Pharmaceutical water must meet quality standards – it participates in the entire pharmaceutical production process, including preparation, cleaning and disinfection. Therefore, pharmaceutical water is an important part of the pharmaceutical production process. It is necessary to ensure that the design contamination risk of pharmaceutical water in the preparation, storage and distribution system is controlled, and […]

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,