Number of Credits
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.
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.
- 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.
This course has been approved for P.A.C.E.® credit. There are no prerequisites for this course.
- The Law and Regulations
- 211 General Good Manufacturing Practices Correlated to CFR Parts Specific to Transfusion Services
- 600 General Biological Good Manufacturing Practices
- 606 Current Good Manufacturing Practice for Blood and Blood Components
- 607 Registration Exemptions
- 610 General Biological Product Standards
- 640 Additional Standards for Blood & Blood Components
- 640.120 Alternative Procedures
- 660 Additional Standards for Diagnostic Substances for Laboratory Tests
- Graded Exam
Free, current version of Internet Explorer, Chrome, Firefox, or Safari. (Some older browsers could produce error messages or not display the content correctly.)
Free, current version of Adobe Flash Player and Adobe Reader.