1 QUALITY SYSTEM質(zhì)量保證系統(tǒng)

1.1 Product reviews (annual) 產(chǎn)品審查(年度)

1.2 Complaint reviews (quality and medical) 投訴審查(質(zhì)量和醫(yī)療)

1.3 Discrepancy and failure investigations 不一致和失敗的調(diào)查

1.4 Document Control 文件控制

1.5 Batch release 批放行

1.6 Change Control變更控制

1.7 Reprocess/Rework再加工/返工

1.8 Returns/Salvages 退回/補(bǔ)救

1.9 Rejects 拒收

1.10 Stability Failures穩(wěn)定性失敗

1.11 Quarantine 待驗(yàn)

1.12Validation: computer, equipment, process, laboratory methods, cleaning 驗(yàn)證：計(jì)算機(jī)、設(shè)備、工藝、實(shí)驗(yàn)方法、清潔

1.13 Training/qualification 培訓(xùn)/資質(zhì)

1.14 internal Audit Program內(nèi)審規(guī)程

1.15 Supplier Audit Program 供應(yīng)商審計(jì)規(guī)程

 

2 FACILITIES AND EQUIPMENT SYSTEM 廠房設(shè)施與設(shè)備系統(tǒng)

I Facilities 廠房設(shè)施

2.1 cleaning and maintenance 清潔與維護(hù)保養(yǎng)

2.2 facility layout and air handling systems廠房設(shè)施布局與空氣處理系統(tǒng)

2.3 general air handling systems 全面的空氣處理系統(tǒng)

2.4control system for implementing changes in the building實(shí)施在廠房方面變更的控制系統(tǒng)

2.5 purified water and compressed air systems純化水與壓縮空氣系統(tǒng)

2.6lighting, potable water, washing and toilet facilities, sewage and refuse -disposal照明、飲用水、清洗和盥洗設(shè)施、污水及垃圾處理

2.7sanitation of the building, use of rodenticides, fungicides, insecticides, cleaning and sanitizing agents廠房衛(wèi)生、滅鼠劑、殺真菌劑、殺蟲劑、清洗劑及消毒劑的使用

2.8 drawings (as built) 布局圖(廠房)

II Equipment 設(shè)備

²equipment installation and operational qualification設(shè)備安裝和運(yùn)行確認(rèn)

²adequacy of equipment design, size, material, construction and location 適當(dāng)?shù)脑O(shè)備設(shè)計(jì)、大小、材質(zhì)、結(jié)構(gòu)與位置²appropriate use of equipment operations substances, (lubricants, coolants, refrigerants, etc.) contacting products/containers/etc. 適當(dāng)?shù)脑O(shè)備運(yùn)行時接觸產(chǎn)品/容器等物質(zhì)的使用（例如，潤滑劑、冷卻劑、制冷劑等等）

²cleaning procedures and cleaning validation清潔規(guī)程與清潔驗(yàn)證²controls to prevent contamination, particularly with any pesticides or any other toxic materials, or other drug or non-drug chemicals 預(yù)防污染的控制措施、尤其是殺蟲劑或其它有毒物質(zhì)、或其它藥物與非藥物化學(xué)物質(zhì)

² qualification, calibration and maintenance of refrigerators and freezers 電冰箱和冷凍機(jī)的確認(rèn)、校驗(yàn)和維護(hù)保養(yǎng)²equipment qualification, calibration and maintenance, including computer qualification/validation and security 設(shè)備確認(rèn)、校準(zhǔn)與維護(hù)保養(yǎng)，包括計(jì)算機(jī)確認(rèn)/驗(yàn)證和安全

²control system for implementing changes in the equipment實(shí)施在設(shè)備方面發(fā)生的變更的控制系統(tǒng)

²equipment identification practices (where appropriate) 設(shè)備驗(yàn)收(如適用)

²documented investigation into any unexpected discrepancy記錄對任何未期望的不一致的調(diào)查

 

3 MATERIALS SYSTEM物料系統(tǒng)

3.1 training/qualification of personnel人員的培訓(xùn)/資質(zhì)

3.2 identification of components, containers, closures組分、容器密封件的鑒定

3.3 inventory of components, containers, closures組分、容器密封件的目錄

3.4 storage conditions貯存條件

3.5 storage under quarantine在隔離下的貯存

3.6representative samples collected, tested or examined using appropriate means 用適當(dāng)?shù)姆椒ㄊ占�、檢驗(yàn)和檢查有代表性樣品

3.7at least one specific identity test is conducted on each lot of each component每個組分每一批，至少做一個專屬性實(shí)驗(yàn)

