藥用產(chǎn)品GMP指南第一部分翻譯.docx

PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME藥品檢驗(yàn)公約藥品檢驗(yàn)合作計(jì)劃GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART I藥用產(chǎn)品良好生產(chǎn)規(guī)范指南第一部分目錄第一章 質(zhì)量管理2第二章人員11第三章 廠房設(shè)施17第四章 文件25第五章 生產(chǎn)41第六章質(zhì)量控制53第七章 委托生產(chǎn)與委托檢驗(yàn)62第八章 產(chǎn)品投訴和召回66第九章 自檢69CHAPTER 1 第一章 質(zhì)量管理QUALITY MANAGEMENTPRINCIPLE 原則The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the companys suppliers and by the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance Incorporating Good Manufacturing Practice, and thus Quality Control and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the manufacturing authorisation and for the authorised person(s). 生產(chǎn)許可證持有人必須生產(chǎn)藥品，從而確保藥品適合預(yù)期用途、符合相應(yīng)的上市許可證或臨床試驗(yàn)許 可證要求，不因?yàn)榘踩詥?wèn)題、質(zhì)量問(wèn)題或有效性問(wèn)題而把患者置于風(fēng)險(xiǎn)之中。實(shí)現(xiàn)上述質(zhì)量目標(biāo)是公司高級(jí)管理人員的職責(zé)，并要求公司的供應(yīng)商、銷(xiāo)售商，公司內(nèi)所有各級(jí)員工與許多不同部門(mén)的員工共同參與、一起努力。要可靠地實(shí)現(xiàn)這一質(zhì)量目標(biāo)，必須綜 合設(shè)計(jì)一個(gè)整合藥品生產(chǎn)質(zhì)量管理規(guī)范（GMP）和質(zhì)量控制、質(zhì)量風(fēng)險(xiǎn)管理的制藥質(zhì)量保證體系并正確實(shí)施。質(zhì)量體系應(yīng)當(dāng)全面文件化，并監(jiān)察其有效性。整個(gè)制藥質(zhì)量體 系應(yīng)當(dāng)配備充足的具有資質(zhì)的人員，以及充分并適用的建筑物、設(shè)備和設(shè)施。生產(chǎn)許可證持有人以及質(zhì)量受權(quán)人有額外的法律責(zé)任。The basic concepts of Quality Assurance, Good Manufacturing Practice, Quality Control and Quality Risk Management are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products.質(zhì)量保證、藥品生產(chǎn)質(zhì)量管理規(guī)范、質(zhì)量控制以及質(zhì)量風(fēng)險(xiǎn)管理的基本概念是相互關(guān)聯(lián)的。在這里對(duì)其進(jìn)行描述是為了強(qiáng)調(diào)它們之間的聯(lián)系以及其對(duì)藥品生產(chǎn)和控制的重要性。QUALITY ASSURANCE質(zhì)量保證1.1 Quality Assurance is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide.質(zhì)量保證是一個(gè)寬泛的概念，涵蓋所有因素，這些因素單獨(dú)或共同影響產(chǎn)品質(zhì)量。質(zhì)量保證是為了保證藥品質(zhì)量符合預(yù)期用途，而進(jìn)行的有組織的安排的總和。因此，質(zhì)量保證中包含著藥品生產(chǎn)質(zhì)量管理規(guī)范以及本指南的范圍內(nèi)的其他因素。The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that: 一個(gè)適當(dāng)?shù)馁|(zhì)量保證體系應(yīng)當(dāng)確保：i. medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice ;藥品的設(shè)計(jì)和開(kāi)發(fā)應(yīng)考慮藥品生產(chǎn)質(zhì)量管理規(guī)范的要求；ii. production and control operations are clearly specified and Good Manufacturing Practice adopted;對(duì)生產(chǎn)和控制操作進(jìn)行明確規(guī)定，并符合藥品生產(chǎn)質(zhì)量管理規(guī)范的要求；iii. managerial responsibilities are clearly specified;明確規(guī)定管理職責(zé)；iv. arrangements are made for the manufacture, supply and use of the correct starting and packaging materials; 對(duì)下述活動(dòng)均有協(xié)議約束：生產(chǎn)、供應(yīng)、使用正確的起始物料與包裝材料。v. all necessary controls on intermediate products, and any other inprocess controls and validations are carried out;對(duì)中間產(chǎn)品以及其他任何中間過(guò)程控制與驗(yàn)證實(shí)施所有必要的控制；vi. the finished product is correctly processed and checked, according to the defined procedures;成品根據(jù)確定的程序進(jìn)行正確生產(chǎn)和檢測(cè)；vii. medicinal products are not sold or supplied before an authorised person has certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorisation and any other regulations relevant to the production, control and release of medicinal products;質(zhì)量受權(quán)人需簽發(fā)證明以確認(rèn)每一批次藥品的生產(chǎn)和控制均符合上市許可要求以及與藥品生產(chǎn) 、控制和放行相關(guān)的任何其他法規(guī)要求，未經(jīng)質(zhì)量受權(quán)人簽發(fā)證明的藥品不得銷(xiāo)售或供貨；viii. satisfactory arrangements exist to ensure, as far as possible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life;藥品貯存 、發(fā)運(yùn)和后續(xù)處理確保有滿(mǎn)意的管理規(guī)程，從而盡量保證藥品貨架期內(nèi)的質(zhì)量ix. there is a procedure for self-inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the quality assurance system.