One distinction that can be particularly challenging is the difference between GMP and cGMP standards. These standard sets sound similar, and they both work to ensure safety, quality, and repeatability in cleanroom environments. However, there are some key differences between the two.
Let’s take a closer look at GMP vs. cGMP standards below.
GMP vs. cGMP Standards for Cleanrooms
We’ll first note that GMP and cGMP standards may differ, but neither is “better” or “more effective” than the other. Often, the two systems work hand in hand to ensure a cleanroom is operating at peak performance and is in continuous compliance. In fact, the terms are frequently used interchangeably, even though they technically shouldn’t be.
Let’s dive into some definitions.
What Are GMP Standards for Cleanrooms?
GMP stands for “Good Manufacturing Practices.” It’s a quality management system used mainly by medical and pharmaceutical manufacturers. Its main goal is to “minimize the risks of microbiological, particulate, and pyrogen contamination during preparation and sterilization of medicines or medical devices.”
GMP standards focus largely on production and quality control. When applied specifically to cleanrooms, they address issues like:
- Sanitation and cleanliness
- Record keeping and documentation
- Personnel qualification
- Process validation
- Equipment verification
In the United States, GMP standards are created and enforced by the Food and Drug Administration (FDA). In other countries, they’re created and enforced by other regulatory agencies. But while GMP standards may have minor differences across the globe, their main goal is the same.
Learn more about GMP standards for cleanrooms in this blog post.
What Are cGMP Standards for Cleanrooms?
cGMP stands for “Current Good Manufacturing Practices.” It’s a quality management system incredibly similar to GMP but with small yet important differences.
With cGMP standards, every production stage is done using GMP guidelines but in the most “current” manner available. In a broad sense, “current” means a cleanroom and its operators must employ technologies and systems that are up to date and comply with GMP requirements.
While cGMP standards have rules and regulations, they’re still somewhat flexible. They allow each manufacturer to choose which controls, systems, and technologies to use and how they want to implement them — as long as they remain compliant. This enables manufacturers to take innovative approaches and to constantly work on improving their processes.
Learn more about cGMP standards in this article from the FDA.
Other Differences Between GMP and cGMP Standards for Cleanrooms
Besides the main distinction of “current,” there are a few other differences to note between GMP and cGMP standards for cleanrooms. The most pertinent ones to many manufacturers are cost and requirements for certification and testing.
Cost
cGMP cleanrooms use new, innovative systems and technologies. This often makes their overall manufacturing, installation, and operating costs higher than those of GMP cleanrooms.
Of course, cleanroom costs can vary depending on the overall project size and scope. This is just a common trend we’ve noticed and something to consider while you’re determining a project budget. For many manufacturers, the additional cost is well worth it for modern systems.
Certification & Testing
In most cases, cGMP cleanrooms are subject to a longer, more rigorous certification process before they’re ready for operation. They also tend to undergo more frequent, thorough tests year after year to verify ongoing compliance. This is to ensure that all controls, technologies, and systems are current, operable, and compliant.
Questions? Contact Angstrom Technology.
Have more questions about cGMP and GMP standards and how they may fit into your cleanroom manufacturing, installation, and operation processes? Contact our team at Angstrom Technology. We have adequate training and an extensive portfolio of cGMP and GMP cleanroom projects under our belt, and we’d be happy to help design and build yours.
