Quality matters in every industry, but let’s be honest. There are some industries where it matters a lot.

If the bun on your burger is soggy, it’s a minor problem. If your air conditioning fails in the middle of summer, it’s a major problem. If the brakes go out on your car, it’s a catastrophic problem.

And if a pharmaceutical company provides you with the wrong pill bottle? You might never have to worry about soggy burger buns ever again. That’s how important quality assurance is to the pharmaceutical industry.

Applying Process Improvement Tools

That’s why many pharmaceutical companies are moving away from the traditional QA system of late-stage testing (to ensure their final products are safe and effective). As a replacement to the late-stage strategy, they’re embracing something called Quality by Design, which is an ingeniously simple notion:

Don’t wait for the end of development; instead, design quality into every step of the process.

How does it work?

Step 1 – Identify Critical Quality Attributes and Critical Process Parameters

Generally speaking, Critical Quality Attributes (CQA) are the factors that will most strongly influence the quality of your finished product. The pharmaceutical industry, for example, tracks attributes that affect the chemical and microbiological makeup of their products. Critical Process Parameters (CPP) are the variables you need to control so they do not negatively influence the production process.

Step 2 – Use the Design of Experiments Method to Test Variables

The Design of Experiments (DOE) method evaluates every factor that goes into developing the final product. Think of it like baking a cake; the factors (ingredients) that have the biggest impact on the product (cake) might be thinks like water, sugar, flour, eggs, and the temperature of the oven. You test and tweak these factors to get the best result. In a pharmaceutical setting, instead of eggs and sugar, you would be evaluating things like acetaminophen and phenylephrine.

Step 3 – Implement a Strategy for Manufacturing

After pinpointing the end goal and the variables that can influence the outcome, you can develop a control strategy. This strategy helps figure out what methods you need to use to control those variables in order to achieve the desired outcome.

The Patient Comes First

Quality by Design doesn’t just ensure quality in the final iteration of the products. It also reduces the chance that a sub-standard product is ever created.

Think about it. If a pharmaceutical company is testing only the final version of a drug, there are only two conclusions they can come to.

  • The drug meets the standards for safety and effectiveness.
  • The drug does not meet the standards for safety and effectiveness.

When those conclusions are drawn late in development, there’s no reasonable corrective action the manufacturers can take. But if one of those conclusions is drawn using the DOE method, there’s still time to tweak and adjust factors and course-correct toward a high-quality final product.

In an industry like pharmaceuticals, high-quality, and, by proxy, Quality by Design, is the only viable option.