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Implementation strategy of ICH guideline EMA Draft Q3D

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

In the ICH Guideline for Q3D 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 Gold Metal Reagents synthesis of the active substance. The form acknowledges That this is one of the MOST significant sources of elemental impurities, aim aussi takes into account --other sources and includes The Therefore Elements not used as Catalysts and reagents. The lath 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Elemental Impurities in Drug Products FDA Draft Guidance

This draft guidance Provides Recommendations Regarding the control of elemental impurities of human drug productsmarketed in the United States with consistent implementation of International Council for Harmonization (ICH) guidance for industry Elemental Q3D impurities.This Draft guidance will assist manufacturers of aussi Compendial drug products in Responding to the issuance of the United States Pharmacopeia (USP) requirement for the control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Quality Metrics Technical Guide Conformance FDA Draft Guidance

This Quality Metrics Conformance Technical Guide (Guide) reserves 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 ict vision of "a maximally efficient, agile, flexible manufacturing sector reliably That 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Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development FDA Draft Guidance

Ce 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 3 CFR Part. This guidance Describes Agency Recommendations Regarding HF information in a combination product marketing or investigational purposes and Clarifies the different kinds of HF studies; the recommended timing and sequencing of HF studies; HF studies and how are hand of the process to maximize the likelihood que la 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 relates to --other clinical studies. The guidance aussi Provides process considerations for HF information in investigational or marketing applications to Promote Timely development and 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 Harmonization (ICH) "Q8 (R2) Pharmaceutical Development," published November 20, 2009, provides information on how to present knowledge Gained When Applying scientific quality and risk management Approaches for Developing and manufacturing a product. The annex in ICH Q8 (R2) further Top Clarifies key concepts Outlined in the original guidance published in June and 2006 Describes the principles of quality by design (QbD). Some of the information Described in ICH Q8 (R2) Represents the minimum amount of information in the application covered shoulds Provide an application. "Enhanced" or QbD Approaches as described in ICH Q8 (R2) are Encouraged.

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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