iSpeak Blog

Why Is Process Validation an Essential Success Factor in Biotechnology Manufacturing?

Mark F. Witcher, PhD

To deliver a consistent and reliable final product, process validation is a crucial concept to understand. The three-stage paradigm covers the entire product lifecycle to manufacture a product by developing control strategies to regulate all attributes of product quality.

The greatest advantage of process validation is that it provides a framework for using ICH Q8 – Quality by Design (QbD) and Design Space, ICH Q9 – Quality Risk Management (QRM), and other tools like Process Analytical Technology (PAT). Process Validation also offers a systematic method to develop the systems necessary to oversee all aspects of manufacturing. Good manufacturing practices for process validation include the development of control strategies for all elements in the manufacturing process.

The challenge with process validation is that the paradigm and quality tools are incompletely described in regulatory guidance. These concepts must be expanded and explained to realize their full potential when developing a high quality final product.

As an instructor of the ISPE Process Validation Biotechnology Manufacturing Training Course, I can tell you that there are many advantages to completing training to expand your knowledge and continue the conversation, including:

  • Understanding the process validation paradigm as a natural and logical approach to building process control strategies for assuring product quality
  • Exploring an expanded form of the process validation lifecycle paradigm as a framework for using the ICH Q8/9 quality tools
  • Reviewing how the ICH Q8/9 quality tools can be effectively defined and used within the process validation lifecycle to build process understanding for control.
  • Learning to use working QbD as a powerful engine to iteratively design quality into the processes during the design stage to produce high quality product

Process validation is becoming an essential part of the manufacturing process by controlling all parts of the product lifecycle. Understanding, embracing, and using process validation is a critical success factor for efficiently and reliably manufacturing biopharmaceuticals.