【文章內(nèi)容簡(jiǎn)介】 followed.如果企業(yè)希望對(duì)檢查結(jié)果進(jìn)行申辯，GMP與企業(yè)強(qiáng)制認(rèn)證政策POL0004 中的“爭(zhēng)議解決與上訴”機(jī)制將被啟動(dòng)。Appendix 1附錄1Risk 1 (Critical) Observations 1類風(fēng)險(xiǎn)（嚴(yán)重）缺陷Premises 廠房 No air filtration system to eliminate airborne contaminants that are likely to be generated during fabrication or packaging. 沒有空氣過濾系統(tǒng)以消除生產(chǎn)和包裝時(shí)可能產(chǎn)生的沉降污染。 Generalized malfunctioning of the ventilation system(s) with evidence of widespread crosscontamination.大范圍交叉污染的事實(shí)表明通風(fēng)系統(tǒng)存在故障。 Inadequate segregation of manufacturing or testing areas from other manufacturing areas for high risk products.高風(fēng)險(xiǎn)產(chǎn)品之間的生產(chǎn)區(qū)域或測(cè)試區(qū)域沒能有效地隔開。Equipment 設(shè)備 Equipment used for plex manufacturing operations of critical products not qualified and with evidence of malfunctioning. 用于最高風(fēng)險(xiǎn)產(chǎn)品復(fù)雜生產(chǎn)過程的設(shè)備不合規(guī)定同時(shí)也存在故障。Personnel 人員 Individual in charge of Quality Control (QC) or production for a fabricator of critical / high risk products does not hold a university degree in a science related to the work being conducted and does not have sufficient practical experience in their responsibility area. 管理最高風(fēng)險(xiǎn)，高風(fēng)險(xiǎn)產(chǎn)品質(zhì)量管理或生產(chǎn)的人員沒有相關(guān)領(lǐng)域的大學(xué)文憑同時(shí)缺乏足夠的實(shí)踐經(jīng)驗(yàn)。Sanitation 衛(wèi)生 Evidence of widespread accumulation of residues / extraneous matter indicative of inadequate cleaning. 清潔的不夠充分，存在大范圍殘留/異物積聚。 Evidence of gross infestation. 明顯的蟲害或污染Raw Material Testing 原料檢驗(yàn) Evidence of falsification or misrepresentation of analytical results.分析結(jié)果造假或歪曲 No evidence of testing (COA) available from the supplier / synthetizer and no testing done by the Canadian fabricator. 缺少供應(yīng)商的檢驗(yàn)報(bào)告同時(shí)企業(yè)也沒做相關(guān)的測(cè)試。Manufacturing Control 生產(chǎn)控制 No written Master Formula. 沒有書面的主處方 Master Formula or manufacturing batch document showing gross deviations or significant calculation errors. 主處方或生產(chǎn)批記錄存在明顯的偏差或嚴(yán)重的計(jì)算錯(cuò)誤。 Evidence of falsification or misrepresentation of manufacturing and packaging orders.生產(chǎn)和包裝訂單的造假或錯(cuò)誤Quality Control Department 質(zhì)控部門 No person in charge of QC available on premises in Canada. 加拿大工廠內(nèi)沒有質(zhì)量管理負(fù)責(zé)人 QC department not a distinct and independent unit, lacking real decisional power, with evidence that QC decisions are often overruled by production department or management.質(zhì)量管理部門不是獨(dú)立的機(jī)構(gòu)，缺乏真正的決定權(quán)，有證據(jù)表明質(zhì)量管理部門的決定常被生產(chǎn)或管理層否定。Finished Products Testing 成品檢驗(yàn) Finished product not tested for pliance with applicable specifications by the importer / distributor before release for sale and no evidence is available that the products have been tested by the fabricator.銷售前，進(jìn)口商/分銷商沒有按照合適的標(biāo)準(zhǔn)對(duì)成品進(jìn)行檢驗(yàn)同時(shí)沒有證據(jù)顯示生產(chǎn)商做過相關(guān)測(cè)試。 Evidence of falsification or misrepresentation of testing results / forgery of COA.檢驗(yàn)結(jié)果造假或歪曲/偽造檢驗(yàn)報(bào)告Records to 記錄 Evidence of falsification or misrepresentation of records. 記錄造假或歪曲事實(shí)Stability 穩(wěn)定性 No data available to establish the shelflife of products. 缺少建立產(chǎn)品效期的數(shù)據(jù) Evidence of falsification or misrepresentation of stability data / forgery of COA.