有自檢和 / 或質(zhì)量審計(jì)規(guī)程，以定期評(píng)價(jià)質(zhì)量保證體系的有效性與適用性。GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (GMP)藥品生產(chǎn)質(zhì)量管理規(guī)范1.2 Good Manufacturing Practice is that part of Quality Assurance which ensures that Medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation or product specification. Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that:藥品生產(chǎn)質(zhì)量管理規(guī)范是質(zhì)量管理體系的一部分，保證按適合預(yù)期用途的質(zhì)量標(biāo)準(zhǔn)及上市許可、臨床試驗(yàn)許可或產(chǎn)品質(zhì)量標(biāo)準(zhǔn)要求始終如一地生產(chǎn)及控制產(chǎn)品。藥品生產(chǎn)質(zhì)量管理規(guī)范涉及生產(chǎn)和質(zhì)量控制。藥品生產(chǎn)質(zhì)量管理規(guī)范的基本要求是：i. all manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifications;所有生產(chǎn)工藝得到明確規(guī)定、按照經(jīng)驗(yàn)經(jīng)過(guò)系統(tǒng)的審核，并經(jīng)過(guò)證明表明有能力始終如一地生產(chǎn)具有所需質(zhì)量且符合質(zhì)量標(biāo)準(zhǔn)的藥品ii. critical steps of manufacturing processes and significant changes to the process are validated;生產(chǎn)工藝的關(guān)鍵步驟以及重大的工藝變更已經(jīng)驗(yàn)證；iii. all necessary facilities for GMP are provided including:提供了 GM P需要的所有設(shè)施，包 括 ：a. appropriately qualified and trained personnel; 有適當(dāng)資質(zhì)并經(jīng)過(guò)培訓(xùn)的員工；b. adequate premises and space; 充足的廠房與空間 ；c. suitable equipment and services; 適 當(dāng) 的 設(shè) 備 及 保 養(yǎng) ；d. correct materials, containers and labels; 恰當(dāng)?shù)牟牧?、?器 和 標(biāo) 簽 ；e. approved procedures and instructions; 經(jīng)批準(zhǔn)的規(guī)程與操作方法；f. suitable storage and transport; 合 適 的 貯 存 與 運(yùn) 輸 ；iv. instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided;操作方法與規(guī)程應(yīng)當(dāng)使用有指導(dǎo)意義的方式來(lái)書(shū)寫(xiě)，并且條理清楚、用語(yǔ)明確 ，特別是要適用于相應(yīng)的設(shè)施 ；v. operators are trained to carry out procedures correctly; 操作人員接受過(guò)正確執(zhí)行規(guī)程的培訓(xùn)；vi. records are made, manually and/or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected. Any significant deviations are fully recorded and investigated; 在生產(chǎn)過(guò)程中進(jìn)行了記錄，可由手工和/ 或儀器記錄，以證明規(guī)程和操作要求的所有步驟切實(shí)得到了執(zhí)行，以及產(chǎn)品的質(zhì)量和數(shù)量達(dá)到預(yù)期要求；所有重大偏差得到了完整記錄、經(jīng)過(guò)了調(diào)查vii. records of manufacture including distribution which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form;生產(chǎn)記錄包括銷(xiāo)售記錄以易懂且可獲得的方式得到了保留，使整個(gè)批次的完整歷史可追溯；viii. the distribution (wholesaling) of the products minimises any risk to their quality;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, from sale or supply;有藥品召回系統(tǒng)，確保任何一批產(chǎn)品都能從銷(xiāo)售商或供應(yīng)處收回；x. complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent re-occurrence.對(duì)產(chǎn)品投訴進(jìn)行檢查，調(diào)查質(zhì)量缺陷原因，對(duì)缺陷產(chǎn)品采取適當(dāng)措施并防止再次發(fā)生。QUALITY CONTROL 質(zhì)量控制1.3 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。質(zhì)量控制的基本要求是：i. adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes;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;由經(jīng)過(guò)批準(zhǔn)的人員按經(jīng)過(guò)批準(zhǔn)的方法對(duì)起始物料、包裝材料、中間產(chǎn)品、半成品、成 品 取 樣 ；iii. test methods are validated; 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;由手工和/ 或儀器做了記錄，以證明所有要求的取樣、檢查和檢驗(yàn)規(guī)程切實(shí)得到了執(zhí)行。