1. Introduction ?筒介
1.1 One o f themain purposes o f the GMP/GDP Inspectors Working Group is to establish andmaintain a system for mutual recognition o f national inspections in respect of the manufacture and, where relevant, wholesale distribution o f medicinalproducts and for the administrative collaboration between Member States (MS) of the European Economic Area (EEA). The general requirements for nationalpharmaceutical inspectorates are to fu lfil the requirements o f nationallegislation and o f the relevant European Directives for EEA countries.Specific obligations o f inspections as contained in national law and if anyEuropean Directives must be included in the national Inspectorate’s qualitysystems. 在進(jìn)行藥品生產(chǎn)及批發(fā)流通方面（相關(guān)的話(huà)）的國家檢查時(shí)，建立并保持一個(gè)互認體系，并管理歐洲 經(jīng) 濟 區 （E E A )成 員 國 （M S )之間的合作，是藥品生產(chǎn)質(zhì)量管理規范/藥品流通質(zhì)量管理規范檢 查員工作組的主要目的之一。對國家藥品檢查員的一般要求是履行國家法規以及歐洲經(jīng)濟區（E E A ) 國家的相關(guān)歐盟法令所要求的職責。國家法律及任何歐盟法令中包含的檢查特定職責必須包含在國 家檢查員的質(zhì)量體系之中。
1.2 This documentoutlines the quality system requirements for GMP pharmaceutical inspectorates.It is intended that each GMP pharmaceutical inspectorate uses the document asthe basis for developing and implementing its quality system and for preparingthe quality manual. In addition to providing a basis for self-assessment and areference document for use by external assessors, establishing and maintainingan effective quality system w ill generate confidence w ithin and between GMPnational pharmaceutical inspectorates in the assessment o f compliance w ithgood manufacturing practice and/or good wholesale distribution practice. 本文件概述藥品生產(chǎn)質(zhì)量管理規范檢査機構質(zhì)量體系的要求。 旨在使每一藥品生產(chǎn)質(zhì)量管理規范檢查機構以本文件為基礎來(lái)開(kāi)發(fā)并實(shí)施其質(zhì)量體系，并制作質(zhì)量手冊。除了給自我評估提供一個(gè)基礎 以及作為外部評估人員的參考文件外，建立并維持一個(gè)有效的質(zhì)量體系將會(huì )在國家藥品檢査機構內部以及檢查機構之間在評估藥品生產(chǎn)質(zhì)量管理規范和/ 或藥品批發(fā)流通管理規范符合性方面建立信心。 Other Documents Related to GMP 與 《藥品生產(chǎn)質(zhì)量管理規范》相關(guān)的其他文件
1.3 National GMPpharmaceutical inspectorates, the European Commission (EC), the EuropeanMedicines Agency (EMEA) and the pharmaceutical Inspection Cooperation Scheme -(PIC/S) should co-operate w ith one another in exchanging experiences in themaintenance and operation o f quality systems and in the further development of this document. 國家藥品生產(chǎn)質(zhì)量管理規范檢查機構、歐 盟 委 員 會(huì ) （E C )、歐 洲 藥 品 管理 局 （E M E A ) 以及藥品檢 查 合 作 計 劃 （P IC/S )應該以在質(zhì)量體系的維持與運行方面彼此交換經(jīng)驗、進(jìn)一步開(kāi)發(fā)本文件的方式 開(kāi)展合作。
1.4 Only onvoluntary basis, this document could be useful for (other) inspectoratesassessing compliance w ith GxP or for the inspection o f pharmacies. 本 文 件 對 于 （其 他 ）檢 查 員 評 估 與 其他 質(zhì) 量 管 理 規 范 （G x P )或對于藥房檢查的使用，以自愿為 基礎。
