藥廠GMP-水檢測.doc

Title: WATER MONITORING SOP: 題目: 水的監(jiān)測 編號: Prepared by準(zhǔn)備者Reviewed by 審閱Approved by 批準(zhǔn)Microbiology Analyst微生物分析師 QC Manager 質(zhì)量控制經(jīng)理 IQC Manager 質(zhì)量部經(jīng)理Name: 姓名： Name:姓名：Name: 姓名：Date:日期：Date:日期：Date:日期：Sign:簽名：Sign:簽名：Sign:簽名：Documentation that may be affected:其他可能受到影響的文件:Specification SN-RM001 Water for pharmaceutical purpose質(zhì)量標(biāo)準(zhǔn)SN-RM001制藥用水Test Method TM-0003 Water for pharmaceutical purpose實(shí)驗(yàn)方法TM-0003制藥用水Unmodified Review History:無變更的復(fù)審記錄:Reviewed By/ Date復(fù)審/日期Approved by IQC Manager/ Date質(zhì)量部經(jīng)理批準(zhǔn)/日期Next Review Date下次復(fù)審日期Affected Department / Area: 受影響的區(qū)域/部門:IQC Manager質(zhì)量部經(jīng)理Microbiology微生物QC質(zhì)量控制QA 質(zhì)量保證1. PURPOSE 目的To define the requirements for the monitoring of water used for pharmaceutical purpose to ensure product quality is not compromised.描述了藥品制藥用水監(jiān)控的要求，以確保產(chǎn)品質(zhì)量不受影響。2. SCOPE 范圍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.此規(guī)程應(yīng)用于制藥公司水的取樣和監(jiān)測，包括純化水，軟化水和城市飲用水。純化水包括純化水車間Stilmas系統(tǒng)制成的純化水和由實(shí)驗(yàn)室Pall PureLab系統(tǒng)制成的實(shí)驗(yàn)室使用的純化水. 3. DEFINITIONS/ABBREVIATIONS 定義 / 縮寫UP user point, 使用點(diǎn)LP loop point, 回路點(diǎn)TOC total organic carbon 總有機(jī)碳TAC total aerobic count總菌數(shù)4. SAFETYNone. 無5. PROCEDURE 程序5.1. Responsibilities 責(zé)任5.1.1. The Quality Operations Manager is responsible for:質(zhì)量部經(jīng)理負(fù)責(zé)如下事項(xiàng)：Ensuring that this SOP complies with local and corporate GMP standards.確保本SOP符合當(dāng)?shù)睾凸镜腉MP 的標(biāo)準(zhǔn)。Ensuring completion of the SOP Training Record attached to this SOP (Attachment 1).確保完成附在本篇SOP后面的SOP培訓(xùn)記錄(附件1)。5.1.2. The Microbiologist is responsible for:微生物實(shí)驗(yàn)室人員負(fù)有如下責(zé)任：Sampling and monitoring the water for microbe為微生物測試采集純水水樣及監(jiān)測。5.1.3. The QC Analyst is responsible for:質(zhì)量控制分析員負(fù)有如下責(zé)任: Sampling and monitoring the water for chemical 為化學(xué)測試采集純水水樣及監(jiān)測。5.2. Physical & Chemical Tests 物理和化學(xué)檢測5.2.1. Monitoring Plan:監(jiān)測計(jì)劃 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. 純水：每周五，從純化水車間的LP2點(diǎn)和實(shí)驗(yàn)室Pall PureLab制水系統(tǒng)的取樣點(diǎn)取樣進(jìn)行全部項(xiàng)目的測試。遇法定節(jié)假日監(jiān)控計(jì)劃將順延或調(diào)整。 Softened water: monthly take the sample from softened water point and tests TOC, PH, Conductivity, and Hardness.軟化水：每月從軟化水取樣點(diǎn)取樣并測試總有機(jī)碳，PH，電導(dǎo)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. 城市飲用水：每年一次，委托*實(shí)驗(yàn)室來進(jìn)行所有化學(xué)項(xiàng)目的檢測。