14 février 2011

ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation

Endorsed by the ICH Steering Committee on 16 June 2011

Download / Télécharger le fichier .pdf

pdf

Quality PtC

Approval by the Steering Committee for Points to Consider on :

- Criticality of Quality Attributes and Process Parameters
- Control Strategy
- Level of Documentation in Enhanced (Qbd) Regulatory Submissions

Read more ...

Eudralex Volume 10 : Clinical Trials - Chapter V Guidance documents applying to clinical trials - Questions & Answers Document, Version 11.0 (May 2013)
Proposal for revision of the supplementary guidelines on Good Manufacturing Practices: validation, appendix 7: non-sterile process validation
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventin Cross-Contamination
EudraGMP Database now also comprises GDP Information
Revision of the EU GMP Guide : EU Commission Proposal for Chapter 6 - Quality Control
Importation of active substances for medicinal products for human use
HAS Description de la régulation de la promotion des produits de santé en France
CDER / CBER Guidance Formal Dispute Resolution: Appeals Above the Division Level
ICH M7 Assessment And Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
Good Distribution Practice of Medicinal Product for Human Use - Mars 2013