任何偏差得到了完整記錄和調(diào)查；v. the finished products contain active ingredients complying with the qualitative and quantitative composition of the marketing authorisation, are of the purity required, and are enclosed within their proper containers and correctly labelled;成品中的活性成分符合上市許可或臨床試驗(yàn)許可的定性和定量要求，及符合純度要求，并貯 存在適當(dāng)?shù)娜萜髦?、貼 上 正 確 的 標(biāo) 簽 ；vi. records are made of the results of inspection and that testing of materials, intermediate, bulk, and finished products is formally assessed against specification. Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures;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。產(chǎn)品評(píng)估包括回顧與評(píng)估相關(guān)生產(chǎn)文件，以及評(píng)估對(duì)特定規(guī)程的偏差；vii. no batch of product is released for sale or supply prior to certification by an authorised person that it is in accordance with the requirements of the relevant authorisations;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。PRODUCT QUALITY REVIEW產(chǎn)品質(zhì)量回顧1.4 Regular periodic or rolling quality reviews of all licensed medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product to highlight any trends and to identify product and process improvements. Such reviews should normally be conducted and documented annually, taking into account previous reviews, and should include at least:應(yīng)當(dāng)對(duì)所有獲得批準(zhǔn)的藥品，包括僅供出口的藥品，進(jìn)行定期的或滾動(dòng)式的質(zhì)量回顧，質(zhì)量回顧的目的是確認(rèn)現(xiàn)有工藝的一致性、起始物料和成品現(xiàn)行質(zhì)量標(biāo)準(zhǔn)的適宜性，強(qiáng)調(diào)任何趨勢(shì)并識(shí)別產(chǎn)品和工藝改進(jìn)點(diǎn)。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 in-process controls and finished product results. 回顧關(guān)鍵中間過(guò)程控制與成品結(jié)果。iii. A review of all batches that failed to meet established specification(s) and their investigation.回顧未能符合既定質(zhì)量標(biāo)準(zhǔn)的所有批次及其調(diào)查結(jié)果。iv. A review of all significant deviations or non-conformances, 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。v. A review of all changes carried out to the processes or analytical methods.回顧工藝或分析方法的所有變更。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。vii. A review of the results of the stability monitoring programme and any adverse trends.回顧穩(wěn)定性監(jiān)測(cè)程序的結(jié)果以及任何不良的趨勢(shì)。viii. A review of all quality-related returns, complaints 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。ix. A review of adequacy of any other previous product process or equipment corrective actions.回顧任何其他先前產(chǎn)品工藝或設(shè)備糾正措施的適宜性。x. For new marketing authorisations and variations to marketing authorisations, a review of post-marketing commitments.對(duì)于新的上市許可和上市許可變更，回顧上市后承諾。xi. The qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc.回顧相關(guān)設(shè)備與公用系統(tǒng)的確認(rèn)狀態(tài)，例如空氣凈化系統(tǒng)、制水系統(tǒng)、壓縮空氣系統(tǒng)等。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)。The manufacturer and marketing authorisation holder should evaluate the results of this review and an assessment made of whether corrective and preventative action or any revalidation should be undertaken. Reasons for such corrective actions should be documented. Agreed corrective and preventative actions should be completed in a timely and effective manner. There should be management procedures for the ongoing management and review of these actions and the effectiveness of these procedures verified during selfinspection. Quality reviews may be grouped by product type, e.g. solid dosage forms, liquid dosage forms, sterile products, etc. where scientifically justified. 