性能確認PQ中英文

1、YUNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：Page: 1 OF 22第1頁共22頁Purified Water System Performance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：EXECUTION APPROVAL SIGNATURES批準執(zhí)行簽名The signatures below indicate approval of this protocol and its attachments and indicate that it is ready for

2、 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本文件及其附件，且表明已經(jīng)為執(zhí)行作好了準備。在批準后，對本文件的目的或驗收標 準進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。Department &

3、 Site 單位部門Signature & Date簽名與日期Issued by起草Reviewed by審核Authorized by批準YUNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：Page: 2 OF 22第2頁共22頁Purified Water System Performance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：Contents目錄1.0SCOPE 范圍32.0PURPOSE 目的33.0BACKGROUND 背景34.0INTRODUCTION 介

4、紹35.0REFERENCES 參考書目46.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES責任方及其責任 47.0SYSTEM DESCRIPTION 系統(tǒng)說明6GENERAL DESCRIPTION 總說明 6PRETREATMENT UNIT 預處理單元 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檢驗程序 99.0ACCEPTANCE CRITERIA驗收

5、標準10ATTACHMENT 1 - VALIDATION TEST EQUIPMENT and materials 附件 1 驗證測試設備和材料 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)第二階段取樣計劃數(shù) 據(jù)表15ATTACHMENT 4 - PW sample test RESULT FORM 附件 4 - PW樣品測試結(jié)果表 18

6、ATTACHMENT5-signature verification list 附件 5-簽名確認清單 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 APPROVAL SIGNATURES DATA SHEET 附件 8 -文件執(zhí)行批準簽名數(shù)據(jù)表 .22YUNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：P

7、age: 3 OF 22第3頁共22頁Purified Water System Performance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：1.0 SCOPE范圍This Performance Qualification (PQ) study will be performed on the Purified Water (PW) System, located in YUNG SHIN PHARM.IND.(KS)CO.,LTD. The scope of this protocol will be for the initial 30

8、days of aggressive sampling. An additional eleven months of sampling 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(PQ)文件應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個月的取樣情況，得到整一年的取樣結(jié)果，取樣方法標準為永信藥品工業(yè)(昆山)有限公司SOP。This protocol

9、 describes the equipment, test procedures, specifications, documents, and references used to establish that the PW System performs in accordance with the manufacturer ' design specifications, and those of YUNG SHIN PHARM.IND.(KS)CO.,LTD.本文件內(nèi)容涉及設備、測試步驟、規(guī)格、文檔和參考書目，這些是用來確保純化水系統(tǒng)的性能符合 生產(chǎn)商設計規(guī)范和永信藥品工業(yè)(

10、昆山)有限公司要求。Shanghai Baoju personnel, have prepared this documentation package. This document will providefor the delineation of responsibilities of Shanghai Baoju and YUNG SHIN PHARM. IND. (KS) CO.,LTD. appropriate approval signatures, support documentation, and other factors that are normally includ

11、ed in a protocol package. All supporting data and documentation will be attached to this validation protocol when completed.本文件包由納盛機電準備。本文件將確定納盛機電和永信藥品工業(yè)(昆山)有限公司的責任、相關 的批準簽名、支持文件和其他一般文件包中都有的因素。完成本驗證文件后附上所有的支持數(shù)據(jù)和 文件。2.0 PURPOSE目的The execution of this protocol will demonstrate and document that the PW

12、 System performs according to the manufacturer's specifications and YUNG SHIN PHARM. IND. (KS) CO., LTD.requirements.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背景The PW System is a new system purchased 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)(

13、昆山)有限公司使用而特別采購的一套新設備。4.0 INTRODUCTION介紹YUNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：Page: 4 OF 22第4頁共22頁Purified Water System Performance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：All instrument calibration, standardization, or adjustment will be performed and documented for the measu

14、ring equipment used during the execution of this protocol. Standards used will be traceable to the National Institute of Standards and Technology (NIST). Other accepted standards will be used where applicable if NIST standards do not exist.在文件執(zhí)行過程中，作為測量工具，所有的儀器校驗、標準化或調(diào)整都將進行，且記錄下來。所使 用的標準都可追溯到美國國家標準和

15、技術(shù)研究院(NIST)。如果NIST不涉及的地方也可使用其他的驗收標準。Performance checks will be performed to verify and document that the system is producing the quality of water required to meet USP guidelines.進行性能確認，確認和記錄系統(tǒng)生產(chǎn)的水的質(zhì)量符合USP規(guī)范。Any deviations from the protocol or from specifications or any exceptional conditions encount

16、eredwill be documented and identified for review on the Protocol Deviation Report Form. The deviations and exceptional conditions noted will be investigated and appropriate actions determined and implemented. The investigations, along with the corrective actions and their justifications, will be doc

