In pharmaceutical development, understanding your Critical Quality Attributes (CQAs) is not just regulatory jargon — it’s the foundation of Quality by Design (QbD). According to ICH Q8(R2), a CQA is any physical, chemical, biological, or microbiological characteristic that must be controlled within an appropriate range to ensure the desired product quality. These attributes have a…
In the evolving pharmaceutical landscape, Quality by Design (QbD) has transformed the Chemistry, Manufacturing, and Controls (CMC) framework, shifting the focus from mere compliance to science- and risk-based drug development. Why QbD Matters in CMC? Traditionally, regulatory submissions relied on empirical data with limited flexibility. QbD, however, ensures a deep understanding of product and process…
In topical pharmaceutical development, achieving batch-to-batch consistency, therapeutic efficacy, and regulatory compliance requires a Quality by Design (QbD) framework. A well-defined design space based on Critical Material Attributes (CMAs), Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs) ensures an optimized, scalable, and reproducible formulation. Identifying CMAs in Topical Formulations API Attributes: Excipient Functionality: Defining…
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