【正文】 ood Manufacturing Practice 。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。質(zhì)量體系應(yīng)當(dāng)全面文件化，并監(jiān)察其有效性。PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION COOPERATION 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(chǎng)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 69CHAPTER 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, ply 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 mitment by staff in many different departments and at all levels within the pany, by the pany’s suppliers and by the distributors. To achieve the quality objective reliably there must be a prehensively 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 petent 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。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。QUALITY ASSURANCE質(zhì)量保證 Quality Assurance is a wideranging 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。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。v. all necessary controls on intermediate products, and any other inprocess controls and validations are carried out。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 selfinspection 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。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。 適 當(dāng) 的 設(shè) 備 及 保 養(yǎng) ；d. correct materials, containers and labels。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。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 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。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。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。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。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。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)。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。 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。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。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 s