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EDQM Management of Documents and Records

Management of documentation and records is one of the pillars of a quality management system (QMS).

Several chapters of the ISO / IEC 17025 4.2 Management system, Document Control 4.3, 4.13 and 5.4.7 Control of records Control of data are dedicated to thesis topics.

Ce document replaces Guideline PA / PH / OMCL (97) 5 and the share of Guideline PA / PH / OMCL (07) 105 DEF related to the archiving of records.


Guideline on validation process for finished products - information and data to be Provided in Regulatory submissions

This guideline replaces the previous Note for guidance on process validation (CPMP / QWP / 848 / 96, EMEA / CVMP / 598 / 99). The guideline is brought` into line with ICH Q8, Q9 and Q10 materials and the possibility to use continuous process verification in addition to, or INSTEAD of, traditional process validation Described in the previous guideline has-been added and is Encouraged. This guideline Does not Introduce new requirements on medicinal products already authorized and on the market, aim Clarifies how companies can take advantage of the new possibilities Given When Applying enhanced process understanding coupled with risk management tools under an efficient quality system as described by ICH Q8, Q9 and Q10.


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.


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.


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.


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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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