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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 guideline Q11 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 est Intended to Provide additional clarification and to Promote convergence on the considerations for the selection and justification of starting materials and on the information Provided That shoulds be in permission marketing applications and / or Master Files. The focus of the Q & A document est one chemical entity drug substances.


ICH guideline is Q11 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 aussi Provides guidance on what information shoulds be Provided in Module 3 of the Common Technical Document (CTD) 3.2.S.2.2 sections - 3.2.S.2.6 ( M4Q ICH). It addresses aspects of development and manufacture That pertain to drug substance, Including the presence of steps designed to Reduce impurities.


Quality Metrics Conformance Technical Guide

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 Metrics. Since publication of the Pharmaceutical cGMPs for the 21st Century in 2004, 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."


EMA pharmacovigilance system manual version 1.2

The EMA pharmacovigilance system is Described in this manual, qui EMA covers the 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.


Submission of Data Quality Metrics 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 be Useful to FDA aussi: 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 The Therefore, Mitigate Possibly, 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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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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BROWSER A3P is a tool comprising the majority of links to texts, guides, regulatory documents and websites for the pharmaceutical, biotechnology and biomedical.
  • GMP & Guides

  • Country Sites

  • Regulatory Sites

  • Pharma areas

  • other Sites

   version 1.00                                                                                                               youtube channel   linkedin