Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
Achieving QbD requires an in-depth understanding of physicochemical properties that predict processability, in vivo, and in vitro performance. Early identification of Critical Quality Attributes (CQA) of excipients and active pharmaceutical ingredients (API) and their impact on a formulation is a key component of QbD. Micromeritics’ instruments and contract analytical services offer solutions for the early identification of CQA’s, continuous process monitoring, and verification, which are the foundation of QbD.
To date, chemical analysis has received the greatest level of emphasis and deployment within a QbD architecture. The need for robust product and process design to ensure lot-to-lot consistency has led to an increased focus on the importance of material characterization.
Historically, particle size has been the dominant physical characteristic control parameter for release. But now, properties such as surface morphology, porosity, particle shape, density, and surface energy are additionally utilized as predictive tools to reduce possible manufacturing failures by predicting scale-up effects on the final product. This effort improves the overall efficiency of a manufacturing process and cuts the cost of waste due to batch rejection, reprocessing, or testing failures.
Micromeritics Material Science Solutions advantages include:
- Streamlining pharmaceutical development
- Identification / evaluation of API, excipient, and blended material critical quality attributes
- Providing predictive tools and lab services for Implementing QbD and PAT initiatives in line with ICH Q6A, Q8, Q9, and Q10 guidelines
- Using materials science to model and predict material behavior
- Characterization solutions for robust quality control
- Raw material qualification
- Assessing lot-to-lot variability
- Assistance in quality investigations and corrective and preventative actions (CAPAs)