5.2.2. Sampling 取樣1. See table 1 for location of sampling points 取樣點(diǎn)的位置見表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.擰開取樣點(diǎn)的水龍頭至最大，讓水流至少1分鐘后再進(jìn)行取樣。這樣做是確保使任何停留在取樣點(diǎn)內(nèi)部的污染物被完全沖出來。3. Collect sample in a non-sterile 1000 mL sampling bottle.用未消毒的規(guī)格為1000毫升的取樣瓶采集樣品。4. Label the sample with date, time and sampling point.在瓶身上貼上標(biāo)簽，寫明取樣日期，時間，以及取樣點(diǎn)。NOTE: When collecting the chemical test sample from the same sampling point as the microbiological test sample, take the chemical sample first.注意: 在與微生物相同的取樣點(diǎn)進(jìn)行化學(xué)取樣時，要先進(jìn)行化學(xué)取樣。5.2.3. Testing 檢測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.化學(xué)測試分析應(yīng)在取樣后盡快完成，如有任何原因不能及時對樣品進(jìn)行檢驗(yàn)分析， 應(yīng)將樣品貯存于2 到8度冰箱中并于24小時內(nèi)進(jìn)行分析實(shí)驗(yàn)。2.For purified water, according to Specification SN-RM001 and Test Method TM-0003 to test and assessment.純化水: 按照質(zhì)量標(biāo)準(zhǔn)SN-RM001和試驗(yàn)方法TM-0003的要求進(jìn)行試驗(yàn)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.軟化水：按照方法TM-0003測試總有機(jī)碳，pH，電導(dǎo)率, 無限度要求, 只記錄實(shí)驗(yàn)數(shù)據(jù)監(jiān)測趨勢。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 城市飲用水：所有的化學(xué)測試將每年一次，委托*的實(shí)驗(yàn)室進(jìn)行檢測。其判定依據(jù)中華人民共和國國家標(biāo)準(zhǔn)GB5749-85 生活飲用水衛(wèi)生標(biāo)準(zhǔn)執(zhí)行。5.3. Microbiological test 微生物監(jiān)測5.3.1. Monitoring Plan:監(jiān)測計(jì)劃 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. 制水車間純化水：每周五，從LP1，LP2和二個使用點(diǎn)取樣進(jìn)行全部項(xiàng)目的測試(每周輪換二個不同的使用點(diǎn))。遇法定節(jié)假日監(jiān)控計(jì)劃將順延或調(diào)整。 Softened water: monthly take the sample from softened water point and test TAC.軟化水：每月從軟化水取樣點(diǎn)取樣并檢測總菌數(shù)。 City water: monthly take the sample from city water point and test TAC,total coliforms.城市用水：每月從城市飲用水取樣點(diǎn)取樣并檢測總菌數(shù)和大腸菌群。 Lab purified water: monthly take the sample from laboratory purified water point and test TAC.實(shí)驗(yàn)室純化水: 每月從實(shí)驗(yàn)室取樣點(diǎn)取樣并檢測總菌數(shù)。5.3.2. Sampling 取樣1. Requirements: Sterilised 100,500, 1000 mL media bottle with cap; Plastic bucket; 70% alcohol; Gloves.取樣需要用：經(jīng)過滅菌的100, 500, 1000 毫升帶蓋培養(yǎng)瓶；塑料桶；濃度為70%的乙醇；手套。2. See table 1 for location of sampling points 取樣點(diǎn)的位置見表13. NOTE: Before and during sampling care must be taken to avoid contamination of the sample.注意: 在取樣前和取樣過程中，要特別注意避免使樣品受到污染。4. Sanitise the outside of the sampling point with 70% alcohol.用濃度為 70% 的乙醇消毒取樣點(diǎn)的外部。5. Allow sanitising alcohol to evaporate.讓用于消毒的乙醇自然揮發(fā)。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.擰開取樣點(diǎn)的水龍頭至最大，讓水流至少1分鐘后再進(jìn)行取樣。