Reporting Requirements

MinorNo validation or comparability study required

Submitted in annual report

Example: Method modifications within the validated range

Any change in analytical methods within the validated range of an analytical method
ModerateValidation and comparability studies

Submit CBE-30[e]

Example: Change in mobile phase or gradient

Any change in analytical methods in exceeding the validated range of an analytic method
MajorValidation and formal statistical comparability studies

Requires a Prior Approval supplement

Example: Change from UV to MS detection

Any change in analytical methods that:

  • Establishes a new analytical method
  • Eliminates tests from the stability protocol
  • Deletes a specification or an analytical method
  • Alters the acceptance criteria of the stability protocol
Table 2.0 Reporting Requirements: The FDA expects that a drug developer reports all minor, moderate and major changes based on risk-based reporting categories.

This table is part of: “Evolving CMC Analytical Techniques for Biopharmaceuticals [Article]”
October 21, 2016 | Corresponding Author: Glenn Petrie | doi: 10.14229/jadc.2016.10.21.001

Received: August 19, 2016 | Published online October 21, 2016 | This article has been submitted for peer reviewed by an independent editorial review board.

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