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      WHO發布《制藥用水GMP指南》

      近日,WHO發布了 《制藥用水GMP指南》,該指南英文全文29頁,包含以下內容:
       
      制藥用水系統的一般原則
      飲用水、純化水、高純水、注射用水和其他級別的水的質量標準要求
      制水系統、儲存和分配系統的注意事項
      水系統良好規范
      系統消毒與生物污染控制
      儲罐的要求
      分配系統的要求
      生物污染控制技術
       
      第一階段、第二階段、第三階段的操作考慮點 
      持續監測的要求
      水系統的維護要求
      系統回顧
      水系統的檢查
       
      部分翻譯如下:
      1.Introduction 介紹
      2.Background to waterrequirements and uses 水的要求和用途背景
      3.General principles forpharmaceutical water systems 制藥用水系統的一般原則
       
      4.Water quality specifications 水的質量標準
      4.1.  Pharmacopoeial specifications 藥典標準
      4.2.  Drinking-water 飲用水 
      4.3.  Bulk purified water 純化水
      4.4.  Bulk highly purified water 高純水
      4.5.  Bulk water for injections 注射用水 
      4.6.  Other grades of water 其他級別的水
       
      5.General considerations forwater purification systems 水凈化系統的一般考慮點
      6.Water storage and distributionsystems 儲存和分配系統
      7.Good practices for watersystems 水系統良好規范
      8.System sanitization and bioburdencontrol 系統消毒與生物污染控制
      9.Storage vessels 儲罐
      10.Water distribution 分配系統
      11.Biocontamination control techniques 生物污染控制技術
      12.Operational considerations 操作的考慮點 
      13.Continuous system monitoring 持續系統監測
      14.Maintenance of water systems 水系統的維護
      15.System reviews 系統回顧
      16.Inspection of water systems 水系統的檢查
      17.References 參考資料
      18.Further reading 延伸閱讀
       
      1 Introduction and scope 介紹及范圍
      1.1  Thisdocument concerns water for pharmaceutical use (WPU) produced, stored anddistributed in bulk form. It intends to provide informationabout different specifications for WPU; guidance on GMP regarding the qualitymanagement of water systems; water treatment (production) systems; waterstorage and distribution systems; qualification and validation; and sampling,testing and the routine monitoring of water.
      本文件包括制藥用水(WPU)的生產、儲存和分配。本文件提供不同制藥用水標準、水系統質量管理的GMP指南、水處理(生產)系統、制藥用水儲存和分配系統、確認和驗證、以及取樣、測試和水的日常監測相關的信息。
      1.2  Althoughdrinking-water is addressed, the focus of this document is on the treatment,storage and distribution of treated water used in pharmaceutical applications.
      雖然提到了飲用水,但本文件的重點是經處理的制藥用水的處理、儲存和分配。
      1.3  Thisdocument does not cover water for administration to patients in the formulatedstate or the use of small quantities of water in pharmacies to compoundindividually prescribed medicines.
      本文件不包括處于配方狀態的供病人使用的水,或在藥房少量使用于配制個別處方藥物的水。
      1.4  Thedocument can be used in whole or in part, as appropriate, to the section andapplication under consideration.
      本文件可全部或部分(視乎情況而定)用于審議中的部分和申請。
      1.5  Inaddition to this document, the “Further reading” section at the end of thisdocument includes some relevant publications that can serve as additionalbackground material when planning, installing and using systems intended toprovide WPU.
      除本文件外,本文件末尾的”延伸閱讀”部分還包括一些相關出版物,在計劃、安裝和使用制藥用水系統時可作為補充背景材料。
      1.6  Thisdocument is supplementary to the World Health Organization (WHO) Goodmanufacturing practices for active pharmaceutical ingredients (2), and WHO Goodmanufacturing practices for pharmaceutical products: main principles (3).
      本文件是對世界衛生組織(WHO)活性藥物成分GMP(2)和WHO藥物成品GMP(3)的補充。
       
