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or hold components of dietary supplements using approved chemical agents at the required frequency to prevent contamination
master production and control records for each drug product and batch size
Returned or reprocessed drug product shall be destroyed unless examination
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 or hold components of dietarySOP 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
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