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:
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.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...