      2.  Backgroundto water requirements and uses 水的要求和使用背景
      2.1  Wateris a widely used substance in the pharmaceutical industry. It is extensivelyused as a raw material or starting material in the production, processing andformulation of active pharmaceutical ingredients (APIs), intermediates andfinished pharmaceutical products (FPP), in the preparation of solvents andreagents, and for cleaning (e.g. washing and rinsing). Water has uniquechemical properties due to its polarity and hydrogen bonds. It is able todissolve, absorb, adsorb or suspend different compounds. These would includecontaminants that may represent hazards in themselves or that may be able toreact with intended product substances, resulting in hazards to health. Watershould therefore meet the required quality standards to mitigate these risks.
      水是制藥工業中廣泛使用的物質。它被廣泛用作活性藥物成分(API)、中間體和成品(FPP)的生產、加工和配方的原料或起始材料,用于溶劑和試劑的制備,以及用于清潔(如清洗和沖洗)。水由于其極性和氫鍵,具有獨特的化學性質。它能夠溶解、吸收、吸附或懸浮不同的化合物。這可能包括本身構成危害或可能與預期產品物質發生反應的污染物,從而對健康造成危害。因此,水應符合必要的質量標準,以減輕這些風險。
      2.2  Themicrobiological and chemical quality of water should be controlled throughoutthe production, storage and distribution of water. Water is not usuallysubjected to testing and batch or lot release before use. It is usually drawnfrom a system on-demand for use. Results from testing arenormally available only after water has already been used as microbiologicaltests may require periods of incubation. The assurance of quality to meet theon-demand expectation of water is therefore essential.
      在水的生產、貯存及分配過程中,應控制水的微生物及化學質量。水在使用之前通常不會經過測試和批放行。它通常來自一個按需使用的系統。由于微生物測試可能需要一段培養期時間,因此一般只有在用水后才可取得測試結果。因此,保證水的質量以滿足用水需求是至關重要的。
      2.3  Toreduce the risks associated with the production, storage and distribution ofwater and, considering the properties and use of water, it is essential:
      為了減少與水的生產、儲存和分配有關的風險,并考慮到水的特性和用途,必須:
      to ensure the appropriate design, installation, operation andmaintenance of the pre-treatment (production of drinking-water), treatment(production of WPU such as purified water (PW) and WFI), and storage anddistribution systems;
      確保預處理(飲用水的生產)、處理(制藥用水的制備,如下純化水(PW)和注射用水(WFI))及貯存和分配系統得到適當的設計、安裝、操作和維修;
      to perform periodic sanitization;
      定期進行衛生處理;
      to take the appropriate measures in order to prevent chemical andmicrobial contamination; and
      采取適當措施,防止化學和微生物污染;以及
      to prevent microbial proliferation.
      防止微生物繁殖。
      2.4  Differentgrades of water quality exist. The appropriate water quality, meeting itsdefined specification, should be used for the intended application.
      水的質量存在不同級別。應使用適當的水質(符合其既定標準)用于其預期目的。
       
      3. Generalprinciples for pharmaceutical water systems
      制藥用水系統的一般原則
      3.1  Pharmaceuticalwater production, storage and distribution systems should be designed,installed, commissioned, qualified, validated, operated and maintained toensure the consistent and reliable production of water of intended quality.
      制藥用水的生產、儲存和分配系統應該設計、安裝、調試、確認、驗證、運行和維護,以確保一致和可靠地生產符合預期質量的水。
      3.2  Thecapacity of these systems should be appropriate to meet the average and peakflow demand. The systems should be able to operate continuously for significantperiods of time in order to avoid the inefficiencies and equipment stressesthat occur when equipment cycles turn on and off too frequently.
      系統的能力應適當,以滿足平均流量和峰值流量的需求。系統應能夠連續長時間運行,以避免因設備頻繁開啟和關閉而造成的效率低下和設備壓力。
      3.3  Theuse of the systems following an initial qualification such as installationqualification (IQ), operational qualification (OQ), performance qualification(PQ) and validation should be approved by the quality unit, e.g. qualityassurance (QA).
      在初始確認(例如安裝確認、運行確認、性能確認和驗證)后,系統的使用應由質量部門批準,例如質量保證(QA)。
      3.4  Watersources and treated water should be monitored regularly for chemical,microbiological and, as appropriate, endotoxin contamination. The performanceof water treatment, storage and distribution systems should also be monitored.Records of the results monitored, trend analysis and any actions taken shouldbe maintained.
      應定期監測原水及處理后水的化學、微生物及(如適用)內毒素污染情況。水的處理、儲存和分配系統的性能也應監測。應保存監測結果,趨勢分析,以及任何所采取行動的記錄。
       
