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.
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...