If you work in biotech, pharma, or cell and gene therapy, you already know this: weak validation creates real risk. Not just regulatory risk, but operational risk. Delays. Rework. Missed GMP timelines.
That’s where content validity comes in.
Content validity is often discussed in statistics and assessment design, but the concept shows up every day in regulated manufacturing and validation work. At its core, content validity answers one simple question:
Does this test, protocol, or assessment fully cover what it’s supposed to cover?
If the answer is no, you’re validating the wrong thing—or not enough of it. Below is a clear, practical look at what to expect from the content validity process and why it matters when you’re preparing for GMP runs.
Content validity measures how well an assessment represents the full scope of a domain. The “domain” is the complete set of knowledge, skills, processes, or requirements you’re trying to evaluate.
In a manufacturing or validation context, that domain might include:
Strong content validity means your validation activities reflect all of these elements, not just a subset.
Weak content validity means gaps. And gaps cause findings.
Regulators don’t just look for completed paperwork. They look for alignment. Your protocols, test cases, and acceptance criteria must reflect the real-world use of equipment and processes.
Content validity helps ensure that:
In short, content validity helps prove that what you tested actually matters.
The content validity process starts with defining the domain. This is the most important step, and the one teams often rush.
You need to spell out:
For example, if you’re validating a piece of manufacturing equipment, the domain isn’t just “does it turn on.” It includes installation, operation, cleaning, alarms, data integrity, and maintenance.
If the domain is vague, content validity fails before testing begins.
Once the domain is defined, it gets broken down into components or elements. These are the specific areas that must be covered for the assessment to be valid.
In validation work, components might include:
This step prevents tunnel vision. Teams often focus on what’s easiest to test instead of what’s most important. Content validity forces a broader view.
Now you create the actual “items.” These are the test cases, protocol steps, questions, or scenarios used in the assessment.
For strong content validity:
If you’re qualifying equipment for GMP use, your tests should reflect how it will be used during actual production runs—not just during commissioning.
This is where experienced engineers and validation professionals add real value. They know where issues usually hide.
Content validity is not a solo activity. It relies on expert judgment.
Subject matter experts (SMEs) review the assessment and answer questions like:
In regulated industries, SMEs often include engineers, quality professionals, validation leads, and operations staff. Each brings a different perspective, which strengthens content validity.
The feedback loop matters. Content validity improves through revision.
This step often leads to:
The goal is balance. You want enough coverage to be defensible without creating unnecessary work that slows timelines.
Content validity does not measure outcomes. It does not prove that a system performs well. It proves that your assessment is designed to measure what matters.
Think of it as setting the right target before you take the shot.
At Bothwell Engineering, content validity shows up in nearly every engagement—whether it’s staffing, consulting, equipment setup, or operational support.
Clients rely on Bothwell teams to:
Bothwell engineers and operational consultants don’t just execute tasks. They help ensure the right tasks are being validated in the first place.
That’s content validity in action.
When teams apply content validity correctly, you see:
Most importantly, you move closer to consistent, successful GMP runs.
Content validity isn’t abstract theory. It’s a practical tool that helps teams ask better questions, design stronger validations, and reduce risk.
If you’re building a facility, qualifying equipment, or scaling manufacturing, content validity should be part of the conversation early—not after issues appear.
If you need experienced engineers or operational consultants who understand this process and how it applies in real GMP environments, Bothwell Engineering can help support your program from concept through execution.
You don’t need the biggest team. You need the right one.