      4.  Water quality specifications 水的質量標準
      4.1  Pharmacopoeialspecifications 藥典標準
      4.1.1Pharmacopoeiasinclude specifications for both bulk and dosage form types of water. Where thisdocument refers to specifications, such as the pharmacopoeias, the relevant,current publications should be used. This document does not attempt to duplicatesuch material. Where subtle points of difference exist between pharmacopoeialspecifications, the manufacturer should choose the appropriate specification inaccordance with the related marketing authorization submitted to the relevantmedicine’s regulatory authority. Pharmacopoeial requirements or guidance forWPU are described in national, regional and international pharmacopoeias (4)and limits for various impurities or classes of impurities are either specifiedor recommended. Requirements or guidance are given in pharmacopoeias on themicrobiological quality of water.
      藥典包括水的使用和制劑標準。本文件所提及標準,例如藥典,則應使用相關的最新版本。本文件將不重復這些內容。如不同藥典標準之間存在細微差別,制造商應根據向相關藥監機構提交的上市許可來選擇的適當的標準。國家、地區和國際藥典(4)對制藥用水的藥典要求或指南進行了描述,并規定或推薦了各種雜質或雜質類別的限值。藥典對水的微生物質量提出了要求或指導。
       
      4.2  Drinking-water 飲用水
      4.2.1 Thequality of drinking-water is covered by the WHO drinking-water qualityguidelines (5) and standards from the International Organization forStandardization (ISO) and other regional and national agencies. Drinking-watershould comply with the relevant regulations laid down by the competentauthority.
      飲用水的質量由WHO飲用水質量指南(5)和國際標準化組織衛生組織(ISO)及其他區域和國家機構的標準所涵蓋。飲用水應當符合主管機構的有關規定。
      4.2.2 Drinking-watermay be derived from a natural or stored source. Examples of natural sourcesinclude springs, wells, rivers, lakes and the sea. The condition of the sourcewater should be considered when choosing a treatment to produce drinking-water. A typical treatment would include desalinization, softening, removal ofspecific ions, particle reduction and antimicrobialtreatment.
      飲用水可來自天然或儲存的水源。自然資源的例子包括泉水、井水、河流、湖泊和海洋。在選擇飲用水處理方法時,應考慮水源水的條件。典型的處理方法包括脫鹽、軟化、特定離子的去除、顆粒降低和抗菌處理。
      4.2.3 Drinking-watershould be supplied under continuous positive pressure by a plumbing system freeof any defects that could lead to contamination of any product.
      飲用水應由管道系統在持續正壓下供應,不得有任何可能污染任何產品的缺陷。
      4.2.4 Drinking-watermay be derived from a public water supply system. This includes an off-sitesource, such as a municipality. The appropriate drinking-water quality shouldbe ensured by the supplier. Tests should be conducted to guarantee that thedrinking-water delivered is of drinking quality. This testing is typicallyperformed on water from the water source. Where required, the quality may beachieved through appropriate processing on-site.
      飲用水可能來自公共供水系統。這包括一個工廠外的來源,比如市政當局。供應商應確保適當的飲用水水質。應當進行檢驗,以保證所提供的飲用水的質量。這種測試通常在原水供應點進行。必要時,應進行適當的內部處理以達到規定質量。
      4.2.5 Wheredrinking-water is purchased in bulk and transported to the user by watertanker, controls should be put in place to mitigate any risks associatedtherewith. Vendor assessment and authorized certification activities, includingconfirmation of the acceptability of the delivery vehicle, should be undertakenin a way similar to that used for any other starting material.
      如果飲用水是散裝購買,并由水罐車運送給用戶,應進行控制以減少與此相關的任何風險。供應商評估和批準認證活動,包括確認運載工具的可接受性,應以類似于任何其他起始物料的方式進行。
      4.2.6  Itis the responsibility of the pharmaceutical manufacturer to assure that thesource water supplying the PW treatment system meets the appropriatedrinking-water requirements. In these situations, the point at whichdrinking-water quality is achieved should be identified and a water sampletaken and tested at defined intervals thereafter.
