《GMP基础培训》.pptVIP

The premises should accomplish with all requirements that GMP make on the location and design of the premises to prevention of the contamination. 1. Premises should be situated in an environment that, when considered together with measures to protect the manufacturing process, presents minimum risk of causing any contamination of materials or products. The land and buildings where the company is located will have an effect upon (que se vea en) the quality of the products 2. Premises should be carefully maintained, and it should be ensured that repair and maintenance operations do not present any hazard to the quality of products. The premises should be constructed with materials that not shedding particles. It should have surfaces smooth and impervious. 3. Premises should be cleaned and where applicable, disinfected according to detailed written procedures. False ceiling should be sealed. Walls, floors and ceilings without uncleanable recesses. 4. Premises should be designed and equipped so as to afford maximum protection against the entry of insects, birds or other animals. Animal houses should be isolated from all other areas with separate entry and air-handling facilities to prevent any risk of cross-contamination. 5. Materials and personnel should entrance trough the airlocks to avoid contamination. Material flow is shown on the plan of the factory as the routing of materials throughout the facility. It is important to show the status of the materials as well. This means indicating whether they are quarantined, approved or rejected, and also the volume, weight or frequency of movement, and the way in which the material is to be moved. Materials should flow in the direction of manufacturing. There should be no cross-flow of materials. All of this information is placed on the factory layout plan. A plan of the factory showing the routing taken by people when they enter the factory, when they move around in the factory from one department to another, and wh