FDA audit series part 1, Preparing for the Audit


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A presentation on US FDA audits.

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FDA audit series part 1, Preparing for the Audit

  1. 1. Part 1 – Preparing for the FDA Visit
  2. 2. • You asked for it… Wanted more review of the steps involved • This series is designed in parts • • • • • Part 1 – Preparing for the FDA Part 2 – What to do when the FDA arrives Part 3 – What to do while the FDA is there Part 4 – What to do during closeout Part 5 – What to do with the 483 This is Part 1 – Preparing for the FDA
  3. 3. People always ask me – “Troy, what is the best way to deal with FDA issues?” I usually say…”Don’t have any” That being said…there are things you can do to mitigate the potential for you and your firm to have any serious FDA problems. Let’s start with the obvious: • Did you have previous 483’s or Warning Letters? If so, did you do everything to which you committed in the response? If not, did you inform the FDA of the delay. During the audit is not the time to find out you have issues… • Will the next audit be – general GMP? For cause? PAI? • If the inspection is going to be focused – you can focus your attention to getting those things ready. Don’t forget – you could always have a general inspection even during a PAI.
  4. 4. Your facility should always be ready for an inspection! But…it is always a good idea to go through the facility to see how things look. • Working in the factory every day can “dull” your senses to problems that might have slowly developed over time • Have someone “new” go through the facility • Develop a “tour” plan for the areas – who will lead the tour in different areas? What pathway to take (just remember – the FDA can always go where they want – within reason)? • Any signs of leaks in the ceiling? Cracked walls? Pealing Paint? • All signage in place? • Facility registration up to date? • How does the exterior of the facility appear? • Remediate anything possible!! • Key is that everything should look organized and in CONTROL!
  5. 5. Look at how you are making the product(s) – specifically on the high risk processes. If you have a PAI, focus on the product in the filing. Are you in CONTROL? How do you know? Does the process match what you have filed? Do the SOP’s conflict with the process? Is your APR (annual product review) process up to date? Have you maintained a good change control system?
  6. 6. Are people trained? How do you control training – updates to SOPs? Annual GMP training performed? How do batch record errors look? Lots of errors or fairly clean? Do the investigations often site “people” as the issue? If so, then you have an issue. Who are the folks that you will use as SME’s?
  7. 7. You need to check a lot of other items in preparation for the audit. You know your system – check those areas that have potential for the largest impact. • • • • • • Warehouse practices Customer complaints Validation – equipment, process, cleaning, utilities, etc. Lab operations Calibration Pest and rodent control The key? Show you are in CONTROL!! How do you know it?
  8. 8. Call us at 513-860-3512 See our website at www.Compliance-Insight.com Send us an email at info@Compliance-Insight.com Thanks for watching!