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GMP SOP Audit Checklist for Dry Products

by Charisse Kyle P. Bedoy, from the Community

60+

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.

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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.

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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/SOP Audit for Tablet and HSC Manufacturing
This comprehensive GMP and SOP audit checklist supports tablet and hard shell capsule manufacturing operations in meeting 21 CFR 111 requirements. It covers receiving, warehousing, weighing, blending and compounding, tablet compression, coating, encapsulation, packaging, quality control laboratory, and quality assurance. Use it to verify documentation, calibration, sanitation, training, investigations, and vendor qualification, helping teams find gaps and improve compliance and product quality.
by Gary Callahan, from the Community
Downloads: 10+
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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 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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GMP SOP Audit Checklist for Dry Products

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ISPEph GMP/SOP Audit for Dry Products

GMP/SOP Audit for Tablet and HSC Manufacturing

GMP SOP Audit for Softgel Manufacturing

GMP/SOP Audit Checklist for 21 CFR 111

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ISPEph GMP/SOP Audit for Dry Products

GMP/SOP Audit for Tablet and HSC Manufacturing

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GMP/SOP Audit Checklist for 21 CFR 111