COVID-19 Prompts WHO To Propose Revisions To GMPs For Investigational Drugs Guideline
WHO Also Proposes GMPs For R&D Facilities
Accelerated development of COVID-19 products prompts World Health Organization to revise a guideline on good manufacturing practices for investigational drugs and propose a new guideline applying GMP principles to R&D facilities.
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The WHO proposes to revise 2011 guidance on technology transfers to ease the hand-off of COVID-19 drugs and vaccines from research and development facilities to commercial sites.
Agency describes criteria for waiving routine prequalification inspections for existing drugs and vaccines as well as new products in light of COVID-19.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”