Implementation strategy of ICH Q3D guideline EMA Draft

The purpose of this document is to describe the practical implementation of ICH Q3D Guideline for 9 Elemental Impurities in the European context.

In the ICH Q3D Guideline for elemental impurities, the focus of the control of elemental impurities is shifted compared to the CHMP Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents synthesis of the active substance. The former acknowledges that this is one of the most important sources of elemental impurities, but also takes into account other sources and therefore includes elements not used as catalysts and reagents. The latter guideline focuses on control of metals intentionally added during the synthesis of the active substance.

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Elemental Impurities in Drug Products FDA Draft Guidance

This draft guidance provides recommendations regarding the control of elemental impurities of human drug productsmarketed in the United States consistent with implementation of International Council for Harmonisation (ICH) guidance for industry Q3D Elemental Impurities.This draft guidance will also assist manufacturers of compendial drug products in responding to the issuance of the United States Pharmacopeia (USP) requirement for the control of elemental impurities 

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Quality Metrics Technical Conformance Guide FDA Draft Guidance

This Quality Metrics Technical Conformance Guide (Guide) serves as the technical reference for implementation of the draft FDA guidance for industry on Request for Quality MetricsSince publication of the Pharmaceutical CGMPs for the 21st Century in 2004,2 CDER has continued to promote its vision of “a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.” 

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Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development FDA Draft Guidance

This document provides guidance to industry and FDA Staff on the underlying principles of human factors (HF) studies during the development of combination products as defined under 21 CFR Part 3. This guidance describes Agency recommendations regarding HF information in a combination product investigational or marketing application and clarifies the different types of HF studies; the recommended timing and sequencing of HF studies; and how HF studies are part of the process to maximize the likelihood that the combination product user interface is safe and effective for use by the intended users, uses, and environments. In addition, the guidance describes how HF studies relate to other clinical studies. The guidance also provides process considerations for HF information in investigational or marketing applications to promote development and timely review of safe and effective combination products.

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Applying ICH Q8(R2), Q9, and Q10 Principles to Chemistry, Manufacturing, and Controls Review (FDA)

The International Council on Harmonisation (ICH) “Q8(R2) Pharmaceutical Development,” published November 20, 2009, provides information on how to present knowledge gained when applying scientific approaches and quality risk management for developing and manufacturing a product. The annex in ICH Q8(R2) further clarifies key concepts outlined in the original guidance published in June 2006 and describes the principles of quality by design (QbD). Some of the information described in ICH Q8(R2) represents the minimum amount of information the applicant should provide in an application. “Enhanced” or QbD approaches as described in ICH Q8(R2) are encouraged. 

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