1.5 In preparingthis text, the working group was advised by ： 在制作本文時(shí)，工作小組已經(jīng)對下述文件給予了仔細考慮： ENISO/IEC 17020 ：2005 General criteria for the operationof various types of bodies performing inspections ? 對不同團體運營(yíng)實(shí)施檢查總標準； EN ISO/IEC 17023 ：2006 General requirementsfor bodies operating assessment and certification/ registration o f qualitysystem ； 團體運營(yíng)評估和質(zhì)量體系認證/ 注冊總要求；ISO 9001-2000 Quality management systems-Requirements ； 質(zhì)量管理體系— 要 求 ： ISO 9004-2000 Quality managementsystems: guidelines for performance improvements 5 質(zhì)量管理體系：性能改進(jìn)指南； ISO 19011 ：2002 Guidelines for qualityand/or environmental managerial systems auditing ； 質(zhì)量和/或環(huán)境管理體系審計指南； PI 002-1 ：2000Recommendations on quality system requirements for pharmaceutical inspectorates； 藥品檢查機構質(zhì)量體系要求推薦； May 2001 2001年 5 月 Revised Compilation of Communityprocedures on administrative collaboration and harmonisation of inspections ；《共同體規程匯編》關(guān)于管理協(xié)作與協(xié)調檢查修訂版； 1998 1998 年P(guān)roceedings of the PIC-PIC/S seminar on quality systems for pharmaceuticalinspectorates. 藥品生產(chǎn)檢查互認公約-藥品生產(chǎn)檢查互認 劃（PIC-PIC/S)的藥品檢查員質(zhì)量體系藥品研討會(huì )議程。
2. Purpose 目的
2.1 The primarypurpose o f a quality system is to ensure that adequate quality standards aremaintained. The purpose o f adopting a common standard for quality system requirementsis to achieve consistency in inspection standards between GMP nationalpharmaceutical inspectorates and thus to facilitate mutual recognition o fthose inspectorates. This standard should facilitate implementation o f theEuropean Joint Audit Programme and PIC/S Joint Re-assessment Programme. 質(zhì)量體系的主要目的是確保維持足夠的質(zhì)量標準。對質(zhì)量體系要求采用共同標準，目的是在各成員 國國家藥品生產(chǎn)質(zhì)量管理規范檢查機構之間就檢查標準取得一致性，從而促進(jìn)檢查互認。這一共同 標準應促進(jìn)歐洲聯(lián)合審計程序以及藥品生產(chǎn)檢查互認公約（P IC /S )聯(lián)合再評估程序。
2.2 Each GMPnational inspection service should use this document as the basis fordeveloping its own quality system, so that inspection activities w ithin eachinspection service are carried out in accordance w ith a system compatible 418 歌渝公 l郁蓄ouryao · com Compilation of Community Procedures on Inspections andExchange of Information ^ 檢查與信息交換共同體規程匯編 w ith those of the other member states. 各成員國國家藥品檢查機構應該以本文件為基礎來(lái)開(kāi)發(fā)各自質(zhì)量體系，從而使各成員國藥品檢查機 構進(jìn)行檢查時(shí)所遵守的體系能與其他成員國的體系兼容。
3. Scope 范圍
3.1 This documentspecifies the quality system requirements for national pharmaceuticalinspection services concerned with good manufacturing practice. 本文件規定了藥品生產(chǎn)質(zhì)量管理規范相關(guān)的國家藥品檢查服務(wù)質(zhì)量體系要求。
3.2 Wherewholesale inspections are required by national legislation to be carried out byGMP national pharmaceutical inspection service, this document specifies thequality system requirements for national pharmaceutical inspection servicesconcerned w ith good wholesale distribution practice o f medicinal products. 當國家法規要求國家藥品生產(chǎn)質(zhì)量管理規范檢査機構對批發(fā)進(jìn)行檢査時(shí)，本文件規定了國家藥品檢查機構針對藥品批發(fā)流通規范檢查的質(zhì)量體系要求。
3.3 The qualitysystem should include all activities involved in the inspection process. 質(zhì)量體系應當包括在檢查過(guò)程中所涉及的所有活動(dòng)。
4. Definitions ?定義
