Template

GMP SOP Audit Checklist for Drug Manufacturing

by Gary Callahan, from the Community

20+

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.

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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 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 and SOP Audit Checklist for Dry Products
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.
by Allen Kent L. Inquit, 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+
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GMP SOP Audit Checklist for Drug Manufacturing

With SafetyCulture you can

Digitize team workflows

Reduce manual errors

Create and share inspection reports

About author

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