Resultado de búsqueda
The ICH Q2(R2) revised Guideline and the Q14 Guideline reached Step 4 of the ICH process on 1 November 2023. The Q2(R2)/Q14 EWG developed a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revised the ICH Q2(R1) Guideline on Validation of Analytical Procedures.
- Ich
ICH Harmonisation Activities. Process of Harmonisation;...
- Quality Guidelines
Quality Guidelines. Harmonisation achievements in the...
- QUALITY RISK MANAGEMENT Q9(R1)
ICH Q9(R1) Guideline 3 64 accordance with official guidance...
- Ich
ICH: quality. The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
6 de ene. de 2008 · ICH Q10 Pharmaceutical quality system - Scientific guideline. Human Scientific guidelines. This document describes a model for an effective quality management system. It applies to the development and manufacture of pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.
This document establishes a new ICH tripartite guideline describing a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. Throughout this guideline, the term “pharmaceutical quality system” refers to the ICH Q10 model.
