cGMP is Extensive and Confusing

Current Good Manufacturing Practices, known as cGMP, are designed by the FDA to regulate the quality of pharmaceutical goods in the United States. With a vast array of current guidance documents to say the library is extensive is an understatement. The library includes validation, data integrity, quality metrics, and even animal and veterinary guidelines.

While the FDA documentation is certainly extensive, it is not always clear. Documents range from 10 to 30 pages in length, navigating the sea of information can be daunting. It is entirely possible that once you have read about a certain topic you are left with more questions than answers.

We hope this article will help you to better navigate the “current” good manufacturing practices and keep a bit of your sanity intact.

Let’s start with the word “current.”

The only reason for the lowercase “c” in cGMP is to remind us to remain vigilant. Because regulations are ever changing we need to keep up with requirements. Administrations change, technology changes, and procedures change. They can easily change faster than your facility does. So staying on top of the “c” can be challenging. It is however very important.

Remember: cGMP provides a flexible, universal framework 

The cGMP standards weren’t created for everyone equally. They are broken into categories that target specific industries and standards. There is a significant amount of logic that goes into this thought process. The main thought process being, “one size does not fit all.” The life science manufacturing industries are diverse. Yet, cGMP standards are broad enough to cover all aspects of the design, monitoring, and control of manufacturing processes and facilities.

Understand how quality management fits in.

Just following the guidelines set aside by your specific cGMP regulations might not produce the highest quality results. Understanding how your cGMP aligns with other systems is what drives a thorough and highly effective quality management approach. As we continue interactions and communication increase throughout the life science industry, it is essential to understand how QMS help meet cGMP standards.

This type of understanding also leads to a “quality by design” process. Building quality assessment into and throughout the entire life cycle is very different from the old method of “quality through inspection.” Improving the flow of business, production, and research by not having to wait for inspections in order to ensure quality dramatically changes how a business operates. And the better ROI bears that out. This approach is defined well in the latest Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

Keep in mind the FDA’s ultimate goal.

It is easy to get caught up in the annoyance of governmental processes. They slow down the flow of work even at maximum efficiency. They make things more trying than we think they should be. However, the FDA’s role is to protect the consumers. Even in the best of times, they are running a basic benefit-risk equation. They do this by continually analyzing the positive impact of a drug and then comparing it to whatever risk factors may be involved. 

The FDA comes into an inspection with the baseline assumption that quality assurance has already been taking place.that is what the cGMP model allows. Risks can take many forms. Harmful interactions between drugs, foods or supplements. Unexpected outcomes. Even possible adverse side effects. That is why the regulations are designed to be flexible. It allows them to adapt to a variety of situations.

Establish a strong cGMP based system.

Let’s be honest, following the FDA regulations requires some serious effort. This means that your company needs to implement a strong QMS. It needs to use high quality materials. It should have in place detailed and automated operating procedures. And it should perform and maintain quality testing throughout the process.There are three basic steps to achieve all of these. One is to have facilities that are in good condition. Second, you should have well maintained and calibrated technology. And finally, you should ensure your employees are fully qualified and trained.

The FDA understands that cGMP requirements are minimum requirements. That is why they strongly encourage organizations to use the regulations as a baseline. What they really want is businesses to exceed them in total quality management. If you embrace this concept it will lead your business down a road of continued quality. As an added bonus, you will also avoid burdensome energy and resource exhaustion.

All-in-all, cGMP makes your company better.

Don’t regard cGMP as a burden. Think of it more as a guard rail. It makes your business more efficient and profitable. Unlike many government regulations, the cGMP is not a rigid platform. It is a flexible. It is more of a framework from which to work. The alternative can be devastating to a business. In fact, a perfect example occurred in 2012.

In 2012, the New England Compounding Center sparked an outbreak of fungal meningitis. Regulations weren’t followed. It turned out that 17,000 vials of contaminated methylprednisolone were distributed to 23 states. The result was connected to 76 deaths, 751 injuries and 25 total counts of second-degree murder. Obviously, the company was financially ruined.

Simply put, your best bet is not to think of the cGMP as a management system. Instead, think of them as a set of principles compiled by the FDA which act as a minimum standard for operations in pharma. So take some time. Make the mental shift. And, ensure that you not only are compliant with the cGMP but excelling well beyond it. That will make pharma better for everyone.

Regulatory Compliance