      藥品制造商有責任確保供應純化水處理系統的源水符合適當的飲用水要求。在這些情況下,應確認達到飲用水質量的點,并在其后以規定的時間間隔取樣和測試。
      4.2.7 Ifdrinking-water is used directly in certain stages of pharmaceuticalmanufacture, such as in the production of APIs or in the feedwater for theproduction of higher qualities of WPU, then testing should be carried outperiodically by the water user’s site to confirm that the quality meets thestandards required for drinking-water.
      如果在藥物制造的某些階段直接使用飲用水,例如在原料藥生產或在生產較高質量制藥用水的給水中直接使用飲用水,工廠應定期進行測試,以確認水質符合飲用水所需的標準。
      4.2.8  Wheredrinking-water is produced through the treatment of raw water by a systemon-site, the system configuration and water-treatment steps used should bedescribed.
      如飲用水是由原水經現場系統處理而產生,則應說明系統配置及所采用的水的處理步驟。
      4.2.9 Examplesof typical processes employed to produce drinking-water may include:
      制備飲用水的典型工序例子包括:
      desalinization;脫鹽;
      filtration;過濾;
      softening;軟化;
      disinfection or sanitization (e.g. by sodium hypochlorite {chlorine}injection);消毒(例如使用次氯酸鈉{氯});
      iron (ferrous) removal;除鐵;
      precipitation;沉降;
      the reduction of concentration of specific inorganic and/or organicmaterials.降低特定無機和/或有機物質的濃度。
      4.2.10 Controls should be implemented toprevent the microbiological contamination of sand filters, carbon beds andwater softeners. The techniques selected should be appropriate and may includebackflushing, chemical and/or thermal sanitization and frequent regeneration.
      應實施控制以防止砂濾器、碳床和水軟化裝置受微生物污染。所選擇的技術應該是適當的,可以包括反沖洗、化學和/或熱消毒以及頻繁的再生。
      4.2.11 The quality of drinking-water shouldbe monitored routinely to account for environmental, seasonal or supply changeswhich may have an impact on the source water quality.
      應定期監測飲用水的水質,考慮可能影響源水水質的環境、季節或供應變化。
      4.2.12 Where drinking-water is stored anddistributed by the user, the storage and distribution systems should not allowthe degradation of the water quality prior to use. After any such storage,testing should be carried out routinely and in accordance with a definedprocedure. The storage and distribution of drinking-water should be done in amanner to ensure a turnover or recirculation of the stored water sufficientenough to prevent stagnation.
      當用戶對飲用水進行儲存和分配時,儲存和分配系統不應在使用前降低水質。任何此類存儲后,應進行日常測試,并符合既定程序。飲用水的儲存和分配應以某種方式確保所儲存水的翻滾或循環足以防止停滯。
      4.2.13 The equipment and systems used toproduce and store drinking-water should be able to be drained and sanitized.
      用于生產和儲存飲用水的設備和系統應能夠排水和消毒。
      4.2.14 Storage tanks should be closed withappropriately protected vents and should allow for visual inspection.
      儲罐應密封,配以受適當保護的通氣口,并應可以目視檢查。
      4.2.15 Distribution pipework should be ableto be drained or flushed and sanitized.
      分配管道應該能夠排水、沖洗和消毒。
      4.2.16 The scope and extent ofqualification for the system should be identified and justified.
      應確定和論證系統確認范圍和程度。
      4.2.17 The results from testingdrinking-water should be subjected to statistical analysis in order to identifytrends and changes. If the drinking-water quality changes significantly, but isstill within specification, the direct use of this water as a WPU, or as thefeedwater to downstream treatment stages, should be reviewed for any risks andthe results of the review and action to be taken and documented.
      飲用水測試結果應作統計分析,以確定趨勢和變化。如果飲用水水質發生重大變化,但仍符合標準,則應審查直接將這種水用作制藥用水或作為下游處理階段的給水,以審查任何風險以及審查的結果和采取的行動并記錄。
      4.2.18 Changes to a system or to itsoperation should be made in accordance with change control procedures.
      系統或其操作的變更應按照變更控制程序進行。
      4.2.19 Additional testing should be consideredif there is any change in the raw water source, treatment techniques or systemconfiguration.
      如原水來源、處理技術或系統配置有任何變更,應考慮進行額外測試。
       