生產(chǎn)企業(yè)，或是上市許可證持有人，如果生產(chǎn)企業(yè)不是上市許可證持有人的話，應(yīng)當(dāng)在制藥質(zhì)量體系下評(píng)估產(chǎn)品質(zhì)量回顧的結(jié)果，并評(píng)估是否應(yīng)當(dāng)釆取糾正與預(yù)防措施或是任何再驗(yàn)證。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。經(jīng)過(guò)科學(xué)論證后 ，可以按產(chǎn)品類(lèi)別進(jìn)行質(zhì)量回顧，例如固體劑型、液體劑型、無(wú)菌產(chǎn)品等。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。授權(quán)人和銷(xiāo)售許可持有人負(fù)責(zé)最后一批認(rèn)證，應(yīng)確保及時(shí)準(zhǔn)確的的進(jìn)行質(zhì)量回顧。QUALITY RISK MANAGEMENT質(zhì)量風(fēng)險(xiǎn)管理1.5 Quality risk management is a systematic process for the assessment, control, communication 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。可以采用前瞻性或回顧性形式。1.6 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;質(zhì)量風(fēng)險(xiǎn)評(píng)估是以科學(xué)知識(shí)和對(duì)工藝的經(jīng)驗(yàn)為基礎(chǔ)，并最終與保護(hù)患者相關(guān)聯(lián)。- the level of effort, formality and documentation of the quality risk management process is commensurate 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)。Examples of the processes and applications of quality risk management can be found inter alia in Annex 20.在附錄20 中所述的質(zhì)量風(fēng)險(xiǎn)管理的過(guò)程與應(yīng)用實(shí)例。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。因此，必須有足夠的有資質(zhì)的人員來(lái)完成與生產(chǎn)企業(yè)職責(zé)相應(yīng)的所有工作。每個(gè)人應(yīng)當(dāng)清楚地理解自己的職責(zé)并記錄。所有人員都應(yīng)當(dāng)知曉與自己相關(guān)的藥品生產(chǎn)質(zhì)量管理規(guī)范基本原則，并且接受培訓(xùn)與繼續(xù)培訓(xùn)，這些培訓(xùn)包括與人員衛(wèi)生相關(guān)的教育工作。GENERAL總則2.1. 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。為防止出現(xiàn)任何質(zhì)量風(fēng)險(xiǎn)，每個(gè)人所承擔(dān)的職責(zé)不應(yīng)當(dāng)過(guò)多。2.2. 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)。這些職責(zé)可以委派給其他人，但受托人必須具有相應(yīng)的資質(zhì)。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。KEY PERSONNEL關(guān)鍵人員2.3. Key Personnel includes the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the release of products the authorised person(s) designated for the purpose. Normally key posts should be occupied by full-time personnel. The heads of Production and Quality Control must be independent from each other. In large organisations, it may be necessary to delegate some of the functions listed in 2.5., 2.6. and 2.7.關(guān)鍵管理人員包括生產(chǎn)負(fù)責(zé)人和質(zhì)量負(fù)責(zé)人，如果這些人中未有至少一人承擔(dān)職責(zé)，則應(yīng)當(dāng)指定 適當(dāng)數(shù)量的質(zhì)量受權(quán)人（至少一名）來(lái)履行該職責(zé)。通常，關(guān)鍵崗位人員應(yīng)當(dāng)為全職人員。生產(chǎn)負(fù)責(zé)人和質(zhì)量負(fù)責(zé)人必須相互獨(dú)立。構(gòu)龐大的組織中，可能需要對(duì)第2.5 2.6 2.7條中所列的職責(zé)進(jìn)行授權(quán)。2.4. .2.5. The head of the Production Department generally has the following responsibilities:生產(chǎn)負(fù)責(zé)人通常有以下職責(zé)：i. to ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality;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;批準(zhǔn)與生產(chǎn)操作相關(guān)的規(guī)程，并確保規(guī)程得到嚴(yán)格執(zhí)行；iii. to ensure that the production records are evaluated and signed by an authorised person before they are sent to the Quality Control Department;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;檢查本部門(mén)廠房、設(shè)施和設(shè)備進(jìn)行了維護(hù)；v. to ensure that the appropriate validations are done;確保實(shí)施了適當(dāng)?shù)尿?yàn)證vi. to ensure that the required initial and continuing 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。2.6. The head of the Quality Control Department generally has the following responsibilities:質(zhì)量負(fù)責(zé)人通常有以下職責(zé)