《變更評(píng)估項(xiàng)目表》

1、項(xiàng)目號(hào)Item No.評(píng)估項(xiàng)目Assessment ItemA 標(biāo)準(zhǔn)方法(原料，成品和包材Specs Methods (Raw materials - Finished products - Packaging Materials)A. 1 人員 PeopleA. L 1實(shí)施培訓(xùn)TrainingA. 2 文件 DocumentsA 2 1 影響對(duì)規(guī)程/內(nèi)控標(biāo)準(zhǔn) Impact on procedures /in-house specificationA. 2. 2 新質(zhì)fit標(biāo)準(zhǔn)的合理性說(shuō)明 Justification of new specification(s)A. 2 3 需微生物評(píng)估 M

2、icrobiological assessmentA. 2. 4 文件的傳送 / 接收 Impact on transfer documents received/sentA25影響取樣原則和方案Impact on sampling instructionsA26需供應(yīng)商批準(zhǔn)和簽字確認(rèn)Approval & Sign off by supplierA. 3實(shí)驗(yàn)室設(shè)備Lab equipmentA. 3. 1 需婆新設(shè)備 New equipmentA 2 (新)設(shè)備驗(yàn)證 / 校驗(yàn)(New) equipment to be qualified / calibratedA. 4 分析 Analy

3、ticsA 4. 1 影響和地方法的開(kāi)發(fā)/驗(yàn)證/確認(rèn) Impact on local method deve 1 opment/validation/verificationA. 4.2影響'"l地方法的等同性(相對(duì)于法規(guī)/供戶(hù)方法)Impact on local method equivalence (versus regulatory / supplier method)A43影響批次整體考察Impact on batch overviewA. 4 4 影響方法傳送 Impact on method transferA. 4. 5 影響免檢 Impact on reduc

4、ed testingA. 4. 6 影響對(duì)照品 Impact on reference standardsA. 5 體系 System需要新的或更新穩(wěn)定性研究New or update of stability study requiredA 6 物流 LogisticsA. 6. 1 影響"i地相關(guān)產(chǎn)品 Impact on locally related productsA & 2 需告知購(gòu)買(mǎi) / 配送 Need to inform Purchasing and/or suppliers and/or distributionA. 6 3 商提供質(zhì)雖標(biāo)準(zhǔn)給供應(yīng)商 Speci

5、fication needed be transferred to supplierA. 6. 4 需要新的或升級(jí)質(zhì)量協(xié)議 New (or update) Quality AgreementA 6 5 齋要更改已處理的訂單 Change applicable to orders already in progressA. 6. 6 影響庫(kù)存 Impact on stockA. 6. 7 限制產(chǎn)品的配送 Restrictions to product distributionA. 8 法規(guī) RegulatoryA & 1 與當(dāng)?shù)氐姆ㄒ?guī)文件符合性 Impact on local regul

6、atory specification documentsA&2需要在當(dāng)?shù)卣畽C(jī)關(guān)備案Need for local filingA. 8 3 等待批準(zhǔn)后才實(shí)施 Implementation wait for approvalB合同方/供應(yīng)商/物料（原料.包材，成品）Contractor/Supplier / Material（Raw Materials - Packaging Materials-Finished Products）B. 1 人員 PeopleB. 1. 1 實(shí)施培訓(xùn) TrainingB 2 文件 DocumentsB. 2. 1 影響打地的內(nèi)部標(biāo)準(zhǔn)文件 Impact

7、on local in-house specification documentsB 2 2 需要批準(zhǔn)供應(yīng)商所簽署的標(biāo)準(zhǔn)文件 Approval sign off on specification documents by supplierB. 2. 3 變址包裝形式 Change to packaging typeB 2 4 影響貯存條件 Impact on storage conditionsB25 影響取樣 Impact on samplingB. 2. 6 需更新（通常的）交貨條件 Update o（general） delivery conditionsB27影響合格供應(yīng)商清單Impa

8、ct on approved vendor listB. 2. 8 影響包裝匸藝 Impact on packaging instructionsB. 2.9影響、"l地法規(guī)中所描述的制造方法 Impact on manufacturing method description in local regulatoryFilesB3實(shí)驗(yàn)室設(shè)備Lab EquipmentB. 3. 1 需要新設(shè)備 New equipment neededB 2（新）設(shè)備需確認(rèn) / 校驗(yàn)（New） equipment to be qualified / calibratedB 4 分析 AnalyticsB

9、. 4. 1 影響檢驗(yàn)方法 Impact on test methodB42與供戶(hù)的方法進(jìn)行比較Method comparison with supplierB 4 3 提供質(zhì)量標(biāo)準(zhǔn)給供應(yīng)商 Specification needed be transferred to supplierB44 影響免檢 Impact on reduced testingB 4 5 需送小樣進(jìn)行檢驗(yàn) Samples need be supplied for testB. 4. 6 需合同實(shí)驗(yàn)室來(lái)檢驗(yàn) Contract lab involved for testingB5 體系 / 質(zhì)量 System/Qualit

