Template

GMP Audit for Holders and Distributors

by Gary Callahan, from the Community

10+

Use this GMP audit checklist to assess compliance with 21 CFR 111 for dietary supplement holders and distributors. It covers facility and grounds, receiving and quarantine, warehouse controls, quality control laboratory practices, quality assurance systems, documentation, and employee training. The checklist references applicable CFR sections, supports scoring for qualification, and includes areas for notes and signatures plus a disclaimer. Ideal for internal audits and supplier or distributor assessments.

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Community

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: 10+
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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: 20+
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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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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+
Get

GMP Audit for Holders and Distributors

With SafetyCulture you can

Digitize team workflows

Reduce manual errors

Create and share inspection reports

About author

You might also like

GMP/SOP Audit Checklist for 21 CFR 111

GMP SOP Audit for Raw Material Supplier

GMP SOP Audit for Softgel Manufacturing

GMP/SOP Packaging Audit Checklist (21 CFR 111)

You might also like

GMP/SOP Audit Checklist for 21 CFR 111

GMP SOP Audit for Raw Material Supplier

GMP SOP Audit for Softgel Manufacturing

GMP/SOP Packaging Audit Checklist (21 CFR 111)