Howard Bleazard1
1Kindeva Drug Delivery Ltd., Upbrooks, Clitheroe, BB7 1NX, Great Britain
Summary
Quality by Design (QbD) is a systematic approach to designing and manufacturing products and processes with quality in mind from the very beginning. It emphasizes understanding the product and process, identifying Critical Quality Attributes (CQAs), and controlling the design and manufacturing to ensure consistent quality. QbD is particularly relevant in the pharmaceutical industry where it is used to ensure the quality and safety of drug products.
Quality Risk Management (QRM) is a systematic process for identifying, assessing, controlling, communicating, and reviewing risks that could impact product or service quality. It is a proactive approach that helps organisations anticipate potential issues and take steps to mitigate them before they occur, ensuring consistent high quality and minimising risks to patients.
Adopting QbD methodologies provided by the FDA’s process validation (PV) guidance[1] and International Conference on Harmonization (ICH) Q8[2], Q9[3] and Q10[4] can pose many challenges in determining the criticality of Key Process Variables (KPVs). KPVs are the controllable design and process parameters that can impact CQAs. In essence KPVs are all of the adjustable parameters in a product design or manufacturing process, while Critical Process Parameters (CPPs) are the subset of KPVs that have the most significant effect on CQAs and require tighter control. CPPs are identified through risk assessments that evaluate the potential impact of each KPV on the CQA.
Kindeva have recently developed a process for combining QbD and risk management principles to facilitate robust development and commercialisation of valves and canisters for metered dose inhalers using next generation propellants.