性能確認(rèn)PQ(中英文)

1、Y UNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào):Page: 1 OF 22 第1頁(yè)共22頁(yè)P(yáng)urified Water System Performa nce Qualificatio n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：EXECUTION APPROVAL SIGNATURES批準(zhǔn)執(zhí)行簽名The sig natures below in dicate approval of this protocol and its attachme nts and in dicate that it i

2、s ready for execution. Any changes or modifications to the intent or the acceptance criteria of this protocol, following approval, requires the generation of an amendment which must be approved prior to execution.下面的簽名表示批準(zhǔn)本文件及其附件，且表明已經(jīng)為執(zhí)行作好了準(zhǔn)備。在批準(zhǔn)后，對(duì)本文件的目的或驗(yàn)收標(biāo) 準(zhǔn)進(jìn)行的任何改變或修正都必須起改善的作用，在執(zhí)行以前就必須取得批準(zhǔn)。Depar

3、tme nt & Site單位部門Sig nature & Date簽名與日期Issued by起草Reviewed by 審核Authorized by 批準(zhǔn)Y UNG SHIN PHARMND.(KS)CO.,LTD 永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào):Page: 2 OF 22 第2頁(yè)共22頁(yè)P(yáng)urified Water System Performa nee Qualificatio n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：Contents目錄1.0SCOPE 范圍32.0PURPOSE 目的33.0BACKGROUND

4、背景34.0INTRODUCTION 介紹35.0REFERENCES 參考書目46.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES責(zé)任方及其責(zé)任 47.0SYSTEM DESCRIPTION系統(tǒng)說(shuō)明6GENERAL DESCRIPTION 總說(shuō)明 6PRETREATMENT UNIT 預(yù)處理單元 6REVERSE OSMOSIS (RO) SYSTEM 反滲透(RO)系統(tǒng)7M IXED BED SYSTEM 混床系統(tǒng)8M ONITOR AND CONTROL SYSTEM 監(jiān)視和控制系統(tǒng) 98.0TESTING PROCEDURES檢驗(yàn)程序 99.0AC

5、CEPTANCE CRITERIA驗(yàn)收標(biāo)準(zhǔn)10ATTACHMENT 1 - VALIDATION TEST EQUIPMENT AND MATERIALS 附件 1 -驗(yàn)證測(cè)試設(shè)備和材料 11ATTACHMENT 2 -PW SYSTEM 30 DAY SAMPLING pLAN DATA SHEET 附件 2 -純化水系統(tǒng) 30 天取樣計(jì)劃數(shù)據(jù)表.12 ATTACHMENT 3 -2ND PHASE PW SYSTEM SAMPLING PLAN DATA SHEET 附件 3 -純化水系統(tǒng)第二階段取樣計(jì)劃數(shù) 據(jù)表15ATTACHMENT 4 - PW sample test RESULT

6、FORM 附件 4 - PW樣品測(cè)試結(jié)果表 18ATTACHMENT5-signature verification list 附件 5-簽名確認(rèn)清單 19ATTACHMENT6-PROTOCOL DEVIATION LOG 附件 6 -文件偏差日志 20ATTACHMENT7-PROTOCOL DEVIATION RECORD 附件 7 -文件偏差記錄 21ATTACHMENT8-PROTOCOL EXECUTION A PPROVAL SIGNATURES DATA SHEET 附件 8 -文件執(zhí)行批準(zhǔn)簽名數(shù)據(jù)表 .22Y UNG SHIN PHARM.IND.(KS)CO.,LTD永信藥

7、品工業(yè)(昆山)有限公司Code: VP402 編號(hào):Page: 3 OF 22 第3頁(yè)共22頁(yè)P(yáng)urified Water System Performa nee Qualificatio n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：1.0 SCOPE范圍This Performa nee Qualificati on (PQ) study will be performed on the Purified Water (PW) System, located in YUNG SHIN PHARM.IND.(KS)CO.,LTD. The scope of this pr

