The purpose of this Compliance Policy Guide (CPG) is to provide guidance to FDA staff on the microbiological control requirements for Anti-Human Globulin (AHG) and Blood Grouping Reagents (BGR) licensed by the Center for Biologics Evaluation and Research (CBER).
In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA’s guidances means that something is suggested or recommended but not required.