TestingandInspection(cGMP培训系列8)教学提纲.pptVIP

TestingandInspection(cGMP培训系列8);General Requirements基本要求;总要求;Receipt and storage of untested components, drug product containers, and closures接受未经测试原料;Receipt and storage of untested components, drug product containers, and closures原料接收;未检验的成份、药品容器和密封件的接收与贮存;Testing and approval or rejection of components, drug product containers, and closures测试;Testing and approval or rejection of components, drug product containers, and closures测试;成份、药品容器和封口物品的试验、批准或拒收;(c) Samples shall be collected in accordance with the following procedures: (1) The containers of components selected shall be cleaned when necessary in a manner to prevent introduction of contaminants into the component. (2) The containers shall be opened, sampled, and resealed in a manner designed to prevent contamination of their contents and contamination of other components, drug product containers, or closures. (3) Sterile equipment and aseptic sampling techniques shall be used when necessary. (4) If it is necessary to sample a component from the top, middle, and bottom of its container, such sample subdivisions shall not be composited for testing. (5) Sample containers shall be identified so that the following information can be determined: name of the material sampled, the lot number, the container from which the sample was taken, the date on which the sample was taken, and the name of the person who collected the sample. (6) Containers from which samples have been taken shall be marked to show that samples have been removed from them. ;How do you clean the containers of components? How do you verify it is clean? During the operation, how do you control contamination ? Do you identify sample containers so that the following information can be determined: name of the material sampled, the lot number, the container from which the sample was taken, the date on which the sample was taken, and the name of the person who collected the sample? ;收集样品程序;Do you do identity test for each component for drug? D