In order to deem a cleanroom “GMP compliant,” it needs to meet various qualification and validation requirements. For facilities that are new to GMP standards and regulations, these processes can be a bit complicated — but we’re here to help clear things up.

Let’s discuss what the GMP qualification and validation processes entail below.

An Overview of the GMP Qualification & Validation Process

The GMP qualification and validation processes are designed to ensure all components of your cleanroom’s design, installation, operations, and performance are optimized for safe, high-quality, repeatable results. They’re critical steps in protecting the safety of both consumers and cleanroom operators. 

In order to understand the processes in more detail, it’s important to break down the difference between them.

GMP Qualification & Validation: What’s the Difference?

While GMP qualification and GMP validation may sound like the same thing, they’re not. GMP qualification generally comes first, then validation follows soon after. 

GMP Qualification

GMP qualification is the act of proving and documenting that equipment and supplementary systems are installed correctly, operate correctly, and comply with specified requirements. Qualification generally follows these four steps: 

  1. Design Qualification (DQ), which determines if your cleanroom design can meet all regulatory and process requirements. 
  2. Installation Qualification (IQ), which determines if your cleanroom is consistent with specified designs after installation is complete. 
  3. Operational Qualification (OQ), which determines if your cleanroom equipment achieves specified operational requirements. 
  4. Performance/Process Qualification (PQ), which determines if your cleanroom equipment performs well together in a controlled and repeatable manner. 

Here’s where things can get a little tricky. These qualification steps are the first part of validation. However, the steps alone aren’t the only part of validation. There’s a little more to it, which we’ll talk about below. 

GMP Validation

GMP validation is the act of documenting objective evidence that offers a high level of assurance that a specific cleanroom process will consistently deliver products that meet predetermined specifications. It follows these four steps: 

  1. Performance/Process Validation, which is step #4 of the qualification process above.
  2. Cleaning Validation, which ensures that equipment is cleaned regularly and in accordance with specified regulations. 
  3. Method Validation, which ensures that the analytical procedure for a specific task is suitable for intended purposes. 
  4. Computer System Validation, which ensures that any cleanroom software applications meet their intended purposes. 

Side Note: What About cGMP Qualification & Validation?

It’s important to note the difference between GMP and cGMP here. You may have seen “cGMP” during your research and wondered if it’s the same as GMP. It’s similar, but it’s not quite the same. 

GMP requires you to ensure your cleanroom is designed, built, and operable in a way that creates safe and effective products, whereas cGMP requires you to use technologies and systems that are modern and comply with GMP standards. Therefore, while the qualification and validation process for these two systems are similar and can be streamlined together, they are a little different. 

How Long Do the GMP Qualification & Validation Processes Usually Take?

The timeline for GMP qualification and validation can vary greatly depending on the scope of your cleanroom project. It’s usually an extensive amount of work, though, so it’s important to plan accordingly in terms of both the time and resources you’ll need. 

GMP qualification and validation happen in stages, often in accordance with the stages you design and build your cleanroom. Therefore, you can expect the entire process to take somewhere between a couple of months to a year, depending on the duration and complexity of your project. 

Who Is Responsible for Obtaining GMP Qualification & Validation?

You, the facility manager or owner of the cleanroom, are responsible for obtaining GMP qualification and validation for your new cleanroom. 

However, there are plenty of resources available to help you get there — one being a reputable cleanroom manufacturer with GMP experience. While they can’t usually carry out the GMP qualification and validation process for you, they can help you understand it, navigate it, and design, build, and install a cleanroom that meets necessary requirements. 

Design & Build Your GMP Cleanroom With Angstrom Technology

GMP qualification and validation can get confusing, especially if you’re new to the processes. If you’re looking for some help, reach out to our team at Angstrom Technology. We’ll be your guide to designing and installing a cleanroom that’s safe, efficient, and compliant with industry standards.