ISPEph GMP/SOP Audit for Dry Products
by Charisse Kyle P. Bedoy, from the Community
This ISPEph GMP and SOP audit checklist helps manufacturers of dry products, such as tablets, capsules, and powders, evaluate compliance with FDA 21 CFR 111 for dietary supplements. It covers facility and grounds, receiving and quarantine, warehousing, weighing, blending and compounding, tablet and coating operations, encapsulation, packaging and powder filling, maintenance, quality control laboratory, quality assurance, and documentation and training. Use it to verify sanitation, labeling, calibration, pest control, equipment identification, personnel practices, investigation procedures, vendor qualification, retain samples, and master production records so you can identify gaps and drive GMP compliance.
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