17、umented 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，加以鑒別，以供文件偏差報告表的 審查。記錄的偏差和例外情況要進行調(diào)查，而且決定并采取相應的措施。文件偏差報告表中需記錄 有調(diào)查、糾正性措施及其理由。Final protocol package approval will be by the same personnel who initially approved the protocol, by their designee, or by another person holding an eq

18、uivalent level of authority.最終文件包的批準人必須是文件最初批準人、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 conforms to the applicable guidelines of the publications listed below. Each publication shall be the latest revision with all addenda in effect on the date of approval of the protocol, unless otherwise

19、 noted.該文件符合下列出版物中的規(guī)范。除非另外注明，否則每個出版物都指的是截止批準之日的最新的 版本，其附錄也有效。 21 CFR Part 211: Code of Federal Regulations; Current Good Manufacturing Practice for Finished Pharmaceuticals21 CFR第210和211部分：聯(lián)邦條例法典，成品藥 cGMP USP 32 - United States PharmacopeiaUSP 32 水國藥典 NIST - National Institute of Standards and Techn

20、ologyNIST Tt國國家標準技術(shù)研究所6.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES責任方及其責任YUNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：Page: 5 OF 22第5頁共22頁Purified Water System Performance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：Shanghai Baoju Fluid Equipment Engineering Co., Ltd.納盛機電流體設備工程有限公司. Wri

21、ting, of this protocol.編寫本文件 Generation of Final Report.編寫最終報告 Review and approval of the original protocol.審核和批準原始文件 Review and approval of the completed protocol package and the final report.審核和批準完成的文件包和最終報告QA Responsibilities:QA責任 Execution of this protocol.執(zhí)行本文件 Supply support and technical expe

22、rtise needed in the preparation and execution of the protocol.準備和執(zhí)行文件時提供支持和技術(shù)意見 Supply all documents, data, procedures, manuals, and drawings needed to generate and execute the protocol and complete the final report.提供編寫和執(zhí)行本文件時所需要的所有文件、數(shù)據(jù)、程序、手冊和圖紙，完成最終報告Engineering/Manufacturing Responsibilities:工程牛

23、正責任 Supply all procedures, data, manuals, drawings, and documentation needed to generate and execute the protocol and complete the final report.提供文件編寫和執(zhí)行時所需的所有程序、數(shù)據(jù)、手冊、圖紙和文件，完成最終報告YUNG SHIN PHARM.IND.(KS)CO.,LTD :永信藥品工業(yè)(昆山)有限公司： Oversee the validation process.監(jiān)督驗證程序 Supply support needed in the prep

24、aration and execution of the protocol.準備和執(zhí)行文件時提供支持 Review and approval of the original protocol.審核和批準原始文件 Review and approval of the completed protocol package and the final report.審核和批準完成的文件包和最終報告YUNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：Page: 6 OF 22第6頁共22頁Purified Water System Pe

25、rformance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：7.0 SYSTEM DESCRIPTION系統(tǒng)說明General Description總說明1) Production Capacity 產(chǎn)育昌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1000升純化水(PW)。2) Quality Standard of PW System純化水系統(tǒng)的質(zhì)量標準The PW syst

26、em will meet the following criteria:純化水系統(tǒng)將達到以下標準：PW quality standards as defined in USP 28 Water for Pharmaceutical PurposesUSP 28制藥用水定義的純化水質(zhì)量標準Meet GMP and FDA requirements and pass appropriate qualification/validation 達到GMP和FDA的要求，通過相關的確認/驗證。3) Distribution Loop分配回路The PW system distribution loop

27、will be constructed of 316L stainless steel pipe with orbital welded joints. Complete specifications for the pipe, valves, pumps, and connectors are provided in the Technical Specification of Purified Water System for YUNG SHIN PHARM.IND.(KS)CO.,LTD. Project. The PW System distribution loop distribu

28、tes Purified Water to the use points listed below. 純化水系統(tǒng)的循環(huán)回路由帶軌道自動焊接焊點的316L不銹鋼管道建造。永信藥品工業(yè)(昆山)有限公司純化水系統(tǒng)技術(shù)規(guī)范中說明了關于管道、閥門、泵和接頭的詳細規(guī) 范。純化水系統(tǒng)循環(huán)回路分配純化水到下面列出的使用點。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Pretreatment Unit預處理單元YUNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品

29、工業(yè)(昆山)有恒公司Code: VP402編號：Page: 7 OF 22第7頁共22頁Purified Water System Performance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：The Pretreatment Unit consists of the following components, listed in the order of process flow:預處理單元包含以下部件，按流程圖的順序列出依次為：1) Chemical Container and Dosing Pump化學容器和計量泵A 80 liter PE

