Design and build a biopharmaceutical factory according to GMP standard

[technical article of chinapharma.com] as a pharmaceutical manufacturer, when designing, constructing and verifying new plant facilities or transforming existing plant facilities, it is necessary to consider meeting the requirements of the new GMP specification Take biopharmaceutical factory as an example In the design and construction of biopharmaceutical factory, equipment configuration and moving line, aseptic operation, quality control, quality assurance and regulations, biosafety, biological waste treatment should be considered, and the production of biopharmaceutical can cooperate with the operation of pharmaceutical factory Relevant experts said that the design, construction and verification of biopharmaceutical plants should meet the requirements of GMP audit Specifically, the process equipment is based on the principles of advanced nature, practicability, economy and reliability, and it is necessary to purchase advanced and key process equipment and improve the production technology level of enterprises The overall design of the plant area shall ensure clear division, reasonable layout, smooth process flow, avoid cross flow of logistics and people, and meet the requirements of fire protection, planning, labor safety and health and environmental protection Engineering design should pay attention to energy conservation, environmental protection and fire control measures Environmental Engineering implements the "three Simultaneities" principle of simultaneous design, construction and production of main works In terms of site selection, design, layout, construction, transformation and maintenance, the plant must meet the requirements of drug production, and be able to avoid pollution, cross contamination, confusion and errors to a large extent, so as to facilitate cleaning, operation and maintenance In addition, relevant enterprises should consider the site selection comprehensively according to the plant and production protection measures, and the plant environment should be able to reduce the risk of material or product pollution to a large extent Therefore, the enterprise should have a clean production environment; the ground, road surface and transportation of the plant area should not cause pollution to the production of drugs; the overall layout of production, administration, living and auxiliary areas should be reasonable and should not interfere with each other; the direction of people and logistics in the plant area and plant should be reasonable In the process design of biopharmaceutical plants, there are also many points that need attention, because the process flow of biopharmaceutical production is becoming more and more complex, the variety and specification of raw materials used are various, and it is easy to cause mistakes and cross contamination of products Therefore, the process layout of clean workshop is also very important In order to prevent the mixture and cross pollution between people flow and logistics, four basic requirements are put forward in the process standardization design of biopharmaceutical plant: setting up the import and export channels of personnel and materials respectively; personnel and materials entering the clean production area should have their own purification rooms and facilities; only necessary process equipment and facilities should be set in the production operation area; The elevator for transporting personnel and materials should be separated Elevators should not be located in clean areas In addition, the layout of clean room, layout of auxiliary production room and cleanliness level are also specified Because the pharmaceutical industry clean workshop can meet GMP requirements, personnel purification is a key link Among the many pollution sources, human is the big one When people enter the clean area, if they do not carry out purification or the purification effect is not good, a large number of particles and microorganisms will be substituted, which will seriously affect the air cleanliness of the clean area When designing biopharmaceutical plants, relevant enterprises should also consider these matters, including product demand and risk assessment; key process steps; product protection and pollution avoidance; hazards / risks and personnel protection; environmental pollution control methods; sterile product process category; open or closed production; overall design of plant facilities; production area and HVAC system At present, China's new GMP has put forward higher requirements for plant facilities, such as the design and layout requirements for the powder production area, storage area, quality control area and auxiliary area of plant facilities At the same time, it also requires drug manufacturers to confirm whether the new plant or transformation, equipment selection, design meets the requirements and GMP requirements, so as to avoid blindness Sex, thus increasing the scientific nature For drug manufacturers, in the face of these regulations, when designing, constructing and verifying new plant facilities or transforming existing plant facilities, enterprises must consider meeting the requirements of the new GMP specification, which is particularly important in the process of understanding and implementing the certification.