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you must wear clean
and composition of the finished batch
master production and control records for each drug product and batch size
and contact surfaces
of materials or drug product must be examined visually for appropriate labeling as to contents
USP 61 Total Aerobic Microbial Count lab sampling you must wear cleanSOP 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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