Template

GMP and SOP Audit Checklist for Dry Products

by Allen Kent L. Inquit, from the Community

10+

This ISPEph-guided checklist supports GMP and SOP compliance for dry product manufacturing, including dietary supplements. It covers facility hygiene, receiving and quarantine, warehouse storage, weighing and batch preparation, blending and compounding, tableting, coating, encapsulation, and packaging. Quality systems are addressed through equipment maintenance, calibration, pest control, documentation control, training, and vendor qualification. QA and QC practices include investigations, CAPA, retain sample management, and record retrieval. Use this audit to identify gaps, standardize procedures, and demonstrate compliance with 21 CFR 111 requirements.

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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 Audit Checklist for CBD Processing
Conduct a comprehensive GMP SOP audit for CBD processing facilities with this checklist. Cover facility and grounds, receiving and quarantine, warehouse storage, weighing, blending and compounding, cosmetic and spray operations, dry processing, packaging and dry filling. Review maintenance, pest control, employee hygiene, equipment calibration, and dust collection. Include QA and QC lab practices, vendor qualification, investigations, retain samples, and documentation and training per 21 CFR 111 and related FDA guidance. Use it to identify gaps, improve compliance, and standardize procedures.
by Gary Callahan, from the Community
Downloads: 20+
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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 and SOP Audit Checklist for Dry Products

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