【文章內(nèi)容簡(jiǎn)介】 lated to quality。g) 評(píng)審糾正措施。review of corrective actions. 對(duì)結(jié)果進(jìn)行分析，必要時(shí),采取糾正措施并記錄、跟蹤和作出結(jié)論。Results should be analyzed and, if necessary, corrective actions should be taken, recorded, followed and concluded. 質(zhì)量自檢 Quality Selfinspections 質(zhì)量自檢活動(dòng)的目標(biāo)是確認(rèn)中間品和藥物活性成分的生產(chǎn)廠家從物料的采購(gòu)到中間品和藥物成分發(fā)貨的過(guò)程符合GMP的要求，自檢活動(dòng)應(yīng)該至少每年進(jìn)行一次Its goal is to verify the conformity of the manufacturer of intermediates and active pharmaceutical inputs with the main GMP, from material acquisition to expedition of intermediates or pharmaceutical input. The selfinspections should be performed, at least, annually. 應(yīng)該對(duì)自檢活動(dòng)制定書(shū)面程序。自檢應(yīng)該包括：It should be elaborated a written procedure on selfinspections. The selfinspection should prise:a) 人員 personnel。b) 設(shè)施 facilities。c) 廠房和設(shè)備維護(hù) building and equipment maintenance。d) 原材料、包裝材料和成品的儲(chǔ)存storage of raw material, packaging material and finished product。 e) 設(shè)備生產(chǎn) equipments。f) 生產(chǎn)和過(guò)程控制 production and inprocess control。g) 質(zhì)量控制 Quality Control。h) 文件 documentation。i) 衛(wèi)生 sanitation and hygiene。j) 驗(yàn)證和在驗(yàn)證計(jì)劃 programs of validation and revalidation。k) 儀器和測(cè)量系統(tǒng)的校驗(yàn) calibration of instruments and measure systems。l) 中間品和藥物活性成分從市場(chǎng)召回recall of intermediate and pharmaceutical input from the market。m) 顧客投訴 plaints。n) 標(biāo)簽控制 label control。o) 廢物處理 waste management:p) 先前自檢的結(jié)果和采取的糾正措施results from early selfinspections and adopted corrective actions. 自檢小組應(yīng)該由合格的專(zhuān)業(yè)人員組成，對(duì)實(shí)際的操作區(qū)和GMP有很好的了解。小組成員可以是公司的專(zhuān)業(yè)人員或者外部的專(zhuān)家The selfinspection team should be constituted by qualified professionals, experts in its actuation area and familiarized with GMP. Team members can be professionals of the pany or outer experts. 對(duì)自檢活動(dòng)應(yīng)進(jìn)行記錄，至少包括下列方面Selfinspection should be documented and contain at least: a) 自檢結(jié)果 selfinspection result。b) 評(píng)估和結(jié)論 evaluations and conclusions。c) 發(fā)現(xiàn)的不合格項(xiàng) detected nonconformities。 d) 建議的糾正措施和期限，在規(guī)定的期限內(nèi)對(duì)自檢報(bào)告中的不合格項(xiàng)采取和完成糾正措施。remended corrective actions and established term for attending. Corrective actions for nonconformities observed in the selfinspection report should be implemented and concluded within the informed term.3 人員PERSONNEL 概述General 建立和維護(hù)中間品和藥物活性成分的質(zhì)量和生產(chǎn)活動(dòng)依靠從事這些活動(dòng)的員工。必須有足夠數(shù)量的合格人員，通過(guò)接收指導(dǎo)培訓(xùn)和積累的經(jīng)驗(yàn)來(lái)完成、監(jiān)督和管理中間品和藥物活性成分的生產(chǎn)活動(dòng)。每個(gè)人的責(zé)任和權(quán)力應(yīng)通過(guò)書(shū)面形式確定，并由所有的相關(guān)人員執(zhí)行。Establishment and maintenance of quality and manufacturing of intermediate and active pharmaceutical input depend on employees that perform them. There must be a adequate number of qualified personnel by instruction, training, and/or experience, to execute, supervise and manage manufacturing activities of intermediates and active Pharmaceutical Inputs by which the manufacturer is responsible. The individual responsibilities and authorities should be established in written procedures, prised and applied by all the involved ones. 公司應(yīng)該有組織結(jié)構(gòu)圖。員工的責(zé)任不能重疊，這樣可避免影響中間品和藥物活性成分的質(zhì)量。員工的工作可以由別人代理完成，條件是代理的人員達(dá)到滿(mǎn)意的質(zhì)量水平。人員的GMP執(zhí)行責(zé)任不能缺位或重疊。