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Defining Critical Quality Attributes in the Pharmaceutical Manufacturing Process

July 15th, 2014 by

Quality By DesignPharmaceutical firms that wish to create product lines and cater to consumers as reliably as possible must ensure that their products are of a consistently high enough quality to fulfill user needs. While certain post-production checks and assurances can aid in this area, many organizations find it far more helpful to institute quality by design standards (QbD).

Why Quality by Design?

The U.N.’s World Health Organization recommends quality by design as a standard because it’s harder (and practically impossible) to implement effective quality controls solely by testing a product after the fact. For instance, many pharmaceuticals involve chemical manufacturing processes that incorporate numerous steps. Because each stage plays a critical role in the end results, it’s prudent to design each step around goals that foster effective quality management.

It’s only natural to wait until a product is completely manufactured to test for quality aspects like color and weight, but without planning the individual processes that contribute to the end result in an understandable fashion, it’s difficult to correct for errors before they spiral out of control. Typical quality management systems therefore rely on a systematic approach that revolves around well-defined objectives.

What Is A Critical Quality Attribute?

Critical quality attributes (CQAs) serve as the benchmarks that most quality by design implementations revolve around. They include physical, chemical, biological and microbiological characteristics or properties that can be consistently measured and quantified. Each CQA also incorporates an acceptable statistical limit, range or distribution against which the actual measurement results are judged.

By ensuring that your critical design processes are in accordance with your CQA goals, it’s possible to minimize deviations and troubleshoot problems more rapidly. If for instance, you know that the humidity of the atmosphere in a chemical mixing chamber is the only measured CQA close to the limit of its acceptable tolerance, you may find it easier to troubleshoot subsequent batch deformities.

Quantifying different CQA factors also makes it simpler to link your control strategies with specific problem types and implement more comprehensive quality systems.

Using CQAs Effectively

One caveat for those who want to institute CQAs is that these controls aren’t effective on their own. It’s important that you have a change management, deviation management and CAPA system in place or some kind of control strategy that will actually lets you respond to the issues you identify through CQA analysis. This control strategy should also figure into the way you manage your product’s lifecycle. You must be able to explicitly describe and justify why each control contributes to the product’s overall quality, especially if you plan on using the quality data you generate for risk assessment.

CQAs can be powerful tools for firms that want to master quality management. GxP-CC consultants understand how to help organizations improve the way they institute quality by design strategies and controls. Get in touch today to learn more.

 

About this author:

Dr. Hussein has over 15 years of experience in the GMP industry as a successful advisor for top medical device and pharmaceutical companies. In 2008 Dr. Hussein was named as an assessor for project management in the “German Society for Project Management” (GPM). Dr. Hussein holds a Master’s in Physics and a Master’s in Biomedical Engineering from the University of Hannover in Germany. He also holds a PhD in Physics from the University of Luebeck in Germany.

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