[PDF] Mise en place dun système qualité pharmaceutique en conformité

What is ICH Guideline Q9 on quality risk management?

ICH guideline Q9 on quality risk management 1. Introduction Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries.

What is Q9 quality risk management?

1 Guidance for Industry1 Q9 Quality Risk Management This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.

What is the purpose of ICH Q8?

To identify risks which should be communicated between inspectors and assessors to facilitate better understanding of how risks can be or are controlled (e.g., parametric release, Process Analytical Technology (PAT)). reduce product and material defects; reduce manufacturing defects. To make use of the “design space” concept (see ICH Q8).

Is the ICH liable for the use of the document?

The document is provided "as is" without warranty of any kind. In no event shall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the document. The above-mentioned permissions do not apply to content supplied by third parties.