The concept of GMP

'Good Manufacturing Practices for Drugs', also known as 'Best Production Process Specifications', English name: GOOD Manufacturing Practices for Drugs, abbreviated as GMP. Production plants, facilities, buildings, equipment, warehousing, production process, quality management, process hygiene, packaging materials and labels, and a complete set of management systems to ensure the quality of medicines, as well as the storage and sales of finished products. In short, the basic point of GMP is that in order to ensure the quality of medicines, it is necessary to prevent mixed batches, mixed contamination and cross-contamination of medicines in production. The basic content of GMP involves personnel, plant, equipment, sanitary conditions, starting materials, production operations, packaging and labeling, quality control systems, self-inspection, sales records, user opinions and adverse reaction reports. In terms of hardware, there must be an environment, workshop, and equipment that meet the requirements; in terms of software, there must be reliable production processes, strict management systems, and perfect verification systems. Its main contents are summarized in the following aspects. Well-trained - suitable production personnel and management personnel - qualified workshops, facilities and equipment - raw materials and packaging materials verified by experience - reliable production methods - perfect monitoring measures - strict after-sales service Yes - management system At present, GMP has been widely implemented in most countries and organizations in the world, and the regulations on air cleanliness in the process of implementing GMP in various countries and organizations have similarities and differences. For any air cleanliness level, GMP not only stipulates the maximum allowable number of dust particles, but also specifies the maximum allowable number of microorganisms. The number of dust particles is controlled to be greater than or equal to the upper limit of 0.5 μm, and the number of microorganisms is controlled to the upper limit of the number of planktonic bacteria per meter. The name of the EU GMP air cleanliness grade is different from that of China's GMP. It is generally believed that the EU's Claaa A and Claaa B are equivalent to China's 100 grade; Claaa C is equivalent to China's 10,000 grade, and Claaa D is equivalent to China's 100,000 grade. Claaa A and Claaa B are Class 100, but generally B reflects the clean room, and A refers to the more stringent local purification area. The number of air cleanliness levels is different. China's GMP air cleanliness levels are divided into four levels: 100, 10000, 10000, and 300,000; Japan's is divided into three levels: 100, 1000, and 100,000; the US FDA is divided into 100 and 100,000. Two grades; the EU has four grades A, B, C, and D. China's GMP requires static testing and dynamic monitoring, while Japan and the United States require dynamic compliance, which stipulates dynamic testing indicators; while the European Union stipulates the number of dust particles in both dynamic and static states, and the number of fungi only specifies dynamic testing. index.