30、 tanks and dosing pumps are used to add flocculating and anti-scaling agents to the raw water.用一個80升的PE箱和計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

31、鋼罐體中的石英砂來除去進水中的懸浮物質(zhì)和膠質(zhì)材料。3) Heat Exchanger (Pretreatment)熱交換器(預處理)A heat exchanger is used to maintain water temperature at 25oC for optimum purification performance. And also it is used to maintain water temperature at 80°C when sterilizing the carbonfilter o為了達到最佳凈化性能，使用熱交換器使水溫保持在 25oC o在碳過濾器

32、滅菌時，使用熱交換器使水 溫保持在80 °C ,達到滅菌效果。4) Activated Carbon Filter活性炭過濾器The activated carbon filter uses activated carbon in a 304 stainless steel housing to remove organic compounds, chlorine, odors, and reduce turbidity from the incoming water.活性炭過濾器在 304不銹鋼罐體內(nèi)使用活性炭來除去進水中的有機化合物、氯、氣味和減少濁度。5) Softener 軟

33、化器To reduce raw water hardness by softener.用軟化器降低原水的硬度。6) Brine Tank 鹽水箱The auto control valve on the top of softener periodically adopts brine from the brine tank for the use of softener regeneration.軟化器上的自動頭定時從鹽箱中抽鹽水，以再生軟化器.7) Precision Filter 精細過濾器The precision filter employs a 5-micron membrane

34、filter to remove any remaining particles to prevent contamination of the Reverse Osmosis (RO) membranes.精細過濾器采用5微米膜過濾來除去任何殘留的微粒，以防止對反滲透( RO)膜的污染。Reverse Osmosis (RO) System反滲透(RO)系統(tǒng)The R.O System is supplied from a standard water softener and pre-treatment system.R.O系統(tǒng)的水來自標準水軟化器和預處理系統(tǒng)。YUNG SHIN PHAR

35、M.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：Page: 8 OF 22第8頁共22頁Purified Water System Performance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：1) Booster Pump 增壓泵A 4 KW pumps are used to pressurize the RO system.用一個4 kW的泵來給RO系統(tǒng)增壓。2) RO Cleaning Tank RO 藥洗箱A 120 liter PE tank is used to feed cleaning

36、agents, during period RO membrane cleaning process.在RO膜潔凈程序中用一個120升PE箱來補充清潔劑。3) RO Water Storage Tank RO 貯水箱The RO water storage tank will be constructed of 304 stainless steel. The tank capacity shall be 2 tons.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 ani

37、on resin and cation resin to remove the cation and anion in the water and thus to reduce water conductivity.混床系統(tǒng)利用陰陽離子樹脂來除去水中的陽離子和陰離子，降低水的電導率.2) Acid Tank and Alkali Tank酸堿水箱The acid and alkali in the acid tank and alkali tank is used to regenerate the anion and cation in the mixed bed.酸堿水箱中的酸和堿用于再生

38、混床中的陰陽離子3) Mixed Bed Regeneration Pump 混床再生泵The system adopts dual 480W regeneration pumps to feed acid and alkali separately into the mixed bed for generation.系統(tǒng)使用兩個480W的再生泵分別將酸和堿打入混床進行再生4) Micro Filter 微濾器The precision filter employs a 1-micron membrane filter to remove any remaining particles fol

39、lowing the mixed bed system.精細過濾器在混床后，采用1微米膜過濾來除去任何殘留的微粒，核子級樹脂交換系統(tǒng)Resin Exchange 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 進料水泵YUNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：Page: 9 OF 22第

40、9頁共22頁Purified Water System Performance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：One 0.48 kW pumps provide feed water to the system.一個0.48 kW的泵為系統(tǒng)給水。3) Nucleon-class Resin Tank 核子級樹脂罐A FRE nucleon-class resin tank with PE liner is adopted for ion exchange.用一個FRE襯PE的核子級樹脂罐中的核子級樹脂進行離子交換。4) The Preci

41、sion Filter 微濾器The precision filter employs a 0.22-micron membrane filter to remove any remaining particles.精細過濾器采用0.22微米膜過濾來除去任何殘留的微粒。4) Ultraviolet Sterilizer紫外線消毒器An ultraviolet sterilizer is installed to eliminate bacteria.安裝一個紫外線消毒器來除去細菌。Monitor and Control System監(jiān)視和控制系統(tǒng)The entire PW/WFI system

42、 shall be automatically monitored and automatically controlled by PLC (Programmable Logic Control).整個PW/WFI系統(tǒng)應該由PLC (可編程邏輯控制)自動監(jiān)視和自動控制。8.0 TESTING PROCEDURES檢驗程序The Performance Qualification will be performed using the protocol attachments. All pertinent information will be recorded on these forms.

