How to Prepare for and Resolve a Pharmaceutical Compliance Crises

Is your company fully prepared to handle a compliance crisis? Effectively managing this process is no easy task, especially if you’re part of the highly regulated pharmaceutical industry. To make this process less daunting, it’s important to plan for each stage of a compliance issue. In this article, we’ll discuss the ins and outs of a pharma incident and share the best ways to handle one effectively, including steps to take before, during, and after. Read on to learn more.

What Does a Compliance Issue Look Like?

While pharma professionals have to avoid an array of various compliance mishaps that can lead to a crisis, there are five major trends regularly cited by the FDA. In 2018, pharma companies received a total of 3,344 observations for 390 different categories of noncompliance. Overall, the majority of these incidents fell into the following categories:

• Absence of written procedures
• Failure to follow written procedures
• Improper maintenance
• Failures in laboratory controls
• Faulty production record reviews

The most effective way to steer clear of compliance crises like these is to design your quality process to ensure you avoid them. However, because mistakes and human error are often inevitable, every company will eventually find themselves under the scrutiny of the FDA. So, let’s look at the most effective ways to prepare for, handle, and learn from a compliance incident.

How to Resolve a Compliance Incident 

1. Before the incident

Arguably the most important step of the entire compliance crisis process is proper preparation. If your company completes this step effectively, even a large-scale incident won’t leave long lasting negative effects on your business. Essentially, this means that your team needs to put a strong emphasis on anticipating what could happen during an incident, as well as delegate tasks ahead of an actual issue.

Implement a Risk Management Process

The first step in ensuring proper prep is to implement a thorough risk management procedure by monitoring your competition, the market, and your necessary regulatory bodies. The better the grasp you have on how these aspects of business may shift and change in the future, the better you’ll be at detecting potential risks and dodging compliance crises.

Develop and Emergency Response Plan (ERP)

Next, it’s time to devise an emergency response plan (ERP). This plan should go into detail about each team member’s role in crisis response, as well as outline when the plan should be put into motion. There also needs to be a report on how a potential crisis may affect your company’s finances and stakeholders, so your company knows how detrimental a regulatory issue could be. Also, make sure your ERP is updated consistently and your line of team communication is open, so everyone knows their role. With these aspects planned for and outlined ahead of time, no part of your incident clean-up process will slip through the cracks.

2. During the incident

If you have done all you can to prep for and avoid a compliance issue and your company is still slapped with a regulatory citation, it’s time to physically delegate tasks for triage. Since you already have an ERP written up, this should be as simple as putting your communicated plan into action. After ensuring that your chosen group leader is informed, allow them to begin delegating tasks and working toward a solution.

An important part of the process to mitigate a quality issue is to find the root cause. Write down the overarching problem you’re trying to solve and use your company quality process and data tracking to uncover the reason your regulatory process fell short. It is very important to find the true root cause rather than just the symptoms the compliance issue created. A good way to look at it is this: imagine a merchandise defect is considered a symptom because it may have been caused by outdated tools or a machinery issue, each of which may have a more detrimental cause (the root). In order to completely solve your compliance problem and ensure it never surfaces again, find the root and eradicate it.

3. After the Incident

Once you’ve finished triaging your compliance crisis and your ERP has been disengaged, your team needs to make it a priority to learn from your original mistakes. The first part of this is to examine the root cause you discovered and ensure it was fully resolved. Taking a critical look at the process you used to find the root and eliminate it can ensure the same issue won’t pop up in the future.

Additionally, take this time to analyze your ERP crisis process and ask yourself these questions:

• Was it effective and efficient?
• Could you have taken less time by cutting out unnecessary steps?

Looking at how your team handled a crisis in real time can help you uncover better ways to manage this process in the future. Take this experience as a learning opportunity and be sure to communicate with your team in terms of their individual performances, so they can work to handling these situations better as well.

By thoroughly preparing your company for compliance issues, it doesn’t have to be a difficult or lengthy process to overcome them. Your team will know exactly how to handle a crisis if it happens, and your company will ultimately benefit from the experience because you’ll learn how to handle any future issues more efficiently. By following the three steps we’ve outlined, your quality triage process will be more thorough and streamlined.

The ENSUR document management system can significantly improve your company’s ability to establish and maintain regulatory compliance at all levels, including handling a compliance crisis. Request a demo today to find out how much easier ENSUR can make preparing for, handling, and learning from a quality issue.