GMP audit checklists

What is a GMP audit checklist?

A GMP audit checklist helps manufacturers verify food, pharmaceutical, medical, and cosmetic products meet quality and safety standards. It walks auditors through supplier controls, sanitary operations, and recordkeeping in one structured format. Regular GMP audits help a business avoid product recalls, safety incidents, and regulatory penalties.

Importance of GMP audit checklists

A GMP audit checklist matters because it turns a legal requirement into a repeatable habit. Skip regular audits, and problems usually surface after a customer complaint or a failed inspection, when they're far more expensive to fix. A consistent checklist also builds a paper trail regulators can trust, which speeds up certifications and cuts down on surprise findings. Platforms like Mitti (by SafetyCulture) help that paper trail live on a phone instead of a binder, so it actually gets kept up to date.

GMP self-inspection checklist

Aside from general GMP checklists that businesses can use, employees are empowered to further ensure safety and hygiene in food manufacturing and across various industries using self-inspection checklists. This GMP Self Inspection Checklist is ideal for staff and employees that need to observe good manufacturing practices starting from their individual work. It also allows lone workers to systematically follow procedures and protocols even without direct supervision from higher-ups.

Who is responsible for GMP compliance?

GMP compliance sits mainly with the quality team. That includes quality control chiefs, quality directors, facilities managers, quality control inspectors, and quality assurance managers, all responsible for making sure GMP requirements, standards, and protocols are followed. On the floor, production operators and site supervisors carry day-to-day responsibility for following GMP procedures correctly.

GMP audits are accomplished by certified auditors and regulated by agencies such as Food and Drug Administration (FDA), however, facilities are encouraged to do their own audits. GMP compliance also sits within a company's broader governance, risk, and compliance program, which coordinates these audits alongside other regulatory obligations.

9 necessary factors for GMP audit certification

The FDA provides guidelines for a proper GMP inspection checklist. For pharmaceutical manufacturers specifically, these same factors map closely to the recordkeeping and quality-unit requirements in FDA's 21 CFR Part 211, which auditors check against directly. The Inspection Operations Manual provides specific guidelines per industry and type of goods manufactured. Products are restricted from entering the market if they are deemed to be contaminated or mislabeled. Strict compliance to good manufacturing practices prevents products from adulteration and misbranding. The following are factors that will be inspected during a GMP audit:

• Building and facilities - This covers flooring, furniture, fixtures, and water systems. The building should be sized and designed for its specific use, with floors, walls, and ceilings that are smooth and easy to clean. Fixtures, ducts, and pipes should be sealed to prevent condensation, and the space needs enough lighting and ventilation for workers and the production floor. Water used for cleaning should meet facility needs.

• Equipment - Suitable equipment should be used for its intended purpose. These should be maintained and cleaned regularly to avoid contamination of the product. Additionally, smaller equipment should have proper storage when not in use.

• Personnel - Workers should be well trained and educated on the manufacturing process of the products. Personnel that directly handle the equipment and products have to wear clean garments and uniforms which includes hair net and gloves. There should be designated areas for eating, drinking, and smoking, away from production.

• Raw materials - These should be stored and labeled appropriately. To avoid adulteration, materials should be sampled and tested. This helps determine if the material meets the specified standards.

• Production - There should be written instructions on formulations, processes, and other operations and control procedures.

• Laboratory controls - This corresponds to the inspection of raw materials, samples, and water supply. Laboratory controls determine if the resources are usable and in good condition.

• Records - This gives importance to proper documentation of every process, laboratory controls, materials, and products. Products that are manufactured by batches should have records on 4 categories:

  • Used material’s kind, lot, and quantity.

  • Processing, handling, transferring, holding, and filling.

  • Sampling, controlling, adjusting, and reworking.

  • Code marks of batches and finished products.

• Labeling - Aside from product name, the contents and composition needs to be clearly stated on the label. Most products need to state a warning that is required for it. The warning depends on location, type of product, and consumption.

• Complaints - The FDA reviews the consumer complaint file during a GMP audit. Auditors check the injury type and severity, which product caused it, any medical treatment given, and the physician's name if available, plus which location or governing body received the complaint.

How to prepare for the audit

Audit processes don't need to be intimidating. Organizations can prepare ahead and take note of these steps to stay audit ready:

Review the scope of the GMP audit

Review in advance the coverage of the audit, such as the locations and processes to be audited, as well as the timeframe needed by the auditors.

Communicate the audit plan to your team

Make sure that the plan is communicated to all site personnel, especially those whose areas will be audited. Clearly list the areas / systems / products to be audited and list
specific dates for each of the audits.

Know which standards are covered

Identify which standards will be covered in the GMP audit. Audit standards may include:

• Applicable policies

• Laws and regulations

• Procedures

• Management system requirement; or

• Contractual agreement with suppliers

Be sure that you are precisely familiar with the standards and any policies regarding their explanation and application.

Know your documents and prepare them ahead of time

Prior to the audit, ensure that your team has reviewed any documentation that an auditor is likely to request. Make sure that all documentation is accessible and that all circulated documents are ‘controlled copies’ and up-to-date.

The documentation may include:

• Relevant management system documents and records

• Applicable standards

• Site master file

• Training records

• SOP’s

• Previous audit reports

Typically, the auditor will review the following documents before arriving on your site:

• Site master file (if the auditor is new to your site)

• Validation master plan

• Previous audit findings and your responses

• Complaints and adverse events

What to include in a GMP audit checklist

A comprehensive GMP (Good Manufacturing Practices) audit checklist should include the following key areas to ensure thorough inspection and compliance with regulatory standards:

• Personal Protective Equipment & Hygiene - Employees must wear appropriate PPE and adhere to strict hygiene practices at all times.

• Cleaning & Sanitation - Cleaning and sanitation activities should be regularly scheduled, properly executed, and thoroughly documented.

• Facility & Environmental Controls - The facility must be designed and maintained to prevent contamination, with controlled environmental conditions.

• Equipment & Maintenance - All equipment should be suitable, regularly maintained, calibrated, and stored to ensure proper functioning.

• Purchasing - Suppliers must be evaluated and approved, with purchasing processes ensuring quality compliance.

• Raw Material & Supplier Controls - Raw materials must be properly labeled, tested, quarantined, and traceable to approved suppliers.

• Storage & Warehousing - Materials and products should be stored under appropriate conditions with controlled access and inventory management.

• Production Process Controls - Production must follow documented procedures, monitor critical parameters, and manage deviations effectively.

• Quality Management - A robust quality management system should oversee audits, corrective actions, and management reviews.

• Packaging & Labeling - Packaging and labeling must be accurate, controlled, and prevent contamination or mix-ups.

• Traceability & Recall Readiness - Traceability systems and tested recall procedures should enable quick identification and retrieval of products.

• Employee Training - Employees must receive ongoing GMP training with documented competency and updates reflecting current practices.

GMP Audit Checklist Sample PDF Report

In just five months, they raised over 550 actions in Mitti (by SafetyCulture), closing 96% and significantly improving company standards.

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