The entire company is divided into production areas (synthetic areas and clean areas), auxiliary facilities, materials and office areas. The pedestrian and logistics channels are separated from each other. The company has 3 synthesis workshops and one clean area workshop, which is used for refining, drying and packaging of apis (cleanliness level: D).
RUI MING PHARMACEUTICAL
GMP standard plant
The production area is divided into synthetic area and clean area. The synthesis area covers 2700 square meters. An accompanying drying room for intermediates and raw materials is also set up in the synthesis area. The intermediates for external sale are dried, mixed and packaged in this area.
The intermediate production process does not use an air evolution system. The cleanliness level of the clean area is Class D. The air passes through a three-stage filtration system (primary filtration, medium filtration, high efficiency filtration). The operation room with large amount of dust in the clean area adopts straight row. The return air volume of the air purification system in the clean area is 30%. The disinfection method is ozone disinfection.
In order to prevent cross-contamination and ensure cleanliness, a buffer room is set up between the clean area and the general area; The pressure difference between the general area and the clean area is ≥10pa, the same cleanliness level, and the pressure difference of different functional rooms is ≥5pa.
RUI MING
Quality management is fundamental for RUI MING pharmaceutical and is implemented by all personnel in their daily activities.
Water system
The process water and cleaning water in the synthesis area are drinking water. QC samples are tested once a month according to internal control standards, and sent to CDC for testing once a year.
No water is used in the refining process for apis. Purified water is only used for cleaning equipment in clean areas. The purified water system uses two stage reverse osmosis to prepare purified water.