8、otocol will be for the initial 30 days of aggressive sampli ng. An additi onal eleve n mon ths of sampli ng will be performed per a YUNG SHIN PHARM.IND.(KS)CO.,LTD. SOP to establish an entire year of sample results.本性能確認(rèn)(PQ )文件應(yīng)用于位于永信藥品工業(yè)(昆山)有限公司的純化水(PW )系統(tǒng)。本文件的范圍將涵蓋初始 30天的取樣。再附上 11個(gè)月的取樣情況，得到整一年的取樣結(jié)

9、果，取樣方法標(biāo) 準(zhǔn)為永信藥品工業(yè)(昆山)有限公司SOP。This protocol describes the equipme nt, test procedures, specificati ons, docume nts, and refere nces used to establish that the PW System performs in accordanee with the manufacturer ' ©esign specifications, and those of YUNG SHIN PHARM.IND.(KS)CO.,LTD.本文件內(nèi)容涉及設(shè)備

10、、測(cè)試步驟、規(guī)格、文檔和參考書目，這些是用來(lái)確保純化水系統(tǒng)的性能符合 生產(chǎn)商設(shè)計(jì)規(guī)范和永信藥品工業(yè)(昆山)有限公司要求。Shan ghai Baoju pers onn el, have prepared this docume ntati on package. This docume nt will providefor the del in eation of respo nsibilities of Sha nghai Baoju and YUNG SHIN PHARM. IND. (KS) CO.,LTD. appropriate approval sig natures, supp

11、ort docume ntati on, and other factors that are no rmally in cluded in a protocol package. All support ing data and docume ntati on will be attached to this validati on protocol whe n completed.本文件包由納盛機(jī)電準(zhǔn)備。本文件將確定納盛機(jī)電和永信藥品工業(yè)(昆山)有限公司的責(zé)任、相關(guān) 的批準(zhǔn)簽名、支持文件和其他一般文件包中都有的因素。完成本驗(yàn)證文件后附上所有的支持?jǐn)?shù)據(jù)和 文件。2.0 PURPOSE目的Th

12、e executi on of this protocol will dem on strate and docume nt that the PW System performs according to the manufacturer's specifications and YUNG SHIN PHARM. IND. (KS) CO., LTD.requireme nts.本文件的執(zhí)行將記錄和證明純化水系統(tǒng)的性能符合生產(chǎn)商規(guī)范和永信藥品工業(yè)(昆山)有限公司要 求安裝和操作。3.0 BACKGROUND冃景The PW System is a new system purchas

13、ed specifically for use at YUNG SHIN PHARM. IND. (KS) CO., LTD純化水系統(tǒng)是為永信藥品工業(yè)(昆山)有限公司使用而特別采購(gòu)的一套新設(shè)備。4.0 INTRODUCTION介紹Y UNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào).Page: 4 OF 22 第4頁(yè)共22頁(yè)P(yáng)urified Water System Performa nee Qualificatio n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：All in strume nt calib

14、rati on, sta ndardizati on, or adjustme nt will be performed and docume nted for the measuring equipment used during the execution of this protocol. Standards used will be traceable to the Nati onal In stitute of Stan dards and Tech no logy(NIST). Other accepted sta ndards will beused where applicab

15、le if NIST sta ndards do not exist.在文件執(zhí)行過(guò)程中，作為測(cè)量工具，所有的儀器校驗(yàn)、標(biāo)準(zhǔn)化或調(diào)整都將進(jìn)行，且記錄下來(lái)。所使 用的標(biāo)準(zhǔn)都可追溯到美國(guó)國(guó)家標(biāo)準(zhǔn)和技術(shù)研究院(NIST)。如果NIST不涉及的地方也可使用其他的驗(yàn)收標(biāo)準(zhǔn)。Performaneechecks will be performed to verify and document that the system is producing thequality of water required to meet USP guideli nes.進(jìn)行性能確認(rèn)，確認(rèn)和記錄系統(tǒng)生產(chǎn)的水的質(zhì)量符合USP規(guī)范

16、。Any deviati ons from the protocol or from specificati ons or any excepti onal con diti ons en cou ntered will be documentedand identified for review on the ProtocolDeviationReport Form. Thedeviati onsandexcepti onalcon diti ons no ted will bein vestigated and appropriate acti onsdeterminedandimplem

17、ented. The investigations, along with the corrective actionsand theirjustifications, will be documented on the Protocol Deviation Report Form.任何與文件或規(guī)范的偏差或遇到任何例外的情況都要記錄下來(lái)，加以鑒別，以供文件偏差報(bào)告表的 審查。記錄的偏差和例外情況要進(jìn)行調(diào)查，而且決定并采取相應(yīng)的措施。文件偏差報(bào)告表中需記錄 有調(diào)查、糾正性措施及其理由。Final protocol package approval will be by the same pers

18、 onnel who in itially approved the protocol, by their desig nee, or by ano ther pers on holdi ng an equivale nt level of authority.最終文件包的批準(zhǔn)人必須是文件最初批準(zhǔn)人、其指定人、或其他的有同等權(quán)力的人員。5.0 REFERENCES參考書目This protocol con forms to the applicable guideli nes of the publicati ons listed below. Each publication shall b

19、e the latest revision with all addenda in effect on the date of approval of the protocol, unl ess otherwise no ted.該文件符合下列岀版物中的規(guī)范。除非另外注明，否則每個(gè)岀版物都指的是截止批準(zhǔn)之日的最新的 版本，其附錄也有效。* 21 CFR Part 211: Code of Federal Regulations;Current Good ManufacturingPractice forFini shed Pharmaceuticals21 CFR第210和211部分：聯(lián)邦條例

20、法典，成品藥cGMP* USP 32 - Un ited States Pharmacopeia USP 32 -美國(guó)藥典* NIST - Nati onal In stitute of Stan dards and Tech no logy NIST -美國(guó)國(guó)家標(biāo)準(zhǔn)技術(shù)研究所6.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES 責(zé)任方及其責(zé)任Y UNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào):Page: 5 OF 22 第5頁(yè)共22頁(yè)P(yáng)urified Water System Perfo

21、rma nee Qualificatio n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：Sha nghai Baoju Fluid Equipme nt Engin eeri ng Co., Ltd. 納盛機(jī)電流體設(shè)備工程有限公司.« Writing, of this protocol.編寫本文件« Generation of Final Report.編寫最終報(bào)告« Review and approval of the original protocol.審核和批準(zhǔn)原始文件« Review and approval of the c

22、ompleted protocol package and the final report.審核和批準(zhǔn)完成的文件包和最終報(bào)告QA Resp on sibilities:QA責(zé)任* Executi on of this protocol.執(zhí)行本文件* Supply support and technical expertise needed in the preparation and execution of the protocol.準(zhǔn)備和執(zhí)行文件時(shí)提供支持和技術(shù)意見(jiàn)* Supply all docume nts,data, procedures, man uals, and draw i

23、ngs n eeded to gen erate andexecute the protocol and complete the final report.提供編寫和執(zhí)行本文件時(shí)所需要的所有文件、數(shù)據(jù)、程序、手冊(cè)和圖紙，完成最終報(bào)告Engineering/Manufacturing Responsibilities:工程牛產(chǎn)責(zé)任* Supply all procedures, data, man uals, draw in gs, and docume ntati onn eeded to gen erate andexecute the protocol and complete the

24、final report.提供文件編寫和執(zhí)行時(shí)所需的所有程序、數(shù)據(jù)、手冊(cè)、圖紙和文件，完成最終報(bào)告YUNG SHIN PHAR M.IN D.(KS)CO.,LTD :永信藥品工業(yè)(昆山)有限公司：* Oversee the validati on process.監(jiān)督驗(yàn)證程序* Supply support needed in the preparation and execution of the protocol.準(zhǔn)備和執(zhí)行文件時(shí)提供支持* Review and approval of the original protocol.審核和批準(zhǔn)原始文件* Review and approva

25、l of the completed protocol package and the final report.審核和批準(zhǔn)完成的文件包和最終報(bào)告Y UNG SHIN PHARMND.(KS)CO.,LTD 永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào).Page: 6 OF 22 第6頁(yè)共22頁(yè)P(yáng)urified Water System Performa nee Qualificatio n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：7.0 SY STEM DESCRIPTION系統(tǒng)說(shuō)明Gen eral Descripti on總說(shuō)明1) Producti on

26、 Capacity 產(chǎn)能Production capacity of the PW system is specified at 1000 liters per hour purified water (PW). 純化水系統(tǒng)的產(chǎn)能定為每小時(shí)1000升純化水(PW )。2) Quality Sta ndard of PW System純化水系統(tǒng)的質(zhì)量標(biāo)準(zhǔn)The PW system will meet the following criteria:純化水系統(tǒng)將達(dá)到以下標(biāo)準(zhǔn)：PW quality sta ndards as defi ned in USP 28 Water for Pharmaceu

27、tical PurposesUSP 28制藥用水定義的純化水質(zhì)量標(biāo)準(zhǔn)Meet GMP and FDA requireme nts and pass appropriate qualificati on/validati on 達(dá)到GMP和FDA的要求，通過(guò)相關(guān)的確認(rèn)/驗(yàn)證。3) Distribution Loop 分配回路The PW system distributi on loop will be con structed of 316L sta ini ess steel pipe with orbital welded join ts. Complete specificati ons

28、 for the pipe, valves, pumps, and conn ectors are provided in the Tech nical Specificatio n of Purified Water System for YUNG SHIN PHAR M.I ND.(KS)CO.,LTD. Project. The PW System distribution loop distributes Purified Water to the use points listed below. 純化水系統(tǒng)的循環(huán)回路由帶軌道自動(dòng)焊接焊點(diǎn)的316L不銹鋼管道建造。永信藥品工業(yè)(昆山)有

29、限公司純化水系統(tǒng)技術(shù)規(guī)范中說(shuō)明了關(guān)于管道、閥門、泵和接頭的詳細(xì)規(guī) 范。純化水系統(tǒng)循環(huán)回路分配純化水到下面列岀的使用點(diǎn)。4) Purified Water (PW) Loop純化水回路一樓軟膏調(diào)劑室一樓洗滌室一樓混合造粒室一樓洗滌室一樓洗滌室三樓洗盤室三樓洗烘衣 M130三樓潔具三樓洗滌三樓洗滌Pretreatme nt Unit 預(yù)處理單元Y UNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào).Page: 7 OF 22 第7頁(yè)共22頁(yè)P(yáng)urified Water System Performa nee Qualificatio

30、 n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：The Pretreatme nt Un it con sists of the followi ng comp onen ts, listed in the order of process flow: 預(yù)處理單元包含以下部件，按流程圖的順序列岀依次為：1) Chemical Co ntai ner and Dosi ng Pump化學(xué)容器和計(jì)量泵A 80 liter PE tanks and dosing pumps are used to add flocculating and anti-scaling agents

31、to the raw water.用一個(gè)80升的PE箱和計(jì)量泵在原水中加入絮凝劑和反垢劑。2) SandFilter 沙濾器The sand filter unit employs quartz sand in a 304 stainless steel housing to remove suspended solids and colloidal materials from the incoming water.沙濾器單元利用304不銹鋼罐體中的石英砂來(lái)除去進(jìn)水中的懸浮物質(zhì)和膠質(zhì)材料。3) Heat Exchanger (Pretreatment)熱交換器(預(yù)處理)A heat exch

32、a nger is used to mai ntain water temperature at 25oC for optimum purificati on performa nee. And also it is used to mai ntain water temperature at 80°C whe n sterilizi ng the carb onfilter。為了達(dá)到最佳凈化性能，使用熱交換器使水溫保持在25oC。在碳過(guò)濾器滅菌時(shí)，使用熱交換器使水溫保持在80 C,達(dá)到滅菌效果。4) Activated Carbo n Filter活性炭過(guò)濾器The activat

33、ed carb on filter uses activated carb on in a 304 stai nless steel hous ing to remove orga nic compounds, chlorine, odors, and reduce turbidity from the incoming water.活性炭過(guò)濾器在 304不銹鋼罐體內(nèi)使用活性炭來(lái)除去進(jìn)水中的有機(jī)化合物、氯、氣味和減少濁度。5) Softener 軟化器To reduce raw water hard ness by softe ner.用軟化器降低原水的硬度。6) Brine Tank 鹽水箱

34、The auto control valve on the top of softener periodically adopts brine from the brine tank for the use of softener regeneration.軟化器上的自動(dòng)頭定時(shí)從鹽箱中抽鹽水,以再生軟化器.7) Precisi on Filter 精細(xì)過(guò)濾器The precision filter employs a 5-micron membrane filter to remove any remaining particles to prevent con tam in ati on o

35、f the Reverse Osmosis (RO) membra nes.精細(xì)過(guò)濾器采用5微米膜過(guò)濾來(lái)除去任何殘留的微粒，以防止對(duì)反滲透(RO)膜的污染。Reverse Osmosis (RO) System反滲透(RO)系統(tǒng)The R.O System is supplied from a sta ndard water softe ner and pre-treatme nt system.R.O系統(tǒng)的水來(lái)自標(biāo)準(zhǔn)水軟化器和預(yù)處理系統(tǒng)。Y UNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào):Page: 8 OF 22 第8頁(yè)

36、共22頁(yè)P(yáng)urified Water System Performa nee Qualificatio n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：1) Booster Pump 增壓泵A 4 KW pumps are used to pressurize the RO system. 用一個(gè)4 kW的泵來(lái)給RO系統(tǒng)增壓。2) RO Clea ning Tank RO 藥洗箱A 120 liter PE tank is used to feed cleaning agents, during period RO membrane cleaning process. 在RO

37、膜潔凈程序中用一個(gè) 120升PE箱來(lái)補(bǔ)充清潔劑。3) RO Water Storage Tank RO 貯水箱The RO water storage tank will be con structed of 304 sta inl ess steel. The tank capacity shall be 2 ton s.RO貯水箱由304不銹鋼制造。容量為 2噸。Mixed Bed System混床系統(tǒng)1) Mixed Bed 混床The mixed bed system adopts anion res in and cati on resi n to remove the cati o

38、n and anion in the water and thus to reduce water con ductivity.混床系統(tǒng)利用陰陽(yáng)離子樹(shù)脂來(lái)除去水中的陽(yáng)離子和陰離子，降低水的電導(dǎo)率.2) Acid Tank and Alkali Tank酸堿水箱The acid and alkali i n the acid tank and alkali tank is used to rege nerate the anion and cati on in the mixed bed.酸堿水箱中的酸和堿用于再生混床中的陰陽(yáng)離子3) Mixed Bed Regeneration Pump混床再

39、生泵The system adopts dual 480W regeneration pumps to feed acid and alkali separately into the mixed bed for gen erati on.系統(tǒng)使用兩個(gè)480W的再生泵分別將酸和堿打入混床進(jìn)行再生4) Micro Filter 微濾器The precision filter employs a 1-micron membrane filter to remove any remaining particles following the mixed bed system.精細(xì)過(guò)濾器在混床后，采用

40、1微米膜過(guò)濾來(lái)除去任何殘留的微粒，核子級(jí)樹(shù)脂交換系統(tǒng)Resin Excha nge System1) Feed Water Tank 原水箱The feed water tank is constructed of 316L with a capacity of 1000 liters.給水箱材料為316L，容量為1000升。2) Feed Water Pumps 進(jìn)料水泵Y UNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào).Page: 9 OF 22 第9頁(yè)共22頁(yè)P(yáng)urified Water System Performa