10、yB 5.1穩(wěn)定性研尤 Impact on stability studies* 加速穩(wěn)定性考察 Accelerated stability test* 長(zhǎng)期穩(wěn)定性考察 Long time stability testB 5.2供應(yīng)商情況調(diào)研 Questionnaire purchasing*營(yíng)業(yè)執(zhí)照.生產(chǎn)許可證，危險(xiǎn)化學(xué)品生產(chǎn)（經(jīng)營(yíng)、運(yùn)輸）許可證：藥包材注冊(cè)證Certificatestatus* IS09001 / IS011001 認(rèn)證 IS09001 / IS014001 complianceB. 5. 3 影響產(chǎn)品效期 Impact shelf lifeB. 5 4 試機(jī) Trial

11、runningB 5.5工藝驗(yàn)證 Impact on process validation*驗(yàn)證方案Protocol*驗(yàn)證報(bào)告Report* 驗(yàn)證次數(shù) Number of runsB. 5. 6 影響包材設(shè)計(jì) Impact on design of ArtworkB. 5. 7 供應(yīng)商審計(jì) Audit supplierB 5 8 特殊釋放 Need specific releaseB» 5. 9 試驗(yàn)(特征)批 Need trial batchesB. 5. 10影響供戶(hù)的產(chǎn)品質(zhì)雖證書(shū)Impact on CoA of supplierB6市場(chǎng)MarketsB. 6. 1 需要通知銷(xiāo)售

12、部 Notification sale(s)B. 6. 2需要銷(xiāo)售部批準(zhǔn)Approval sale(s)B 7 物流 LogisticsB. 7. 1 涉及其他的生產(chǎn)場(chǎng)所/承包商 Involve other manufacturing sites / contractorsB.7.2 影響進(jìn)程中的訂單 Change applicable to orders already in progressB. 7. 3 影響庫(kù)存 Impact on stockB. 8 法規(guī) RegulatoryB & 1 與銷(xiāo)售國(guó)法規(guī)沖突 Impact on marketing countries regula

13、tory requirementsB& 2需要在銷(xiāo)售國(guó)政府機(jī)關(guān)備案Need for marketing countries filingB 8 3 需審批后執(zhí)行 Implementation after approvalB & 6 影響殘留溶劑/揮發(fā)性有機(jī)朵質(zhì) Impact on residual solvents / organic volatile impurities (OVI)C生產(chǎn)工藝Production ProcessesC. 1 概述 GeneralC. 1.1 進(jìn)行培訓(xùn) TrainingC 1.2文件 Update documents (weighing, fi

14、ling, manufacturing, packaging)*管理/操作程序Update procedures* 匸藝路線數(shù)據(jù)表 Routing Data Collection Form*工藝規(guī)程MPI* 批記錄BPR Update Batch Production RecordC. 2 GMPC. 2. 1匸藝驗(yàn)證 Process Validation*驗(yàn)證方案Protocol*驗(yàn)證報(bào)告Report* 驗(yàn)證次數(shù) Number of runs* 再驗(yàn)證(Re)"validationC. 2.2淸潔驗(yàn)證 Cleaning validation*驗(yàn)證方案protocol*驗(yàn)證報(bào)告Rep

15、ort* 驗(yàn)證次數(shù) Number of runs* 再驗(yàn)證(Re)"validationC. 2. 3 穩(wěn)定性研尤 Stability studies* 加速穩(wěn)定性考察 Accelerated stability test* 長(zhǎng)期穩(wěn)定性考察 Long time stability testC. 2. 4 微生物評(píng)估 Microbiological assessmentC. 2.5 影響批址 Impact on the Batch SizeC. 2. 6 物料編碼淸笊 Update material code listC. 2. 7 設(shè)備清單 Update equipment list

16、C.3 物流LogisticsC. 3.1 影響到相關(guān)產(chǎn)品 Affect related productsC 2 涉及到其他的生產(chǎn)地或合同方 Other manufacturing sites / contractors involvedC. 3. 3 升版或起草質(zhì):ft協(xié)議 Need to draft new (or update) Quality AgreementC S 4 限制產(chǎn)品配送 Restrictions to product distributionC5創(chuàng)建或改變物料/產(chǎn)品編碼Create / changed material /product codesC. 3. 6 影響到

