Free GMP Compliance Checklist | Audit Your Facility

How to carry out a GMP compliance audit with this checklist

## How to carry out a GMP compliance audit with this checklist - Confirm the paperwork before you walk. Check the facilities map, environmental monitoring records, calibration certificates, pest control reports, cleaning and use logs, and the chemical register. Anything you can verify at a desk saves time on the floor. - Walk the production areas and cover surfaces, backflow protection, handwashing facilities, sealing of floors and windows, segregation of areas, and loading dock doors. Note what is actually there, not what the file says should be there. - Follow staff through a cleaning cycle. Watch how brushes and utensils are stored and labelled, how cleaning chemicals are controlled, and whether the cleaning and use log is signed off at the end of the run rather than the next morning. - Walk the receiving and material storage areas. Trace incoming material to its batch, verify segregation from quarantine, and check that hoppers and tanks are properly covered. Trace finished product and confirm the record holds. If any link depends on someone's memory, there is no trace. - Inspect the laboratory, calibration records, and equipment maintenance logs. Verify that weighing, measuring, monitoring and testing equipment is calibrated to schedule using traceable standards. Review the internal rejected-material and rework records to see how quality costs are tracked. - Review training records and observe whether the systems on paper are in use on the floor. The person operating the equipment should be able to explain a cleaning log, a changeover procedure, or a calibration check without prompting. - Close the audit on the spot where possible. Score each item, record the evidence, assign any corrective action with an owner and a completion date, and have the responsible person sign off. A finding without a signed corrective action is an open risk, not a closed item.

What is a GMP compliance audit?

## What is a GMP compliance audit? A GMP compliance audit is an internal inspection that checks whether your day-to-day operations meet the requirements of Good Manufacturing Practice. It looks at the whole production environment: facilities and equipment, cleaning and hygiene, material management and traceability, quality control in the laboratory and on received goods, production controls, packaging and labelling, your quality management system, and personnel training. A good GMP system rests on evidence. It is not enough to have a documented procedure; you need documented proof that the procedure was carried out. This checklist is built around that idea. It captures what you observe, records deviations, and gives you a record you can act on and refer back to. GMP is used across food and pharmaceutical manufacturing, but the specific requirements vary by product, process, and jurisdiction. This checklist does not replace the regulations or standards that apply to your site — it is a consistent way to conduct an internal audit and keep the resulting records together.

Why a GMP compliance checklist matters

## Why a GMP compliance checklist matters - **It builds an audit trail.** Each inspection is completed, scored, and signed, so you have a dated record of what was checked and what was found. - **It turns findings into corrective actions.** Deviations are captured with evidence and assigned a corrective measure, owner, and date, so issues do not sit open. - **It supports traceability.** Calibration records, cleaning and use logs, batch records, and recall procedures all depend on a link between the product and the evidence that it was made correctly. - **It spreads ownership.** Quality is not the quality manager's job alone. The checklist covers production, maintenance, cleaning, receiving, and training, so each area sees what it is accountable for. - **It gives you a baseline.** Repeated use with the same checklist shows whether performance is stable or drifting.

What a good GMP compliance checklist covers

## What a good GMP compliance checklist covers There is no single GMP checklist that fits every site. A food manufacturer and a pharmaceutical manufacturer share core expectations, but the emphasis differs. This template covers eight core areas: - **Facilities and equipment.** Design and construction, surfaces that contact food, water system protection, sealing, drainage, loading docks, segregation, and the materials used in the process. - **Pest control.** A documented program with mapped trap locations, routine inspections, protected building exteriors, properly labelled and stored pesticides, and some evaluation of your pest control contractor. - **Cleaning and hygiene.** A written program, controlled and labelled food-contact cleaning utensils, verification that cleaning works, and cleaning and use logs that record the date, product, batch number, who used it, and who cleaned it. - **Maintenance and calibration.** A preventive maintenance program for critical equipment, and calibration of weighing, measuring, monitoring, and testing equipment to a schedule using certified or traceable standards. - **Chemical control.** A program covering the use, storage, and handling of non-food chemicals, and the safe use of food-grade lubricants and chemicals on machinery. - **Material management and traceability.** A batch trail that holds up from receiving through production to finished goods. - **Quality management.** Complaint investigation and response, a recall procedure, mock recalls with recorded results, a documented stability program, and quality cost tracking such as scrap, downtime, rework, and material usage. - **Personnel and training.** An updated organisational chart, defined responsibilities, and training records that match the work people actually do. It also covers purchasing and customer service: delivery date notifications, a customer service system, a company contact list, a sample or information request procedure, emergency plans, and a system for deciding future needs for facilities, equipment, and supplies. That section is community-specific — delete it if it does not apply to you.

