Non-repudiation is non-negotiable in regulated manufacturing

“It wasn’t me.” This phrase is something we’ve all said or heard at some point in our life, whether in response to glass breaking or a teacher’s stern glance at the corner of the classroom. In everyday life, passing the buck may not carry significant repercussions; in the tightly regulated pharmaceutical manufacturing industry, however, the stakes are much higher. It is imperative that a company uncovers where an error occurred in the manufacturing process since the burden of proof lies with the company. Failing to do so can have severe consequences, both in lost revenue and regulatory fines. This is where non-repudiation plays a crucial role.

What does non-repudiation mean? Simply put, non-repudiation is the assurance that someone cannot deny something. Source: Margaret Rouse, (@WhatIsDotComTechTarget.

Non-repudiation is one of the goals the FDA lays out in Current Good Manufacturing Practices (CGMP). According to the FDA, “CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations,”

What are the consequences if a company doesn’t meet CGMPs? They can range from warnings to a push for a recall if a previously released product is deemed unsafe. If the company doesn’t recall the drug, the FDA can mandate a seizure. (Source: FDA.com).

Now, a recall is a worst-case scenario, and most manufacturers will catch any issues before the necessity of FDA involvement. However, to find these problems, companies need to sift through a tremendous amount of data. This is where trusting the data comes into play and where non-repudiation becomes incredibly important.

Though many things in the modern manufacturing facility are automated now, the process still requires employees conducting specialized tasks. Employees typically perform tasks from weighing and combining raw ingredients through to boxing and palletizing. It’s imperative that a company know who has done what and when so that any irregularities can be traced to their source.

Strong authentication procedures are the mechanism by which a company can identify who was doing what at any given moment. The stronger and more secure the method of authentication a company has in place, the more confident it can be about what’s transpiring on the manufacturing floor, and the faster it can move to prevent any problems. This approach to non-repudiation minimizes the need for costly internal audits, can help avoid costly regulatory intervention, and helps reduce potential harm to the end-user.

If you’re a manufacturing company, it’s worth looking at the system of authentication you’ve deployed. How well does it support non-repudiation? Ask yourself whether you’re 100% confident that if the worst happens, you can count on the data you’re seeing and won’t find yourself surrounded by blank expressions and a chorus of “it wasn’t me.”

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