Affichage #
Titre Date de publication
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventin Cross-Contamination 13 mai 2013
EudraGMP Database now also comprises GDP Information 25 avril 2013
Revision of the EU GMP Guide : EU Commission Proposal for Chapter 6 - Quality Control 25 avril 2013
Importation of active substances for medicinal products for human use 25 avril 2013
HAS Description de la régulation de la promotion des produits de santé en France 11 avril 2013
CDER / CBER Guidance Formal Dispute Resolution: Appeals Above the Division Level 11 avril 2013
ICH M7 Assessment And Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk 12 mars 2013
Good Distribution Practice of Medicinal Product for Human Use - Mars 2013 12 mars 2013
USP 39(2) In-Process Revision (Mar-Apr 2013) 8 mars 2013
Guideline on the principles of Good Distribution Practices (GDP) for active substances for medicinal products for human use 15 février 2013
Guideline on the formalised risk assessment for ascertaining the appropriate GMP for excipients of medicinal products for human use 15 février 2013
L’ANSM installe ses commissions et ses groupes de travail 12 février 2013
L'ANSM rend public son programme de travail pour 2013 12 février 2013
Revision of EU Commission guidelines on Good manufacturing Practice Medicinal Products 25 janvier 2013
21 CFR Part 4 Current Good Manufacturing Practice Requirements for Combination Products 23 janvier 2013
Guidance for Industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA 23 janvier 2013
Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products 23 janvier 2013
USP : 39(1) In-Process Revision 17 janvier 2013
EMA : Reflection paper on medicinal product supply shortages caused by GMP Compliance problems 17 janvier 2013
PIC/S GMP GUIDE PE 009-10 (Revision Chapter 4 & Annexes 6, 7 11 and 13) 19 décembre 2012

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