How to conduct the audit

## How to conduct the audit 1. **Prepare before you walk the floor.** Review the facilities map, environmental monitoring records, calibration certificates, pest control reports, cleaning logs, and the chemical register. Confirm the organisational chart is current. 2. **Start with the grounds and building envelope.** Check that roads, parking, lawns, and drainage are maintained, and that floors, walls, ceilings, doors, and windows are sealed against pest entry. Confirm loading dock doors sit flush when closed. 3. **Inspect the production areas.** Check surfaces that contact food, backflow protection on water systems, handwashing facilities, environmental controls such as temperature and air filtration, and segregation for contamination control. Look at seams and the materials used in the process. Note where lubricants and machine chemicals are stored and whether they are approved for food use. 4. **Walk the cleaning and hygiene programme.** Confirm a written programme exists, that food-contact cleaning utensils are controlled and labelled, that the effectiveness of cleaning is verified, and that the cleaning and use logs are complete. 5. **Review pest control.** Confirm the programme is documented, traps are mapped, routine inspections happen, the exterior is protected, pesticides are labelled and stored securely, and contractor performance is evaluated. 6. **Follow material through the process.** Receive the goods, check segregation and storage, trace the batch into production, and confirm the finished product can be traced back. Check that hoppers, tanks, and similar food containers are covered. 7. **Inspect the laboratory and equipment records.** Verify calibration against traceable standards and on schedule, and check preventive maintenance records for critical equipment. 8. **Review quality management systems.** Look at complaint handling, recall procedures, mock recalls and their results, the stability programme, and how quality costs are tracked. 9. **Verify training and responsibilities.** Check the organisational chart against who is actually doing the work, and confirm training records are current. 10. **Close the audit.** Score each item, record the evidence and any deviations, assign corrective measures with owners and dates, and sign off. Follow up on open items before the next inspection.

Frequently Asked Questions

Yes, but only if you make it fit. The core areas cover facilities and equipment, cleaning and hygiene, material management and traceability, quality control, production controls, packaging and labelling, quality management systems, and personnel training. Pharmaceutical work will lean more on cross-contamination controls, cleaning validation evidence and documentation; food work will lean more on pest control, food-contact surfaces, water protection and hygiene. There is also a section on purchasing and customer service that is easy to remove if it does not apply.

No. Cleaning and hygiene is one area, but the template also covers construction and maintenance, pest control, environmental controls, calibration of critical measuring and testing equipment, chemical control, documentation and logs, complaint and recall procedures, and personnel training. A cleaning checklist alone would not give you the record you need for an internal GMP audit.

You record permission or exemption in writing, with the reason and any compensating controls. The points where a batch record trace fails are exactly where you may be able to show a controlled deviation rather than an uncontrolled gap. The checklist is built to capture that evidence — photos, notes and deviations — so the exemption is documented at the time of the inspection, not reconstructed later.

The checklist covers the underlying practices and evidence. It asks about recall procedures and mock recalls, complaint investigation, stability programs, calibration against traceable standards, chemical control, pest control programs, cleaning and use logs, and documented operating procedures. It does not test your understanding of any specific regulatory text, so if your auditor expects a particular citation you still need to know it separately.

Written by

Arne Reis

Founder

Process optimizer with 25 years of expertise, focused on operational excellence in quality, maintenance, EHS, and commissioning. Emphasizes innovative solutions and top-quality standards.

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