【正文】 操作沒有書面規(guī)程規(guī)定。 Nonstandard occurrences during packaging not investigated by qualified personnel. 有資質(zhì)的人員未對(duì)包裝過程中出現(xiàn)的非正常情況進(jìn)行調(diào)查。 Inadequate control of coded and noncoded printed PM (including storage, dispensing, printing, disposal).編碼，未編碼打印的包裝材料（儲(chǔ)藏， 發(fā)放，打印和銷毀）控制不嚴(yán)。 No or inadequate selfinspection program / Program does not address all applicable sections of GMPs / Records inplete or not maintained.自檢計(jì)劃缺少或不完全/自檢計(jì)劃沒能涵蓋所應(yīng)涉及的GMP領(lǐng)域/自檢記錄不完整或沒有保存。 Products imported from foreign sites that are not listed on the Foreign Site Annex of the Establishment Licence (↑ )產(chǎn)品由海外工廠進(jìn)口，但海外工廠沒有在企業(yè)許可證附件海外工廠中列出。 Recall:召回： Absence of recall procedure bined with distribution practices that would not permit an adequate recall (distribution records unavailable or not kept).缺少召回程序同時(shí)發(fā)貨操作的方式導(dǎo)致不可能完全召回（發(fā)貨記錄缺失或未留記錄） Improper quarantine and disposal practices that would allow recalled / rejected units to be returned for sale.隔離和銷毀操作不當(dāng)，可能導(dǎo)致召回產(chǎn)品，退貨重新被銷售。 Quality Control Department 質(zhì)量管理部門 Inadequate facilities, personnel and testing equipment.設(shè)施，人員和測(cè)試儀器不足 No authority to enter production areas.(↑ )無權(quán)進(jìn)入生產(chǎn)區(qū)域 No SOPs approved and available for sampling, inspection and testing of materials.物料抽樣，檢查和測(cè)試的SOP未被批準(zhǔn)或無法獲得。 Products made available for sale without approval of QC department. (↑ )產(chǎn)品未經(jīng)質(zhì)量管理部門批準(zhǔn)便可以銷售。 Products released for sale by QC without proper verification of manufacturing and packaging documentation. 質(zhì)量管理部門未核對(duì)生產(chǎn)與包裝的文件，便批準(zhǔn)銷售產(chǎn)品。 Deviations and borderline conformances not properly investigated and documented, according to a SOP.偏差和緊扣質(zhì)量底線的合格情況沒能按照SOP進(jìn)行完全的調(diào)查并做書面記錄。 RM / PM used in production without prior approval of QC.原料與包材未經(jīng)質(zhì)量管理部門批準(zhǔn)便已用于生產(chǎn)。 Reprocessing / Reworking done without prior approval of QC department. (↑ )未經(jīng)質(zhì)量管理部門批準(zhǔn)而進(jìn)行再制/返工操作。 No system for plaint handling and returned goods.沒有投訴與退處理貨的系統(tǒng)。 SOPs covering operations that can affect the quality of a product such as transportation, storage, etc. not approved by QC department / not implemented.可能影響產(chǎn)品品質(zhì)的操作如運(yùn)輸，存儲(chǔ)等等的SOP沒有經(jīng)質(zhì)量管理部門批準(zhǔn)/沒有被執(zhí)行。 Absence of change control system.缺少更改控制 For testing laboratories, (in house or contract) the systems and controls in place for the proper qualification, operation, calibration and maintenance of equipment, standards, solutions, and records keeping do not assure that the results and conclusions generated are accurate, precise and reliable. (↑ )測(cè)試實(shí)驗(yàn)室（內(nèi)部或外部）的現(xiàn)場管理與監(jiān)控體系（包括驗(yàn)證，操作，校驗(yàn)，設(shè)備維護(hù)，標(biāo)準(zhǔn)品，各種溶液，記錄保存）無法保障其出具數(shù)據(jù)的準(zhǔn)確，精密和可靠。Packaging Material Testing Reduce testing program in place without adequate certification of vendors / suppliers. 在未對(duì)銷售商/供應(yīng)商進(jìn)行足夠資質(zhì)認(rèn)證的情況下減少測(cè)試項(xiàng)目。 Absence of testing of PM.缺少包材檢驗(yàn) Specifications not approved by QC.質(zhì)量標(biāo)準(zhǔn)沒有被質(zhì)量管理部門批準(zhǔn)。 No identity test done by the packager / labeller after receipt on its premises.包裝/貼簽人員領(lǐng)料后未做鑒別測(cè)試。 Certification of brokers or wholesalers done without proper documentation.