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…
Changes in equipment used for manufacturing a product can have different implications depending on the market. Regulatory authorities assess these changes based on their potential impact on product quality, safety, and efficacy. Below is a comparative view of how major markets handle equipment changes: USFDA Risk-Based Approach: Major Change (Prior Approval Supplement – PAS): If…
Transferring a formulation to a new site requires careful planning to ensure product consistency, regulatory compliance, and quality assurance. Technical Considerations Quality & Regulatory Considerations Conclusion A well-managed site transfer ensures product integrity, regulatory approval, and seamless market continuity. Read also: Resource Person: Moinuddin syed. Ph.D, PMP
Changing the API source requires evaluating its impact on safety, efficacy, stability, and manufacturability. Below are the key factors to assess: Physicochemical Properties Dissolution & Bioavailability Stability Considerations Regulatory & Compliance Manufacturing & Process Impact In-vivo Considerations Risk Assessment & Final Decision Conclusion API source changes demand scientific, regulatory, and process evaluations to prevent any…
In pharmaceutical development, a drug’s success depends not only on its formulation but also on how efficiently it reaches the bloodstream. One of the most critical yet often overlooked factors? Dissolution testing and its direct impact on pharmacokinetics (PK). What’s a Dissolution Profile? Dissolution testing simulates how a tablet releases its active ingredient in the…
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