This document presents a process to assess and control elemental impurities in the drug product using the principles of risk management as described in ICH Q9. This process provides a platform for developing a risk-based control strategy to limit elemental impurities in the drug product.

3D(R1) Revision of the Cadmium Inhalation PDE Endorsement by the Members of the ICH Assembly under Step 2 and release for public consu.

By harmonizing the regulatory expectations in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized...

Q3D Extractor calculates the parasitic parameter of frequency-dependent resistance, inductance, capacitance and conductance (RLCG) for electronic products. It is ideal for designing advanced electronics packages and connectors used in high-speed electronic equipment.

The current Q3D (R2) Guideline reached Step 4 in April 2022, and included a correction of PDEs for Gold, Silver and Nickel; Gold and Silver monographs; and an addition of limits for elemental impurities by the cutaneous and transcutaneous route.

ICH Q3D contains recommendations on applying a risk-based approach to control elemental impurities and permitted daily exposure (PDE).

This guidance provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with implementation of International Council for...

Sep 15, 2022 · The guidance revises the guidance for industry “Q3D (R1) Elemental Impurities” issued in March 2020 to provide Permissible Daily Exposures (PDEs) for the cutaneous and transcutaneous routes of administration.

Applicants should refer to regional guidance/recommendations or best practice for managing and labeling of allergens. The new Appendix 5 to the ICH Q3D Guideline applies to cutaneous and transcutaneous drug products whether intended for local or systemic effect.

For questions regarding this draft document, contact (CDER) Tim McGovern 240-402-0477.