穩(wěn)定性數(shù)據(jù)的造假或歪曲/偽造檢驗(yàn)報(bào)告Sterile Products 無(wú)菌產(chǎn)品 Critical sterilization cycles based on Probability of Survival not validated.關(guān)鍵滅菌過程沒有基于細(xì)菌存活率的進(jìn)行驗(yàn)證。 Water for Injection (WFI) systems not validated with evidence of problems such as microbial /endotoxin counts not within specifications.注射用水系統(tǒng)未作驗(yàn)證，存在微生物/內(nèi)毒素超標(biāo)的情況。 No media fills performed to demonstrate the validity of aseptic filling operations.無(wú)菌灌裝工藝未做培養(yǎng)基灌裝驗(yàn)證。 No environmental controls / No monitoring for viable microorganisms during filling for aseptically filled products. 無(wú)菌灌裝產(chǎn)品在灌裝期間缺少環(huán)境監(jiān)控/微生物監(jiān)控。 Aseptic filling operations maintained following unsatisfactory results obtained for media fills.培養(yǎng)基灌裝驗(yàn)證失敗后仍繼續(xù)進(jìn)行無(wú)菌灌裝生產(chǎn)。 Batches failing initial sterility test released for sale on the basis of a second test without proper investigation.產(chǎn)品基于第二次無(wú)菌檢測(cè)結(jié)果放行，而對(duì)首次的菌檢失敗未作調(diào)查。Appendix 2 附錄2Risk 2 (Major) Observations 2類風(fēng)險(xiǎn)（主要）缺陷Premises Malfunctioning of the ventilation system that could result in possible localized or occasional crosscontamination.通風(fēng)系統(tǒng)的故障導(dǎo)致固定的或間歇性的交叉污染。 Maintenance / periodic verification such as air filter replacement, monitoring of pressure differentials not performed. (↑ )沒有做維護(hù)/周期性的性能確認(rèn)如：空氣過濾器的更換，檢測(cè)壓差。 Accessory supplies (steam, air, nitrogen, dust collection, etc...) not qualified.輔助系統(tǒng)（蒸氣，空氣，氮?dú)?，灰塵收集）不符合要求 Heat Ventilation Air Conditioning (HVAC) and purified water (PW) system not qualified.空調(diào)系統(tǒng)和純化水系統(tǒng)不符合要求 Temperature and humidity not controlled or monitored when necessary (e. g. storage not in accordance with labelling requirements).在需要監(jiān)控溫濕度的環(huán)節(jié)沒能監(jiān)控溫濕度（如未按溫濕度要求存放標(biāo)簽） Damages (holes, cracks or peeling paint) to walls / ceilings immediately adjacent or above manufacturing areas or equipment where the product is exposed.與產(chǎn)品暴露區(qū)域直接相鄰或在其上方的墻面，天花板損壞（破洞，裂縫或油漆剝落） Uncleanable surfaces created by pipes, fixtures or ducts directly above products or manufacturing equipment. 無(wú)法進(jìn)行表面清潔的管道經(jīng)過產(chǎn)品或生產(chǎn)設(shè)備的上方。 Surfaces finish (floors, walls and ceilings) that do not permit effective cleaning. 地板，墻體和天花板表面的外層涂料或覆蓋無(wú)法有效清潔。 Unsealed porous finish in manufacturing areas with evidence of contamination (mildew, mould, powder from previous productions, etc..) (↑ )生產(chǎn)區(qū)域未封閉的孔狀表面內(nèi)在污染（霉菌，前批生產(chǎn)的藥粉等等） Insufficient manufacturing space that could lead to mixups. (↑ )生產(chǎn)區(qū)域空間太小易造成差錯(cuò) Physical and electronic quarantine accessible to unauthorized personnel / Physical quarantine area not well marked and /or not respected when used. (↑ )未經(jīng)授權(quán)的人員可以通過機(jī)械和電子門禁/機(jī)械隔離的區(qū)域缺少標(biāo)示而且/或沒有按規(guī)程使用。 No separate area / Insufficient precautions to prevent contamination or crosscontamination during RM sampling.原料抽樣缺少獨(dú)立區(qū)域/沒有足夠的預(yù)防措施來(lái)防止污染或交叉污染。 Equipment Equipment does not operate within its specifications. (↑ )不在其額定范圍內(nèi)操作設(shè)備。 Equipment used for plex manufacturing operations not qualified. (↑ )用于復(fù)雜生產(chǎn)的設(shè)備不合要求。 Clean in Place (CIP) equipment not validated.在線清潔設(shè)備沒有驗(yàn)證。 Tanks for manufacturing of liquids and ointments not equipped with sanitary clamps.液體制劑或油膏劑的生產(chǎn)罐沒有采用清潔卡箍。