Template

GMP/SOP Packaging Audit Checklist (21 CFR 111)

by Gary Callahan, from the Community

10+

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.

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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 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: 20+
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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 Audit Checklist for Drug Manufacturing
This GMP SOP audit checklist helps assess compliance in drug manufacturing facilities against FDA and industry requirements. It guides auditors through facility and grounds, receiving, warehouse, weighing, blending and compounding, encapsulation, polishing and inspection, packaging, and powder filling. It covers sanitation, pest control, gowning, labeling, quarantine controls, calibration and maintenance, environmental controls, documentation accuracy, and training. Quality functions include vendor qualification, retain samples, investigations, and calibration systems. References include 21 CFR 210, 211, and 111.
by Gary Callahan, from the Community
Downloads: 20+
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Template
GMP SOP Audit for Raw Material Supplier
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.
by Gary Callahan, from the Community
Downloads: 30+
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GMP/SOP Packaging Audit Checklist (21 CFR 111)

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GMP/SOP Audit Checklist for 21 CFR 111

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