药厂GMP文件-水检测.doc

Title: WATER MONITORING SOP: 题目: 水的监测 编号: 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1. 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。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 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. 3. 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4. SAFETYNone. 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 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 Monitoring 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12. 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 to test and assessment.纯化水: 按照质量标准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, its 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, assessment according to Chinese 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。 City water: monthly take the sample from city water point and test TAC,total coliforms.城市用水：每月从城市饮用水取样点取样并检测总菌数和大肠菌群。 Lab purified water: monthly take the sample from laboratory purified water point and test TAC.实验室纯化水: 每月从实验室取样点取样并检测总菌数。5.3.2. Sampling 取样1. Requirements: Sterilised 100,500, 1000 mL media bottle with cap; Plastic bucket; 70% alcohol; Gloves.取样需要用：经过灭菌的100, 500, 1000 毫升带盖培养瓶；塑料桶；浓度为70%的乙醇；手套。2. See table 1 for location of sampling points 取样点的位置见表13. NOTE: Before and during sampling care must be taken to avoid contamination of the sample.注意: 在取样前和取样过程中，要特别注意避免使样品受到污染。4. Sanitise the outside of the sampling point with 70% alcohol.用浓度为 70% 的乙醇消毒取样点的外部。5. Allow sanitising alcohol to evaporate.让用于消毒的乙醇自然挥发。6. 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 microbial 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微生物污染物被完全冲出来。7. Holding the media bottle near its base, bring close to the flowing stream of water.托住培养瓶靠瓶底的部位，将培养瓶靠近水流。8. Remove the cap sufficiently to allow the collection of the sample and place the media bottle under the flowing stream. 完全打开盖子以便于样品的采集，将培养瓶的瓶口置于水流下。9. Replace the cap of the bottle immediately the sampling is complete.在取样结束后，立即盖上瓶盖。10. Label the sample with date and sampling point.在瓶身上贴上标签，写明取样日期以及取样点。11. Sanitise the sampling point with 70% alcohol again.用70%的酒精将取样点再次消毒。5.3.3. Testing检测1.Microbiological analysis should commence within 1 hour of sampling. If this is not possible, the sample must be immediately stored in a refrigerator (2 to 8 deg C) and analysis must commence within 24 hours of sampling.微生物分析应在取样后的1小时内进行。如果不能按上述要求执行，则需立即将样品放入冰箱内(2 至 8C)保存，且必须在取样后的24小时内做测试分析。2. For purified water纯化水:According to Specification SN-RM001 and Test Method TM-0003 to test and assessment.按照质量标准*和试验方法*的要求进行试验和判定。3. For softened water软化水Test method: according to Test Method TM-0003 to do total viable aerobic count.实验方法：按照试验方法TM-0003中总菌数测定的方法进行总菌数的检测。 Limit: no limit has been established currently, but the trend has to be monitored. 限度：目前还无限度，但必须监测其趋势。4. For city drinking water城市饮用水According to Specification SN-RM001 and Test Method TM-0003 to test and assessment.按照试验方法TM-0003和质量标准SN-RM001 的要求进行试验和判定。5.4. Documentation 文件5.4.1 Record the all test on the logbook or record sheet. 将实验记录于实验记录本或表上。5.4.2 All the results must be trended and analysis regularly 所有的结果必须定期做趋势分析.5.4.3 Any OOS must be immediately communicated to the QO and Engineering managers and an investigation should start. 任何超出质量标准的结果必须立即报告给质量部经理和工程部经理，同时应开始调查。If the OOS appear on microbiological monitoring of purified water from purified water plant and investigation show that it is not caused by laboratory error, microbiologist must immediately notice engineering department to sanitize the PW system as below:Out of alarm limit , sanitization at 85 30 minutes.Out of alarm limit 3 times or out of action limit , sanitization at 121 20 minutes.如果制水车间纯化水的微生物监测出现超标结果且调查结果表明没有实验室错误，微生物主管应立即通知工程部对纯水系统进行消毒如下：超出警告限, 系统应于85 消毒30分钟.连续超出警告限三次或超出行动限一次，系统应于121 消毒20分钟.If the OOS appear on microbiological monitoring of laboratory purified water, the purified water system must be sanitized according to sop S-QC052.如果实验室纯化水监测结果超出限度，按照标准操作规程*对实验室纯化水系统进行消毒.If the OOS appear on microbiological monitoring of city water, the reserve tank and the pipeline must be sanitized with free active chlorine 0.05 mg/L (measured at the sampling point TW-01).如果城市饮用水监测结果超出限度，其贮罐及输送管道必须用0.05毫克/升（在TW-01取样点测试的）的游离活性氯进行消毒。Table 1. Location of Sampling Points 表1. 取样点的位置sampling Point取样点Location & description 位置及描述Room No.房间号UP1UP2UP3UP4UP5UP6UP7UP8Softened water软化水LP1 LP2City drinking wate