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變更評估項目表

A

標準方法（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 Training

A.2

文件 

Documents

A.2.1

影響規(guī)程/內(nèi)控標準 Impact on procedures  /in-house specification

A.2.2

新質(zhì)量標準的合理性說明 Justification  of new specification(s)

A.2.3

需微生物評估 Microbiological  assessment

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

需供應商批準和簽字確認 Approval  & Sign off by supplier

A.3

實驗室設備 

Lab  equipment

A.3.1

需要新設備 New  equipment

A.3.2

(新)設備驗證／校驗 (New)  equipment to be qualified / calibrated

A.4

分析 

Analytics

A.4.1

影響方法開發(fā)/驗證/確認  Impact on local method development/validation/verification

A.4.2

影響方法與相對于法定/供應商方法的等同性 Impact on local method  equivalence (versus

A.4.3

影響批次整體考察 Impact  on batch overview

A.4.4

影響方法轉(zhuǎn)移 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.5.1

需要新的或更新穩(wěn)定性試驗 New or update of stability study required

A.6

其他

Logistics

A.6.1

影響當?shù)叵嚓P產(chǎn)品 Impact  on locally related products

A.6.2

需告知采購/供應/發(fā)運  Need to inform Purchasing and/or suppliers and/or  distribution

A.6.3

需提供質(zhì)量標準給供應商 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 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

影響法規(guī)文件符合性 Impact  on local regulatory specification documents

A.8.2

需要備案 Need  for local filing

A.8.3

等待批準方可實施 Implementation  wait for approval

B

合同方／供應商／物料（原料, 包材, 成品）

Contractor/Supplier / Material

(RawMaterials - Packaging Materials-Finished Products)

B.1

人員 

People

B.1.1

實施培訓 Training

B.2

文件 

Documents

B.2.1

影響企業(yè)標準文件 Impact  on local in-house specification documents

B.2.2

需要批準供應商所簽署的標準文件 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 conditions

B.2.5

影響取樣 Impact  on sampling

B.2.6

需更新（通常的）交貨條件 Update of(general) delivery conditions

B.2.7

影響合格供應商清單 Impact  on approved vendor list

B.2.8

影響包裝工藝 Impact  on packaging instructions

B.2.9

影響當?shù)胤ㄒ?guī)所規(guī)定的制造方法 Impact on manufacturing method description in local regulatory Files

B.3

實驗室設備 

Lab  Equipment

B.3.1

需要新設備 New  equipment needed

B.3.2

（新）設備需確認／校驗 (New)  equipment to be qualified / calibrated

B.4

分析 

Analytics

B.4.1

影響分析方法 Impact  on test method

B.4.2

與供戶的方法進行比較 Method  comparison with supplier

B.4.3

提供質(zhì)量標準給供應商 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 testing

B.5

體系/質(zhì)量 

System／Quality

B.5.1

穩(wěn)定性試驗 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

供應商情況調(diào)研 Questionnaire  purchasing

* 營業(yè)執(zhí)照，生產(chǎn)許可證，危險化學品生產(chǎn)（經(jīng)營、運輸）許可證；藥包材注冊證  Certificate status

* ISO9001／ISO14001 認證 ISO9001／ISO14001 compliance

B.5.3

影響產(chǎn)品效期 Impact  shelf life

B.5.4

試機 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

影響包材設計 Impact  on design of Artwork

B.5.7

供應商審計 Audit  supplier

B.5.8

特殊釋放 Need  specific release

B.5.9

試驗(特征）批 Need trial batches

B.5.10

影響供應商的檢驗報告書 Impact  on CoA of supplier

B.6

市場 

Markets

B.6.1

需要通知銷售部 Notification  sale(s)

B.6.2

需要銷售部批準 Approval  sale(s)

B.7

其他

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

與銷售國的法規(guī)沖突 Impact  on marketing countries regulatory requirements

B.8.2

需要在銷售國政府機關備案 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)性有機雜質(zhì) Impact on residual  solvents / organic volatile impurities (OVI)

C  生產(chǎn)工藝

Production Processes

C.1

概述 

General

C.1.1

培訓 Training

C.1.2

文件修訂 Update  documents (weighing, filing, manufacturing, packaging)

* 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 runs

* 再驗證( Re)-validation

C.2.3

穩(wěn)定性試驗 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 Microbiological  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

設備清單 Update  equipment list

C.3

其他

Logistics

C.3.1

影響到相關產(chǎn)品 Affect  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

影響到供應商 Impact  on suppliers

C.4

法規(guī) 

Regulatory

C.4.1

需要備案 Need  for filing in FDA

C.4.2

審批后執(zhí)行 Implementation  after approval

D  設備／設施

Equipment -Facilities - Utilities

D.1

概述 

General

D.1.1

培訓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 Production Record (BPR)

* 設備備件標準  Update specification of equipment parts (=components)

* 系統(tǒng)描述  Update system description

* 更新布局圖  Update lay-out drawing

* 房間的潔凈級別  Update room classification plan

* 相關電機或氣動原理圖  Update electrical - mechanical or pneumatic drawing

* PID 圖紙  Update of P&ID (process and instrumental diagram)  required ?