41、 nee Qualificatio n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：One 0.48 kW pumps provide feed water to the system. 一個(gè)0.48 kW的泵為系統(tǒng)給水。3) Nucleo n-class Resi n Ta nk核子級(jí)樹(shù)脂罐A FRE n ucle on-class res in tank with PE liner is adopted for ion excha nge. 用一個(gè)FRE襯PE的核子級(jí)樹(shù)脂罐中的核子級(jí)樹(shù)脂進(jìn)行離子交換。4) The Precisi on Filter 微濾器The prec

42、ision filter employs a 0.22-micron membrane filter to remove any remaining particles. 精細(xì)過(guò)濾器采用0.22微米膜過(guò)濾來(lái)除去任何殘留的微粒。4) Ultraviolet Sterilizer紫外線消毒器An ultraviolet sterilizer is in stalled to elimi nate bacteria.安裝一個(gè)紫外線消毒器來(lái)除去細(xì)菌。Mon itor and Con trol System監(jiān)視和控制系統(tǒng)The en tire PW/WFI system shall be automat

43、ically mon itored and automatically con trolled by PLC (Programmable Logic Con trol).整個(gè)PW/WFI系統(tǒng)應(yīng)該由PLC (可編程邏輯控制)自動(dòng)監(jiān)視和自動(dòng)控制。8.0 TESTING PROCEDURES檢驗(yàn)程序The Performa nee Qualificati on will be performed using the protocol attachme nts. All pert inent information will be recorded on these forms. Copies of

44、forms may be obtained from QA.Docume nt results and data con curre ntly with the executi on of this protocol. Mark through any unused spaces with a single line and initial and date. Mark spaces that do not apply to the system being qualified with Not Applicable (N/A) and provide an expla nati on whe

45、re appropriate. Docume nt any deviati ons or abn ormalities observed duri ng the executi on of the protocol.進(jìn)行性能鑒定要用到文件附件。所有相關(guān)信息都將會(huì)記錄在這些表格上。如果需要可以復(fù)印這些表 格。記錄下執(zhí)行文件時(shí)的結(jié)果和數(shù)據(jù)。表格復(fù)印件可向QA索取。在文件執(zhí)行過(guò)程同時(shí)記錄結(jié)果和數(shù)據(jù)。用單線劃過(guò)不用的地方，簽名且注明日期。用不合適(N/A )標(biāo)明不適合系統(tǒng)的地方，并且在合適的地方寫明理由。記錄下執(zhí)行文件時(shí)發(fā)現(xiàn)的任何偏差或不正常的情況。NOTE: Any exceptions to th

46、is protocol must be fully investigated and documented. This PQ can be considered acceptable with exceptional data only if the cause of the exception has been determined or an assignable cause can be attributed to it and it can be proven that such data willnot in validate the protocol studies. Qualit

47、y Assura nee is respon sible for determ ining the acceptability of any excepti onal data備注：對(duì)本文件中的任何例外進(jìn)行完全調(diào)查和記錄。只有當(dāng)例外的原因已經(jīng)確定，或可以歸結(jié)為特定的原因，且能證明該數(shù)據(jù)不會(huì)使文件無(wú)效時(shí)，這個(gè)有例外數(shù)據(jù)的PQ才可以接受，QA有權(quán)決定是否接受例外數(shù)據(jù)。Y UNG SHIN PHARMND.(KS)CO.,LTD 永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào):Page: 10 OF 22 第10頁(yè)共22頁(yè)P(yáng)urified Water System Performa nee

48、 Qualificatio n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：9.0 ACCEPTANCE CRITERIA驗(yàn)收標(biāo)準(zhǔn)« All data forms required for executi on of the protocol must be completely, accurately, and properly filled out.執(zhí)行文件時(shí)所有必需的數(shù)據(jù)表都必須完整、準(zhǔn)確，且正確填寫。« All of the above sample points will be collected as defined in the table

49、and test results will be recorded on the PW System Sample Result Datasheets.以上所有的取樣點(diǎn)都收集在表中，在純化水系統(tǒng)取樣結(jié)果數(shù)據(jù)表中記錄結(jié)果。* All required data will be collected and recorded and all samples will meet test requireme nts. 所有需要的數(shù)據(jù)都已經(jīng)收集并記錄，所有的樣品都符合測(cè)試要求。* All deviations must have been corrected or an action plan for

