What is 21 CFR?

“21 CFR” means Title 21 of the Code of Federal Regulations (CFR ). You may also hear it referred to as “CFR Title 21”. It covers the various requirements regulated by the FDA that a company must comply with.

21 CFR regulations mostly apply to manufacturers of medical devices, drugs or nutraceuticals. Consider companies that manufacture life science products like an insulin pump, drugs like ibuprofen, or nutritional supplements like vitamins. The Food and Drug Administration (FDA ) cares about two main things:

Your product is safe and poses no danger to consumers. Your product does what it claims (referred to as “effectiveness”).

Note: The FDA regulates companies that sell products to the United States market. However, regulatory requirements for other countries/regions such as Canada or the European Union are usually met when a company complies with 21 CFR.

How does maintenance relate to 21 CFR?
Manufacturers use a variety of machinery to produce medical devices, drugs, and nutraceuticals. If these machines are not properly maintained, they can adversely affect the quality of the final product.

Let’s consider the air filtration system for a production room.

If the filtration system is not maintained, particles can enter the production chamber and contaminate the final product. As a result, the product may no longer be safe for use as it is contaminated. As a maintenance professional, you won’t need to know everything about 21 CFR. However, you will need to be aware of the regulations for quality systems, computer systems and electronic records as they relate to 21 CFR.

Why do you need to pay attention to 21 CFR in maintenance?
One word: control.

The 21 CFR audit will focus on your company’s records. Consequently, it is important to have a system that can accurately indicate that the equipment has been properly maintained. The consequences of audit non-compliances ( such as findings that do not comply with 21 CFR) can, in the extreme, lead to the complete shutdown of the company.

You want to make sure that your company and your team are as prepared as possible to meet auditor expectations and the 21 CFR regulation.

What can be expected in a 21 CFR audit?
21 CFR controls come in many different shapes and sizes. Here are some quick facts about what a control might look like.