Code of Federal Regulations (CFR) ensure their transfusion services departments provide safe products that are in compliance with the FDA regulations.

Continuing Education Credits

Objectives

  • Explain what constitutes good manufacturing practices for transfusion services.
  • Locate current Good Manufacturing Practices Regulations (cGMP) in the US Code of Federal Regulations.
  • Identify regulations applicable to situations encountered in the transfusion service laboratory.

Course Outline

  • The Law and Regulations
      • Introduction
      • FDA Registration and Exemptions
      • Current Good Manufacturing Practice (cGMP) Defined
      • Donor vs Transfusion Service
      • Redundancy
      • Section Summary
      • Good Manufacturing Practices apply to:
      • Which of the following activities could a facility perform and still be exempt for registration and submission of a list of components manufactured?
  • 211 General Good Manufacturing Practices Correlated to CFR Parts Specific to Transfusion Services
      • Quality Control Unit
      • Personnel Requirements
      • Building and Facilities Requirements
      • Building and Facilities, continued
      • Equipment
      • Control of Components & Reagents
      • Control of Components and Reagents, continued
      • Production and Process Controls
      • Packaging and Label Control
      • Holding & Distribution and Traceability
      • Laboratory Controls
      • Records and Reports
      • Complaint and Adverse Reaction Files
      • Returned and Salvaged Drugs
      • Section Summary
      • The regulations that are listed in the Code of Federal Regulations (CFR) should be considered:
  • 600 General Biological Good Manufacturing Practices
      • Addresses and Definitions
      • Shipment Temperatures
      • Establishment Inspections
      • Annual Reporting
      • Section Summary
      • A transfusion service that does not manufacture blood components may be inspected by which of the following organizations for compliance with good man...
  • 606 Current Good Manufacturing Practice for Blood and Blood Components
      • Current Good Manufacturing Practices (cGMP) For Blood and Blood Components
      • Standard Operating Procedures
      • Container Label
      • Additional Container Labeling Requirements
      • Specific Label Statements
      • Machine-Readable Label
      • Emergency Labeling
      • Autologous Labeling
      • What additional information is required on a label or tie tag of an autologous unit that is not required on the container label of blood or blood comp...
      • Compatibility Testing
      • Deviation Reporting
      • Deviation Reporting, continued
      • Section Summary
      • Which of the following scenarios would require that a biological product deviation be reported to the FDA?
  • 610 General Biological Product Standards
      • Testing for Communicable Diseases: 21CFR Part 610
      • Donor Deferral & Lookback
      • Dating Period of Blood Components
      • Section Summary
      • Which of the following activities would require that a label be added to the blood label indicating the name and location of a second manufacturer?
  • 640 Additional Standards for Blood & Blood Components
      • Title 21 Part 640 Overview
      • Reissue of Blood
      • Red Blood Cells
      • Platelets
      • Plasma
      • Cryoprecipitate
      • 640.120 Alternative Procedures
      • Section Summary
      • A platelet donor can donate by apheresis to a specific recipient who does not meet normal donor requirements if a licensed physician has determined th...
  • 660 Additional Standards for Diagnostic Substances for Laboratory Tests
      • 21CFR 660.20 Blood Grouping Reagents
      • Section Summary
      • The specifications for antibody screening cells are found in:
      • Conclusion
  • References
      • References

Additional Information

Level of instruction: Intermediate
 
Intended audience: Laboratory personnel who are involved in the production and processing of blood and blood components, including compatibility testing. This course is also useful for Medical Laboratory Science (MLS)  students and all MLS, MLT, and MT personnel who would like to maintain their knowledge and skills in transfusion medicine.
 
Author Information: Suzanne H. Butch, MA, MLS(ASCP)CM, SBB, DLM is currently working on special projects for the Department of Pathology at Michigan Medicine in Ann Arbor, Michigan. She formerly worked in Quality Assurance in the Department of Pathology and as the Administrative Manager for Healthcare, Blood Bank & Transfusion Service at the University of Michigan Hospitals and Health Centers in Ann Arbor, Michigan. She holds a Bachelors in Medical Technology from the University of Michigan, a Masters Degree in Management and Supervision from Central Michigan University, and Certifications as a Specialist in Blood Bank, as a Quality Audit, and as a Diplomate in Laboratory Medicine. She has edited books and written numerous book chapters and articles and has been invited to present numerous lectures in the field of computerization in the blood bank, automation, and transfusion medicine.
 
Reviewer Information: Rory Huschka, M.Ed., MT(ASCP), has over 20 years of combined experience as a Medical Technologist, Technical Supervisor, Professor, and Manager. He is the former Director of Clinical Laboratory Science and Medical Laboratory Technician Programs at Brookline College. He is currently a Program Director at MediaLab, Inc. Rory holds a BS degree in Medical Technology from North Dakota State University and a Masters in Educational Leadership.
 
Reviewer Information: Sheri Goertzen, MT(ASCP)BB, CLS(CA), CQA(ASQ), has over 25 years of experience as the Supervisor of Transfusion Services at Valley Children's Healthcare in Madera, CA. She has almost 40 years of experience in transfusion services. She has been a presenter at AABB conferences and has served on several AABB committees as a contributing member or the committee chair.
 

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This course is part of:
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On-Line Biological Product Deviation Report
Autologous Unit
Photo by Suzanne Butch
Event Report Form