      4.3  Bulkpurified water 純化水
      4.3.1  Bulkpurified water (BPW) should meet the relevant pharmacopoeial specifications forchemical and microbiological purity.
      純化水(BPW)應符合相關藥典的化學和微生物標準。
      4.3.2 BPWshould be prepared from drinking-water as a minimum-quality feedwater.
      純化水應最少由飲用水制備而成。
      4.3.3  Anyappropriate, qualified purification technique, or sequence of techniques, maybe used to prepare BPW. BPW may be prepared by, for example, a combination ofion exchange, RO, RO/electro-deionization (EDI), ultrafiltration and vapourcompression.
      可使用適當的、經確認的純化技術或技術組合制備純化水。純化水可通過,例如,離子交換、反滲透、反滲透/電去離子(EDI)、超濾和蒸汽壓縮的組合來制備。
      4.3.4 Thefollowing should be considered when configuring a water purification system ordefining user requirement specifications (URS):
      在配置純化水系統或定義用戶需求規范(URS)時,應考慮以下因素:
      the quality of feedwater and its variation over seasons;給水質量及其季節變化;
      the quantity of water required by the user;用戶所需的用水量;
      the required water-quality specification;所需的水質標準;
      the sequence of purification stages required;所需的純化階段順序;
      energy consumption;能耗;
      appropriately located sampling points designed in such a way so asto avoid potential contamination; and適當設置取樣點,以避免潛在污染;以及
      unit process steps provided and documented with the appropriateinstrumentation to measure parameters suchas flow, pressure, temperature, conductivity, pH and total organic carbon.
      各單元處理步驟提供并記錄適當的儀器,以測量諸如流量、壓力、溫度、電導率、pH值和總有機碳等參數。
      4.3.5 Ambient-temperaturesystems such as ion exchange, RO and ultrafiltration are especially susceptibleto microbiological contamination, particularly when equipment is static duringperiods of no or low demand for water. Sanitization, at defined intervals, aswell as other controls, should be defined to prevent and minimizemicrobiological contamination.
      離子交換、反滲透和超濾等環境溫度系統特別容易受到微生物污染,尤其是當設備在沒有或需水量很低處于停止的時候。為了防止和減少微生物污染,應該定期進行消毒處理以及其他控制措施。
      4.3.6 Appropriate,validated methods for sanitizing each stage of purification needs to be inplace. Where agents are used for sanitization, their removal must be proven.
      每個純化階段都需要適當的、經過驗證的消毒方法。如使用消毒劑,應證明消毒效果。
      4.3.7 Thefollowing controls should be considered:應考慮以下控制措施:
      the maintenance of water flow at all times, in order to preventwater from stagnating;時刻保持水的流動,防止滯留;
      control of temperature in the system by heat exchangers or plantroom cooling in order to reduce the risk of microbial growth (guidance value< 25 °C);
      通過熱交換器或工廠房間冷卻來控制系統內的溫度,以減少微生物生長的風險(指導值<25℃);
      the provision of ultraviolet disinfection at appropriate locationsin the system;在系統的適當位置進行紫外線消毒;
      the use of water-treatment system components that can periodicallybe thermally sanitized;使用可以周期性地進行熱消毒的水處理系統組件;
      in addition to thermal sanitization, the application of chemicalsanitization such as ozone, hydrogen peroxide and/or peracetic acid; and
      除熱消毒外,使用化學消毒劑如臭氧、過氧化氫和/或過氧乙酸;以及
      thermal sanitization at > 70 °C.70℃熱消毒。
      4.3.8  BPWshould have the appropriate action and alert limits for microbiological puritydetermined from a knowledge of the system and data trending. BPW should beprotected from recontamination and microbial proliferation.
      純化水應根據對系統和數據趨勢的知識,確定微生物純度的適當行動和警戒限。應該防止二次污染和微生物繁殖。
       
      4.4  Bulkhighly purified water,高純水
      4.4.1 Bulkhighly purified water (BHPW) must meet the same quality standards as WFI,including the limit for endotoxins.
      高純水(BHPW)必須達到與WFI相同的質量標準,包括內毒素標準。
      4.4.2 BHPWshould be prepared from drinking water as a minimum-quality feedwater.
      高純水應最低使用飲用水制備。
      4.4.3 Anyappropriate and qualified purification technique, or sequence of techniques,may be used to prepare BHPW. BHPW is often produced by double pass RO coupledwith other suitable techniques such as ultrafiltration and deionization.
      可使用適當并經確認的純化技術,或者技術組合制備高純水。高純水通常采用兩級反滲透與超濾和去離子等其他適當技術相結合的方法制備。
      4.4.4  BHPWshould also be protected from recontamination and microbial proliferation.
      還應保護高純水免受再污染和微生物增殖。
      4.4.5  BHPWand WFI have identical microbiological requirements.
      高純水和WFI具有相同的微生物要求。
      Note: The guidance provided in section 4.3 for BPW is equally applicable to BHPW.
      注:第4.3節提供的純化水指南同樣適用于高純水。
       