17、供應(yīng)商 Impact on suppliersC. 4 法規(guī) RegulatoryC. 4.1相關(guān)信息/支持文件備案Need for filing in SFDA/PFDAC 4 2 審批后執(zhí)行 Implementation after approvalD設(shè)備/設(shè)施Equipment -Facilities - UtilitiesD1概述GeneralD. 1.1 實(shí)施培訓(xùn) TrainingD 1.2需要更新文件 Update of documents required* 操作程序 Update Operational procedures* 清潔程序 Update Cleaning proc

18、edure* 維修 / 校驗(yàn)程序 Update Mamtenance/Calibration procedure* 批記錄 Update Batch Production Record (BPR)* 設(shè)備備件標(biāo)準(zhǔn) Update specification of equipment parts (components)* 系統(tǒng)描述 Update system description* 平面圖 Update lay-out drawing* 房間的潔凈級(jí)另lj Update room classification plan* 相關(guān)電機(jī)或氣動(dòng)原理圖 Update electrical - mecha

19、nical or pneumatic drawing* PID 圖紙 Update of P&ID (process and instrumental diagram) required ?D. 2 GMPD. 2. 1需婆進(jìn)彳亍確認(rèn)Qualification* 驗(yàn)證主訃劃 Update VMP (Validation Master Plan)* 用戶(hù)需求規(guī)范 (URS) Issue URS (User Requirements Specifications)* 風(fēng)險(xiǎn)評(píng)估(RA) Issue Risk Assessment* 項(xiàng)目驗(yàn)證計(jì)劃 (P&QP) Issue Projec

20、t qualification plan* 廠方接收測(cè)試(FAT) Issue Factory acceptance test* 設(shè)計(jì)確認(rèn) (DQ) Issue DQ (Design qualification)* 安裝確認(rèn) (IQ) Issue IQ (installation qualification)* 運(yùn)行確認(rèn)(OQ) issue OQ (operation qualification)* 性能確認(rèn)(PQ) issue PQ (performance qualification)* 確認(rèn)總結(jié)報(bào)告(QSR) Issue Qualification Summary ReportD 2.2

21、更新預(yù)防維修計(jì)劃 Update Preventive Maintenance plan (program)更新預(yù)防維修指南 / 清單 Update Preventive Maintenance instruction/ checklistJi!新校驗(yàn)汁劃 Update calibration programJi!新校驗(yàn)記錄 Update calibration records進(jìn)行校驗(yàn) Need CalibrationD. 2. 3 進(jìn)行功能測(cè)試(方案/報(bào)告)Functionality test ( protocol /report)D. 24需要提供材料證明/精確度/完工證明Certifica

22、te for material, accuracy or finishingD25 設(shè)備標(biāo)識(shí) Labeling of equipmentD 2.6自動(dòng)化(汁算機(jī)化)系統(tǒng) Automated (computerized) systems* 計(jì)算機(jī)驗(yàn)證 Computer system validationD 2 7 環(huán)境監(jiān)測(cè)(微生物.物理及化學(xué))Impact on environmental monitoring (microbiology, physical, chemical)D28設(shè)備臺(tái)帳日志New logbooksD 3 物流 LogisticsD. 3. 1 影響相關(guān)設(shè)備 Affect

23、related equipmentD. 8.2 需雯購(gòu)買(mǎi) / 供戶(hù) / 發(fā)貨確認(rèn) Need to inform Purchasing and/or suppliers and/or distribution (=updatedescription of equipment parts )D 3 3 需要簽署新的或更新質(zhì)址協(xié)議 New (or update) Quality Agreement with contractorD 4 法規(guī) RegulatoryD4l需要在銷(xiāo)售國(guó)政府機(jī)關(guān)備案Need for marketing countries filingD. 4. 2 等待批準(zhǔn)后才實(shí)施 Imp

24、lementation wait for approvalE環(huán)境、健康及安全EHSE. 1 安全 SafetyE. 1.1人員的安全 Risk for the safety of persons* 1：業(yè)的風(fēng)險(xiǎn)：爆沸.墜落 By an industrial risk: bumping, falling* 移動(dòng)的部件或熱的表面 By moving parts and/or hot surfaces*噪音，商熱.壓力，放射性的電離輻射，非電離輻射(如激光)，生物制品及振動(dòng)Bynoise, heat, pressure, radio-active ionizing radiation, nonion

25、izing radiation (eg laser), biological agents and vibrations* 危險(xiǎn)或高活性物料(致癌物質(zhì).激素,OEL,. ) By hazardous materials (carcinogens,hormone, OEL,)* 電擊 By electrocution* 靜電 By static electricityE. 1.2設(shè)備的安全 Impact on the safety of equipment* 超過(guò) / 低于壓力 OverAmder pressure* 過(guò)fit灌裝 Overfilling* 報(bào)警，互鎖.控制及監(jiān)視系統(tǒng) Alarm

