FDA GMP audit checklist template

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.