Templates
FDA GMP audit checklist

FDA GMP audit checklist

Use this FDA GMP audit checklist to cover key compliance details, from quality management to record-keeping. Conduct thorough audits that simplify reporting.

Use this template
or download pdf
FDA GMP audit checklist

Use this FDA GMP audit checklist to cover key compliance details, from quality management to record-keeping. Conduct thorough audits that simplify reporting.

Use this template
or download pdf

About the FDA GMP audit checklist

Staying compliant with FDA GMP (Good Manufacturing Practices) regulations is a top priority for businesses in regulated industries like pharmaceuticals, food production, and cosmetics. This FDA GMP audit checklist helps you systematically evaluate your processes, maintain high-quality standards, and identify areas for improvement. Whether you’re preparing for an inspection or conducting routine internal audits, this checklist ensures your team stays organized and focused.

Enhance compliance with a FDA GMP audit checklist

This checklist is thoughtfully structured to guide you through critical aspects of compliance. It’s divided into clear sections, covering areas like quality management systems, premises and equipment, documentation, and personnel. Each section includes specific, actionable checkpoints to ensure nothing is overlooked.

You can use this template to standardize your audit process, making it easier to identify gaps and implement corrective actions. With its organized layout, your team can conduct thorough evaluations without getting overwhelmed by details.

By breaking complex requirements into manageable steps, this checklist serves you by improving efficiency and confidence during audits. Whether you’re assessing materials management or monitoring laboratory controls, the template helps you maintain consistent standards across the board.

How to use the FDA GMP audit checklist

Here’s how to make the most of the checklist:

  1. Start by customizing the checklist in the app to align it with your facility’s processes and equipment. You can add, remove, or adjust sections to reflect the specifics of your operations. This makes the template relevant and effective.
  2. Assign the checklist to a responsible team member who will oversee the entire audit. While others can view results, having one person conduct the audit maintains consistency and accountability.
  3. Document findings directly in the app during the audit using the provided fields for notes, photos, and signatures. This simplifies record-keeping and ensures all data is centralized and accessible for review.
  4. Use the app’s analytics feature to identify trends or recurring issues after completing the checklist. This helps you prioritize corrective actions and make informed decisions to improve compliance.
  5. Share the audit results with relevant stakeholders to promote transparency and align on next steps. Regularly updating the checklist based on audit findings keeps your processes adaptive and effective.

Download Lumiform’s FDA GMP audit checklist today

Make compliance audits faster and more effective with this checklist. It guides you through critical details, so you never miss a critical point. With intuitive sections covering key aspects of GMP, you’ll easily keep your processes up to standard and improve your team’s workflow.

Categories

  • Risk management and compliance templates
  • General templates
  • Templates for manufacturing processes
Preview of the template
Page 1
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 are common mistakes companies make during FDA GMP audits?

One common mistake is failing to maintain accurate, up-to-date records. Auditors rely heavily on documentation, and missing records can raise red flags. Another frequent error is neglecting routine equipment maintenance. Additionally, overlooking training requirements for staff or failing to conduct regular internal audits can expose gaps in compliance.

What documentation is essential to have ready during an FDA GMP audit?

Key documentation includes your quality management system, standard operating procedures (SOPs), training records, and equipment maintenance logs. Batch production records and laboratory testing results are also critical. Make sure your records are legible, easily accessible, and properly dated, and include evidence of corrective actions.

What should I do if I identify a major non-compliance issue during an internal audit?

Immediately document the issue and investigate its root cause to prevent recurrence. Create a corrective action plan outlining the steps to address the non-compliance and assign responsibilities for each task. While implementing the plan, communicate openly with your team, then follow up with a targeted re-audit.

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.