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Q11 Implementation Working Group Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers

Since the ICH Q11 guideline was finalised, worldwide experience with implementation of the recommendations on the development and manufacture of drug substances has given rise to requests for clarification relating to the selection and justification of starting materials. This Question and Answer (Q&A) document is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials and on the information that should be provided in marketing authorisation applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances.

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ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/ biological entities)

This guideline describes approaches to developing and understanding the manufacturing process of the drug substance, and also provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) sections 3.2.S.2.2 – 3.2.S.2.6 (ICH M4Q). It addresses aspects of development and manufacture that pertain to drug substance, including the presence of steps designed to reduce impurities.

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Quality Metrics Technical Conformance Guide

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 Metrics. Since publication of the Pharmaceutical CGMPs for the 21st Century in 2004, 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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EMA pharmacovigilance system manual Version 1.2

The EMA pharmacovigilance system is described in this manual, which covers the EMA organisational structure, responsibilities, procedures, processes and resources, appropriate resource management, compliance management and record management. This manual does not cover pharmacovigilance aspects related to veterinary medicines.

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Submission of Quality Metrics Data Guidance for Industry

Quality metrics are used throughout the drugs and biologics ndustry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be useful to FDA: to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.

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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.

Elle regroupe aujourd’hui plus de 1700 adhérents qui partagent leurs expériences techniques, scientifiques et réglementaires.

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