43、Copies of forms may be obtained from QA.Document results and data concurrently with the execution 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 explanation

44、 where appropriate. Document any deviations or abnormalities observed during the execution of the protocol.進行性能鑒定要用到文件附件。所有相關信息都將會記錄在這些表格上。如果需要可以復印這些表 格。記錄下執(zhí)行文件時的結(jié)果和數(shù)據(jù)。表格復印件可向QA索取。在文件執(zhí)行過程同時記錄結(jié)果和數(shù)據(jù)。用單線劃過不用的地方，簽名且注明日期。用不合適( N/A)標明不適合系統(tǒng)的地方，并且在 合適的地方寫明理由。記錄下執(zhí)行文件時發(fā)現(xiàn)的任何偏差或不正常的情況。NOTE: Any exceptions to th

45、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 will not invalidate the protocol studies. Qualit

46、y Assurance is responsible for determining the acceptability of any exceptional data備注：對本文件中的任何例外進行完全調(diào)查和記錄。只有當例外的原因已經(jīng)確定，或可以歸結(jié)為特定的原因，且能證明該數(shù)據(jù)不會使文件無效時，這個有例外數(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)。YUNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：Page: 10 OF 22 第10頁共22頁Purified Water System Performance Quali

47、ficationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：9.0 ACCEPTANCE CRITERIA驗收標準 All data forms required for execution of the protocol must be completely, accurately, and properly filled out.執(zhí)行文件時所有必需的數(shù)據(jù)表都必須完整、準確，且正確填寫。 All of the above sample points will be collected as defined in the table and test results will

48、be recorded on the PW System Sample Result Datasheets.以上所有的取樣點都收集在表中，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 requirements.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試要求。 All deviations must have been corrected or an action plan for correction of the deviatio

49、n(s) must have been developed所有的偏差必須糾正，或提出一個糾偏計劃。YUNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：Page: 11 OF 22 第11頁共22頁Purified Water System Performance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：Attachment 1 - Validation Test Equipment and Materials附件1 -驗證測試設備和材料List the instruments/equ

50、ipment/materials not installed on or part of the equipment and/or system being qualified that are used for the installation qualification.在下表中列出安裝確認中要使用，但未安裝的儀器/設備/材料，或需鑒定的設備和 /或系統(tǒng)的一部分。Page of 第 頁共 頁Description說明Calibrated （Y/N） 已校驗 （是/否）ID No./ Serial No.ID號系歹0號Calibration Date校驗日期Calibration Due D

51、ate 校驗到期日Copies of the most recent calibration reports for applicable instruments are: 儀器的最近校驗報告復印件在（）Attached 附件中Comments:注釋：Acceptance Criteria: All test equipment used during protocol execution must be documented. If the test equipment is not calibrated, a reason must be recorded and justified.驗收

52、標準：記錄下文件執(zhí)行過程中所有的檢測設備。如果檢測設備沒有校驗，則記錄原因，說明理由。Meets Acceptance Criteria 符合驗收標準：Yes 是（） No 否（）Compiled By 編輯： Date 日期： YUNG SHIN PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：Page: 12 OF 22 第12頁共22頁Purified Water System Performance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：Attachment 2- PW System 30

53、 Day Sampling Plan Data Sheet附件2 -純化水系統(tǒng)30天取樣計劃數(shù)據(jù)表Test Method: Obtain at least one water sample from the PW Storage Tank and all points of use for thirty consecutive business days (Monday thru Friday), obtain at least one sample for each point of use per week. Record the results on the PW System Samp

54、le From. '測試方法：連續(xù)30個工作日(星期一到星期五)從純化水貯水箱或所有使用點取至少一個水樣，每個使用點 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頁共3頁Week of 6 第 周共6周Purified Water Thirty Day Sampling Plan純化水30天取樣計劃PW SamplePoint純化水取樣點編號Room Name房間名Monday星期一Tuesday星期二Wednesday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YUNG SHI

55、N PHARM.IND.(KS)CO.,LTD永信藥品工業(yè)(昆山)有恒公司Code: VP402編號：Page: 13 OF 22 第13頁共22頁Purified Water System Performance QualificationVersion: A版本：純化水系統(tǒng)性能確認Date:日期：Attachment 2 PW System 30 Day Sampling Plan Data Sheet (cont ' d)附件2 -純化水系統(tǒng)30天取樣計劃數(shù)據(jù)表(接上表)Page 2 of 3 第2頁共3頁Week of 6 第 周共6周Purified Water Thirty Day Sampling Plan純化水30天取樣計劃PW SamplePoint純化水取樣點編號Room Name房間名Monday星期