3.8a visual identification is conducted on each lot of containers and closures每批容器和密封件，應(yīng)做一個目測確認(rèn)

3.9testing or validation of supplier's test results for components, containers and closures對供應(yīng)商的組分、容器和密封件的化驗(yàn)結(jié)果的檢驗(yàn)或驗(yàn)證

3.10rejection of any component, container, closure not meeting acceptance requirements不符合可接受要求的組分、容器和密封件的拒收

3.11 appropriate retesting/reexamination of components, containers, closures 組分、容器和密封件適當(dāng)?shù)膹?fù)驗(yàn)/復(fù)查

3.12first in-first out use of components, containers, closures 組分、容器和密封件的先入先出

3.13 quarantine of rejected materials 拒收物料的隔離

3.14water and process gas supply, design, maintenance, validation and operation 水與工藝用氣的供應(yīng)、設(shè)計(jì)、維護(hù)保養(yǎng)、驗(yàn)證和操作

3.15control system for implementing changes in the materials handling operations 實(shí)施在物料處理操作方面所發(fā)生的變更的控制系統(tǒng)

3.16qualification/validation and security of computerized or automated processes 計(jì)算機(jī)化或自動化過程的確認(rèn)/驗(yàn)證和安全

3.17 finished product distribution records by lot 最終產(chǎn)品按批的銷售記錄

3.18documented investigation into any unexpected discrepancy記錄任何未期望的不一致的調(diào)查

 

4 PRODUCTION SYSTEM生產(chǎn)系統(tǒng)

4.1 training/qualification of personnel人員的培訓(xùn)/資質(zhì)

4.2control system for implementing changes in processes實(shí)施在工藝方面所發(fā)生的變更的控制系統(tǒng)

4.3adequate procedure and practice for charge-in of components對于控制組分的適當(dāng)?shù)囊?guī)程和操作

4.4identification of equipment with contents, and where appropriate phase of manufacturing and/or status 裝有內(nèi)容物的設(shè)備的標(biāo)注，以及適當(dāng)?shù)纳�產(chǎn)階段和/或狀態(tài)

4.5 calculation and documentation of actual yields and percentage of theoretical yields 實(shí)際產(chǎn)率和理論產(chǎn)率百分?jǐn)?shù)的計(jì)算與記錄

4.6 complete batch production documentation全部的批生產(chǎn)記錄

4.7established time limits for completion of phases of production 針對生產(chǎn)階段完成而制訂的時間限度

4.8implementation and documentation of in-process controls, tests, and examinations (e.g., pH, adequacy of mix, weight variation, clarity)過程控制、檢測和檢查（例如pH、混合的充分、重量差異和透明度）的實(shí)施與記錄

4.9Justification and consistency of in-process specification and drug product final specifications 中間體的質(zhì)量標(biāo)準(zhǔn)和成品的質(zhì)量標(biāo)準(zhǔn)的合理性及其一致性

4.10 final specifications 最終的質(zhì)量標(biāo)準(zhǔn)

4.11prevention of objectionable microorganisms in non-sterile drug products 在非無菌產(chǎn)品中，有害微生物的預(yù)防

4.12pre-processing procedures (e.g., set-up, line clearance, etc.) 前處理規(guī)程（例如安裝，清場等）

4.13 equipment cleaning and use logs 設(shè)備清潔與使用日志

4.14 master production and control records主要生產(chǎn)與控制記錄（工藝規(guī)程）

4.15 batch production and control records批生產(chǎn)與控制記錄

4.16process validation, including validation and security of computerized or automated processes 工藝驗(yàn)證：包括計(jì)算機(jī)化和自動化工藝的驗(yàn)證和安全

4.17 change control變更控制

4.18 documented investigation into any unexpected discrepancy記錄任何未期望的不一致的調(diào)查

 

5 PACKAGING AND LABELING SYSTEM包裝與標(biāo)示系統(tǒng)

5.1 training/qualification of personnel人員的培訓(xùn)/資質(zhì)

5.2acceptance operations for packaging and labeling materials適當(dāng)?shù)陌�裝和標(biāo)示材料的操作

5.3 control system for implementing changes in packaging and labeling operations實(shí)施在包裝和標(biāo)示操作方面所發(fā)生的變更的控制系統(tǒng)

5.4adequate storage for labels and labeling, both approved and returned after issued 標(biāo)簽和標(biāo)示適當(dāng)?shù)馁A存，包括已批準(zhǔn)的和分發(fā)后退回的