26、, interlock, control & monitoring system*設(shè)備是否有零進(jìn)入的安全防護(hù)裝宜Zero access machine guarding*設(shè)備具有一定機(jī)械強(qiáng)度(對(duì)設(shè)備，管道.建筑.地面等的使用過(guò)程)Mechanical strength(process equipment, pipes, structure, floor) of equipment* 設(shè)備耐腐蝕(匸藝設(shè)備，管道等)Corrosion resistance (process equipment, pipes) of equipment* 兼容物料和生產(chǎn)設(shè)備 Compatibility of

27、 materia 1 s/production equipmentE 1. 3 引入新的風(fēng)險(xiǎn)(對(duì)于操作和維修)Introduce a risk on accessibility (operation and maintenance)E- 1.4是否影響風(fēng)險(xiǎn)的識(shí)別和評(píng)估(危險(xiǎn)源的識(shí)別，暴爲(wèi)區(qū)域的識(shí)別.剩余風(fēng)險(xiǎn)的評(píng)估，方法的描述，安迓的順序)The change have an impact on the risk identification & evaluation (= identification of danger, identification of those exposed

28、/target/risk area, assessment of rest risks, description of measures* 關(guān)健的安全系統(tǒng) / 設(shè)備 / 元器件 Safety-critical system./equipment/component*爆炸的風(fēng)險(xiǎn)explosion risksE. 1.5需要被卜列部門(mén)/人員控制檢査或評(píng)估Control, inspection or evaluation is needed by :* 安全部 Safety department* 1：業(yè)衛(wèi)生人員(測(cè)雖噪音.光照，溫度，化學(xué)物質(zhì))Industrial hygienist (measu

29、rement:noise, light, temperature, chemical substances, )* 業(yè)健康醫(yī)師 Occupational health physician* 獨(dú)立的權(quán)威的檢査機(jī)構(gòu) Independent authorized inspection body (pressurizedequipment,)E. 1. 6 是否影響安全驗(yàn)證或測(cè)試程序 The change have an impact on safety validation/test procedure E> 1. 7 是否影響設(shè)備的安全證明 The change have an impact

30、 on safety certificates of equipmentE. 1.8是否影響安全指令/程序/公司政策(運(yùn)行/維修/緊急情況/啟動(dòng))The change have animpact on safety instructions/procedures/company policies (operation /maintenance/emergency/start-up)E9是否帶來(lái)人機(jī)匸程學(xué)風(fēng)險(xiǎn)The change introduce an ergonomic riskE. 1. 10是否會(huì)引入新的限制區(qū) The change introduce confined spaces*

31、在限制區(qū)上方是否需要錨定點(diǎn) Anchoring points are required above confined spacesE. 1. 11生產(chǎn)流程中碎玻璃的污染是否被排除或減少到最低程度Process glass been eliminated or reduced to a minimum levelE. 1. 12對(duì)J亠區(qū)安全設(shè)施布迓圖的影響Impact on site safety drawingsE. L 13影響消防(灑水牟，便攜式滅火器)及緊急響應(yīng)系統(tǒng)(火警.煙霧檢測(cè)應(yīng)急照明)Impacton Fire Protection (sprinklers, portable fi

32、re protection equipment) & Emergency Response (fire alarm, smoke detectors, emergency lighting,)E. 1. 14 影響地的泄漏程序及設(shè)備 Impact on the local spill procedure & equipmentE» 1.15 影響設(shè)備的標(biāo)識(shí) Impact on labeling of equipmentE. 2 環(huán)境 EnvironmentE. 2.1影響環(huán)境許可（控制物質(zhì)，放射能，電離一非電離試劑麻醉品.）Impact on theenvironme

33、ntal permit(regulated substances, radioactivity, ionizing & nonionizmg agents, narcotics,)E.2.3影響地區(qū)的規(guī)劃（植樹(shù)，綠地）E. 2. 2 影響建筑物的許可證 Impact on the building permitImpact on the regional planning (planting, green space)E. 2.4影響對(duì)大氣的扌IE放 Impact on air emissions in the atmosphere* 排放有機(jī)物 Emission of organic

34、 substances* 排放無(wú)機(jī)物 Emission of inorganic substances* 排放CO: Emission of CO:* 排放較低/較商的臭味 Emission of a lower/higher odor*使用對(duì)臭氧層造成危吿的物質(zhì)(如氛利昂)？ Does the change involves the use of substances dangerous for ozone layer (eg Freon)?E. 2. 5 影響水的消耗 Impact on consumption of waterE 2 6 對(duì)廢水的影響(收集和處理Impact on waste water (collection & discharge of water)E. 2. 7 引入前是否需要合適的清潔方法 Require an adapted cleaning method before introductionE. 2