动物源物料调查问卷.doc

No.

Animal Resource Material Questionnaire
动物源物料调查问卷

MATERIAL NAME
(Brand Name & Generic 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：
(Telephone 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 consistent 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 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。
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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)
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）
¨¨ Yes 是 ¨ ¨ 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 ¨¨ 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（请说明）:

2 Are other materials (also reagents like chromatographic media, buffers etc.) of animal or 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 ¨ No 否
If YES, specify 如果是，请说明:

3 Are there procedures in place to avoid cross-contamination with residue of animal or human origin materials that come into contact with the equipment used for manufacture of the product (e.g. other products and/or cleaning or disinfecting agents, 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 ¨ No 否
¨ Not applicable(i.e., no animal/human origin materials come into contact with the equipment) 不适用（例如，没有人或动物来源物料接触设备）

4 Animal or human origin of material used in production.
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 ¨ Other (specify) 其他（请说明）：
¨ Unknown 不知道

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If 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 assurance given that the milk is fit for human consumption?
如果物料来源于牛奶，牛奶是否能食用？
¨ Yes 是 ¨ 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
¨ Yes 是 ¨ No 否

Is the milk derived material prepared with the use of other ruminant materials (e.g. pancreatic enzyme digests of casein or rennet)?
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 ¨ No
If YES, specify 如果是，请说明：

6 If the material is derived from wool or hair, is assurance given that wool and hair are sourced from live animals?
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 ¨ No 否

Is the derived material prepared with the use of other ruminant materials (e.g. pancreatic enzymes)?
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 ¨ No 否
If YES, specify 如果是，请说明：

7 Is a Certificate of suitability granted 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 not required 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 ¨ 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 Country (ies) of origin of the animal(s). List each individual country if material is obtained from a pool of different countries:
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。

o unknown 不知道

9 Is feeding of mammalian protein to ruminants banned in the country (ies) of origin?
在物料来源国家，哺乳动物蛋白喂养是否被禁止？

¨ Yes 是 ¨ No 否

10 Are compulsory notification of BSE and a compulsory clinical verification of suspected BSE cases in place in the country (ies) of origin?
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

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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 specify) 否，请说明

12 Which type of tissue (according to EMEA/410/01 rev2) has been used (please underline material)?
什么类型的组织（根据EMEA/410/01 rev2）被使用？（请在物料下划线）
¨ Category A: High-infectivity tissues A类：高传染性组织
underline the material used: brain, spinal cord, spinal ganglia, if other high-infective tissue was used, please specify
请在使用的物料下划线：脑，脊髓，脊椎神经，如果其他高传染性物料被使用，请说明：

¨ Category B: Lower-infectivity tissues B类：低传染性组织
underline the material used: peripheral nerves, lymph nodes, spleen, tonsil, ileum, placenta, bone marrow, if other lower infectivity tissue was used, please specify
请在使用的物料下划线：周围神经，淋巴节，脾，扁桃体，回肠，胎盘，骨髓，如果其他低传染性物料被使用，请说明：

¨ Category C: Tissues with no detected infectivity C类：没有传染性组织
underline the material used: bone, skeletal muscles, tongue, heart, tendon, skin, trachea, adipose tissue, testis, ovary, uterus, foetal tissue, milk, colostrum, cord blood, urine, if other no detected infectivity tissue was used, please specify
请在使用的物料下划线：骨骼，骨骼肌，舌，心脏，肌腱，皮，气管，脂肪组织，睾丸，卵巢，子宫，胎儿组织，奶，初乳，脐带血，尿，如果其他无传染性物料被使用，请说明：

13 Are regulations or procedures in place in the country (ies) of origin for:
在物料来源国家是否有以下相关法规或程序：
o Removal of skulls/vertebrae/spinal cord during collection of the raw materials
在收集原材料时去除头，脊椎，脊髓
¨ Yes 是 ¨ No 否
o Avoiding the risk of cross contamination
防止交叉污染
¨ Yes 是 ¨ No 否
o Health status of animals. Are the animals declared fit for human consumption?
动物健康状态。这些动物是否可以食用？
¨ Yes 是 ¨ No 否
Please attach relevant certificates, e.g. veterinary certificates
请附相关证书，例如兽医证书

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14 Please describe 请描述
· How is the provenance of the animal origin raw materials documented?
请描述记录的动物源物料属性？

· Is the raw material obtained directly from the manufacturer or via one or many intermediary (ies)? Please specify
原材料是从生产商直接得到？还是通过一个或多个中间商得到？请说明：

· How do you know that the information of the manufacturer or intermediary (ies) is
correct? How is it documented?
你怎样知道供应商或中间商的信息是否正确？怎样记录？

15 Do (es) the animal part(s) and derivatives undergo any form of treatment or processing which may remove or reduce infectivity of the agents responsible for transmission of TSE?
动物源原料和衍生物采取了去除或降低TSE传染性的处理或加工措施
¨ Yes 是 ¨ No 否

§ If YES, please describe the manufacturing process and characteristics of the treatment steps which could remove infectivity (physical or chemical steps):
如果选是：请描述能去除物料传染性的生产流程和处理步骤的参数

§ or attach manufacturing process (c.f. Appendix II to Resolution AP-CSP(99)4)
或附生产流程（决议AP-CSP(99)4，附件II）

16 Has the process been validated for TSE infectivity reduction or removal?
去除或降低疯牛病传染的工艺过程是否被验证过？
¨ Yes 是 ¨ No 否

17 What is your reduction of infectivity if applicable, by physical (heat, pressure) or chemical (solvents, chemicals) steps:
降低传染性的方式是什么？是物理方式（加热，压力）或化学方式（溶剂，化学试剂）
o Validated reduction (number of TSE pathogens in raw material divided by number of TSE pathogens in your product): 降低的效果（原料中的TSE致病因子/产品中致病因子）
Factor因数 ______________ (e.g. ≥100 and ≤101; ≥101 and <102 etc.)
What is the validation model applied? 使用的验证模型是什么？

18 How much animal material (in kg) is needed to prepare 1 kg of product?
生产1公斤产品需要多少公斤动物原料？
We need ___________ kg of animal material to prepare 1 kg of product
生产1公斤产品，我需要 公斤原料。

19 Are quality assurance systems such as GMP, ISO 9000 or HACCP (Hazard Analysis and Critical Control Point) in place for monitoring the production process, traceability and batch consistency?
是否有监控生产过程，产品追溯性和批次一致性的质量保证体系（例如GMP，ISO9000或HACCP危险检验和紧急控制点）
o Yes 是 o¨ No 否
If Yes (please specify) 如果是，请说明：

问卷填写人（签名/日期）： 职务：
（Completed by/date） （function）

QA负责人（签名/日期）：
（QA manager/date）
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