1、項目號Item No.評估項目Assessment ItemA 標準方法(原料，成品和包材Specs Methods (Raw materials - Finished products - Packaging Materials)A. 1 人員 PeopleA. L 1實施培訓TrainingA. 2 文件 DocumentsA 2 1 影響對規程/內控標準 Impact on procedures /in-house specificationA. 2. 2 新質fit標準的合理性說明 Justification of new specification(s)A. 2 3 需微生物評估 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需供應商批準和簽字確認Approval & Sign off by supplierA. 3實驗室設備Lab equipmentA. 3. 1 需婆新設備 New equipmentA 2 (新)設備驗證 / 校驗(New) equipment to be qualified / calibratedA. 4 分析 Analy

3、ticsA 4. 1 影響和地方法的開發/驗證/確認 Impact on local method deve 1 opment/validation/verificationA. 4.2影響'"l地方法的等同性(相對于法規/供戶方法)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 影響對照品 Impact on reference standardsA. 5 體系 System需要新的或更新穩定性研究New or update of stability study requiredA 6 物流 LogisticsA. 6. 1 影響"i地相關產品 Impact on locally related productsA & 2 需告知購買 / 配送 Need to inform Purchasing and/or suppliers and/or distributionA. 6 3 商提供質雖標準給供應商 Speci

5、fication needed be transferred to supplierA. 6. 4 需要新的或升級質量協議 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 影響庫存 Impact on stockA. 6. 7 限制產品的配送 Restrictions to product distributionA. 8 法規 RegulatoryA & 1 與當地的法規文件符合性 Impact on local regul

6、atory specification documentsA&2需要在當地政府機關備案Need for local filingA. 8 3 等待批準后才實施 Implementation wait for approvalB合同方/供應商/物料（原料.包材，成品）Contractor/Supplier / Material（Raw Materials - Packaging Materials-Finished Products）B. 1 人員 PeopleB. 1. 1 實施培訓 TrainingB 2 文件 DocumentsB. 2. 1 影響打地的內部標準文件 Impact

7、on local in-house specification documentsB 2 2 需要批準供應商所簽署的標準文件 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地法規中所描述的制造方法 Impact on manufacturing method description in local regulatoryFilesB3實驗室設備Lab EquipmentB. 3. 1 需要新設備 New equipment neededB 2（新）設備需確認 / 校驗（New） equipment to be qualified / calibratedB 4 分析 AnalyticsB

9、. 4. 1 影響檢驗方法 Impact on test methodB42與供戶的方法進行比較Method comparison with supplierB 4 3 提供質量標準給供應商 Specification needed be transferred to supplierB44 影響免檢 Impact on reduced testingB 4 5 需送小樣進行檢驗 Samples need be supplied for testB. 4. 6 需合同實驗室來檢驗 Contract lab involved for testingB5 體系 / 質量 System/Qualit

10、yB 5.1穩定性研尤 Impact on stability studies* 加速穩定性考察 Accelerated stability test* 長期穩定性考察 Long time stability testB 5.2供應商情況調研 Questionnaire purchasing*營業執照.生產許可證，危險化學品生產（經營、運輸）許可證：藥包材注冊證Certificatestatus* IS09001 / IS011001 認證 IS09001 / IS014001 complianceB. 5. 3 影響產品效期 Impact shelf lifeB. 5 4 試機 Trial

11、runningB 5.5工藝驗證 Impact on process validation*驗證方案Protocol*驗證報告Report* 驗證次數 Number of runsB. 5. 6 影響包材設計 Impact on design of ArtworkB. 5. 7 供應商審計 Audit supplierB 5 8 特殊釋放 Need specific releaseB» 5. 9 試驗(特征)批 Need trial batchesB. 5. 10影響供戶的產品質雖證書Impact on CoA of supplierB6市場MarketsB. 6. 1 需要通知銷售

12、部 Notification sale(s)B. 6. 2需要銷售部批準Approval sale(s)B 7 物流 LogisticsB. 7. 1 涉及其他的生產場所/承包商 Involve other manufacturing sites / contractorsB.7.2 影響進程中的訂單 Change applicable to orders already in progressB. 7. 3 影響庫存 Impact on stockB. 8 法規 RegulatoryB & 1 與銷售國法規沖突 Impact on marketing countries regula

13、tory requirementsB& 2需要在銷售國政府機關備案Need for marketing countries filingB 8 3 需審批后執行 Implementation after approvalB & 6 影響殘留溶劑/揮發性有機朵質 Impact on residual solvents / organic volatile impurities (OVI)C生產工藝Production ProcessesC. 1 概述 GeneralC. 1.1 進行培訓 TrainingC 1.2文件 Update documents (weighing, fi

14、ling, manufacturing, packaging)*管理/操作程序Update procedures* 匸藝路線數據表 Routing Data Collection Form*工藝規程MPI* 批記錄BPR Update Batch Production RecordC. 2 GMPC. 2. 1匸藝驗證 Process Validation*驗證方案Protocol*驗證報告Report* 驗證次數 Number of runs* 再驗證(Re)"validationC. 2.2淸潔驗證 Cleaning validation*驗證方案protocol*驗證報告Rep

