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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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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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Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development FDA Draft Guidance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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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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L’Association A3P est un acteur incontournable de l’industrie pharmaceutique et biotechnologique. 
Créée en 1986, elle contribue au bon développement de la production de médicaments et de matériels propres et stériles, elle anime un réseau de 21 000 professionnels, fabricants et fournisseurs, dans le cadre de Congrès internationaux et de journées techniques.

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