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ICH Q3D(R2)

Guideline for Elemental Impurities

The ICH quality guideline establishing permitted daily exposures (PDEs) and a risk-based approach for controlling elemental impurities in drug products. Q3D(R2) updated PDEs and added cutaneous and transcutaneous routes of administration.

LAST REVISED
April 2022
PRODUCT AREAS
SterileSolid DoseBiotechApi
SCOPE & APPLICABILITY

Drug products and their components across ICH regions. Implemented through the pharmacopoeias (e.g. USP <232>/<233>).

KEY REQUIREMENTS
  • 01Establish a documented elemental-impurities risk assessment
  • 02Control impurities to within route-specific PDEs
  • 03Justify analytical controls (e.g. ICP-MS)
IMPLEMENTATION TIPS
›Build the risk assessment from all components and the intended route, not just the API
REVISION NOTES

Q3D(R2) (2022) updated PDEs and added cutaneous and transcutaneous routes of administration.

ICH Q3D(R2): frequently asked questions

Quick answers to common questions about ICH Q3D(R2).

What is ICH Q3D(R2)?

ICH Q3D(R2) — Guideline for Elemental Impurities — is a guidance issued by the International Council for Harmonisation. The ICH quality guideline establishing permitted daily exposures (PDEs) and a risk-based approach for controlling elemental impurities in drug products. Q3D(R2) updated PDEs and added cutaneous and transcutaneous routes of administration.

Who does ICH Q3D(R2) apply to?

Drug products and their components across ICH regions. Implemented through the pharmacopoeias (e.g. USP <232>/<233>).

What are the key requirements of ICH Q3D(R2)?

ICH Q3D(R2) requires, among other things: Establish a documented elemental-impurities risk assessment; Control impurities to within route-specific PDEs; Justify analytical controls (e.g. ICP-MS).

When was ICH Q3D(R2) last updated?

The current version of ICH Q3D(R2) dates from April 2022. Q3D(R2) (2022) updated PDEs and added cutaneous and transcutaneous routes of administration.

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