By Keith Bowen
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.