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.
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...
ISPE hosted more than 450 attendees in person and virtually for the 2024 ISPE Aseptic Conference in Vienna, Austria. Keynotes and education sessions provided a comprehensive overview of key topics and trends...
Biopharmaceutical facility design is a critical aspect of the industry. Overall cost pressures in the global health system, regional requirements to deploy manufacturing rather than centralize manufacturing in one location, technology enhancements in cell biology and format, flexibility to accommodate multi-product campaigns with different production schedules, and speed-to-market are among...