Refers to a process from the quality of personnel and production operators responsible for directing the quality control of pharmaceutical production to production plants, facilities, buildings, equipment, warehousing, production processes, quality management, process hygiene, packaging materials and labels, to the storage and sale of finished products. A complete management system to ensure drug quality.
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 to ensure the quality of medicines.
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 comments and adverse reaction reports. In terms of hardware, there must be reliable production technology, strict management system, and perfect verification system.
The GMP workshop requires process-oriented, and completes the process layout in close cooperation with other majors such as general drawing, civil engineering, equipment, installation, electric power, HVAC, external piping, etc.:
1) The production area should have enough plane and space, and there should be enough places to place equipment and materials reasonably, to prevent the mixing of intermediates of different drugs, and to prevent cross-contamination caused by other drugs or other substances;
①Store the raw materials to be inspected and the area of semi-finished products;
②Intermediate laboratory area;
③ Equipment cleaning area;
④ Cleaning tool room area;
⑤ Processing and processing area of raw and auxiliary materials;
⑥Store the area of unqualified raw materials and semi-finished products to be processed, so as to avoid wrong production;
2) There are corresponding measures to ensure that different operations are not carried out in the same area at the same time;
3) There should be anti-fouling measures between rooms with different cleanliness levels that are connected to each other;
4) There should be purification facilities and rooms suitable for the cleanliness level in the layout;
5) The storage area of raw and auxiliary materials, semi-finished products and finished products and packaging materials should be obvious, and the products to be inspected, qualified products and unqualified products should be stored in sufficient areas and strictly separated, and the distance between the storage area and the production area should be shortened as much as possible;
6) The flow of people and logistics in the whole workshop should be simple and reasonable, and avoid the flow of people and logistics;
7) The production areas of different production processes should be connected reasonably according to the sequence of the processes;
8) There should be a wide enough aisle, and the junction should be marked with signs to prevent mixing of drugs;
9) There should be a washing and drying room for sterile clothing (especially for the production or distribution of penicillin drugs), and should meet the corresponding air cleanliness requirements;
10) There should be a washing area for equipment and containers;
On the premise that the process conditions are met, the rooms with cleanliness requirements shall be arranged according to the following requirements:
1) The clean room (area) with high cleanliness level should be arranged in the place where the least people can reach, and should be close to the air-conditioning room;
2) Clean rooms (areas) with different cleanliness levels should be arranged from the inside to the outside according to the cleanliness level;
3) Clean rooms (areas) with the same air cleanliness level should be relatively concentrated;
4) The entry and exit of personnel and materials between rooms with different air cleanliness levels should have anti-pollution measures, such as setting up changing rooms, buffer rooms, transfer windows, etc.;
5) How to recycle the purified air in the clean room (area), and take effective measures to avoid contamination and cross-contamination;
6) The floor drain of the pool installed in the clean room (area) shall not pollute the medicine; the floor drain shall not be installed in the 100-level clean room (area), and the operator should not operate with bare hands. If it is unavoidable, the hands should be disinfected in time; The transmission equipment used in the 10000-level clean room (area) shall not pass through the lower-level area; the clean work clothes in the 100,000-level or higher area should be washed, dried, arranged in the clean room (area), and sterilized as required if necessary;
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