What Are Qualification And Validation

Qualification and validation are two words we use a lot in GMP, and sometimes we interchange them. This blog explains the difference between these two terms and introduces how qualification and validation help ensure compliance in the pharmaceutical industry.

And just for fun, we'll add in calibration and verification as well! Are you ready? On your mark! Go!

Level 1: What is validation?

As you might expect, there's a sequence to these words. We will start by taking a look at validation and work our way down to verification.

In short, validation is the documented objective evidence that a specific process, procedure, or activity will consistently produce results meeting predetermined specifications.

Validation is a requirement of food, drug, and pharmaceutical regulating agencies (such as the United States FDA) and GMP (Good Manufacturing Practices). The fields in which validation can take place are varied, and we've decided to list a couple of them below:

  • Equipment validation

  • Cleaning Validation

  • Process Validation

  • Analytical method validation

  • Computer system validation

For the longer answer, let's first set up our example. We all like our freshly squeezed orange juice in the morning, but it does not magically appear on the table for some strange reason. No, you're going to need a juicer to get the good stuff flowing. So, the juicer is going to be our example for the rest of the blog.

The validation of said juicer will go as follows:

  • Defining the intended use: does it just need to make orange juice or other things as well?

  • Listing the user requirement specifications (URS): minimum volume, speed, mesh size for the pulp, power source available …

  • Conduct a risk assessment: what are the possible risks that cause an impact on safety and quality, and how can we reduce them?

  • Perform the qualification (ta-daaa, you discovered level 2)

  • Maintaining the validated state (in case of upgrades, changes, …)

Level 2: What is a qualification?

So, you've made it to level 2! Welcome to the wonderful world of qualification! As you might have noticed earlier, qualification is the part of the validation process focusing on the system itself. The series of inspections and tests performed to ensure that all requirements (listed among the user requirements) are satisfied and that documents and procedures necessary to operate and maintain the system correctly are in place.

We've already listed some for our juicer: speed, minimum volume, and mesh size. Qualification is where the magic happens and where we actually test our piece of equipment.

What are the phases of qualification: