Prepared by 准备者 | Reviewed by 审阅 | Approved by 批准 |
Microbiology Analyst可以了歌词 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： | 泡脚Name: 姓名： |
Date: 日期： | Date: 日期： | Date: 日期： |
Sign: 签名： | Sign: 签名： | Sign: 签名： |
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Documentation that may be affected: 其他可能受到影响的文件: Specification SN-RM001 Water for pharmaceutical purpo 质量标准SN-RM001制药用水 Test Method TM-0003 Water for pharmaceutical purpo 实验方法TM-0003制药用水 |
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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 |
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Affected Department / Area :
受影响的区域/部门致青春演员表:
陕西省大学排名IQC Manager 质量部经理 | |
Microbiology 微生物 | |
QC 质量控制 | |
QA 质量保证 | |
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1.
PURPOSE 目的
To define the requirements for the monitoring of water ud for pharmaceutical purpo to ensure product quality is not compromid.
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。
2. 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 ud 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.
3. DEFINITIONS/ABBREVIATIONS 定义 / 缩写
UP – ur 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
4. SAFETY
None. 无
5. PROCEDURE 程序
5.1. Responsibilities 责任
5.1.1. 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)。
5.1.2. 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。
5.1.3. 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。
5.2. Physical & Chemical Tests 物理和化学检测
5.2.1. Monitoring Plan:监测计划
♦ Purified water: take sample from LP2 at purified water plant and sampling point at lab Pall PureLab system研究生中期考核 on every Friday, Full test。Monitoring action will be postponed or be adjusted during Public Holiday period.
纯水：每周五，从纯化水车间的LP2点和实验室Pall PureLab制水系统的取样点取样进行全部项目的测试。遇法定节假日监控计划将顺延或调整。
♦ Softened water: monthly take the sample from softened water point and tests TOC, PH, Conductivity, and Hardness.
软化水：每月从软化水取样点取样并测试总有机碳，PH，电导率，硬度。
♦ City water: Once a year, all chemical tests are delegated to the laboratories of Beijing M
onitoring Station of the National Municipal Water Supply.
城市饮用水：每年一次，委托******实验室来进行所有化学项目的检测。
5.2.2. Sampling 取样
1. See table 1 for location of sampling points
取样点的位置见表1
2. Turn on the sampling point tap in maximum and allow water to flush through the tap at least 1 minute prior to sampling. This is to ensure that any contamination on the inside of the sampling point is thoroughly flushed out.
拧开取样点的水龙头至最大，让水流至少1分钟后再进行取样。这样做是确保使任何停留在取样点内部的污染物被完全冲出来。
3. Collect sample in a non-sterile 1000 mL sampling bottle.
用未消毒的规格为1000毫升的取样瓶采集样品。
4. Label the sample with date, time and sampling point.
在瓶身上贴上标签，写明取样日期，时间，以及取样点。
NOTE: When collecting the chemical test sample from the same sampling point as the microbiological test sample, take the chemical sample first.
注意: 在与微生物相同的取样点进行化学取样时，要系统变量先进行化学取样。
5.2.3. Testing 检测
1. Chemical analysis should be carried out promptly, if for any reason it is not possible, the samples must be held in the 2-8℃ refrigerator and analysis must commence within 24 hours.
化学测试分析应在取样后尽快完成，如有任何原因不能及时对样品进行检验分析， 应将样品贮存于2 到8度冰箱中并于24小时内进行分析实验。
2. For purified water, according to Specification SN-RM001 and Test Method TM-0003 t
o test and asssment.
纯化水: 按照质量标准实木床的款式SN-RM001和试验方法TM-0003的要求进行试验和判定。
3. For softened water：Test TOC, PH, Conductivity using the method as TM-0003, it’s no limit has been established currently, but the trend has to be monitored.
软化水：按照方法TM-0003测试总有机碳，pH，电导率, 无限度要求, 只记录实验数据监测趋势。
4. For city drinking water：All chemical tests are delegated, once a year, to the laboratories of Beijing Monitoring Station of the National Municipal Water Supply, asssment according to Chine standard GB5749-85 ‘Sanitary Standard For Drinking Water’
城市饮用水：所有的化学测试将每年一次，委托*****的实验室进行检测。其判定依据中华人民共和国国家标准GB5749-85 ‘生活饮用水卫生标准’执行。
5.3. Microbiological test 微生物监测
仁爱英语官网
5.3.1. Monitoring Plan:监测计划
♦ Purified water from purified water plant: take samples from LP1, LP2 and two using points on every Friday to do the full tests.(circulation the difference two using points weekly ). Monitoring action will be postponed or be adjusted during Public Holiday period.
制水车间纯化水：每周五，从LP1，LP2和二个使用点取样进行全部项目的测试(每周轮换二个不同的使用点)。遇法定节假日监控计划将顺延或调整。
♦ Softened water: monthly take the sample from softened water point and test TAC.
软化水：每月从软化水取样点取样并检测总菌数。
