CMC

Common Pitfalls in CMC Dossier Authoring

Common Pitfalls in CMC Dossier Authoring

ByPharma Lesson Reading Time: 1 minute

Authoring a high-quality CMC (Chemistry, Manufacturing & Controls) dossier is crucial for regulatory approval. However, many submissions face delays due to avoidable mistakes. Here are some common pitfalls and how to avoid them: Inconsistent Data Across Sections Lack of Justification for Critical Parameters Poorly Structured or Redundant Content Incomplete Stability Data Failure to Address Regional…

The Role of Quality by Design (QbD) in CMC

The Role of Quality by Design (QbD) in CMC

ByPharma Lesson Reading Time: 1 minute

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…

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