15、ort* 驗證次數 Number of runs* 再驗證(Re)"validationC. 2. 3 穩定性研尤 Stability studies* 加速穩定性考察 Accelerated stability test* 長期穩定性考察 Long time stability testC. 2. 4 微生物評估 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 設備清單 Update equipment list

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

17、供應商 Impact on suppliersC. 4 法規 RegulatoryC. 4.1相關信息/支持文件備案Need for filing in SFDA/PFDAC 4 2 審批后執行 Implementation after approvalD設備/設施Equipment -Facilities - UtilitiesD1概述GeneralD. 1.1 實施培訓 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 / 校驗程序 Update Mamtenance/Calibration procedure* 批記錄 Update Batch Production Record (BPR)* 設備備件標準 Update specification of equipment parts (components)* 系統描述 Update system description* 平面圖 Update lay-out drawing* 房間的潔凈級另lj Update room classification plan* 相關電機或氣動原理圖 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需婆進彳亍確認Qualification* 驗證主訃劃 Update VMP (Validation Master Plan)* 用戶需求規范 (URS) Issue URS (User Requirements Specifications)* 風險評估(RA) Issue Risk Assessment* 項目驗證計劃 (P&QP) Issue Projec

20、t qualification plan* 廠方接收測試(FAT) Issue Factory acceptance test* 設計確認 (DQ) Issue DQ (Design qualification)* 安裝確認 (IQ) Issue IQ (installation qualification)* 運行確認(OQ) issue OQ (operation qualification)* 性能確認(PQ) issue PQ (performance qualification)* 確認總結報告(QSR) Issue Qualification Summary ReportD 2.2

21、更新預防維修計劃 Update Preventive Maintenance plan (program)更新預防維修指南 / 清單 Update Preventive Maintenance instruction/ checklistJi!新校驗汁劃 Update calibration programJi!新校驗記錄 Update calibration records進行校驗 Need CalibrationD. 2. 3 進行功能測試(方案/報告)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 設備標識 Labeling of equipmentD 2.6自動化(汁算機化)系統 Automated (computerized) systems* 計算機驗證 Computer system validationD 2 7 環境監測(微生物.物理及化學)Impact on environmental monitoring (microbiology, physical, chemical)D28設備臺帳日志New logbooksD 3 物流 LogisticsD. 3. 1 影響相關設備 Affect

23、related equipmentD. 8.2 需雯購買 / 供戶 / 發貨確認 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址協議 New (or update) Quality Agreement with contractorD 4 法規 RegulatoryD4l需要在銷售國政府機關備案Need for marketing countries filingD. 4. 2 等待批準后才實施 Imp

24、lementation wait for approvalE環境、健康及安全EHSE. 1 安全 SafetyE. 1.1人員的安全 Risk for the safety of persons* 1：業的風險：爆沸.墜落 By an industrial risk: bumping, falling* 移動的部件或熱的表面 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Bynoise, heat, pressure, radio-active ionizing radiation, nonion

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

26、, interlock, control & monitoring system*設備是否有零進入的安全防護裝宜Zero access machine guarding*設備具有一定機械強度(對設備，管道.建筑.地面等的使用過程)Mechanical strength(process equipment, pipes, structure, floor) of equipment* 設備耐腐蝕(匸藝設備，管道等)Corrosion resistance (process equipment, pipes) of equipment* 兼容物料和生產設備 Compatibility of

27、 materia 1 s/production equipmentE 1. 3 引入新的風險(對于操作和維修)Introduce a risk on accessibility (operation and maintenance)E- 1.4是否影響風險的識別和評估(危險源的識別，暴爲區域的識別.剩余風險的評估，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* 關健的安全系統 / 設備 / 元器件 Safety-critical system./equipment/component*爆炸的風險explosion risksE. 1.5需要被卜列部門/人員控制檢査或評估Control, inspection or evaluation is needed by :* 安全部 Safety department* 1：業衛生人員(測雖噪音.光照，溫度，化學物質)Industrial hygienist (measu

29、rement:noise, light, temperature, chemical substances, )* 業健康醫師 Occupational health physician* 獨立的權威的檢査機構 Independent authorized inspection body (pressurizedequipment,)E. 1. 6 是否影響安全驗證或測試程序 The change have an impact on safety validation/test procedure E> 1. 7 是否影響設備的安全證明 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(運行/維修/緊急情況/啟動)The change have animpact on safety instructions/procedures/company policies (operation /maintenance/emergency/start-up)E9是否帶來人機匸程學風險The change introduce an ergonomic riskE. 1. 10是否會引入新的限制區 The change introduce confined spaces*

31、在限制區上方是否需要錨定點 Anchoring points are required above confined spacesE. 1. 11生產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J亠區安全設施布迓圖的影響Impact on site safety drawingsE. L 13影響消防(灑水牟，便攜式滅火器)及緊急響應系統(火警.煙霧檢測應急照明)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備 Impact on the local spill procedure & equipmentE» 1.15 影響設備的標識 Impact on labeling of equipmentE. 2 環境 EnvironmentE. 2.1影響環境許可（控制物質，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影響地區的規劃（植樹，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影響對大氣的扌IE放 Impact on air emissions in the atmosphere* 排放有機物 Emission of organic

34、 substances* 排放無機物 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*使用對臭氧層造成危吿的物質(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