The pany should have an organization chart. Employees shouldn’t accumulate responsibilities in order to avoid that the quality of the intermediates and active pharmaceutical inputs is put in danger. Their attributions may be delegated to assigned substitutes as long as those present satisfactory qualification level. It can not be absence or accumulation of personnel responsibilities referring to GMP application. 所有的人員應(yīng)該了解GMP的原則并接收最初和連續(xù)的培訓(xùn)。培訓(xùn)應(yīng)該由合格的專(zhuān)業(yè)人員定期進(jìn)行，其內(nèi)容至少應(yīng)包括員工所從事的工作，與員工的工作職責(zé)和衛(wèi)生要求相關(guān)的GMP知識(shí)。對(duì)培訓(xùn)記錄要進(jìn)行保存。應(yīng)該定期對(duì)培訓(xùn)進(jìn)行評(píng)估。所有的員工應(yīng)該熱情支持公司維護(hù)質(zhì)量標(biāo)準(zhǔn)。All personnel should know GMP principles and receive initial and continuous training. Training should be regularly conducted by qualified professionals and should cover, at least, operations performed by the employee, the GMP related to the collaborator’s functions and hygiene instructions as required. Training records should be kept. Training should be evaluated periodically. All employees should be motivated to support the pany in maintaining quality standards. 培訓(xùn)Training 生產(chǎn)廠家應(yīng)該通過(guò)書(shū)面的明確的計(jì)劃對(duì)工作影響到中間品和藥物活性成分質(zhì)量的所有員工進(jìn)行培訓(xùn)。The manufacturer should, through a written and defined program, promote trainings of all personnel whose activities may interfere with the quality of the intermediate and active pharmaceutical input. 除了 GMP理論和實(shí)踐方面的基本培訓(xùn)外，新聘用的人員應(yīng)該參加公司的整合活動(dòng)，接受崗位責(zé)任方面的培訓(xùn)，并持續(xù)進(jìn)行，接受評(píng)估。 Additionally to the basic training on GMP theory and practice, the newly hired personnel should take part in the integration program and receive proper training for attributions and be continuously trained and evaluated. 培訓(xùn)計(jì)劃應(yīng)該考慮到所有的人員，并且經(jīng)過(guò)生產(chǎn)和質(zhì)量管理部門(mén)負(fù)責(zé)人的批準(zhǔn)，保存好培訓(xùn)記錄。The training programs should contemplate all personnel, as well as be approved by responsible persons of production, quality unit and Quality Control, and records should be kept. 在潔凈區(qū)和具有危險(xiǎn)污染源的區(qū)域工作的人員應(yīng)得到相關(guān)的培訓(xùn)。 Personnel working in clean areas and areas where there is contamination hazard, where highly active, toxic, infectious or sensitizing materials are handled, should receive specific Training. 健康、衛(wèi)生、著裝和行為Health, Hygiene, Clothing and Conduct 所有的人員應(yīng)該在錄用時(shí)進(jìn)行體檢，并在以后根據(jù)相關(guān)的法律法規(guī)，針對(duì)所從事的工作，接受定期體檢All personnel should undertake health exams for admission and, later, to periodic exams, required for performed activities, according to the specific legislation into force.. 所有的人員應(yīng)該受到個(gè)人健康和安全操作方面的培訓(xùn)。遵守衛(wèi)生和安全規(guī)定。培訓(xùn)應(yīng)該包括如何應(yīng)付傳染病和外露傷口的情況。All personnel should be trained in personal health and security practices. All personnel should respect hygiene and security rules. Training should include conduct situations in case of contagious diseases or exposed wound.. 患有可疑的和確認(rèn)的傳染病或者有外露傷口的人員不得從事可能對(duì)中間品和藥物活性成分的質(zhì)量造成損害的活動(dòng)，直到他們的健康狀況對(duì)中間品和藥物活性成分的質(zhì)量和安全不會(huì)構(gòu)成風(fēng)險(xiǎn)。 All personnel with suspected or confirmed infectious disease or exposed wound can39。t perform activities that may promise the quality of intermediates and active pharmaceutical inputs. They should be excluded from these activities until the health status does not represent risk to the quality and security of the intermediate