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1、No.Animal Resource Material Questionnaire动物源物料调查问卷MATERIAL NAME(Bra nd Name & Gen eric Name): 物料名称(商品名&通用名)MFG COMPANY NAME :生产厂名称：MFG COMPANY ADRESS:生产厂地址：CONTACT NAME/TITLE:联系人姓名/职位：CONTACT INFORMATION：(Teleph one No., Fax No., Email address)联系信息：(电话，传真，电子邮件)Notice:注意：In the interest of a consiste
2、nt evaluation, the responder is requested to adhere quite accurately to the respective questions Missing or unfounded answers would lead to call backs or deductions 为了评估的完整性，回答者应对相应问题附加附件，没有答复或无根据的答复将导致退回或 降级。The responder is free to supply any additional information that could support the interest
3、and the capabilities of his company. This information is to be added to the questionnaire in the attachment 回答者可以提供任何能够支持公司利益或能力的附加信息。这些信息可以填加在附件中。1 Are the starting materials of the product partly or fully of animal or human origin? (e.g. tissue, tissue extract or fluid such as milk, serum, blood)
4、原材料是部分或全部来源于动物或人？(例如，组织，组织提取物或液体，例如牛奶，血清，血液等)口 Yes 是口 No 否If NO, specify the origin of the starting materials 如果否，请指出原材料的来源 Vegetable 植物口 Synthetic合成 Fermentation/cell culture origin without any animal or human derived product in the broth没使用人或动物来源的培养基的发酵或细胞培养 Inorganic 无机的 Other (please specify)其他(
5、请说明)：2 Are other materials (also reage nts like chromatographic media, buffers etc.) of ani mal o human origin used in the manufacturing process of the product?是否在产品生产过程中使用了其他人或动物来源物料(包括试剂，例如色谱溶媒，缓冲 液等)。 Yes 是口 No 否If YES, specify如果是，请说明：3 Are there procedures in place to avoid cross-c on tam in ati
6、 on with residue of ani mal or huma n origi n materials that come in to con tact with the equipme nt used for manu facture of the product (e.g. other products an d/or clea ning or dis inf ecti ng age nts, media fills)? 在生产过程中是否采取了避免人或动物来源物料残留对使用该设备生产的物料的交叉污 染(例如其他产品，和/或清洁剂或消毒剂，溶媒)？ Yes是口 No 否 Not ap
7、plicable(i.e., no ani mal/huma n orig in materials come in to con tact with the equipment)不适用(例如，没有人或动物来源物料接触设备)4 Ani mal or huma n orig in of material used in producti on.用于生产的人或动物来源物料Please specify 请说明 Bovine (cattle)牛 Caprine (goat) 山羊 Ovine (sheep)绵羊 Human 人口 Other (specify)其他(请说明)： Unknown不知道If
8、 the animal origin material is NOT of bovine, ovine, or caprine origin, jump to Question 8, otherwise continue如果动物源物料不是来源于牛，羊或山羊，则直接回答问题8,否则继续If the material is NOT derived from milk or wool, jump to Question 7, otherwise continue如果物料不是来源于牛奶或羊毛，则直接回答问题7,否则继续5 If the material is derived from milk, is
9、 assuranee given that the milk is fit for human con sumpti on?如果物料来源于牛奶，牛奶是否能食用？口 Yes 是口 No 否Does the milk originates from United Kingdom, Portugal or Ireland? 牛奶是否来源于英国，葡萄牙或爱尔兰 口 Yes 是口 No 否Is the milk derived material prepared with the use of other ruminant materials (e.g. pan creatic en zyme dige
10、sts of case in or renn et)?是否牛奶来源的物料需要同其他反刍动物来源物料一起使用(例如，干酪素或凝乳的胰腺酶 消化) Yes NoIf YES, specify如果是，请说明：6 If the material is derived from wool or hair, is assura nee give n that wool and hair are sourced from live ani mals?如果物料来源于羊毛或毛发，能否确认羊毛和头发来源于活的动物？ Yes 是口 No 否Is the derived material prepared with
11、the use of other ruminant materials (e.g. pan creatic en zymes)?是否这个来源的物料需要同其他反刍动物来源物料一起使用(例如:胰腺酶) Yes 是口 No 否If YES, specify如果是，请说明：7 Is a Certificate of suitability gra nted by EDQM (Ph.Eur.)? 是否有欧洲药品质量管理局授予的欧洲药典适用性证书？ Yes 是Number of Certificate:Date of issue:证书号:发证日期: Not applicable, as no t requ
12、ired for this ruminant material(according to EMEA/410/01 rev 2).不适用，对于这个物料不需要。(根据EMEA/410/01 rev 2)If NO, do you have applied for a Certificate of suitability at EDQM?如果否，请问是否向EDQM申请这个证书？ Yes 是口 No 否If YES, please provide EDQM Letter of Receipt as attachment to this questionnaire 如果是，请提供EDQM受理通知，并附在
13、本调查问卷后。If the material is of ruminant origin (i.e bovine, caprine, ovine and other ruminants) and NO EDQM Certificate of suitability is granted or applied for, please provide a dossier for those materials covered by Resolution AP CSP (99) 4 2). Otherwise continue如果物料来源于反刍动物(牛，山羊，绵羊和其他反刍动物)，并且没有欧洲药典适
14、用性证 书或没有申请，请提供这些物料包括在AP CSP(99)42决议的资料。否则请继续。8 Coun try (ies) of orig in of the ani mal(s). List each in dividual coun try if material is obta ined from a pool of differe nt coun tries:动物来源的国家。如果物料是来源于不同国家原料的混合物，请列出每一国家。口 unknown不知道9 Is feed ing of mammalia n prote in to ruminants banned in the coun
15、 try (ies) of orig in? 在物料来源国家，哺乳动物蛋白喂养是否被禁止？ Yes 是口 No 否10 Are compulsory notification of BSE and a compulsory clinical verification of suspected BSE cases in place in the coun try (ies) of orig in?在物料来源国家，是否有疯牛病或疑似疯牛病的案例发生？ Yes 是 No 否11 Are the materials sourced from countries which are free of BSE according to OIE3, where the presence of BSE is highly unlikely) or from closed, well monitored herds according to Chap. 3.2.2. of EMEA/410/01 rev21?根据OIE3物料是否来源于没发生疯牛病的国家(疯牛病根本不可能发生的国家)或被封 闭管理，并很好监控的动物(根据EMEA/410/01 rev21第3.2.2章)？ Yes (please specify)是，请说明 No (please