這樣做是確保使任何停留在取樣點(diǎn)內(nèi)部的微生物污染物被完全沖出來。7. Holding the media bottle near its base, bring close to the flowing stream of water.托住培養(yǎng)瓶靠瓶底的部位，將培養(yǎng)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. 完全打開蓋子以便于樣品的采集，將培養(yǎng)瓶的瓶口置于水流下。9. Replace the cap of the bottle immediately the sampling is complete.在取樣結(jié)束后，立即蓋上瓶蓋。10. Label the sample with date and sampling point.在瓶身上貼上標(biāo)簽，寫明取樣日期以及取樣點(diǎn)。11. Sanitise the sampling point with 70% alcohol again.用70%的酒精將取樣點(diǎn)再次消毒。5.3.3. Testing檢測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.微生物分析應(yīng)在取樣后的1小時內(nèi)進(jìn)行。如果不能按上述要求執(zhí)行，則需立即將樣品放入冰箱內(nèi)(2 至 8C)保存，且必須在取樣后的24小時內(nèi)做測試分析。2. For purified water純化水:According to Specification SN-RM001 and Test Method TM-0003 to test and assessment.按照質(zhì)量標(biāo)準(zhǔn)*和試驗(yàn)方法*的要求進(jìn)行試驗(yàn)和判定。3. For softened water軟化水Test method: according to Test Method TM-0003 to do total viable aerobic count.實(shí)驗(yàn)方法：按照試驗(yàn)方法TM-0003中總菌數(shù)測定的方法進(jìn)行總菌數(shù)的檢測。 Limit: no limit has been established currently, but the trend has to be monitored. 限度：目前還無限度，但必須監(jiān)測其趨勢。4. For city drinking water城市飲用水According to Specification SN-RM001 and Test Method TM-0003 to test and assessment.按照試驗(yàn)方法TM-0003和質(zhì)量標(biāo)準(zhǔn)SN-RM001 的要求進(jìn)行試驗(yàn)和判定。5.4. Documentation 文件5.4.1 Record the all test on the logbook or record sheet. 將實(shí)驗(yàn)記錄于實(shí)驗(yàn)記錄本或表上。5.4.2 All the results must be trended and analysis regularly 所有的結(jié)果必須定期做趨勢分析.5.4.3 Any OOS must be immediately communicated to the QO and Engineering managers and an investigation should start. 任何超出質(zhì)量標(biāo)準(zhǔn)的結(jié)果必須立即報告給質(zhì)量部經(jīng)理和工程部經(jīng)理，同時應(yīng)開始調(diào)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.如果制水車間純化水的微生物監(jiān)測出現(xiàn)超標(biāo)結(jié)果且調(diào)查結(jié)果表明沒有實(shí)驗(yàn)室錯誤，微生物主管應(yīng)立即通知工程部對純水系統(tǒng)進(jìn)行消毒如下：超出警告限, 系統(tǒng)應(yīng)于85 消毒30分鐘.連續(xù)超出警告限三次或超出行動限一次，系統(tǒng)應(yīng)于121 消毒20分鐘.If the OOS appear on microbiological monitoring of laboratory purified water, the purified water system must be sanitized according to sop S-QC052.如果實(shí)驗(yàn)室純化水監(jiān)測結(jié)果超出限度，按照標(biāo)準(zhǔn)操作規(guī)程*對實(shí)驗(yàn)室純化水系統(tǒng)進(jìn)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).如果城市飲用水監(jiān)測結(jié)果超出限度，其貯罐及輸送管道必須用0.05毫克/升（在TW-01取樣點(diǎn)測試的）的游離活性氯進(jìn)行消毒。Table 1. Location of Sampling Points 表1. 取樣點(diǎn)的位置sampling Point取樣點(diǎn)Location & description 位置及描述Room No.房間號UP1UP2UP3UP4UP5UP6UP7UP8Softened water軟化水LP1 LP2City drinking wate