What does Quality by Design (QbD) in the design of clean manufacturing equipment and processes look like? This might be easier to visualize if we look at it from the perspective of the absence of it. Design and optimization based on only the engineering point of view, and not on understanding of the process, often leads to unintended impacts on the end-use of the equipment. These unintended outcomes include, but are not limited to, decreased productivity and product quality and increased cost to overcome contamination control hurdles.
QbD from the Regulatory point of view emphasizes an understanding of the product and process fundamental enough to result in process control. This understanding is based on sound engineering, product science and quality risk management (QRM). It is intended to increase the robustness of the process and reduce manufacturing deviations and failed/reworked batches. Agencies that have established recommendations include the FDA, ISO, ICH Q8-10 and EMA, among other local and regional requirements. ISO 14644-2 most clearly requires a “formal evaluation of a risk document to identify all areas/locations which may represent risk to the product and environment cleanliness, and therefore require constant control.”
In the remaining blogs in this series we will examine what a new fill line looks like with and without QbD implemented at the design phase. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.