【文章內(nèi)容簡(jiǎn)介】 vels of microorganisms?連續(xù)生產(chǎn)或?qū)Ｓ蒙a(chǎn)設(shè)施：設(shè)備/設(shè)施是否定期清洗防止積料或傳播污染物，例如，降解物或過多的微生物？155　Is the cleaning frequency justified and documented?清洗頻率是否合適并有文件規(guī)定？156Is equipment cleaned between production of different products?不同品種生產(chǎn)之間設(shè)備是否清洗？157For multipurpose equipment is the Maximum Acceptable Carry Over and other Acceptance criteria for residues justified and determined?對(duì)于多用途設(shè)備，是否規(guī)定了可接受的最大殘留水平和其他指標(biāo)，規(guī)定是否合理？158　Are the cleaning procedures validated?是否驗(yàn)證清洗程序？159Equipment identified as to its content and cleanliness status?設(shè)備清洗狀態(tài)和內(nèi)容物是否有標(biāo)識(shí)牌？160Calibration校驗(yàn)161Instruments critical for IM and/or API quality are calibrated?涉及IM和API質(zhì)量的關(guān)鍵儀表是否校驗(yàn)？162　How is critical defined?關(guān)鍵儀表如何確定？163　Written procedure in place?是否有書面程序？164　Schedule followed?是否按照規(guī)定進(jìn)行校驗(yàn)？165Calibration done with standards that are traceable to certified standards?校驗(yàn)使用的衡器是否可追朔到法定標(biāo)準(zhǔn)？166Records of calibration maintained?有關(guān)的校驗(yàn)記錄？167Calibration status of instruments known?儀表校驗(yàn)狀態(tài)？168　How (label, electronic)?校驗(yàn)狀態(tài)是標(biāo)簽式或電子式？169How is it ensured that instruments out of calibration are not used?如何保障未經(jīng)校驗(yàn)的儀表不得使用？170If instruments have been shown out of calibration, are deviation investigations performed to determine if this fact has an influence on the release of the IM/API?如發(fā)現(xiàn)儀表已過校驗(yàn)有效期，是否進(jìn)行偏差調(diào)查來(lái)決定是否放行有關(guān)的IM和API？171Computerised Systems計(jì)算機(jī)系統(tǒng)172Are GMP related puter systems validated?與GMP有關(guān)的計(jì)算機(jī)系統(tǒng)是否驗(yàn)證？173IQ, OQ for Hard and Software available to demonstrate suitability of puter hardware/software to perform task?軟硬件的IQ,OQ是否能證實(shí)軟硬件能夠滿足工作需要？174Retrospective validation for existing systems if not validated at time of installation?如果現(xiàn)存系統(tǒng)安裝時(shí)沒有進(jìn)行驗(yàn)證，是否進(jìn)行了回顧性驗(yàn)證？175What controls are in place to prevent unauthorized access?采取何種措施防止非授權(quán)進(jìn)入計(jì)算機(jī)系統(tǒng)？176　What controls are in place to prevent changes to data?采取何種措施防止修改數(shù)據(jù)？177　What controls are in place to prevent omissions in data?采取何種措施防止數(shù)據(jù)錯(cuò)漏？178　Is there an audit trail / documents available where changes to data are recorded, who made the change, when the change was made and of the previous entry?對(duì)于那些數(shù)據(jù)進(jìn)行了更改，誰(shuí)進(jìn)行的更改，何時(shí)進(jìn)行的，原來(lái)輸入的什么數(shù)據(jù)等，有無(wú)核查/文件記錄？179Written procedures for the operation and maintenance of puterized systems available?計(jì)算機(jī)系統(tǒng)的運(yùn)行維護(hù)有無(wú)書面規(guī)定？180Is the manual entry of critical data checked by additional means (second operator or system itself)?人工輸入關(guān)鍵數(shù)據(jù)是否有額外的復(fù)核手段（其他人員或系統(tǒng)自己）？181Are all quality related incidents and deviations relating to puterized systems investigated according to defined procedures investigated?計(jì)算機(jī)系統(tǒng)發(fā)生涉及質(zhì)量的故障和偏差是否按照既定步驟進(jìn)行調(diào)查？182Changes to the puterized system are made according to a defined procedure?是否按照既定步驟進(jìn)行計(jì)算機(jī)系統(tǒng)變更？183How is data protected in cases of system breakdowns?系統(tǒng)發(fā)生癱瘓時(shí)如何保護(hù)數(shù)據(jù)？