Man-machine material method refers to the effective management of the environmental requirements of people, machines and raw materials in GMP (Good Manufacturing Practices) to ensure the quality and safety in the production process. This paper will introduce the content of man-machine material law ring from three aspects: man, machine and raw materials.
I. Human environmental requirements
In GMP, human environmental requirements mainly include personnel training and health status management. First of all, personnel engaged in production must receive necessary training, including training in quality standards, operating procedures and safety measures during production. Only with the necessary knowledge and skills can we ensure the quality and safety in the production process.
Human health is also very important. In the production process, any person suffering from infectious diseases or other diseases that may affect the quality of products shall not engage in production work. In addition, personnel engaged in specific operations, such as those exposed to toxic substances or susceptible to microorganisms, need special health management, such as regular physical examination and health monitoring.
Second, the environmental requirements of the machine
In GMP, the environmental requirements of machines mainly include the selection, maintenance and calibration of equipment. First of all, for the equipment used in the production process, we must choose the equipment that meets the quality standards and can meet the production requirements. The selection of equipment should be based on full demonstration and verification to ensure its stable and reliable production.
It is also very important for the maintenance and calibration of equipment. The equipment should be maintained regularly to maintain its normal operation. At the same time, the calibration of equipment also needs to be carried out regularly to ensure the accuracy and reliability of its measurement results. Only when the equipment is in normal operation can the quality and safety in the production process be guaranteed.
Third, the environmental protection requirements of raw materials
In GMP, the environmental requirements for raw materials mainly include the selection, storage and use of raw materials. First of all, the raw materials used in the production process must meet the quality standards and meet the requirements of the products. The selection of raw materials should be based on full demonstration and verification to ensure its stable and reliable quality.
It is also very important for the storage and use of raw materials. Raw materials should be stored in qualified environment to avoid pollution or deterioration. When using raw materials, it should be carried out in accordance with the prescribed procedures to ensure that the raw materials used meet the requirements and will not affect the product quality.
Man-machine material method is a very important content in GMP. By effectively managing the environmental requirements of people, machines and raw materials, the quality and safety in the production process can be ensured. Only under the good man-machine material method can enterprises produce products that meet the quality standards and meet the needs of consumers. Therefore, enterprises should strictly abide by the requirements of man-machine material law in the production process to ensure the controllability and stability of the production process and improve the quality and safety of products.