4.1 Qualitysystem 質(zhì)量體系 The sum o f all that is necessary to implement an organisation’squality policy and meet quality objectives. It includes organisation structure,responsibilities，procedures, systems, processes andresources. Typically these features w ill be addressed in different kinds o fdocuments as the quality manual and documented procedures, modus operandi. 一個(gè)組織實(shí)施其質(zhì)量方針以及實(shí)現其質(zhì)量目標所必需的一切的總和。它包括組織結構、職責、規程、體系、過(guò)程與資源。這些要素在不同類(lèi)型文件，如質(zhì)量手冊、文件規程、操作方法中會(huì )得到闡述。
4.2 Quality 質(zhì)量 Thetotality o f characteristics o f an entity that bear on its ability to satisfystated and implied needs. 一個(gè)組織盡其能力滿(mǎn)足明示的與隱含的需求特性的總和。
4.3Pharmaceutical Inspectorate 藥品檢查機構 The national body responsible forco-ordinating and carrying out GMP inspections, including inspections o fpharmaceutical manufacturers and/or wholesale distributors. I f relevant, thiscould include making decisions concerning the issue or withdrawal o festablishment licences or authorisations for their activities, the issue orwithdrawal o f GMP certificates, providing advice and handling suspectedquality defects. 負責協(xié)調與實(shí)施藥品G M P檢查的國家機構，包括對藥品生產(chǎn)企業(yè)和/ 或批發(fā)流通企業(yè)的檢查。如果 相關(guān)，可能負責有關(guān)簽發(fā)或撤銷(xiāo)企業(yè)許可或其活動(dòng)授權、簽發(fā)或撤銷(xiāo)藥品生產(chǎn)質(zhì)量管理規范證書(shū)、 提出建議以及處理可疑質(zhì)量缺陷。 419
4.4 Licence 許可 For thepurposes o f this document, a licence is defined as an authorisation tomanufacture or distribute medicinal products. 在本文件中，“ 許可” 被定義為批準進(jìn)行藥品生產(chǎn)或流通活動(dòng)。
5. Quality Manual 丨質(zhì)量手冊
5.1 Thepharmaceutical inspectorate shall prepare and maintain 汪 qualitymanual covering the elements described in this document. It is for eachpharmaceutical inspectorate to decide on the format and style o f their qualitymanual, but it must include, or make reference to, the quality systemprocedures which define the activities o f the Inspectorate and thearrangements for maintaining the quality system. The reference used to completeit (as ISO or EN norms) must be quoted too. 藥品檢查機構應當準備并維護一個(gè)質(zhì)量手冊，質(zhì)量手冊中應當覆蓋本文件所描述的要素。質(zhì)量手冊的格式和風(fēng)格取決于各藥品檢查機構，但是應當包括或引用定義檢查機構活動(dòng)的質(zhì)量體系規程和維 護質(zhì)量體系的安排。應當引用完成質(zhì)量手冊所用的參考（國際標準化組織或歐盟標準）。 Other Documents Related to GMP 與 《藥品生產(chǎn)質(zhì)量管理規范》相關(guān)的其他文件
6. Administrative Structure ^管理的結構
6.1 Thestructure, membership and operation o f the GMP pharmaceutical inspectorateshall be such as to enable it to meet the objectives o f quality management andto ensure that im partiality is safeguarded 藥品生產(chǎn)質(zhì)量管理規范藥品檢查機構應當有適當的結構：戒 員 ，并合理運行使其能實(shí)現質(zhì)量管理目 標 ，并確保公平公正。
6.2 The personnelo f the inspection service, including sub-contracted personnel and experts,shall be free from any commercial, financial and other pressures which mightaffect their judgement and freedom to act. The pharmaceutical inspectorateshall ensure that persons or organisations external to the inspectionorganisation cannot influence the result o f inspections. The system forobtaining fees should not improperly influence the inspection procedure. Rulesfor deontology, ethic and conflict o f interests should be clearly defined. 藥品檢查機構的人員，包括分包人員與專(zhuān)家，他們的檢查工作及對檢查所作的評價(jià)不得受商業(yè)、財務(wù)或任何其他方面影響。藥品檢查機構應當確保其檢查結果不受本機構以外的任何個(gè)人或組織影響。 收取費用的體系不應對撿查規程產(chǎn)生錯誤影響。應明確規定行為規范準則及利益沖突。
