USP 61 Total Aerobic Microbial Count lab sampling You must hold or retain

You must hold or retain reserve samples of each lot of packaged and labelled dietary supplements that you distribute

You must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine that specifications are met

and composition of the finished batch

master production and control records for each drug product and batch size

USP 61 Total Aerobic Microbial Count lab sampling You must hold or retainSOP for determining the TAMC, formerly known as TVC or Total Viable Count, the quantity of bacteria in a sample according to USP <61> and EP 2. 6. 12 and to limits stated in USP <1111> and EP 5. 1. 4