Integrity in Biopharma: Do we really need it?

I get it. Times are hard. The same for being caught in a situation where an FDA auditor finds out you knew about a compliance violation yet you did nothing to correct it. Integrity is everything and yes, it’s needed.

When you see the word “integrity”, think about personal integrity and data integrity. And yes, some individuals do not view these as closely related and mutually reinforcing, but, they are. You need personal integrity to establish a good base or foundation for data integrity. 

During FDA audits, honesty is not just the best policy—it’s the only policy. Integrity is your audit superpower, providing guidance in everything from data accuracy to clarity of documentation. On the flip side of this, dishonesty will be your kryptonite, leading to anything from warning and injunction letters from the FDA, loss of reputation of the company meaning more frequent audits, hefty fines, product recalls, facility shutdowns, or (as a last resort) being banned from operation in the industry itself. If you reach this last point, though, . Seriously. 

In biopharma, we’re held to the highest standards because lives depend on it. Many of the drugs in biopharma (especially biologics) require more stringent regulations because, as injectables, they bypass the body’s immune system as they are administered. If negative interactions with the drug occur, they will most likely be more severe or sometimes fatal, as a result.

Every step of the process, every test, and every result must be beyond reproach. Integrity, helps keep oversight of the process proactive in nature but also helps keep audits to a minimum, and potential repercussions, when violations are found, as painless as possible. 

Here are three of the most important elements required to help maintain integrity throughout biopharmaceutical processes:

Data Integrity and traceability 

Every piece of data must be accurate, thoroughly documented, and easily traceable from its origin through each step of the process. Think about ALCOA. I’ve posted about ALCOA in the past (check it out here and here). This refers to data being attributable, legible, contemporaneous, original, accurate, complete, and consistent. The resulting transparency ensures that all data is trustworthy and issues can be quickly identified and addressed.

Accurate data not only supports compliance but also ensures the safety and efficacy of the final product. Happy patients. Happy company.

Robust Quality Systems

Integrity hinges on having strong, reliable quality systems in place that include Standard Operating Procedures (SOPs), rigorous and accurate testing, and ongoing monitoring. These systems provide a framework to ensure consistency and accountability in all processes, preventing recurring errors and lapses in quality. 

Think about what it takes to implement repeatability and reproducibility in your processes. This will help maintain a high level of quality across the board.

Culture of Compliance and Accountability

Beyond systems and procedures, integrity is ultimately driven by people. And a good quality system would not be complete without the contributions of those people. A culture that prioritizes compliance and holds everyone accountable—from top leadership to process and/lab technicians (service personnel are not excluded)—reinforces ethical standards and a proactive stance when it comes to compliance. This is also what it takes to create a cGMP mindset. This helps minimize environments conducive to additional violations. When team members understand the importance of integrity and feel empowered to speak up about potential issues, the entire organization benefits.

Now, if team members do not feel empowered to speak up, you may also have other internal issues to address . 

If you’re not sure where to begin, start with the three elements mentioned here. These are the foundation for long-term success and growth of the company. Beyond compliance, if you’re looking to maintain trust, transparency, and reliability with investors, patients, and within the industry, this will help. There are other benefits like increased efficiency in operations and patient safety, but we can discuss these in more detail later.

So, keep it classy with integrity at the core of your work. When the auditors (who have good intentions) show up there are no regrets, you exude confidence, and can say, “We’re ready”.