Template

GMP/SOP Audit for Tablet and HSC Manufacturing

by Gary Callahan, from the Community

10+

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.

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Digitize any process, procedure or policy

Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

About author

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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 Tablet HSC and Softgel
Conduct a thorough GMP SOP audit across tablet, hard shell capsule, and softgel operations. This checklist references 21 CFR 111 and related FDA standards and covers facility and grounds, receiving and quarantine, warehouse storage, weighing, blending and compounding, tablet pressing and coating, hard shell and softgel encapsulation, packaging and powder filling, maintenance, quality control laboratory, quality assurance, documentation, training, vendor qualification, investigations, and sample retention. Use it to score compliance and capture auditor and company sign off.
by Gary Callahan, from the Community
Downloads: 0
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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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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
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+
Get

GMP SOP Audit for Tablet HSC and Softgel

Conduct a thorough GMP SOP audit across tablet, hard shell capsule, and softgel operations. This checklist references 21 CFR 111 and related FDA standards and covers facility and grounds, receiving and quarantine, warehouse storage, weighing, blending and compounding, tablet pressing and coating, hard shell and softgel encapsulation, packaging and powder filling, maintenance, quality control laboratory, quality assurance, documentation, training, vendor qualification, investigations, and sample retention. Use it to score compliance and capture auditor and company sign off.

by Gary Callahan, from the Community

Get

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

60+

Get

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

10+

Get

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

10+

Get

GMP/SOP Audit for Tablet and HSC Manufacturing

About author

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GMP SOP Audit for Tablet HSC and Softgel

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GMP SOP Audit for Tablet HSC and Softgel

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