Preparing for a Safety Inspection

Abstract

Large and small pharmaceutical companies alike face a growing and complex set of international regulations designed to protect patient safety and ensure good pharmacovigi-lance practices. Inspectors from FDA and European regulatory authorities are increasing their efforts to verify that companies comply with these regulations. The penalties for non-compliance can be severe, including revoking a product’s marketing authorization. To prepare for an inspection, companies must perform a thorough drug safety and pharmacovigilance audit. This will assess the company’s compliance with applicable worldwide laws, regulations, and guidance. Indeed, regulatory inspectors will look for evidence that such an audit has taken place. This article is designed to give companies operating in the United States and EU the information and insight needed to ensure compliance with global drug safety and pharmacovigilance regulations. It addresses the most recent drug safety regulations from both FDA and EMA.