ICH Guidelines Reference

This reference explains which guideline family is relevant to a MolTrace review and what the user should do with the threshold result.

Coverage

• Q3A(R2): organic impurities in new drug substances
• Q3B(R2): impurities in new drug products
• Q3C: residual solvents
• Q3D: elemental impurities
• M7(R2): mutagenic impurities
• Q2(R2) and Q14: analytical validation and development

Guideline tables and jurisdiction-specific language require regulatory-owner review before production publication.

Source verification workflow

Do not invent threshold numbers. For each guideline page, the regulatory owner must:

1. Download the current official guideline from ICH or the relevant agency site.
2. Extract the threshold table and page reference.
3. Record the effective date and document version.
4. Compare FDA, EMA, PMDA, and Health Canada interpretations where they differ.
5. Add a reviewer note explaining any MolTrace-specific implementation choice.

Threshold table template

Guideline	Context	Threshold type	Value	Source page	Reviewer
Q3A(R2)	New drug substance impurity	Reporting	TBD after source verification	TBD	Regulatory owner
Q3A(R2)	New drug substance impurity	Identification	TBD after source verification	TBD	Regulatory owner
Q3A(R2)	New drug substance impurity	Qualification	TBD after source verification	TBD	Regulatory owner
Q3C	Residual solvent	Class-specific limit	TBD after source verification	TBD	Regulatory owner
M7(R2)	Mutagenic impurity	Acceptable intake or control class	TBD after source verification	TBD	Regulatory owner

Jurisdiction comparison

Each jurisdiction note should answer:

• Does the agency use the ICH text directly or add local implementation guidance?
• Which submission sections or forms are affected?
• Are nitrosamine or mutagenic impurity expectations updated by separate guidance?
• What evidence does MolTrace show to justify the threshold used?

The published page must show the official source citation next to every numeric threshold.