Common Pitfalls in CMC Dossier Authoring

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

• Misalignment between Module 3 and other CTD sections (e.g., 2.3.S/P and 3.2.S/P) leads to questions from regulators.
• Tip: Ensure data consistency with a thorough cross-check before submission.

Lack of Justification for Critical Parameters

• Missing or weak scientific rationale for control strategies, specifications, or manufacturing process parameters.
• Tip: Clearly justify choices using risk assessments and supporting data.

Poorly Structured or Redundant Content

• Repetitive information across sections makes the dossier hard to review.
• Tip: Follow a logical structure and avoid unnecessary duplication.

Incomplete Stability Data

• Submitting insufficient stability data, especially for post-approval changes, can lead to additional regulatory queries.
• Tip: Provide robust stability studies aligned with ICH guidelines.

Failure to Address Regional Regulatory Differences

• Assuming that one dossier fits all regions can cause compliance issues.
• Tip: Tailor content to specific agency expectations (FDA, EMA, TGA, etc.).

A well-prepared CMC dossier not only speeds up approval but also minimizes regulatory pushback.

Read also:

• The Role of Quality by Design (QbD) in CMC
• FDA Queries Related to Drug Substances in the CMC
• Types of FDA Applications for Drugs and Biologics

Read also: Pratik Pawar