GMP SOP Audit for Softgel Manufacturing

This GMP SOP audit checklist is designed for softgel manufacturing and dietary supplement facilities. It guides auditors through facility and grounds, receiving, warehouse, weighing, blending, encapsulation, polishing and inspection, packaging, maintenance, quality control laboratory, quality assurance, and documentation. Checks cover sanitation, pest control, equipment identification and calibration, gowning, labeling, in process controls, record keeping, vendor qualification, investigations, and training. Use it to benchmark operations against FDA 21 CFR 111 requirements and capture notes, evidence, and signatures. The scoring approach supports percentage based compliance evaluation, with typical qualification at 90 percent and a minimum of 85 percent based on severity.