GMP workshop is a set of mandatory standards applicable to pharmaceutical, food and other industries, requiring enterprises from raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control and other aspects according to the relevant national regulations to meet the health quality requirements, the formation of a set of operational norms to help enterprises improve the health environment of enterprises, timely discovery of problems in the production process, to improve.

In brief, GMP requires that food production enterprises should have good production equipment, reasonable production process, perfect quality management and strict testing system to ensure that the quality of the final product (including food safety and hygiene) meets the requirements of regulations.

According to GMP regulations, plants and facilities are required to meet the following basic requirements:

1. Reasonable overall layout

GMP stipulates that the production area, administrative area, auxiliary area and living area of a drug production enterprise should be rationally distributed overall. The production area includes workshop, public system, storage area, quality control area and other areas. Administrative region refers to the area where employees of the enterprise carry out non-drug production work, such as: offices of administrative departments, conference rooms, etc. The auxiliary area includes the rest room, changing room, lavatory, maintenance room and other areas. Living area refers to the non-work activities of enterprise employees, such as: canteen, dormitory and so on. Planning personnel and logistics access to and from the plant and workshop. And shall not interfere with each other.

2. Clean production environment

GMP stipulates that drug manufacturers should have a clean production environment. General drug manufacturers will have 5S or even 7S management system. One of the S's is for neat. From the perspective of production management, a clean production environment is more conducive to employees to carry out various production activities and avoid abnormal occurrence than a dirty and bad production environment. This is the common sense of production management.

3. Hardening of factory floor

GMP stipulates that the ground, road and transportation of the factory should not cause pollution to the production of drugs. Exposed concrete is eroded by ultraviolet light, atmospheric composition and water chemical composition, usually after 3-6 months begins to weather, dust, sand, powder, flake off and so on. From a microscopic point of view, the pores of concrete will breed microorganisms that continue to corrode the steel bars, resulting in soft necrosis of concrete, fragmentation, falling off, pulverizing, etc. This will shorten the service life of concrete buildings and floors. Hardening treatment uses concrete floor hardeners to effectively penetrate deep into the concrete. The gel reaction with the free calcium component in the concrete forms a network structure in the void of the concrete, making the structure in the concrete more dense and tight, and the capillary pores are effectively closed. Avoid concrete dust precipitation from the surface gap. Thus a dust-free, dense, high strength, high wear resistance and a certain luster concrete floor is obtained. The hardened ground can be a good solution to sand, ash, cracking, peeling, empty drum and other situations.

4. Sufficient plant and space

GMP stipulates that the production workshop needs to have sufficient workshop and space. The author works in the enterprise have encountered such a situation: the production workshop because the design is unreasonable, resulting in the high-frequency use of room area, volume is too small, not convenient for production operation activities; Insufficient warehouse space, cold storage volume is too small. These conditions are not conducive to the management of enterprises to produce qualified drugs.

5. Maintenance of plant facilities

GMP stipulates that the responsibility of the production manager is to ensure the maintenance of the plant and equipment to keep it in good running condition; Production management regulations require that the plant should be properly maintained and that maintenance activities do not affect the quality of the drug. The premises shall be cleaned or disinfected as necessary in accordance with detailed written operating procedures.