【正文】 ? 申請 EDQM (European Directorate for the Quality of Medicines) ? 如何申請 ? ? 申請表 ? 程序 ? 時間表 How to Apply ? 如何申請 ? ALFRED E. TIEFENBACHER (GmbH amp。 Co) VanderSmissenStr. 1 22767 Hamburg Germany Tel.: +49404418090 Fax.: +494044180926 Mail.: Technical Advice to Applicants and Holders of Certificates of Suitability (CEP) 對適應(yīng)性證書 (CEP)的 申請者和持有者的 技術(shù)建議 Technical Advice ?Request for Technical advice for CEP : ?Write a letter to EDQM ?Mention the name and address of the applicant ?Make reference to the relevant . Monograph ?Name of the substance /material ?If applicable number of the corr. CEP ?Charge of 1000 € 技術(shù)建議 ?CEP技術(shù)建議的要求 : ?寫信給 EDQM ?陳述申請者的名字和地址 ?制作與歐洲藥典專論相關(guān)的參考 ?物質(zhì) /物料的名字 ?是否是正確的 CEP的適用號碼 ?1000 €（ 歐元）費用 Technical Advice ? Payment should include ref. To ?Technical Advice? ? Follow instructions at EDQM website ? Submission either by to ? or EDQM certification Unit ? 226 Avenue de Colmar ( entrance rue Schertz) ? F67029 Strasbourg France ? Technical questions or questions about the planning of the procedure ? Phrase Questions clearly add necessary supplementary information 技術(shù)建議 ? 付款方式應(yīng)當包括參考 ‘技術(shù)建議 ’ ? EDQM網(wǎng)站上的遵循指令 ? 可以選擇用電子郵件遞交到 ? 或 EDQM認證部門： 226 Avenue de Colmar ( entrance rue Schertz) F67029 Strasbourg France ? 技術(shù)詢問或關(guān)于程序計劃的詢問 ? 詢問語句清晰，加上必要的補充信息 Technical Advice ? EDQM will anize provision of the advice in a hearing ? Hearings must be booked in advance ? Takes place at EDQM ? Once a month, next meetings October 6, November 3 and December 1st ? Note : Procedure does not replace the submission or assessment of the CEP application 技術(shù)建議 ? EDQM將在一場聽證中組織建議的條款 ? 聽證必須預(yù)先登記 ? 在 EDQM發(fā)生 ? 每月一次 , 下次會議十月六日 , 十一月三日和十二月 1日 ? 注意 : 程序并不代替 CEP申請的遞交或評定 Hearing at EDQM 在 EDQM 聽證 ALFRED E. TIEFENBACHER (GmbH amp。 Co) VanderSmissenStr. 1 22767 Hamburg Germany Tel.: +49404418090 Fax.: +494044180926 Mail.: Procedure for Revision / Renewals of Certificates of Suitability (CEP) 適應(yīng)性證書 (CEP)的修訂 /更新程序 Revision / Renewal ?Guideline on Requirements for Revision/Renewal of certificates : ?Holder of a CEP shall inform the EDQM of any change in the information ?Classification of changes : three categories ?Notification (N)/minor (R or T)/major ?Note : any change not classified as notification or minor change should be classified as a Major Change 修訂 /更新 ?證書的修訂 /更新要求的指南 : ?CEP的持有者應(yīng)當把任何變更信息告知 EDQM ?變更的分類 : 三類 ?通知 (N)/次要的 (R or T)/主要的 ?注意 : 任何沒有被《通知》或次要變更歸類的變更應(yīng)當被歸類為 主要變更 Revision / Renewal ?Documentation to be provided : ?Justification of the change ?Application form, enclosing a parative list of updated sections ?Specific documents as described in the Guideline on Requirements for Revision/ renewal of certificates 修訂 /更新 ?須提供的文件 : ?變更的說明 ?申請表，包括一個更新章節(jié)的對照表 ?在證書的修訂 /更新要求的指南中有對具體文件的描述 Revision / Renewal ?Notifications (N) : ? Change in name or address of CEP holder or the name of the manufacturer ? Change in name or address of the manufacturing site ? Deletion of any manufacturing site ? Deletion of a manufacturer of any intermediate/staring material ? Change in batch size of final substance, intermediate up to 10 fold to original batch ? Change in batch size downscaling 修訂 /更新 ?通知 (N) : ? CEP持有者的名字或地址，或者制造商名字的變更 ? 制造場所的地址或名字變更 ? 任何制造場所的刪除 ? 任何中間體 /起始原料的制造商的刪除 ? 最終物質(zhì)，中間體比原始批次擴大 10倍的，批量的變更 ? 批量縮減的變更 Revision / Renewal ?Notifications (N) : ? Minor Change to a test procedure ? Tightening of the specification limits ? Change in the code product/reference number or in the brand of the final substance ? Amendment to stability data further to a mitment ? Removal of the retest period from the CEP ? TSE certificate , deletion of source country etc. 修訂 /更新 ?通知 (N) : ? 檢測程序的次要變更 ? 規(guī)格限度的嚴格化 ? 產(chǎn)品代碼 /參考號或最終產(chǎn)品商標的變更 ? 修訂穩(wěn)定性數(shù)據(jù)進一步到穩(wěn)定性聲明 ? 從 CEP上去除復檢期 ? TSE證書，刪除原料國家等內(nèi)容 Revision / Renewal ?Minor Changes/Revisions (R) : ? Minor Change in manufacturing process, conditions : no change in imp. Profile, not sterilisation step, synthetic route remains the same ? Change in batch size of substance or intermediate more than 10 fold , conditions :changes in manufacturing process only necessitated by scale up, no biological or sterile product, change does not affect reproducibility a test procedure 修訂 /更新 ?次要變更 /修訂 (R) : ? 制造工藝的次要變更，條件： 雜質(zhì)概況，非消毒步驟沒有變更，合成路線保持相同 ? 原料藥或中間體的批量變更超過 10倍，條件： 工藝的變更只有在擴大規(guī)模，非生物的或非無菌產(chǎn)品時是可行的，變化不影響到檢測程序的再現(xiàn)性 Revision / Renewal ?Minor Changes/Revisions (R) : ? Specification of the final substance /intermediate /reagent , addition of a new test parameter change or replacement of a test procedure ? Conditions: change is not a result of unexpected events, new test procedure not a novel nonstandard technique, new test procedure validated ,test results of at least two batches ? Change in the manufacturer or addition of a new manufacturer of starting material or intermediate , conditions: specifications and route of synthesis identical,not a biological substance,test results of 2 batches 修訂 /更新 ?次要變更 /修訂 (R) : ? 最終物質(zhì) /中間體 /反應(yīng)物的規(guī)格，增加的新的檢測參數(shù)的變更或檢測程序的替換， 條件 : 變更不是意外事件的結(jié)果，新檢測程序不是異常的非標準技術(shù) ,新檢測程序被驗證，至少兩批的檢測結(jié)果 ? 在制造商內(nèi)或新起始原料或中間體制造商的增加的變更 , 條件：規(guī)格和合成路線確認，非生物物質(zhì)，兩批檢測結(jié)果 Revision / Renewal ?Minor Changes/Revisions (R) : ? For “double” CEP chemical purity and TSE risk , change in source of material ? Conditions: no change in manufacturing process, specification remains the same, substance not biological ? Change in the manufacturing site or addition of a new site for the f