4.3 - Equipment Program of Maintenance stability You must keep written records

You must keep written records required by this part for 1 year past the shelf life date

SOP and report form for testing for the absence or presence of Salmonella in products or materials according to USP <62> and EP 2

Procedure and report form for testing the absence or presence of staphylococcus aureus in products or materials by Quality Control according to USP <62> and EP 2

to determine whether or not they involve a possible failure of a dietary supplement to meet any of its specifications

4.3 - Equipment Program of Maintenance stability You must keep written recordsEquipment must be adequately maintained as part of a preventive maintenance program to protect components and dietary supplements from being contaminated by any source, to ensure that it functions in accordance with its intended use, and is capable of operating satisfactorily within the operating limits required by the process