Current Good Manufacturing Practices for Transfusion Services (by LabCE)

2 P.A.C.E. contact hour(s)

(based on 705 customer ratings)

Author: Suzanne H. Butch, MA, MLS(ASCP)CM, SBB, DLM
Reviewer: Barbara Cebulski, MS, MLS(ASCP)

Course provided by LabCE.

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.

See more courses in: Blood Banking / Immunohematology

Continuing Education Credits

P.A.C.E.® Contact Hours (acceptable for AMT, ASCP, and state recertification): 2 hour(s)
Course number 566105, approved through 9/1/2018
Florida Board of Clinical Laboratory Personnel Credit Hours - General (Blood Banking / Immunohematology): 2 hour(s)
Course number 20-547615, approved through 9/1/2018

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.

Customer Ratings

(based on 705 customer ratings)

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Course Outline

  • The Law and Regulations
      • Introduction
      • FDA Registration and Exemptions
      • Current Good Manufacturing Practice (cGMP) Defined
      • Donor vs Transfusion Service
      • Redundancy
      • Section Summary
  • 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
  • 600 General Biological Good Manufacturing Practices
      • Addresses and Definitions
      • Shipment Temperatures
      • Establishment Inspections
      • Annual Reporting
      • Section Summary
  • 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
      • Compatibility Testing
      • Deviation Reporting
      • Section Summary
  • 610 General Biological Product Standards
      • Testing for Communicable Diseases: 21CFR Part 610
      • Donor Deferral & Lookback
      • Dating Period of Blood Components
      • Section Summary
  • 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
  • 660 Additional Standards for Diagnostic Substances for Laboratory Tests
      • 21CFR 660.20 Blood Grouping Reagents
      • Section Summary
      • 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: 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: Barbara Cebulski, MS, MLS(ASCP) has over 40 years of experience in the medical laboratory profession as a technologist, section supervisor, and laboratory manager. She was an Inspection and Technical Specialist for nine years with the College of American Pathologists in the Laboratory Accreditation Program and, until her retirement in 2015, was Program Director for MediaLab, Inc. 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 Unit

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Autologous Unit
Photo by Suzanne Butch


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