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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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Annual Reporting

Annual reporting of the types of products manufactured is required for those facilities that manufacture blood components. If changes are made, the report must be amended. For licensed facilities (those that ship products they produce across a state line), additional information about the changes must be submitted, including validation studies and standard operating procedures.