D.2 GMP

D.2.1

確認Qualification

* 更新驗證主計劃  Update VMP (Validation Master Plan)

* 用戶需求規(guī)范  （URS） Issue URS (User Requirements  Specifications)

* 風險評估（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 Report

D.2.2

更新預防維護計劃 Update  Preventive Maintenance plan (program)

更新預防維護指南／清單 Update  Preventive Maintenance instruction/ checklist

更新校準計劃 Update  calibration program

更新校準記錄 Update  calibration records

需要校準 Need  Calibration

D.2.3

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/光潔度證明  Certificate for material, accuracy or finishing

D.2.5

設備標識 Labeling  of equipment

D.2.6

自動化（計算機化）系統(tǒng) Automated  (computerized) systems

* 計算機驗證  Computer system validation

D.2.7

影響環(huán)境監(jiān)測（微生物，物理及化學）Impact on environmental monitoring (microbiology, physical, chemical)

D.2.8

設備臺帳日志 New  logbooks

D.3             其他  

Logistics

D.3.1

影響相關設備 Affect  related equipment

D.3.2

需要采購／供應商／發(fā)運確認 Need to inform Purchasing and/or suppliers and/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關備案 Need for marketing countries filing

D.4.2

等待批準后才實施 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，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

設備的安全 Impact  on the safety of equipment

* 超過／低于壓力  Over/under pressure

* 過量灌裝  Overfilling

* 報警，互鎖，控制及監(jiān)視系統(tǒng)  Alarm, interlock, control & monitoring system

* 設備是否有零進入的安全防護裝置  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

* 設備耐腐蝕  （工藝設備，管道等） Corrosion  resistance (process equipment, pipes) of

* 兼容物料和生產(chǎn)設備  Compatibility of materials/production equipment

E.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，暴露區(qū)域的識別，剩余風險的評估，方法的描述，安置的順序）

* 關鍵的安全系統(tǒng)／設備／元器件  Safety-critical system/equipment/component

* 爆炸的風險  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 :

* 安全部  Safety department

* 工業(yè)衛(wèi)生人員（測量噪音，光照，溫度，化學物質(zhì)) Industrial hygienist (measurement:

* 職業(yè)健康醫(yī)師  Occupational health physician

* 獨立的權威的檢查機構  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

是否影響設備的安全證明 The  change have an impact on safety certificates of equipment

E.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 an

E.1.9

是否帶來人機工程學風險 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  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度 Process glass been eliminated or

E.1.12

對廠區(qū)安全設施布置圖的影響 Impact on site safety drawings

E.1.13

影響消防（灑水車，便攜式滅火器）及緊急響應系統(tǒng)（火警，煙霧檢測，應急照明）  Impact

E.1.14

影響當?shù)氐男孤┏绦蚣霸O備 Impact on the local spill procedure & equipment

E.1.15

影響設備的標識 Impact  on labeling of equipment

E.2           環(huán)境  

Environment

E.2.1

影響環(huán)境許可（受監(jiān)管物質(zhì)，放射性，電離－非電離劑，麻醉品，..) Impact on the environmental permit (regulated substances,  radioactivity, ionizing & non-ionizing agents, narcotics,…)

E.2.2

影響建筑許可 Impact  on the building permit

E.2.3

影響地區(qū)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

* 排放有機物  Emission of organic substances

* 排放無機物  Emission of inorganic substances

* 排放CO2 Emission of CO2

* 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 substances dangerous for  ozone layer (e.g. Freon)?

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)生危險廢物(液體,固體,氣體,石棉)  Generation of hazardous waste (liquid, solid, gas,

* 產(chǎn)生無害廢物(液體,固體,氣體) Generation of non-hazardous waste (liquid, solid, gas)

* 廢物  (液體,固體,氣體)的處置和運輸  Waste logistics (liquid, solid, gas)

E.2.9

影響外部噪音(對周圍環(huán)境的噪音水平) Impact on external  noise (noise level to surrounding

E.2.10

對土壤的影響 Impact  on soil

E.2.11

影響危險物質(zhì)的儲存及使用 Impact on hazardous substances (storage & use)

E.2.12

需評估以確保有效的能源設計 The modification need be assessed to ensure an energy efficient

E.2.15

需要來自一個獨立的\權威的檢查機構的控制或檢查 Inspection needed by  an independent

E.2.16

對當前的環(huán)境監(jiān)測程序的影響 Impact on the current environmental monitoring program

E.3

健康 

Health

E.3.1

需采取控制措施減少個人健康和安全風險Controls been applied to minimize the H&S risk to

E.3.2

對MSDS 的影響 Impact on the Material Safety  Data Sheet database and

E.3.3

使用不合法的化學品 Involve  use of chemical substances that have not been codified

E.3.4

影響個人防護用品（PPE） Impact on Personal Protective  Equipment (PPE)

* 建立相關PPE 儲存， 清洗和凈化規(guī)定  Provision for storage, cleaning and

* 需要供給呼吸用的空氣  Requirement for breathing air