Template

GMP/SOP Audit Checklist for 21 CFR 111

by Gary Callahan, from the Community

10+

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.

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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
ISPEph GMP/SOP Audit for Dry Products
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.
by Charisse Kyle P. Bedoy, 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+
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Template
GMP/SOP Packaging Audit Checklist (21 CFR 111)
This GMP/SOP Packaging Audit checklist helps manufacturers assess compliance with 21 CFR 111 across packaging and related operations. It covers facility and grounds hygiene, receiving and quarantine controls, warehouse storage practices, packaging line readiness, powder and liquid filling standards, and general housekeeping. It also reviews maintenance records, quality control laboratory practices, and quality assurance systems including investigations, vendor qualifications, pest control, retain samples, and employee hygiene. Documentation requirements span master manufacturing records, batch and packaging records, testing, distribution, and training logs, supporting consistent, compliant packaging operations.
by Gary Callahan, from the Community
Downloads: 10+
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Template
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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GMP/SOP Audit Checklist for 21 CFR 111

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