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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Current Good Manufacturing Practice (cGMP) Defined

The Food Drug and Cosmetic Act defines blood as a drug. Thus, multiple sections of the general drug manufacturing regulations apply to blood products as well as the specific regulations for blood and blood components.
Many of the regulations are simply good practices. A number of these practices are taught, coached, and mentored from initial training in laboratory science to job training and competency assessments. These practices are part of department policies and procedures. For example, using the oldest supplies first to prevent outdating is a good practice. Without knowing that there is a federal regulation supporting the practice, some individuals might be tempted to take a short cut to save time. Knowing the regulations provides a sound basis for setting policies and decision making when writing new procedures and considering revisions to existing procedures.