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Guidance on IMPS and ISPMs Volume 10

This document supplements the "Detailed guidance on the request to the competent Authorities for Authorization of a clinical trial was medicinal product for human use, the notification of Substantial amendments and the declaration of the end of the trial (CT-1) '2 ('detailed guidance CT-1') and the "Detailed guidance on the application of size and documentation to be Submitted for implementation in year year Ethics Committee opinion on the clinical trial on medicinal products for human use"


Publication of the revised Annex 14 of the GMP guide as regards the manufacture of medicinal products Derived from Human Blood or Plasma

Today, the unit in charge of pharmaceuticals launches the publication of the revised Annex 14 of the GMP guide on the manufacturing of medicinal products Derived from Human Blood or Plasma
The Annex has-been revised in the light of Directive 2002 / 98 / EC and relevant Implementing guidelines setting standards of quality and safety for the collection and testing of human blood and blood components for all uses, Including the manufacture of medicinal products.

Deadline for coming into operation: November 30 2011

Download Annex 14.pdf



Annex 11: Computerised Systems

This annex forms Applies To all of Computerised systems used as a share of GMP regulated
activities. A Computerised system is a set of software and hardware components Which
Fulfill some Functionalities together.

Deadline for coming into operation: June 30 2011

Download Annex 11.pdf



ICH guideline on development and manufacture Q11 of drug substances

This guideline Describes Approaches to Developing process and drug substance understanding and aussi Provides guidance on what information shoulds be Provided in CTD sections 3.2.S.2.2 - 3.2.S.2.6. It further Top Provides clarification on the principles and concepts Described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) As They pertain to the development and manufacture of drug substance.

Consultation end date: 01 / 09 / 2011

ICH guideline Q11.pdf


European GMP vol4

Download the .pdf file


These notes are intended to provide guidance on the recommended contents of the "Site Master File."

Requiring a "Site Master File" is referenced in the chapter of the GMP Guide 4

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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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