6.3 Therelationship o f the pharmaceutical inspectorate to other agencies and to otherorganisations w ithin and outside the Inspectorate shall be described whererelevant. 如果相關(guān)，應當描述藥品檢查機構在本機構內外與其他機構或組織的關(guān)系。
6.4 Thepharmaceutical inspectorate shall implement a policy which distinguishesbetween the process o f inspection and that o f issuing a GMP manufacturingauthorisation. 藥品檢查機構應當實(shí)施一個(gè)方針用于區分檢查過(guò)程與簽發(fā)藥品生產(chǎn)質(zhì)量管理規范證書(shū)的過(guò)程。
6.5 Whererelevant, the pharmaceutical inspectorate shall implement a policy whichdistinguishes between the process o f inspection and that o f providing anadvisory service to clients. This service should be o f benefit to all o findustry and not solely to individual organisations. 如果相關(guān)，藥品檢查機構應當實(shí)施一個(gè)方針用于區分檢查過(guò)程與對客戶(hù)提供咨詢(xún)服務(wù)的過(guò)程。這種咨詢(xún)服務(wù)應有益于整個(gè)行業(yè)而不是單獨針對個(gè)別組織。 Compilation of Community Procedureson Inspections and Exchange of Information 檢查與信息交換共同體規程匯編
7. Organisation and Management ?組織與管理
7.1 Seniormanagement o f the pharmaceutical inspectorate shall make a formal commitmentto the recommended principles embodied in this document by ensuring that thequality policy o f the Inspectorate is documented, that it is relevant to theobjectives o f that organisation and that it is implemented. 藥品檢查機構的高級管理層應當將該檢查機構的質(zhì)量方針文件化，以對本文件中包括的原則作出正式承諾。質(zhì)量方針與該檢查機構的質(zhì)量目標相關(guān)，且質(zhì)量方針得到實(shí)施。
7.2 Theresponsibility, authority and reporting structure o f the pharmaceuticalinspectorate shall be clearly defined and documented. The structure shall bedefined in organisation charts and shall be supported by written jobdescriptions for each member o f staff. 藥品檢查機構的職責、權力與工作匯報關(guān)系應當得到明確規定并文件化。工作匯報關(guān)系應當在組織 機構圖中規定，并用每個(gè)員工的書(shū)面工作描述來(lái)支持。
7.3 There shallbe nominated an appropriately qualified and experienced person or persons w ithresponsibility to carry out the quality assurance function, includingimplementing and maintaining the quality system. This person shall have directaccess to senior management. 藥品檢查機構應當任命一名有恰當資質(zhì)與經(jīng)驗的人員或一組人員來(lái)負責履行質(zhì)量保證職能，包括質(zhì) 量體系的實(shí)施與維護。該人員應當有與高級管理層直接交流的渠道。
7.4 Senior managemento f the competent authority shall ensure that the pharmaceutical inspectoratehas sufficient resources at all levels to enable it to meet its objectiveseffectively and efficiently. The senior management o f the pharmaceuticalinspectorate shall ensure that a ll personnel are competent and qualified tocarry out their assigned duties and that they receive appropriate training.Such training shall be documented and its effectiveness assessed. 主管官方的高級管理層應當確保藥品檢査機構在所有層次上有足夠資源，使藥品檢查機構能夠有效且高效地實(shí)現其目標。藥品檢查機構的高級管理層應當確保所有人員有能力與資質(zhì)來(lái)履行分配的工 作職責，并確保所有人員接受恰當的培訓。對此類(lèi)培訓應進(jìn)行記錄并評估培訓效果。
7.5 There shallbe a system for periodic management review o f the quality system. Such reviewsshall be documented and records shall be retained for a defined period. 應當有一個(gè)系統來(lái)定期地對質(zhì)量體系進(jìn)行管理評審。應當對此評審進(jìn)行記錄，記錄應當保存規定期 限 。
