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Non-Penicillin Beta-Lactam Risk Assessment : A CGMP Framework



 This guidance describes the importance of implementing appropriate steps during the 20 manufacturing process to prevent cross-contamination of finished pharmaceuticals and active 21 pharmaceutical ingredients (APIs) with non-penicillin beta-lactam antibiotics.

This guidance 22 also provides information regarding the relative health risk of, and the potential for, cross23 reactivity in the classes of sensitizing beta-lactams (penicillins and non-penicillin beta-lactams). 24 This guidance is intended to assist manufacturers in assessing whether separate facilities should 25 be used based on the relative health risk of cross-reactivity.


Document.pdf

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Pharmaceutical Legislation: Eudralex CD version 24



Create your own CD with the whole Pharmaceutical Legislation (Human and Veterinary) and an integrated search engine.

The CD-Rom is similar to the EudraLex section of this web site, but it can be used off-line with the search engine. All the documents are in.pdf format and without protection.

For a non-commercial use, the CD-Rom may be duplicated and the documents may be printed
 
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pdf
 

eudralex_couverture_cd


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 manufacture 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 directives 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: 30 November 2011


 
Download Annex 14.pdf

pdf

 

Guidance on IMPS and NIMPs Volume 10



This document complements the: “Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a 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 format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use”
 
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pdf

ICH guideline Q11 on development and manufacture of drug substances



This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further 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

pdf



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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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