USP 61 Total Aerobic Microbial Count lab sampling Quantitative test methods must be

Quantitative test methods must be validated by determining in assays the sensitivity

or hold components of dietary supplements using approved chemical agents at the required frequency to prevent contamination

and composition of the finished batch

and contact surfaces

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

USP 61 Total Aerobic Microbial Count lab sampling Quantitative test methods must beSOP 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