8. Documentation and Change Control 文件與變更控制
8.1 Thepharmaceutical inspectorate shall establish and maintain a system for thecontrol o f all documentation relating to the inspection system. This shallinclude policies, procedures, guidelines and any documents o f external originsuch as regulations and directives which may direct the activities o f theInspectorate or influence the quality o f its operations. 藥品檢查機構應當針對現場(chǎng)檢查體系相關(guān)的所有文件建立一個(gè)管理體系，并對文件管理體系進(jìn)行維護 。該管理體系應當包括方針、規程、指南與任何外部來(lái)源文件，諸如可能指導檢查機構活動(dòng)或影 響其運行質(zhì)量的法規與法令。
8.2 The documentcontrol system shall ensure that documents are authorised by appropriatepersons prior to issue and that only current versions are held by nominatedindividuals. A record o f all relevant documents and document hold- 42/ ersshall be maintained. The system shall ensure that superseded documents arewithdrawn from use. Superseded documents shall be retained for an appropriateand defined period. 文件管理系統應當確保文件在簽發(fā)前經(jīng)過(guò)相應人員授權，并確保文件接收人員僅持有現行版本。應 當對所有相關(guān)文件及對應的持有人做記錄。文件管理系統應當確保被替換的文件得到撤銷(xiāo)，不得被使用。被替換的文件應當保存適當期限，應當規定這類(lèi)文件的保存期限。
8.3 Thedocumentation system shall ensure that any changes to documents are made in acontrolled manner and are properly authorised. There shall be a means o fidentifying changes in individual documents. 文件管理系統應當確保對文件進(jìn)行的任何變更都以受控的方式進(jìn)行，并經(jīng)過(guò)適當授權。應當有一個(gè) 方式來(lái)識別每個(gè)文件中的變更。 ^4-4^4 Other Documents Related to GMP 與 （藥品生產(chǎn)質(zhì)量管理規范》相關(guān)的其他文件
9. Records 記錄
9.1 Thepharmaceutical inspectorate shall establish and maintain a system o f recordsrelating to its activities which complies w ith any existing regulations. I frelevant, the system shall include documents received from licence applicantsand licence holders as appropriate. 藥品檢查機構應當針對該機構符合任何現有法規活動(dòng)的相關(guān)記錄建立一個(gè)管理體系，并對記錄管理 體系進(jìn)行維護。如果有關(guān)，記錄管理體系應當包括從許可申請人和許可持有人接收的文件。
9.2 Records shallprovide detailed information about the planning o f inspections, the way inwhich each inspection was applied, a description o f the inspection process,follow-up activities and recommendations to the body responsible for issuinglicences. 記錄應當提供下述活動(dòng)的詳細信息：檢查計劃、每次檢查所應用的方式、檢查過(guò)程的描述、后續活動(dòng)及給發(fā)證機構的建議。
9.3 A ll recordsshall be handled in such a way as to prevent their damage or loss and shall beretained for an adequate period consistent w ith any legal requirements. A llrecords shall be maintained in confidence to the inspected party unlessotherwise required under freedom o f information legislation, or unlessrequired under exchange o f information procedures and arrangements betweennational pharmaceutical inspectorates, the EU/EEA, the EMEA and M utualRecognition Agreement (MRA) or PECA partners. 所有記錄的處理方式應當防止記錄受損或丟失，所有記錄的保存期限應當符合任何法規的要求。除 非在信息自由化法規下另有要求，或除非在國家檢查機構、歐盟/ 歐洲經(jīng)濟區、歐洲藥品管理局與互 認 協(xié) 議 （M R A ) 或工業(yè)產(chǎn)品符合性評估與驗收歐洲協(xié)定議定書(shū)（P E C A ) 簽署方信息交換規程與安 排下有要求，所有記錄應當對被檢查方保密。
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