The steering committee of the International Conference on Harmonization and its expert working groups adopted Quality Guideline Q10 "Quality Systems" last week at a meeting in Portland, Oregon.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) recently closed consultation on its draft guidance, ICH Q10 ...
Provides a comprehensive understanding of the key elements required for a successful Pharmaceutical Quality System (PQS) implementation and ongoing maintenance of quality standards, based on ICH Q10, ...
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