防止交叉污染指南-总则(gmp)

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1、國際醫藥品稽查協約組織（PIC/S）藥品優良製造規範指導手冊（總則）GuidetoGoodManufacturingPractice（GMP）forMedicinalProducts（PartI）©PIC/SApril2007行政院衛生署中華民國九十六年八月i總則（PartI）目錄第一章品質管理（QUALITYMANAGEMENT）...........................1原則（PRINCIPLE）...................................................................................

2、.........................1品質保證（QUALITYASSURANCE）..............................................................................2藥品優良製造準則（GMPFORMEDICINALPRODUCTS）.......................................3品質管制（QUALITYCONTROL）.......................................................................

3、...........5產品品質檢討（PRODUCTQUALITYREVIEW）.........................................................6第二章人事（PERSONNEL）........................................9原則（PRINCIPLE）............................................................................................................9一般規定（GENERAL）.

4、.....................................................................................................9關鍵人員（KEYPERSONNEL）......................................................................................10訓練（TRAINING）.......................................................................

5、....................................12個人衛生（PERSONALHYGIENE）..............................................................................13第三章廠房設施與設備（PREMISESANDEQUIPMENT）................15原則（PRINCIPLE）.........................................................................................

6、.................15廠房設施（PREMISES）...................................................................................................15一般規定（General）...................................................................................................15生產區（ProductionArea）........................

7、.................................................................16儲存區（StorageAreas）.............................................................................................18品質管制區（QualityControlAreas）.................................................