【正文】 tinuing training of his department personnel is carried out and adapted according to need.確保對(duì)本部門(mén)人員進(jìn)行了必要的入職培訓(xùn)與持續(xù)培訓(xùn)，培訓(xùn)應(yīng)符合實(shí)際需要。在送到質(zhì)量控制部門(mén)前，確保生產(chǎn)記錄經(jīng)過(guò)授權(quán)人員評(píng)估和簽字；iv. to check the maintenance of his department, premises and equipment。確保產(chǎn)品按照造當(dāng)?shù)奈募?guī)定生產(chǎn)和貯存，從而達(dá)到質(zhì)量要求 ；ii. to approve the instructions relating to production operations and to ensure their strict implementation。構(gòu)龐大的組織中， 。通常，關(guān)鍵崗位人員應(yīng)當(dāng)為全職人員。在藥品生產(chǎn)質(zhì)量管理規(guī)范實(shí)施過(guò)程中，員工職責(zé)之間應(yīng)無(wú)縫銜接，并且沒(méi)有無(wú)故的重疊。. The manufacturer must have an organisation chart. People in responsible positions should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice.生產(chǎn)企業(yè)必須具有組織機(jī)構(gòu)圖，針對(duì)各崗位員工應(yīng)制定崗位職責(zé)說(shuō)明書(shū)，對(duì)崗位職責(zé)進(jìn)行書(shū)面描述并給員工充分的授權(quán)來(lái)履行職責(zé)。GENERAL總則. The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality.生產(chǎn)企業(yè)應(yīng)當(dāng)配備足夠數(shù)量并具有適當(dāng)資質(zhì)及實(shí)際經(jīng)驗(yàn)的人員。每個(gè)人應(yīng)當(dāng)清楚地理解自己的職責(zé)并記錄。CHAPTER 2第二章人員PERSONNEL PRINCIPLE原則The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.符合要求的質(zhì)量保證體系的建立和維護(hù)以及藥品的正確生產(chǎn)依賴(lài)于人。 the level of effort, formality and documentation of the quality risk management process is mensurate with the level of risk.質(zhì)量風(fēng)險(xiǎn)管理過(guò)程的投入、正式程度與文件應(yīng)當(dāng)與風(fēng)險(xiǎn)水平相適應(yīng)。 The quality risk management system should ensure that: 質(zhì)量風(fēng)險(xiǎn) 管理的原 則是 ： the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient。QUALITY RISK MANAGEMENT質(zhì)量風(fēng)險(xiǎn)管理 Quality risk management is a systematic process for the assessment, control, munication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. 質(zhì)量風(fēng)險(xiǎn)管理是一個(gè)用于藥品質(zhì)量風(fēng)險(xiǎn)評(píng)估、控 制 、交流與評(píng)審的系統(tǒng)過(guò)程。Where the marketing authorisation holder is not the manufacturer, there should be a technical agreement in place between the various parties that defines their respective responsibilities in producing the quality review. The authorized person responsible for final batch certification together with the marketing authorisation holder should ensure that the quality review is performed in a timely manner and is accurate.如果上市許可證持有人不是生產(chǎn)企業(yè)，各方之間應(yīng)當(dāng)簽訂技術(shù)協(xié)議，規(guī)定各自在產(chǎn)品貭量回顧中的責(zé)任。對(duì)于現(xiàn)有管理活動(dòng)及這些管理活動(dòng)的回顧，應(yīng)當(dāng)有管理規(guī)程，并通過(guò)自檢確認(rèn)這些規(guī)程的有效性。xii. A review of any contractual arrangements as defined in Chapter 7 to ensure that they are up to date.回顧第7 章規(guī)定的所有合同、協(xié) 議 ，以確保未過(guò)時(shí)。x. For new marketing authorisations and variations to marketing authorisations, a review of postmarketing mitments.對(duì)于新的上市許可和上市許可變更，回顧上市后承諾。viii. A review of all qualityrelated returns, plaints and recalls and the investigations performed at the time.回顧與質(zhì)量相關(guān)的所有退貨、投訴與召回，以及當(dāng)時(shí)實(shí)施的調(diào)查。vi. A review of Marketing Authorisation variations submitted/granted/refused, including those for third country (export only) dossiers.回顧已遞交的、 已批準(zhǔn)的或被拒絕的上市許可變更，包括已遞交的、 已批準(zhǔn)的或被拒絕的第三 國(guó) （ 僅供出口）上市許可變更資料。iv. A review of all significant deviations or nonconformances, their related investigations, and the effectiveness of resultant corrective and preventative actions taken.回顧所有重大偏差或不符合事件與相關(guān)調(diào)查，以及后續(xù)糾正與預(yù)防措施的有效性。通常應(yīng)當(dāng)每年回顧并文件化，回顧中還應(yīng)當(dāng)考慮以前的回顧情況，并至少應(yīng)當(dāng)包括：i. A review of starting materials including packaging materials used in the product, especially those from new sources.回顧產(chǎn)品所用起始物料、包裝材料，特別是來(lái)自新供應(yīng)商的起始物料和包裝材料，ii. A review of critical inprocess controls and finished product results. 回顧關(guān)鍵中間過(guò)程控制與成品結(jié)果。在質(zhì)量受權(quán)人確認(rèn)產(chǎn)品批次符合相應(yīng)許可要求之前，任何批次不被放行銷(xiāo)售或供貨；viii. sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the product is retained in its final pack unless exceptionally large packs are produced.留有足夠的起始物料和成品對(duì)照樣品， 以備將來(lái)有需要的時(shí)候?qū)Ξa(chǎn)品進(jìn)行檢驗(yàn)，樣品包裝方式與對(duì)應(yīng)的產(chǎn)品最終包裝方式相同。物料 、中間體、半成品及成品的檢查與檢驗(yàn)結(jié)果有記錄，成品按質(zhì)量標(biāo)準(zhǔn)做了正式評(píng)估。任何偏差得到了完整記錄和調(diào)查；v. the finished products contain active ingredients plying with the qualitative and quantitative position of the marketing authorisation, are of the purity required, and are enclosed within their proper containers and correctly labelled。 檢 驗(yàn) 方法 經(jīng)過(guò) 驗(yàn) 證 ；iv. records are made, manually and/or by recording instruments, which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are fully recorded and investigated。有 充足 的設(shè)施設(shè) 備、經(jīng)過(guò)培訓(xùn)的人員及經(jīng)過(guò)批準(zhǔn)的規(guī)程用于起始物料、包 裝 材 料 、中間體、半成品與成品取樣和檢驗(yàn)，以及 G M P 要 求 的 環(huán) 境 監(jiān) 測(cè)ii. samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by Quality Control。QUALITY CONTROL 質(zhì)量控制 Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. The basic requirements of Quality Control are that:質(zhì)量 控 制 是 G M P 的一部分，涉及取樣、質(zhì)量標(biāo)準(zhǔn)、檢驗(yàn)，同樣也涉及組織機(jī)構(gòu)、文件和放行規(guī)程，以保證切實(shí)執(zhí)行了必要的相關(guān)檢驗(yàn)，并且確保物料或產(chǎn)品被判定符合要求之前不被放行使用或銷(xiāo)售。降低產(chǎn)品銷(xiāo)售過(guò)程中的質(zhì)量風(fēng)險(xiǎn)；ix. a system is available to recall any batch of product, f