對(duì)中間商或批發(fā)商所做認(rèn)證沒有正確地書面歸檔。Finished Product Testing ↑ Nonpliant products made available for sale without proper justification.(↑ )沒有充分的解釋而銷售不合格品。 Inplete / inadequate specifications.不完整/不正確的質(zhì)量標(biāo)準(zhǔn) Finished product specifications not approved by QC.成品標(biāo)準(zhǔn)未經(jīng)質(zhì)量管理部門批準(zhǔn)。 Inplete testing.測(cè)試不完全。 No identity testing upon receipt in Canada from nonMRA country and no periodic plete confirmatory testing. 從非互認(rèn)國家進(jìn)口到加拿大的產(chǎn)品未做鑒別試驗(yàn)同時(shí)沒有周期性的全項(xiàng)檢驗(yàn)。 Test methods not validated.分析方法沒有驗(yàn)證。 No SOP for conditions of transportation and storage.沒有SOP規(guī)定儲(chǔ)藏運(yùn)輸?shù)臈l件。 Use of unique identifier principles not meeting the acceptable options.使用不被接受的特殊鑒別方法Records to Absence of Master Production Documents.缺少生產(chǎn)主記錄 Unavailability of documentation from suppliers in a timely manner.供應(yīng)商提供文件不及時(shí)。Samples Retained samples not kept for finished products.成品未做留樣。 Failure to submit retained samples when alternative sample retention granted.沒有遞交留樣而擅自改變留樣計(jì)劃。Stability ↑穩(wěn)定性 Insufficient number of lots / insufficient data to establish shelflife.用于建立效期的數(shù)據(jù)和樣品數(shù)量不夠。 No action taken when data shows that the products do not meet their specifications prior to the expiry date.對(duì)效期未到產(chǎn)品便出現(xiàn)達(dá)不到標(biāo)準(zhǔn)的情況未采取措施。 No continuing stability program.沒有持續(xù)的穩(wěn)定性監(jiān)測(cè)計(jì)劃 No stability studies pertaining to changes in manufacturing (formulation) / packaging materials.生產(chǎn)（配方）/包材改變后沒做穩(wěn)定性試驗(yàn) Testing methods not validated.穩(wěn)定性實(shí)驗(yàn)方法未經(jīng)驗(yàn)證。Sterile products Aqueousbased products not subject to terminal steam sterilisation without proper justification or approval through the marketing authorization.缺乏充分的理由或管理部門的批準(zhǔn)，對(duì)水溶性產(chǎn)品不做最終滅菌處理。 Inadequate room classification for processing / filling operations. (↑ )加工/灌裝房間級(jí)別不夠。 Aseptic manufacturing suites under negative pressure pared to clean 169。D) areas. Clean 169。D) areas under negative pressure to unclassified areas. (↑ )無菌生產(chǎn)間對(duì)萬級(jí)車間呈負(fù)壓，萬級(jí)車間對(duì)無級(jí)別間呈負(fù)壓。 Insufficient number of samples for room classification / inadequate sampling methods. (↑ )測(cè)定房間級(jí)別時(shí)采樣數(shù)不夠/采樣方法不正確。 Insufficient environmental controls / Insufficient monitoring for viable microorganisms during filling for aseptically filled products. (↑ )無菌灌裝時(shí)的環(huán)境監(jiān)控/微生物監(jiān)測(cè)不充分。 Premises and equipment not designed or maintained to minimize contamination / generation of particles. (↑ )廠房與設(shè)備設(shè)計(jì)上或維護(hù)上沒能做到盡量減少污染與顆粒。 Inadequate maintenance of PW and WFI systems.純化水與注射用水的維護(hù)不力。 Inadequate revalidation of PW and WFI systems after maintenance, upgrading, outofspecs trends. 純化水與注射用水系統(tǒng)在維護(hù)，升級(jí)和出現(xiàn)超標(biāo)趨勢(shì)后沒能進(jìn)行充分的再驗(yàn)證。 Inadequate training of personnel.人員培訓(xùn)不足。 Inadequate gowning practices for clean and aseptic areas.清潔區(qū)，無菌區(qū)著裝規(guī)程不充分 Inadequate sanitation /disinfection program.清潔與消毒計(jì)劃不夠完備 Inadequate practices / precautions to minimize contamination or prevent mixups.減少污染或防止混批方面缺少足夠的操作程序/預(yù)防措施 Nonvalidated time lapse between cleaning, sterilization, use of ponents, containers and equipment.沒有對(duì)清潔，滅菌，部件，容器和設(shè)備使用的有效時(shí)限進(jìn)行驗(yàn)證。 No consideration given to bioburden