5.5control of labels which are similar in size, shape, and color for different products對于不同的產(chǎn)品，標(biāo)簽在大小、形狀和顏色相似方面的控制

5.6 label verification system標(biāo)簽確認(rèn)系統(tǒng)

5.7 is gang printing used?使用大批量的印刷嗎？

5.8adequate packaging records that will include specimens of all labels used 適當(dāng)?shù)陌�裝記錄，它應(yīng)包括所有所用的標(biāo)簽的種類

5.9 control of issuance of labeling, examination of issued labels and reconciliation of used labels標(biāo)示分發(fā)的控制，被分發(fā)的標(biāo)簽和被使用的標(biāo)簽的物料衡算

5.10 examination of the labeled finished product被標(biāo)示的最終產(chǎn)品的檢查

5.11adequate inspection (proofing) of incoming labeling進(jìn)廠標(biāo)示的適當(dāng)?shù)臋z查（校對）

5.12 use of lot numbers, destruction of excess labeling bearing lot/control numbers 批號的使用，多余的帶有批號/控制號標(biāo)示的銷毀

5.13physical separation between different labeling and packaging lines在不同標(biāo)示和包裝線之間的物理的分隔

5.14monitoring of printing devices associated with manufacturing lines與生產(chǎn)線相關(guān)的打印裝置的監(jiān)測

5.15 line clearance, inspection and documentation生產(chǎn)線的清潔、檢查和記錄

5.16 adequate expiration dates on the label關(guān)于標(biāo)簽的適當(dāng)?shù)挠行��?/p>

5.17 validation of packaging and labeling operations包裝和標(biāo)示操作的驗(yàn)證

5.18documented investigation into any unexpected discrepancy記錄任何任何未期望的不一致的調(diào)查

 

6 LABORATORY CONTROL SYSTEM實(shí)驗(yàn)室控制系統(tǒng)

6.1training/qualification of personnel人員的培訓(xùn)/資質(zhì)

6.2 adequacy of staffing for laboratory operations足夠的實(shí)驗(yàn)室操作人員

6.3adequacy of equipment and facility for intended use適當(dāng)?shù)脑O(shè)備與設(shè)施

6.4 calibration and maintenance programs for analytical instruments and equipment分析儀器和設(shè)備的校準(zhǔn)與維護(hù)保養(yǎng)

6.5validation and security of computerized or automated processes計(jì)算機(jī)化或自動化過程的驗(yàn)證和安全

6.6reference standards; source, purity and assay, and tests to establish equivalency to current official reference standards as appropriate對照標(biāo)準(zhǔn)品：來源、純度和含量、以及為建立與目前官方的對照標(biāo)準(zhǔn)品等效所做的檢測項(xiàng)目

6.7system suitability checks on chromatographic systems (e.g., GC or HPLC) 有關(guān)色譜系統(tǒng)（例如氣相或高壓液相）的系統(tǒng)適用性檢查

6.8specifications, standards, and representative sampling plans質(zhì)量標(biāo)準(zhǔn)、標(biāo)準(zhǔn)品和有代表性的取樣計(jì)劃

6.9 adherence to the written methods of analysis遵循書面的分析方法

6.10 validation/verification of analytical methods分析方法的驗(yàn)證/確認(rèn)

6.11control system for implementing changes in laboratory operations 實(shí)施在實(shí)驗(yàn)室操作方面所發(fā)生的變更的控制系統(tǒng)

6.12Required testing is performed on the correct samples

對于正確的樣品，執(zhí)行所要求的檢驗(yàn)

6.13documented investigation into any unexpected discrepancy 記錄任何未期望的不一致的調(diào)查

6.14complete analytical records from all tests and summaries of results來自所有檢驗(yàn)的完整的分析記錄和結(jié)果的總結(jié)

6.15quality and retention of raw data (e.g., chromatograms and spectra)原始數(shù)據(jù)的質(zhì)量和保存（例如色譜圖和光譜圖）

6.16correlation of result summaries to raw data; presence of unused data結(jié)果總結(jié)與原始數(shù)據(jù)的相關(guān)性，未使用的數(shù)據(jù)的存在

6.17adherence to an adequate Out of Specification (OOS) procedure which includes timely completion of the investigation遵循一個適當(dāng)?shù)腛OS的規(guī)程，此規(guī)程包括調(diào)查的及時完成

6.18adequate reserve samples; documentation of reserve sample examination足夠的留樣、留樣檢查的文件

6.19stability testing program, including demonstration of stability indicating capability of the test methods穩(wěn)定性檢測的規(guī)程，包括檢測方法的顯示穩(wěn)定性的證明

 

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