目录1。药物微生物学实验室能力的一般要求............................................................................................................................................................................................................. 3 2。Terms & Definitions ........................................................................................................................ 4 3.Personnel ......................................................................................................................................... 6 4.Environment .................................................................................................................................... 7 5.Microbial Limit test facilities ........................................................................................................ 13 6.Endotoxin test ................................................................................................................................ 14 7.Validation of test methods ............................................................................................................. 14 8.Equipment ..................................................................................................................................... 14 8.1 Maintenance of equipment ............................................................................................................ 14 8.2 Qualification .................................................................................................................................. 14 8.3 Calibration, performance verification and monitoring of use ....................................................... 15 9.试剂和培养媒体....................................................................................................................................................................................................................................................................................................................................................................................................................................................... 9.3 Labelling ........................................................................................................................................ 19 10.Reference materials and reference cultures ................................................................................... 19 11.Sampling ........................................................................................................................................ 20 12.Sample handling and identification ............................................................................................... 21 13.Disposal of contaminated waste .................................................................................................... 22 14.Quality assurance of results and quality control of performance .................................................. 22 15.Testing procedures ........................................................................................................................ 22 16.测试报告...................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................