1. Problems in laboratory management
1. There are some reagents in the reagent room that require cool and dry storage, but there is no thermometer and hygrometer.
2. Some reagents have expired.
3. The inspection items of the commissioned inspection agreement do not conform to the quality standards of the products produced.
2. Problems with plant and facilities
1. The powder filling room is not isolated from the cream workshop, and it lacks dust collection facilities and electrical explosion-proof facilities.
2. There is no transfer window or buffer room between the inner packaging material clean room (non-clean area) and the clean filling room.
3. Problems with material and product management
1. The registration of raw materials used does not use INCI and standard Chinese names correctly.
Four, there are problems in the production process
1. Product batch production records are not standardized, and the preparation and records of production process related parameters are incomplete.
2. The dynamic operation of the clean room purification level fails to meet the design requirements (such as positive and negative pressure difference).