變更評估項目表

1、變更評估項目表項目號評估項目a 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 people a.1.1實施培訓(xùn)training a.2 文件 documents a.2.1影響對規(guī)程 /內(nèi)控標(biāo)準(zhǔn)impact on procedures /in-house specification a.2.2新質(zhì)量標(biāo)準(zhǔn)的合理性說明justification of new specification(s) a.2.3需微生物評估m(xù)icrobiological assessm

2、ent a.2.4文件的傳送接收impact on transfer documents received/sent a.2.5影響取樣原則和方案impact on sampling instructions a.2.6需供應(yīng)商批準(zhǔn)和簽字確認(rèn)approval & sign off by supplier a.3 實驗室設(shè)備lab equipment a.3.1需要新設(shè)備new equipment a.3.2(新)設(shè)備驗證校驗(new) equipment to be qualified / calibrated a.4 分析 analytics a.4.1影響當(dāng)?shù)胤椒ǖ拈_發(fā)/驗證 /確

3、認(rèn)impact on local method development/validation/verification a.4.2 影響當(dāng)?shù)胤椒ǖ牡韧?相對于法規(guī) /供戶方法 ) impact on local method equivalence (versusa.4.3影響批次整體考察impact on batch overview a.4.4影響方法傳送impact on method transfer a.4.5影響免檢impact on reduced testing a.4.6影響對照品impact on reference standards a.5 體系 system a.5

4、.1需要新的或更新穩(wěn)定性研究new or update of stability study required a.6 物流 logistics a.6.1影響當(dāng)?shù)叵嚓P(guān)產(chǎn)品impact on locally related products a.6.2需告知購買配送need to inform purchasing and/or suppliers and/or distribution a.6.3需提供質(zhì)量標(biāo)準(zhǔn)給供應(yīng)商specification needed be transferred to supplier a.6.4需要新的或升級質(zhì)量協(xié)議new (or update) quality

5、agreement a.6.5需要更改已處理的訂單change applicable to orders already in progress a.6.6影響庫存impact on stock a.6.7限制產(chǎn)品的配送restrictions to product distribution a.8 法規(guī) regulatory a.8.1與當(dāng)?shù)氐姆ㄒ?guī)文件符合性impact on local regulatory specification documents a.8.2需要在當(dāng)?shù)卣畽C(jī)關(guān)備案need for local filing a.8.3等待批準(zhǔn)后才實施implementation wa

6、it for approval b 合同方供應(yīng)商物料（原料, 包材 , 成品）b.1 人員 people b.1.1實施培訓(xùn)training b.2 文件 documents b.2.1影響當(dāng)?shù)氐膬?nèi)部標(biāo)準(zhǔn)文件impact on local in-house specification documents b.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 supplier b.2.3變更包裝形式change to packaging type b.2.4影響貯存條件impact on storage condi

7、tions b.2.5影響取樣impact on sampling b.2.6需更新（通常的）交貨條件update o(general) delivery conditions b.2.7影響合格供應(yīng)商清單impact on approved vendor list b.2.8影響包裝工藝impact on packaging instructions b.2.9 影響當(dāng)?shù)胤ㄒ?guī)中所描述的制造方法b.3 實驗室設(shè)備lab equipment b.3.1需要新設(shè)備new equipment needed b.3.2（新）設(shè)備需確認(rèn)校驗(new) equipment to be qualified

8、/ calibrated b.4 分析 analytics b.4.1影響檢驗方法impact on test method b.4.2與供戶的方法進(jìn)行比較method comparison with supplier b.4.3提供質(zhì)量標(biāo)準(zhǔn)給供應(yīng)商specification needed be transferred to supplier b.4.4影響免檢impact on reduced testing b.4.5需送小樣進(jìn)行檢驗samples need be supplied for test b.4.6需合同實驗室來檢驗contract lab involved for testi

9、ng b.5 體系 /質(zhì)量systemquality b.5.1穩(wěn)定性研究impact on stability studies * 加速穩(wěn)定性考察accelerated stability test * 長期穩(wěn)定性考察long time stability test b.5.2供應(yīng)商情況調(diào)研questionnaire purchasing * 營業(yè)執(zhí)照，生產(chǎn)許可證，危險化學(xué)品生產(chǎn)（經(jīng)營、運(yùn)輸）許可證；藥包材注冊證certificate status * iso9001 iso14001 認(rèn)證 iso9001iso14001 compliance b.5.3影響產(chǎn)品效期impact shelf

