In the world of biotech, regulatory inspections are an ever-looming concern. Health authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others routinely conduct inspections to ensure compliance with applicable regulations and guidelines. 

These assessments are necessary to ensure the health and safety of research subjects and the accuracy of data, but they can certainly trigger as a failed inspection can cost a substantial amount of time and money. 

Rather than avoiding the inevitable, why not face the challenge head-on? This is where inspection readiness comes in. By creating a plan for future inspections, you can meet all the necessary regulatory requirements and feel confident in the work you’re doing. All you need is an inspection readiness plan. 

Here, we explain the importance of inspection readiness for biotech and pharmaceutical companies and provide simple tips for building resiliency into your operations. By the time you’re done reading, you’ll know exactly what to do should the regulatory authorities come knocking.

4 Key Elements of Inspection Readiness

When you think about inspection readiness, what comes to mind? While facility cleanliness and available meeting space are important considerations, your company’s processes, systems, and documentation take priority. That’s because to build a culture of perpetual inspection readiness, you have to lay a strong foundation. Specifically, you need to focus on four key areas:

1) Document Control & Management

Bringing a new drug or therapeutic to market requires a small village, not to mention thousands of documents monitoring everything from standard operating procedures and batch records to recruitment materials and patient protocols. None of these things can be left to chance. Without clear procedures for maintaining, updating, and completing documentation, problems will arise. Not if, but when. Ensuring that your entire team knows proper documentation etiquette can go a long way toward your success. 

2) Training and Competency

Continuing education is an essential component of any successful career, but that training should extend beyond traditional employee responsibilities. For example, anyone working in biotech needs to be familiar with regulatory requirements, quality standards, and company procedures. There are various ways to approach this; some companies schedule mandatory educational sessions two or three times a year, while others incorporate online training programs into employees’ daily responsibilities.

Regardless of the approach you take, maintaining comprehensive training records is key. Without them, it’s nearly impossible to demonstrate your team’s competence, even if they’re great at what they do.

3) Quality Systems

Quality management systems play a crucial role in regulatory inspections. In their simplest form, they illustrate your processes, procedures, and responsibilities for achieving optimal results. 

Biotech leaders need to focus on several specific processes, including:

• Procedures for change control
• Deviation management
• Complaint handling
• Corrective and Preventive Action (CAPA) processes

These systems should be written down and consistently adhered to. They also require routine audits to identify and address potential compliance issues. Although establishing quality systems takes time, the benefits go beyond peace of mind. With a system in place to routinely reevaluate your processes, you can catch minor mistakes before they turn into major problems.

4) Mock Inspections and Internal Audits/Readiness Assessments

Mock inspections and internal audits are similar to dress rehearsals in that they give your team the chance to practice and implement their professional responsibilities in a low-pressure environment. That way, if a real inspection does take place, they can act quickly and confidently, reducing the risk of mistakes. 

That said, a mock inspection is only as effective as its design. Ideally, these activities should simulate real-life scenarios. If they don’t, it’s harder to assess your organization’s readiness and identify deficiencies. 

Why Inspection Readiness Matters – The Bottom Line

Inspections by regulatory authorities are a matter of when not if. Instead of hoping for the best, why not take control and develop an inspection-readiness program? Although time-consuming and resource-intensive, conducting regular reviews of your processes, procedures, and systems is one of the easiest and most effective ways to identify shortcomings and make corrections before they result in fines and penalties. 

Since different regulatory agencies take different inspection approaches, we know that a “one-size-fits-all” strategy isn’t always effective. That’s why we’ve developed a three-phase plan to help our clients maintain inspection readiness. It includes an assessment phase, an implementation phase, and a train and sustain phase. These three phases include a thorough, yet efficient assessment of compliance, a component of training, and a long-term self-sustaining plan that allows you to build a culture of inspection readiness.

Now that the new year is upon us, there’s no better time to take action. Laying a strong foundation now can relieve stress and ensure your success in the future. To learn more about our three-phase inspection readiness program, call (781) 775-0342 or send us an email at [email protected].