药厂GMP文件-水检测辩析.doc

Prepared by?准备者 Reviewed by 审阅 Approved by 批准 Microbiology Analyst 微生物分析师 QC Manager 质量控制经理 IQC Manager 质量部经理 Name: 姓名： Name: 姓名： Name: 姓名： Date: 日期： Date: 日期： Date: 日期： Sign: 签名： Sign: 签名： Sign: 签名： Documentation that may be affected: 其他可能受到影响的文件: Specification SN-RM001 Water for pharmaceutical purpose 质量标准SN-RM001制药用水 Test Method TM-0003 Water for pharmaceutical purpose 实验方法TM-0003制药用水 Unmodified Review History: 无变更的复审记录: Reviewed By/ Date 复审/日期 Approved by IQC Manager/ Date 质量部经理批准/日期 Next Review Date 下次复审日期 Affected Department / Area?: 受影响的区域/部门: IQC Manager 质量部经理 Microbiology 微生物 QC 质量控制 QA 质量保证 PURPOSE 目的 To define the requirements for the monitoring of water used for pharmaceutical purpose to ensure product quality is not compromised. 描述了药品制药用水监控的要求，以确保产品质量不受影响。 SCOPE 范围 This procedure covers the water sampling and monitoring in APB, including purified water, softened water as well as city water. Purified water includes that produced by the Stilmas system located at the purified water plant and produced by Pall PureLab system located and used in laboratory. 此规程应用于制药公司水的取样和监测，包括纯化水，软化水和城市饮用水。纯化水包括纯化水车间Stilmas系统制成的纯化水和由实验室Pall PureLab系统制成的实验室使用的纯化水. DEFINITIONS/ABBREVIATIONS 定义 / 缩写 UP – user point, 使用点 LP – loop point, 回路点 TOC – total organic carbon 总有机碳 TAC – total aerobic count总菌数 SAFETY None. 无 PROCEDURE 程序 Responsibilities 责任 The Quality Operations Manager is responsible for: 质量部经理负责如下事项： ( Ensuring that this SOP complies with local and corporate GMP standards. 确保本SOP符合当地和公司的GMP 的标准。 ( Ensuring completion of the SOP Training Record attached to this SOP (Attachment 1). 确保完成附在本篇SOP后面的SOP培训记录(附件1)。 The Microbiologist is responsible for: 微生物实验室人员负有如下责任： ( Sampling and monitoring the water for microbe 为微生物测试采集纯水水样及监测。 The QC Analyst is responsible for: 质量控制分析员负有如下责任: Sampling and monitoring the water for chemical 为化学测试采集纯水水样及监测。 Physical Chemical Tests 物理和化学检测 Monitoring Plan:监