高标准 standard (Good Manufacturing Practice) is to ensure the quality of medicines prescribed under continuous production system. It is to reduce drug production process to minimize the risk of failure and concluded. 高标准 contains all aspects of requirements, from the plant to the ground, equipment, personnel and training, health, air and water purification, production and documentation. "高标准" Good Manufacturing Practice is the English abbreviation, in Chinese means "Good Manufacturing Practices", or "Good Manufacturing Practice" is a particular emphasis on product quality and the implementation of the autonomy of health and safety management system in the production process . Principle requires validation rules to implement 高标准 certification verification, process validation has the following specific requirements: 1, the key process should be reviewed prior to verification or validation; 2, before the new process of order or a new preparation method, you should verify their routine Applicability of production; the use of certain specified materials and equipment to determine the production process should be able to consistently and production to meet the quality requirements of the product. 3, the production process of major changes must be verified; 高标准 workshop construction material 1. purification plant wall, the top sheet generally use more steel plate 50mm thick sandwich of color, which is characterized by beautiful, strong rigidity. Arc corner, doors, window frames and other general uses special aluminum oxide manufacture. 2. ground can be used epoxy artesian Ping Ping or advanced wear-resistant plastic flooring, anti-static requirements, the choice of anti-static type. 3. The return air duct made of hot galvanized plate, attached to purify the insulation effect good flame retardant foam plastic plate PF. 4. HEPA stainless steel frame, beautiful and clean, perforated metal mesh plate with aluminum paint, no rust dust free, appropriate cleaning. 高标准 clean room purification parameters: ventilation frequency: 100 000 ≥15 times; 10000 ≥20 times; 1000≥30 times. Pressure: the main workshop adjacent to the room ≥5Pa average wind speed: 10, 100 0.3-0.5m / s; winter temperatures> 16 ℃; summer <26 ℃; fluctuation ± 2 ℃. Humidity 45-65%; 高标准 powder workshop humidity around 50% is appropriate; electronic workshop slightly higher humidity to avoid static electricity. Noise ≤65dB (A); fresh air replenishment is 10% -30% of the total air volume; illumination 300LX.