Quality metrics for pharma manufacturing is back in a big way, with FDA pledging to 'objectively rate' firms
After the FDA signaled an interest last month in returning to its hotly-contested quality metrics program for pharma manufacturers, the agency this week outlined what it wants to do while pledging a public workshop in May and an adcomm later this year.
While the nitty gritty on these metrics may be more than a year from fleshing out, a new white paper outlines the FDA’s tentative plans, explaining how transparent “Quality Management Maturity” ratings could empower manufacturers to identify ways to improve the effectiveness of their quality systems.
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