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- The Law and Regulations
- 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
- 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
- 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
- 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
- 607 Registration Exemptions
- FDA Registration and Exemptions
- Which of the following activities could a facility perform and still be exempt for registration and submission of a list of components manufactured?
- 610 General Biological Product Standards
- Testing for Communicable Diseases: 21CFR Part 610
- Donor Deferral & Lookback
- Dating Period of Blood Components
- Additional Container Labeling Requirements
- 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
- 660 Additional Standards for Diagnostic Substances for Laboratory Tests
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: Suzanne H. Butch, MA, MLS(ASCP)CM, SBB, DLM is 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: Barbara Cebulski, MS, MLS(ASCP)CM is a Program Director for MediaLab, Inc., located in Lawrenceville, GA. She has over 30 years experience in the medical laboratory profession as a technologist, section supervisor, and laboratory manager. She also was employed for nine years by the College of American Pathologists in the Laboratory Accreditation Program. Barbara holds a Masters in Instructional Technology from Georgia State University.
Course content: This course reviews good manufacturing practices that apply to Transfusion Services and correlates these practices with the regulations that are part of Title 21 of the US Code of Federal Regulations. Laboratory staff in the United States who manufacture blood components are expected to comply with and understand these regulations.