184　Backup system provided?有無(wú)備份系統(tǒng)？185　Is Recovery from backups tested periodically?是否定期進(jìn)行從備份恢復(fù)系統(tǒng)的演練？1866Documentation and Records文件和記錄187Documentation System and Specifications文件系統(tǒng)和標(biāo)準(zhǔn)188Is there a written procedure in place describing preparation, review, approval and distribution of all quality related documents?是否有書面規(guī)定描述如何起草，審核，批準(zhǔn)和分發(fā)與質(zhì)量有關(guān)的所有文件？189How is revision, superseding and withdrawal of documents controlled?如何控制文件的修訂，替代和撤銷？190　Is a revision history maintained?是否體現(xiàn)了文件修訂歷史？191Procedure in place for retaining all appropriate documents?對(duì)于各種文件保留有無(wú)書面規(guī)定？192　Retention period specified?文件的保留期限？193Retention period for APIs with expiry date: 1 year after expiry (min.)有有效期的API文件：至少保留到有效期以后1年194　Retention period for APIs with retest date: 3 years after plete distribution (min.)有復(fù)驗(yàn)期的API文件：至少保留到全部分發(fā)完成后3年195Are corrected entries in documents dated and signed?文件改動(dòng)處是否簽上日期和姓名？196　Original entry still readable?原來(lái)的數(shù)據(jù)是否依然可見？197Are documents promptly retrievable (copies or electronic means acceptable)?文件是否可以迅速查找（印刷版或電子版都可以）？198Are specifications for all materials, IM and APIs established?是否建立了所有的IM和API質(zhì)量標(biāo)準(zhǔn)？199Are electronic signatures authenticated and secure?電子簽名是否授權(quán)和安全？200Equipment Cleaning and Use Records儀器清潔和使用記錄201Are there records for the major equipment used , cleaning and maintenance showing the following主要儀器的使用，清潔和維護(hù)記錄要包括下列內(nèi)容：202　date，time日期，時(shí)間203　product and batch number of each batch產(chǎn)品和批號(hào)204　person who performed cleaning清潔人員姓名205　person who performed maintenance維護(hù)人員姓名206Records of Raw Materials, IM, API Labeling and Packaging Materials原料，IM,API標(biāo)簽和包裝材料的記錄207Records of each delivery should contain:發(fā)貨記錄應(yīng)包括：208　name of manufacturer/supplier生產(chǎn)商/供應(yīng)商名稱209　identity and quantity標(biāo)識(shí)和數(shù)量210　supplier control or identification number供應(yīng)商控制或標(biāo)識(shí)碼211　number allocated on receipt收貨時(shí)賦予的號(hào)碼212　date of receipt收貨日期213　acceptable condition of received goods assessed收貨條件是否進(jìn)行評(píng)估214　result of tests and conclusion derived from this檢驗(yàn)結(jié)果和檢驗(yàn)結(jié)論215　trace of use使用的蹤跡216　review of labels and packaging materials showing conformity with specifications審查標(biāo)簽和包材是否符合質(zhì)量標(biāo)準(zhǔn)217　final decision release or reject放行或拒絕的最后決定權(quán)218Are master labels maintained?是否保存標(biāo)簽?zāi)赴妫?19Master Production Instructions生產(chǎn)工藝規(guī)程220Are Master Production Instructions for each IM/API每個(gè)IM/API是否都有生產(chǎn)工藝規(guī)程？221　prepared起草222　dated日期223　signed簽名224　independently checked by QU由質(zhì)量部門獨(dú)立審核225Do Master Production Instructions contain the following:生產(chǎn)工藝規(guī)程是否包括下列內(nèi)容：226　name of product including document reference code產(chǎn)品名稱包括其文獻(xiàn)編碼227　plete list of raw materials全部原料清單228　accurate statement of quantities needed or calculation of quantity準(zhǔn)確表達(dá)所需的數(shù)量或計(jì)算方法229　production location and major equipment to be used生產(chǎn)地點(diǎn)和使用的主要設(shè)備230　detailed production instructions including sequences, ranges of parameters, sampling instructions, IPC, time limits, expected yie