Guidance Document - American Association of Tissue Banks

V. LABELINGQ1. Given that new infectious diseases are emerging, SARS and WNV forexample, should the label make any claims about the safety of the tissue?A1. Any tissue safety claims should be supported by appropriate verification orvalidation data so they are true and accurate. For example this could includesuitable inactivation and/or sterility studies data (i.e., terminal sterilization, viralinactivation, specific data regarding level of log reduction), wherein theorganization has determined the starting bioburden and applied appropriateprocesses to demonstrate the level of assurance being claimed.Q2. Does tissue labeling have to take place in an area that has controlledaccess?A2. Labeling operations are required to be controlled in a manner that preventslabeling errors/mix-ups.Q3. What types of control systems are required to prevent improper labeling? Isa completely separate and dedicated area required for this function?A3. The establishment must demonstrate that adequate controls are in place.Typically this is accomplished through a specific labeling procedure, dedicatedwork area, and controlled separation of activities to assure there will be no mixups.Q4. Should a claim that is made on the label of a tissue be accompanied bysupporting evidence listed in the package insert?A4. It would be overly burdensome to expect detailed supporting evidence toaccompany each tissue graft. Rather, verification/validation data should beretained by the tissue establishment and a review of labeling claims may beincluded as part of routine inspection activities.Q5. If a process-related claim is made on the label, package insert or otherpromotional materials, is it acceptable to use the data/information from themanufacturer (i.e.; manufacturer’s claim to the sterility of a chemical used inprocessing) or must the tissue establishment perform their own validation inorder to make “claims”?A5. The establishment whose name appears on the label and releases the tissue fordistribution is ultimately responsible for ensuring that process validations areacceptable and completed to support labeling claims. Information from themanufacturer should be verified by the labeling establishment and it should meetthe validation requirements of the tissue establishment.Page 26 of 44