These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: International Conference on Harmonisation; guidance on Q9 Quality Risk Management; availability. Notice.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2006 Jun 02; 71(106):32105-6. PubMed ID: 16795933.
    Abstract:
    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q9 Quality Risk Management."' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions.
    [Abstract] [Full Text] [Related] [New Search]