50、correction of the deviation(s) must have bee n developed所有的偏差必須糾正，或提岀一個(gè)糾偏計(jì)劃。Y UNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào):Page: 11 OF 22 第11頁(yè)共22頁(yè)P(yáng)urified Water System Performa nee Qualificatio n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：Attachme nt 1 - Validati on Test Equipme nt and Materials附件

51、1 -驗(yàn)證測(cè)試設(shè)備和材料List the in strume nts/equipme nt/materialsnot in stalled on or part of the equipme nt an d/or system beingqualified that are used for the installation qualification.在下表中列岀安裝確認(rèn)中要使用，但未安裝的儀器/設(shè)備/材料，或需鑒定的設(shè)備和/或系統(tǒng)的一部分。Pageof 第頁(yè)共頁(yè)Descriptio n 說(shuō)明Calibrated （Y/N） 已校驗(yàn) （是 /否）ID No./ Serial No.ID號(hào)系列

52、號(hào)Calibrati on Date校驗(yàn)日期Calibrati on Due Date 校驗(yàn)到期日Copies of the most recent calibration reports for applicable instruments are: 儀器的最近校驗(yàn)報(bào)告復(fù)印件在（）Attached 附件中Comments:注釋：Accepta nee Criteria:All test equipme nt used duri ng protocol executi on must be docume nted. If the testequipment is not calibrated,

53、 a reason must be recorded and justified.驗(yàn)收標(biāo)準(zhǔn)：記錄下文件執(zhí)行過(guò)程中所有的檢測(cè)設(shè)備。如果檢測(cè)設(shè)備沒(méi)有校驗(yàn)，則記錄原因，說(shuō)明理由。Meets Acceptanee Criteria符合驗(yàn)收標(biāo)準(zhǔn)：Yes 是（）No 否（）Compiled By 編輯: Date 日期: Y UNG SHIN PHARMND.(KS)CO.,LTD 永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào):Page: 12 OF 22 第12頁(yè)共22頁(yè)P(yáng)urified Water System Performa nee Qualificatio n 純化水系統(tǒng)性能確認(rèn)Ve

54、rsio n: A版本：Date:日期：Attachment 2-PW System 30 Day Sampling Plan Data Sheet附件2 -純化水系統(tǒng)30天取樣計(jì)劃數(shù)據(jù)表Test Method: Obtain at least one water sample from the PW Storage Tank and all points of use for thirty con secutive bus in ess days (Mon day thru Friday), obta in at least one sample for each point of use

55、per week. Record the results on the PW System Sample From. '測(cè)試方法：連續(xù)30個(gè)工作日(星期一到星期五)從純化水貯水箱或所有使用點(diǎn)取至少一個(gè)水樣，每個(gè)使用點(diǎn) 每周必須取樣一次.在純化水系統(tǒng)樣品表中記錄結(jié)果。Page 1 of 3 第1頁(yè)共3頁(yè)Week of 6 第 周共6周Purified Water Thirty Day Sampli ng Pla n純化水30天取樣計(jì)劃PW SamplePoi nt純化水取樣點(diǎn)編號(hào)Room Name房間名Mo nday星期一Tuesday星期二Wedn esday星期三Thursday星期四Friday星期五A一樓軟膏調(diào)劑室B一樓洗滌室AC一樓洗滌室BD一樓洗滌室CE一樓混合造粒室Y UNG SHIN PHARMND.(KS)CO.,LTD 永信藥品工業(yè)(昆山)有限公司Code: VP402 編號(hào):Page: 13 OF 22 第13頁(yè)共22頁(yè)P(yáng)urified Water System Performa nee Qualificatio n 純化水系統(tǒng)性能確認(rèn)Versio n: A版本：Date:日期：Attachment 2-PW System 30 Day Sampling