How Does the FDA’s Risk-Based Inspection Model Work?

Are your facility’s manufacturing processes compliant with the Food and Drug Administration’s (FDA's) current guidelines? You already know how strict the FDA is when it comes to the health and safety of consumers.  

Regulatory compliance is an essential aspect that all pharmaceutical, biotech, and medical device companies must follow at all times. 

But is your organization familiar with the FDA’s risk-based inspection model? And are you aware of how facilities are selected?

Understanding the FDA’s Risk-Based Inspection Model

The FDA first implemented the risk-based approach in 2005 as part of the “Pharmaceutical Quality for the 21st Century, A Risk-Based Approach” initiative. They increased the minimum inspection interval for domestic establishments in 2012.

Based on current guidelines, the FDA prioritizes inspecting higher risk sites. The Site Selection Model (SSM) is an inspection list is generated by the Office of Pharmaceutical Quality. The annual capacity is determined through the Office of Regulatory Affairs.

The risk-based inspection program aims to:

• Verify that manufacturers are maintaining compliance with current good manufacturing practices (cGMP) requirements. Where violations are detected, a company must provide proof that dangerous products are not entering the market.

• Assess a company’s overall adherence to CGMP requirements.

• Provide valuable feedback during the inspection process.

• Improve current drug manufacturing processes and to update CGMP requirements, regulations, and guidance.

But how does the FDA assess an individual company’s risk level? They start by looking at important risk factors such as:

• Past compliance history.

• What recalls a company has had in the past.

• The overall risk of the drugs that a company manufactures.

• How often the facility has been inspected in the past.

• Whether an inspection was carried out by a foreign government or an agency related to a foreign government as per section 809.

• Any other extenuating circumstances that warrant an increase in risk.

Is Your Facility Ready for an FDA Inspection?

Your facility must be prepared for an FDA inspection at any time. Even if your facilities are classified as low-risk, you should always strive to keep your facility compliant with the latest CGMPs.

The Center for Professional Innovation and Education can help improve your internal processes by educating your employees on the latest regulatory changes, what the FDA is looking for, and other essential information that can help your company avoid costly fines and failed inspections.

We offer a wide variety of pharmaceutical training courses that specialize in CGMP, FDA regulatory compliance, risk factors, and more. Please visit our website or contact us today at 1-610-658-7550 to learn more about our training programs.