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GMP SOP Audit for Raw Material Supplier

by Gary Callahan, from the Community

20+

This comprehensive GMP and SOP audit checklist helps evaluate raw material suppliers against 21 CFR Part 111 requirements for dietary supplement manufacturing. It covers facility and grounds, receiving and quarantine, warehouse controls, weighing and subdividing, blending and processing, bulk packaging, general housekeeping, maintenance, and pest control. Quality control and quality assurance checks include calibration, lab practices, retain samples, vendor qualification, HACCP, investigations, and training records. Documentation requirements span master records, specifications, certificates of analysis, distribution and test records. Includes scoring guidance with typical qualification at ninety percent and minimum acceptance at eighty five percent, plus auditor and company sign offs.

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Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

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This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.

Template
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.
by Gary Callahan, from the Community
Downloads: 30+
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GMP SOP Audit Checklist for Dry Products
Evaluate GMP SOP compliance for dry product operations with this comprehensive audit checklist aligned to 21 CFR 111. Cover facility and grounds, receiving, warehousing, weighing, blending and compounding, tablet and coating, hard shell encapsulation, packaging and powder filling, general housekeeping, maintenance, quality control laboratory, quality assurance, and documentation. Verify calibration, labeling, sanitation, pest control, training records, vendor qualifications, investigations, and master manufacturing files. Includes guidance on audit scoring, with ISPEph recommending 90 percent for qualification and a minimum of 85 percent based on severity.
by Charisse Kyle P. Bedoy, from the Community
Downloads: 60+
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Template
GMP/SOP Audit Checklist for 21 CFR 111
This GMP and SOP audit checklist helps manufacturers evaluate compliance with 21 CFR 111 for dietary supplements. It covers facility and grounds, receiving and quarantine, warehouse controls, weighing, blending and compounding, hard shell encapsulation and polish/inspect, packaging and powder filling, maintenance, quality control laboratory, quality assurance, documentation, and training records. Prompts reference applicable FDA requirements, verify SOPs and calibration logs, and guide investigations and vendor qualifications. Ideal for pharmaceutical and supplement operations seeking structured GMP audits and clear scoring thresholds.
by Gary Callahan, from the Community
Downloads: 10+
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Template
GMP and SOP Audit Checklist for Softgel Manufacturing
This GMP SOP audit checklist supports softgel manufacturers in meeting FDA 21 CFR 111 requirements for dietary supplements. Use it to review facility hygiene, pest control, receiving, quarantine, warehousing, weighing, blending, encapsulation, polishing, inspection, packaging, and general housekeeping. Verify calibration and maintenance, documentation, batch and master records, vendor qualification, training, investigations, quality control lab practices, and quality assurance procedures to drive compliance and product quality.
by Gary Callahan, from the Community
Downloads: 10+
Get

GMP SOP Audit for Raw Material Supplier

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