USP 61 Total Aerobic Microbial Count lab sampling and distributors

and distributors

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

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

of materials or drug product must be examined visually for appropriate labeling as to contents

USP 61 Total Aerobic Microbial Count lab sampling and distributorsSOP 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