      4.5  Bulkwater for injections 注射用水
      4.5.1 Bulkwater for injections (BWFI) should meet the relevant pharmacopoeialspecifications for chemical and microbiological purity (including endotoxins).BWFI is the highest quality of pharmacopoeial WPU.
      注射用水(BWFI)應符合相關藥典的化學和微生物純度(包括內毒素)標準。注射用水是最高質量的制藥用水。
      4.5.2 BWFIis not sterile water and is not a final dosage form. It is an intermediate bulkproduct suitable to be used as an ingredient during formulation.
      散裝注射用水不是無菌水,也不是成品制劑。它是一種適合在配方中作為配料使用的中間體產品。
      4.5.3 Asa robust technique should be used for the production of BWFI, the followingshould be considered when designing a water purification system:
      注射用水的制備應采用穩健的技術,在設計注射用水系統時應考慮以下因素:
      the quality of feedwater (e.g. drinking-water, usually with furthertreatment, or PW);給水的質量(例如飲用水,通常需要進一步處理,或者PW);
      the required water quality specification;所需的水質標準;
      the quantity of water;水量;
      based on the selection of components and type of system, theappropriate URS, qualification and validation;基于部件和系統類型的選擇,適當的URS、確認和驗證;
      the optimum generator size or generators with variable control toavoid over-frequent start/stop cycling;制水機最優規格或可調控制的制水機,以避免頻繁啟動/停止;
      blow-down and dump functions; 吹掃和排放功能;以及
      cool-down venting to avoid contamination ingress.冷卻水排放,防止污染進入。
      4.5.4 BWFImay be prepared, for example, by distillation as the final purification step.Alternatively, techniques such as deionisation, electro deionization, nanofiltration, ultrafiltration, water softening, descaling, pre-filtration anddegasification, ultraviolet treatment, along with other techniques, may beconsidered in conjunction with a single or double pass RO system.
      注射用水可以通過蒸餾作為最后的提純步驟來制備。或者,諸如去離子、電去離子、納米過濾、超濾、水軟化、除垢、預過濾和除氣、紫外線處理以及其他技術,可以與一級或兩級反滲透系統一起考慮。
      4.5.5 BWFIshould have the appropriate action and alert limits and should also beprotected from recontamination and microbial proliferation.
      注射用水應有適當的行動和警戒限度,并應防止再污染和微生物增殖。
      Note: For a full description, seeProduction of water for injection by means other than distillation.
      注:詳細說明請參閱非蒸餾法制備注射用水指南。
       
      4.6  Othergrades of water 水的其他級別
      When a specific process requires a specialnon-pharmacopoeial grade of water, its specification must be documented withina company’s quality system. As a minimum, it must meet the pharmacopoeialrequirements relating to the grade of WPU required for the type of dosage formor process step.
      當一個特定的工藝需要特殊的非藥典級別的水時,其標準必須在公司的質量體系中規定。至少,它必須滿足與劑型或工藝步驟類型所需的制藥用水等級相關的藥典要求。
       
      5.  General considerations for water purificationsystems 純化水系統的一般考慮點
      5.1  Pharmaceuticalmanufacturers should apply the current principles of quality risk management(6) in selecting and using the appropriate water purification systems. Anappropriate method for the production of WPU should be used.
      藥物制造商在選擇和使用合適的純化水系統時,應采用現行的質量風險管理原則。制藥用水(WPU)的生產應采用合適的方法。
      5.2  Risksand controls should be identified for each stage of the production, storage,distribution, use and monitoring of WPU.
      制藥用水的生產、儲存、分配、使用和監測的每個階段都應確定風險和控制措施。
      5.3  Risksidentified should be analyzed and evaluated in order to determine the scope andextent of validation and qualification of the system, including thecomputerized systems used for the production, control and monitoring of WPU.
      應分析和評估所識別的風險,以確定該系統的驗證和確認的范圍和程度,包括用于制備、控制和監測的計算機化系統。
      5.4  Riskmanagement should be an ongoing part of the quality management process for WPU.A mechanism to review or monitor events associated with the production,storage, distribution and use of WPU should be implemented.
      風險管理應作為制藥用水質量管理過程的一個持續的部分。應實施一種機制,以審查或監測與制藥用水的生產、儲存、分配和使用有關的事件。
      5.5  Proceduresfor managing changes and deviations should be followed. Where applicable, theappropriate risk and impact assessments should be done where changes anddeviations are managed.
      應遵循變更和偏差的管理程序。適當時,變更和偏差的管理應進行適當的風險和影響評估。


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