EMA’s CHMP to monitor Genzyme manufacturing improvements
This article was originally published in The Gold Sheet
Executive Summary
At its May 17-20 monthly meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use requested Genzyme to carry out a risk assessment of its manufacturing processes, and to use that assessment to develop a detailed plan for improvement. The committee wants regular progress reports on implementation, it told Genzyme officials who made a presentation about the company's management and quality assurance systems at the meeting