Global GMPs: How Much Faith Will U.S. FDA Put In Private Third-Party Audits?
This article was originally published in PharmAsia News
Executive Summary
Private and third-party audits may not replace U.S. FDA's typical inspection duties, but could help direct the agency to problematic facilities and relieve some of the inspection burden on those that already are compliant
You may also be interested in...
What Multinational Companies Need To Know About China's New GMP Regs - Webinar (Part 1 of 2)
SHANGHAI - Multinational pharma companies need to review their manufacturing practices to ensure full compliance with China's new GMP regulations, which went into effect March 1
What Multinational Companies Need To Know About China's New GMP Regs - Webinar (Part 1 of 2)
SHANGHAI - Multinational pharma companies need to review their manufacturing practices to ensure full compliance with China's new GMP regulations, which went into effect March 1
International "Comparability" Of Regulatory Standards May Be FDA's Solution To GMP Oversight
As the agency struggles to adapt to globalization of the pharmaceutical supply chain, exact harmonization of regulatory standards may not be a goal worth pursuing.