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一. 前言Preface *********药业股份有限公司始创于1989年1 月，主要从事原料药及制剂的研发、制造、销售及相关服务活动。制剂大楼于2001 年建成，建筑占地面积1.1 万平方米，建筑面积2.2 万平方米。口服固体制剂车间（包括片剂和硬胶囊剂）位于制剂大楼内。车间建筑面积3500 平方米,其中洁净区面积2000 平方米，按10 万级净化标准设计建造；仓贮面积3500 平方米；公用机房等辅助用房建筑面积3000 平方米。固体制剂车间年设计生产能力片剂10 亿片、胶囊2 亿粒，从造粒到包装整条生产线全套引进国际先进设备，现生产盐酸帕罗西汀片、厄贝沙坦片及抗艾滋病药物奈韦拉平片等5 个产品（7 个包装规格，见附件一）。 ********* Pharmaceutical Co.,Ltd., established in January 1989, is devoted to the development, production, distributionand relative services, of API and Preparation. The preparation building area is11,000m2, floor space is 22,000m2 and area was built in2001. The oral solid finished dosage form workshop (including tablets and hardcapsules) is located in the building. The floor space of the workshop is 3,500m2, clean room area is 2,000m2, and it was designedand constructed according to class100, 000. The area of the warehouse is 3,500m2 while the floor spacefor utility room and auxiliary room is 3,000m2. The annually capacity is: 1 billion tablets,and capsules 200 million. The workshops which house the imported production lines,now produce 5 products including Paroxetine Hydrochloride, Irbesartan Tabletsand Nevirapine Tablets used for anti-AIDS (7 packing specifications, see appendix 1). 公司建立了完善的质量管理体系，厂房、设备等硬件设施按照cGMP要求设计和建造，物料、生产过程控制和销售均严格遵循cGMP 要求，确保产品质量。 The company has established:a quality assurance system. The facilityand equipments were designed and constructed according to cGMPs. The control ofmaterial, production and sales also comply with the cGMPs, as well as thecompany’s own product quality assurance policies. 厂内主要构成Main section in plant： 生产区、生产辅助区、仓储区及厂前区（见********厂区平面布置总图）。
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发表于 2014-12-1 20:42:20
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