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In recent years, the FDA (U.S. Food and Drug Administration) has found an increasing number of cGMP violations in terms of data integrity in its cGMP (current Good Manufacturing Practices) inspections. cGMP violations related to data integrity have led to a number of regulatory actions (including warning letters, import bans, and writs of acceptance). China’s […]

The 2010 edition of GMP (Good Manufacturing Practice for Pharmaceuticals) puts forward the following two requirements for the interior decoration of the clean room – the inner surface of the clean area (wall, ground, ceiling) should be smooth and smooth, without cracks, with a tight interface, no particulate matter falling off, to avoid dust accumulation,

More and more people are getting better and better treatment through drugs and medical devices – 50 drugs were approved in the US market alone in 2021, continuing the positive growth trend of recent years. However, compared with the achievements and commercial potential of pharmaceutical companies, the return of investors is not high, so it