White Paper

Our Top 10 Tips to Pass Your Next FDA Audit

Like it or not, your next FDA audit is coming. Fortunately, you can welcome it with open arms (and ace it!) by using the 10 tips we outline in this article.

September 12, 2022

Augmented Solutions

FDA audits are a regular part of pharma manufacturing. They help ensure drugs meet regulatory, quality, and safety standards so patients don’t end up with ineffective or potentially dangerous therapies. But that doesn't mean preparing for (and passing) audits is a breeze.

Fortunately, we’re here to help. If you’ve been frantically Googling “how to pass an FDA audit” or searching for FDA audit tips online, you’re in the right place. In this article, we’ll share our top 10 recommendations to ensure you ace your next inspection.

Want to find out more about what happens during an FDA audit? Check out our 3 Crucial Steps to Survive an FDA Audit.

Drum roll, please!

Jump to...

How to Pass an FDA Audit: Our Top 10 Tips

Tip #1: Make sure relevant data is accessible.

Your processes, deviations, corrections, and workflows should all be readily available and easy to navigate. If you maintain paper records, make sure they’re organized and easy to sort through.

Tip #2: Review your standard operating procedures (SOPs).

Make sure your written instructions for processes, procedures, and operations adhere to the FDA’s requirements. During an FDA inspection, the auditor will review each department’s SOPs to verify that procedures are thoroughly documented and up to par with the latest regulations.

If you need a refresher, here’s guidance directly from the horse’s mouth, aka the FDA:

Tip #3: If necessary, revise your SOPs.

Your standard operating procedures will change as your processes, personnel, and overall operations change. As such, it’s important to revisit, tweak, and update these instructions regularly.

Remember, when the FDA conducts an audit, the inspector will ask to see your company’s SOPs to verify they’re being followed fully and properly documented.

Tip #4: Digitize your processes and data.

If you’re not using a manufacturing execution system to track and document your drug production processes, you’re missing out.

These smart solutions are designed to improve productivity, efficiency, and reliability so your pharma company can reduce batch release times. Plus, they help ensure all of your data is available at your fingertips, when you need it.

By digitizing your data and processes, you can quickly organize the documentation needed for an audit without having to spend days or weeks combing through disparate paper-based data.

Tip #5: Even better, swap to a cloud-based MES solution.

If you’re not currently using a cloud-based MES solution designed specifically for pharma, consider making the switch. Purpose-built solutions (like this one) will help you maintain security and compliance because they’re ISO 27001 certified and GDPR ready. Plus, they’re fully validated by third parties for pharma compliance standards like cGxP and 21 CFR Part 11.

Cloud-based manufacturing execution systems will allow you to record and store all the documentation and data needed for regulatory bodies to audit and approve a batch release, all within one platform — in real time.

Tip #6: Create an internal “readiness” team.

Assemble an internal readiness team to act as the point of contact during inspections. This group will work with the FDA personnel throughout the inspection process to answer questions and provide relevant and requested documentation as needed.

Tip #7: Have an inspection workplace ready.

Inspections generally take two to three days to complete, and require FDA personnel to sort through a mountain of data. As such, you’ll want to prepare a quiet environment where the inspector can work with minimal distraction.

To accomplish this, try to find a workspace area away from offices, labs, and co-working spaces. This will safeguard confidential information, such as trade secrets and financial data.

Tip #8: Conduct random internal inspections.

The best way to familiarize yourself with the FDA audit process, and ace it, is to conduct random internal inspections. These inspections should occur every few months.

These inspections will help you identify discrepancies that would lead to a form 483. For example, you may uncover procedures that don’t meet FDA requirements or realize documentation is not always complete. Stay up to date on evolving FDA guidance to make sure your internal inspections are in line.

Tip #9: Review internal inspection findings with your teams.

If you realize procedures don’t meet FDA requirements, aren’t being followed fully, or aren’t documented correctly, this is an opportunity for you to meet with your teams to discuss your findings in detail.

Be prepared to answer your teams’ questions, offer guidance, and come up with a plan of action together. Then, outline the next steps which should include addressing the issues and setting a follow up meeting to ensure the departments are compliant.

Tip #10: Bolster data protection and security.

The FDA requires all pharma organizations to implement controls and electronic audit trails, as well as system validations. As such, it’s crucial you document everything throughout the drug production lifecycle, including who did what and when. In order to bolster data protection and security, leverage a software solution specific to the life science industry. These systems are purpose-built for pharma, and will enable you to weave through all of the shifting guidelines and red tap with ease.

Make sure to set up recurring reminders to review your historical records and documents on a regular basis. Also, keep a pulse on who has access to your systems, and update the login information as needed. This will keep your data safe, and prevent unauthorized access from occurring that may compromise the integrity of your documentation and data.

Our Take: Keep Calm and Audit On

There you have it — our top 10 tips on how to ace an FDA audit. By following the guidelines above, you’ll have no issues passing your next inspection.

The three biggest reasons why organizations fail their audits are because the procedures either don’t meet FDA requirements, aren’t followed fully, or aren’t documented correctly. That's why it's key to ensure your data is accessible, updated, and your standard operating procedures are accurate.

We’re wishing you the best of luck, and we know you’ll pass with flying colors. Reach out to our team if you have any questions about this article, or would like to learn more about digitizing your data and cloud-based solutions.

Featured Thought Leader: Keith Bowen

When it comes to FDA audits, Keith Bowen is the go-to resource you want on your team. And we’re lucky to have him on our team here at Apprentice! 

Meet Keith and learn his top FDA takeaway:

Keith’s Background

With 24 years of experience in the life science industry, Keith is well respected for his knowledge of and experience with MES product development, solution design, system integration, implementations, and support services for both large and small MES projects.

Keith has worked with many of the Top 10 Pharma, Biotech and Medical Device companies, on both automation and MES solutions. Today, he is an MES/LES Advocate at Apprentice and works primarily with new customer engagement, interfacing between sales, product, and marketing.

Keith’s Top FDA Recommendation

“During FDA inspections, be confident, only answer the question asked of you, and never guess. You have a team behind you, do not offer immediate solutions — less is more!”

References 

  1. § 211.160 Production and controls. (2022). In § 211.160 Production and controls (p. Part 211-Subpart F). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F
  2. § 211.160 General requirements. (2022). In § 211.160 General requirements (p. Part 211-Subpart I). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-I/section-211.160
  3. § 211.56 Sanitation. (2022). In § 211.160 Sanitation (p. Part 211-Subpart C). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-C/section-211.56
  4. U.S. Food and Drug Administration. (2015, January). Developing, Issuing and Maintaining Standard Operating Procedures for CDER. https://www.fda.gov/files/about%20fda/published/Developing--Issuing-and-Maintaining-Standard-Operating-Procedures-for-CDER.pdf
  5. van Arnum, P. (2022, August 5). FDA & Remote Inspections: What Is Next? DCAT Value Chain Insights. https://www.dcatvci.org/features/fda-remote-inspections-what-is-next/