GMP workshop refers to a set of management systems that ensure the quality of drugs from the quality of personnel and production operators responsible for guiding the quality control of drug production to the quality of production plants, facilities, buildings, equipment, warehousing, production processes, quality management, process hygiene, packaging materials and labels, to the storage and sale of finished products.

The basis of GMP is to ensure the quality of the drug, it must be done to prevent the production of about the batch, dye and cross contamination to ensure the quality of the drug.

The basic content of GMP involves personnel, plant, equipment, sanitary conditions, starting raw 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 a consistent environment, plant, equipment; In terms of software, it is necessary to have a reliable production process, a strict management system, and a perfect verification system.

GMP workshop is required to be process-oriented, and in close cooperation with other majors such as general drawing, civil engineering, equipment, installation, power, HVAC, external pipe and so on to complete the process layout:

1) The production area should have enough plane and space, and there should be enough place for reasonable placement of equipment and materials to prevent mixing between different drug intermediates and prevent cross-contamination caused by other drugs or other substances;

① Storage area of raw materials to be inspected and semi-finished products; 2 Intermediates laboratory area;

③ equipment cleaning area; ④ Area of cleaning tool room;

⑤ raw materials processing, processing area;

⑥ Storage of unqualified raw materials to be processed, semi-finished products of the area, 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-pollution measures between rooms with different cleanliness levels;

4) There should be purification facilities and rooms suitable for the cleanliness level in the layout;

5) The storage area of raw materials, semi-finished products and finished products and packaging materials should be obvious, the products to be inspected, qualified products and unqualified products should have enough areas for storage and strictly separated, and the distance between the storage area and the production area should be shortened as far as possible;

6) The flow of people throughout the workshop, logistics should be simple, reasonable, to avoid the flow of people, logistics mixed;

7) The production areas of different production processes should be reasonably connected according to the sequence of processes;

8) There should be a wide enough aisle, and the joint should be marked to prevent drug mixing;

9) There should be washing and drying rooms for sterile clothing (especially for the production or distribution of penicillin drugs), and meet the corresponding air cleanliness requirements;

10) There should be equipment and containers with washing areas;