FDA GMP Audit Checklist Template | Free PDF

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FDA GMP audit checklist template

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Use this template with Lumiform

The Lumiform application helps frontline teams uphold internal standards effortlessly.

Customize this template or build your own
Fill out templates via mobile app
Assign and track corrective actions
Get reports and analyse your data

Prices start from ░░░ per month

Book a demo

Learn more

Navigate FDA compliance confidently with this comprehensive GMP audit checklist template. This specialized tool covers all critical areas FDA inspectors evaluate—from documentation and equipment validation to personnel qualifications and quality control systems. What makes this template distinctive is its alignment with current FDA cGMP regulations for pharmaceuticals, medical devices, or food products, depending on your industry.

For example, when preparing for a routine GMP surveillance inspection, you can systematically audit your facility using the same framework FDA investigators use, identifying potential compliance issues before they become regulatory findings. The FDA notes that these inspections serve as periodic check-ins that allow facilities to demonstrate continuous improvement, making preparation essential for maintaining your compliance status.

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Preview of the template

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Quality Management System

Is there a quality management system in place?

Does the quality management system cover all aspects of the organization's activities?

Is the quality management system documented and communicated to all relevant personnel?

Are there documented procedures for the review and approval of the quality management system?

Premises and Equipment

Are the premises suitable for the operations being carried out?

Are the premises and equipment properly maintained and cleaned?

Are the premises and equipment designed to minimize the risk of contamination?

Are there documented procedures for the maintenance and cleaning of the premises and equipment?

Documentation and Records

Are all relevant documents and records maintained and controlled?

Are there documented procedures for the creation, review, approval, and distribution of documents?

Are records legible, readily retrievable, and stored to prevent deterioration?

Are there documented procedures for the retention and disposition of records?

Production and Process Controls

Are all critical manufacturing processes validated?

Are in-process controls and testing procedures in place to monitor the manufacturing process?

Are there documented procedures for the handling of non-conforming materials and products?

Are there procedures for the investigation and resolution of deviations and complaints?

Laboratory Controls

Are all testing and analytical methods validated?

Are there procedures for the calibration and maintenance of laboratory equipment?

Are there procedures for the review and approval of laboratory results?

Are there procedures for the handling and storage of samples?

Materials Management

Are there procedures for the procurement, receipt, and storage of raw materials and components?

Are there procedures for the identification, quarantine, and disposal of rejected materials?

Are there procedures for the handling and distribution of finished products?

Are there procedures for the management of supplier and contractor qualifications?

Personnel

Are there documented job descriptions and training programs for all personnel?

Are personnel given appropriate training on GMP and quality systems?

Are there documented procedures for the evaluation and monitoring of personnel performance?

Are there procedures for the management of personnel hygiene and health requirements?

Packaging and Labeling

Are there procedures for the procurement, inspection, and storage of packaging and labeling materials?

Are there procedures for the control and reconciliation of packaging and labeling materials?

Are there procedures for the review and approval of product labels and labeling?

Are there procedures for the handling and storage of finished products?

Facility and Equipment Qualification

Are there protocols and reports for the qualification of facilities and equipment?

Are there procedures for the ongoing monitoring and maintenance of qualified facilities and equipment?

Are there procedures for the management of changes to qualified facilities and equipment?

Are there procedures for the decommissioning and disposal of facilities and equipment?

Deviation and CAPA Management

Are there procedures for the identification, investigation, and documentation of deviations?

Are there procedures for the implementation and verification of corrective and preventive actions?

Are there procedures for the review and approval of deviations and CAPAs?

Are there procedures for the tracking and trending of deviations and CAPAs?

Change and Risk Management

Are there procedures for the identification, assessment, and control of changes?

Are there procedures for the identification, assessment, and mitigation of risks?

Are there procedures for the review and approval of changes and risk assessments?

Are there procedures for the documentation and communication of changes and risk assessments?

Frequently asked questions

What information should I gather before using the FDA GMP audit checklist?

Before starting your audit, collect your facility’s FDA registration information, previous inspection reports, current SOPs, training records, and documentation of any corrective actions from past findings. Having these materials ready ensures you can thoroughly assess compliance against both your internal standards and FDA expectations.

How can I customize this FDA GMP audit checklist for my specific industry?

Identify the specific FDA regulations that apply to your product category (pharmaceuticals, medical devices, food, etc.), then adjust the relevant sections of the checklist. For example, pharmaceutical manufacturers should emphasize 21 CFR Parts 210/211, while device makers should focus on 21 CFR Part 820 requirements.

What are the most common areas where companies fail FDA GMP inspections?

Companies most frequently fail in documentation practices, deviation management, contamination control, equipment qualification, and data integrity. This checklist specifically addresses these high-risk areas, guiding you through proper assessment of your systems and highlighting where remediation efforts should be focused.

This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.