10、 life b.5.4試機(jī) trial running b.5.5工藝驗證impact on process validation * 驗證方案protocol * 驗證報告report * 驗證次數(shù)number of runs b.5.6影響包材設(shè)計impact on design of artwork b.5.7 供應(yīng)商審計audit supplierb.5.8特殊釋放need specific release b.5.9試驗 (特征）批need trial batches b.5.10影響供戶的產(chǎn)品質(zhì)量證書impact on coa of supplier b.6 市場 markets

11、b.6.1需要通知銷售部notification sale(s) b.6.2需要銷售部批準(zhǔn)approval sale(s) b.7 物流 logistics b.7.1涉及其他的生產(chǎn)場所/承包商involve other manufacturing sites / contractors b.7.2影響進(jìn)程中的訂單change applicable to orders already in progress b.7.3影響庫存impact on stock b.8 法規(guī) regulatory b.8.1與銷售國法規(guī)沖突impact on marketing countries regulato

12、ry requirements b.8.2需要在銷售國政府機(jī)關(guān)備案need for marketing countries filing b.8.3需審批后執(zhí)行implementation after approval b.8.6影響殘留溶劑 /揮發(fā)性有機(jī)雜質(zhì)impact on residual solvents / organic volatile impurities (ovi) c 生產(chǎn)工藝c.1 概述 general c.1.1進(jìn)行培訓(xùn)training c.1.2文件 update documents (weighing, filing, manufacturing, packagin

13、g) * 管理操作程序update procedures * 工藝路線數(shù)據(jù)表routing data collection form * 工藝規(guī)程mpi * 批記錄 bpr update batch production record c.2 gmp c.2.1工藝驗證process validation * 驗證方案protocol * 驗證報告report * 驗證次數(shù)number of runs * 再驗證 ( re)-validation c.2.2清潔驗證cleaning validation * 驗證方案protocol * 驗證報告report * 驗證次數(shù)number of r

14、uns * 再驗證 ( re)-validation c.2.3穩(wěn)定性研究stability studies * 加速穩(wěn)定性考察accelerated stability test * 長期穩(wěn)定性考察long time stability test c.2.4微生物評估m(xù)icrobiological assessment c.2.5影響批量impact on the batch size c.2.6物料編碼清單update material code list c.2.7設(shè)備清單update equipment list c.3 物流 logistics c.3.1影響到相關(guān)產(chǎn)品affect

15、related products c.3.2涉及到其他的生產(chǎn)地或合同方other manufacturing sites / contractors involved c.3.3升版或起草質(zhì)量協(xié)議need to draft new (or update) quality agreement c.3.4限制產(chǎn)品配送restrictions to product distribution c.3.5創(chuàng)建或改變物料產(chǎn)品編碼create / changed material /product codes c.3.6影響到供應(yīng)商impact on suppliers c.4 法規(guī) regulatory

16、c.4.1相關(guān)信息 /支持文件備案need for filing in sfda/pfda c.4.2審批后執(zhí)行implementation after approval d 設(shè)備設(shè)施d.1 概述 general d.1.1實施培訓(xùn) training d.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 procedure * 維修校驗程序update maintenance/calibration procedure * 批記錄update batch

17、 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 * 房間的潔凈級別update room classification plan * 相關(guān)電機(jī)或氣動原理圖update electrical - mechanical or pneumatic drawing * pid 圖紙 update of p&id (process and instrum

18、ental diagram) required ? d.2 gmp d.2.1需要進(jìn)行確認(rèn) qualification * 驗證主計劃update vmp (validation master plan) * 用戶需求規(guī)范（urs） issue urs (user requirements specifications) * 風(fēng)險評估（ ra） issue risk assessment * 項目驗證計劃（p&qp ） issue project qualification plan * 廠方接收測試（ fat ） issue factory acceptance test * 設(shè)計確

19、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)報告（ qsr）issue qualification summary report d.2.2更新預(yù)防維修計劃update preventive maintenance plan (program) 更新預(yù)防維修指南清單u

20、pdate preventive maintenance instruction/ checklist 更新校驗計劃update calibration program 更新校驗記錄update calibration records 進(jìn)行校驗need calibration d.2.3進(jìn)行功能測試 (方案 /報告） functionality test （ protocol /report) d.2.4需要提供材料證明/精確度 /完工證明certificate for material, accuracy or finishing d.2.5設(shè)備標(biāo)識labeling of equipment

