Current Good Manufacturing Practices for Transfusion Services
Continuing Education Credits
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.
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 versus Transfusion Service
- Redundancy
- Section Summary
- Good Manufacturing Practices apply to:
- Which of the following activities could a facility perform and still be exempt from registration and submission of a list of components manufactured?
- General Good Manufacturing Practices Correlated to CFR Parts Specific to Transfusion Services Part 211
- Quality Control Unit
- Personnel Requirements
- Building and Facilities Requirements
- Building and Facilities, continued
- Equipment
- Control of Components and Reagents
- Control of Components and Reagents, continued
- Production and Process Controls
- Packaging and Label Control
- 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:
- General Biological Good Manufacturing Practices Part 600
- 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 manufacturing practices?
- Current Good Manufacturing Practices for Blood and Blood Components Part 606
- 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 components from an allogeneic donor?
- Compatibility Testing
- Deviation Reporting
- Section Summary
- Which of the following scenarios would require that a biological product deviation be reported to the FDA?
- General Biological Product Standards Part 610
- Testing for Communicable Diseases
- Donor Deferral and Lookback
- Blood Components Storage Temperature and Dating Period
- Section Summary
- Which of the following diseases is not mandated to be tested for on all donors?
- Additional Standards for Blood and Blood Components Part 640
- Overview of Part 640
- Reissue of Blood
- Red Blood Cells
- Platelets
- Plasma
- Cryoprecipitate
- 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 that the recipient must be transfused with the platelets from that specific donor. What additional requirements must be met?
- Additional Standards for Diagnostic Substances for Laboratory Tests Part 660
- Blood Grouping Reagents
- 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 to include Medical Laboratory Scientists (MLS), Medical Laboratory Technicians (MLT), and transfusion medicine administration/management. It can also be useful for MLS and MLT students.
Author Information: Suzanne H. Butch, MA, MLS(ASCP)CM, SBB, DLM 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 Bachelor's degree in Medical Technology from the University of Michigan, a Master's Degree in Management and Supervision from Central Michigan University, and Certifications as a Specialist in Blood Bank, Quality Audit, and 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: Jules Zinni, MS, MLS(ASCP)CM, MBCM, SBBCM began his career in transfusion medicine at tertiary and quaternary care facilities in Chicago and the Chicagoland area before moving to the immunohematology reference laboratory. He has experience in blood banking, transfusion services, cellular therapy, molecular testing, donor testing, product manufacturing, and teaching. He greatly appreciates the opportunities he has had to serve as a guest member of the ISBT Transfusion Red Cell Immunogenetics and Blood Group Terminology Working Party, an AABB assessor, and a member-at-large for the Illinois Association of Blood Banks. He is an advocate for transfusion education for people within and ancillary to the field.