ICH六大系統(tǒng)檢查內(nèi)容

1、agenda議程comprehensive review with ref ere nee to fda's “six system compliance program manual: 與fda”六體系”順應(yīng)性程序手冊相關(guān)的綜合檢查quality svstem - this system assures overall complianee with cgmps and internal procedures (sops) and specifications.質(zhì)量體系系統(tǒng)確保要與cgmps, sops,及質(zhì)量標(biāo)準(zhǔn)有總的順應(yīng)性a) fda compliance historyfda順

2、應(yīng)性歷史b) quality control unit and all of its review and approval duties, including:質(zhì)量控制部分和所有的冋顧及批準(zhǔn)職責(zé)，包括：i)change control（變化控制）(1) changes to dmf or applicationdmf變更及申報ii)reprocessi ng返工iii)batch release批放行iv)annual record review年記錄冋顧v)validation protocols and reports驗證計劃、方案和報vi)product defect evaluati

3、ons產(chǎn)品缺陷回顧(1) complaint file投訴檔案vii) returned and salvaged goods evaluation產(chǎn)品退貨及回收評估viii)table of organization組織機構(gòu)圖ix) curricula vitae of key personnel關(guān)鍵人員履歷書x)sop indexsop索引xi) training program培訓(xùn)計劃xii) internal audit program內(nèi)部審計程序xiii)vendor qualification program客戶確認(rèn)程序(1) vendor audits客戶審計facilities

4、 and equipment svstem - this system includes the measures and activities which provide an appropriate physical environment and resources used in the production of apts.設(shè)備和儀器系統(tǒng)-系統(tǒng)包括（捉供api產(chǎn)品所需的適當(dāng)?shù)淖匀画h(huán)境和資源的）措施和活動c) buildings and facilities廠房和設(shè)施i) general tour甩、體布局ii) map / floor plan of plant layout工廠平面

5、布置圖iii) maintenance維護iv) qualification確認(rèn)v) monitoring監(jiān)控d) equipment設(shè)備（儀器）i) qualification (installation, operation)確認(rèn)（安裝和運行）(1) note: performance qualification to be evaluated as part of process validation(see production system below).注：性能確認(rèn)評估作為工藝驗證的一部分ii) calibration校驗iii) preventative maintenanee

6、program維護保養(yǎng)計劃iv) cleaning清潔v) validation of cleaning processes, as appropriate 清洗程序適應(yīng)性驗證vi) use logs儀器設(shè)備使用紀(jì)錄e) utilities that are not intended to be incorporated into the product公用設(shè)施i) hvac空調(diào)凈化系統(tǒng)ii) compressed gases壓縮氣體iii) steam蒸汽iv) water systems水系統(tǒng)(1) validation驗證(2) routine monitoring常規(guī)監(jiān)測(a) che

7、mical purity化學(xué)純度(b) microbial purity微牛物純度materials system - this system in eludes measures and activities to control 物料系統(tǒng)系統(tǒng)包括措施和行為控制成品產(chǎn)品組件，包括容器包裝f) finished productsg) comp on ents of the product, includingi) containersii) closuresiii) water水iv) gases氣休h) raw material retest program原料的再檢驗程序i) valida

8、tion of computerized inventory control processes計算機存貨系統(tǒng)的控制程序j) drug storage藥品貯存i) temperature / humidity mapping and monitoring溫度濕度圖表和監(jiān)控ii) bulk holding times studies貯存吋間研究k)distribution controls發(fā)放控制1)reserve sample program留樣計劃m) records記錄production systems this includes measures and activities to c

9、ontrol the manufacture of apts, including:生產(chǎn)系統(tǒng)控制api生產(chǎn)的程序和措施n) batch compounding混批工藝流程圖i) process flow chartso) in-process sampling and testing屮間取樣和檢驗p) process validation工藝驗證q) solve nt recovery溶劑回收r) approved, written manufacturing procedures工藝規(guī)程的起草和批準(zhǔn)程序i) establishment of起草ii) following of審核批準(zhǔn)iii)

10、 documenting performs nee of文件執(zhí)行packaqinq and labelinq system this system includes measures and activities that control the packaging and labeling. it includes:包裝和標(biāo)簽體系包括控制包裝和標(biāo)簽的措施和行為的系統(tǒng)s) written procedures書面程序t) label examination and usage標(biāo)簽檢查和使用u) label storage and issuance標(biāo)簽貯存和發(fā)放v) packaging and

11、labeling operations controls包裝和標(biāo)簽的操作控制w) validation of these operations操作驗證？ ？ ？x) lot numbering system批號編制化驗室操作程序laboratory control system this system includes measures and activities related to 化驗室控制體系x) laboratory proceduresi) sop for investigation of out of specification (oos) results oos調(diào)查的sop分

12、析操作技能培訓(xùn)計劃檢測及實驗記錄新進原材料中間體成品殘留溶劑y)analyst training programz)testi ng and test recordsaa)i) incoming raw materialsii) intermediatesiii) finished productsiv) residual solventsv）lab notebooks - bound or loose sheetsiii) polymorphismiv) expiration dates冇效期實驗記錄一裝訂記錄（批檢驗記錄等）及零散記錄bb)analytical methodology分析方法i) development開發(fā)ii) validation or verification驗證cc) lab equipment實驗室設(shè)備（儀器）i) qualification確認(rèn)ii) maintenance 一 con tracts維護iii) calibration校驗iv) use logs設(shè)備使用紀(jì)錄dd)stability program穩(wěn)定性程序i) ich