21、 d.2.6自動化（計算機(jī)化）系統(tǒng)automated (computerized) systems * 計算機(jī)驗證computer system validation d.2.7環(huán)境監(jiān)測（微生物，物理及化學(xué)）impact on environmental monitoring (microbiology, physical, d.2.8設(shè)備臺帳日志new logbooks d.3 物流 logistics d.3.1影響相關(guān)設(shè)備affect related equipment d.3.2需要購買供戶發(fā)貨確認(rèn)need to inform purchasing and/or suppliers a

22、nd/or distribution (= update d.3.3需要簽署新的或更新質(zhì)量協(xié)議new (or update) quality agreement with contractor d.4 法規(guī)regulatory d.4.1需要在銷售國政府機(jī)關(guān)備案need for marketing countries filing d.4.2等待批準(zhǔn)后才實施implementation wait for approval e 環(huán)境、健康及安全ehs e.1 安全 safety e.1.1人員的安全risk for the safety of persons * 工業(yè)的風(fēng)險：爆沸，墜落by an

23、 industrial risk: bumping, falling * 移動的部件或熱的表面by moving parts and/or hot surfaces * 噪音，高熱，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by * 危險或高活性物料（致癌物質(zhì)，激素，oel,.）by hazardous materials (carcinogens, * 電擊 by electrocution * 靜電 by static electricity e.1.2設(shè)備的安全impact on the safety of equipment * 超過低于壓力over/under pr

24、essure * 過量灌裝overfilling * 報警，互鎖，控制及監(jiān)視系統(tǒng)alarm, interlock, control & monitoring system * 設(shè)備是否有零進(jìn)入的安全防護(hù)裝置zero access machine guarding * 設(shè)備具有一定機(jī)械強(qiáng)度（對設(shè)備，管道，建筑，地面等的使用過程）mechanical strength * 設(shè)備耐腐蝕（工藝設(shè)備，管道等）corrosion resistance (process equipment, pipes) of * 兼容物料和生產(chǎn)設(shè)備compatibility of materials/produc

25、tion equipment e.1.3 引入新的風(fēng)險（對于操作和維修）introduce a risk on accessibility （operation and maintenance）e.1.4是否影響風(fēng)險的識別和評估（危險源的識別，暴露區(qū)域的識別，剩余風(fēng)險的評估，方法的描述，安置的順序）* 關(guān)鍵的安全系統(tǒng)設(shè)備元器件safety-critical system/equipment/component * 爆炸的風(fēng)險explosion risks e.1.5需要被下列部門人員控制，檢查或評估control, inspection or evaluation is needed by :

26、 * 安全部safety department * 工業(yè)衛(wèi)生人員（測量噪音，光照，溫度，化學(xué)物質(zhì)) industrial hygienist (measurement: * 職業(yè)健康醫(yī)師occupational health physician * 獨(dú)立的權(quán)威的檢查機(jī)構(gòu)independent authorized inspection body (pressurized 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(shè)備的安全證明the change have a

27、n impact on safety certificates of equipment e.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）the change have an e.1.9是否帶來人機(jī)工程學(xué)風(fēng)險the change introduce an ergonomic risk e.1.10是否會引入新的限制區(qū)the change introduce confined spaces * 在限制區(qū)上方是否需要錨定點(diǎn)anchoring points are required above confined spaces e.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

28、度process glass been eliminated or e.1.12對廠區(qū)安全設(shè)施布置圖的影響impact on site safety drawings e.1.13 影響消防（灑水車，便攜式滅火器）及緊急響應(yīng)系統(tǒng)（火警，煙霧檢測，應(yīng)急照明）impact e.1.14影響當(dāng)?shù)氐男孤┏绦蚣霸O(shè)備impact on the local spill procedure & equipment e.1.15影響設(shè)備的標(biāo)識impact on labeling of equipment e.2 環(huán)境 environment e.2.1影響環(huán)境許可（控制物質(zhì)，放射能，電離非電離試劑，麻醉

29、品，.) impact on the e.2.2影響建筑物的許可證impact on the building permit e.2.3影響地區(qū)的規(guī)劃 (植樹 ,綠地 ) impact on the regional planning (planting, green space) e.2.4影響對大氣的排放impact on air emissions in the atmosphere * 排放有機(jī)物emission of organic substances * 排放無機(jī)物emission of inorganic substances * 排放 co2 emission of co2

30、* 排放較低 /較高的臭味emission of a lower/higher odor * 使用對臭氧層造成危害的物質(zhì)（如氟利昂）？does the change involves the use of e.2.5影響水的消耗impact on consumption of water e.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 introduction e.2.8廢物的影響impact on waste * 產(chǎn)生危險廢