制药类企业供货商问卷调查.doc

制药类企业供货商问卷调查 QUESTIONNAIRE FOR SUPPLIERS OF ACTIVE OR INACTIVE PHARMACEUTICAL INGREDIENTS Supplier 供货商供货商 Name of vendor company 卖方国家 Address 地址 Country 国家 Phone No 电话 Fax No 传真 Concerned products 联系产品 Name of contact person 联系人 Title 职位 Phone No 电话 Fax No 传真 E mail address of contact person 联系人邮箱地址 Buyer 买方买方 Date 日期 Confirmed by 确定日期 Quality Assurence team leader 质检组领导 Quality Control manager 质量控制经理 1 General Information No YESNODescriptions 1 1 What type of products do you manufacture 贵司生产何种产品 Plant Extracts Food additive Feed additive Chemical Intermediate 植物提取物 食品添加剂 饲料添加剂 化学溶媒 1 2 Are any of the following materials produced at the same site as materials to be being purchased 我们所购产品的生产场地是否同时生产如下产品 a Antibiotics 抗生素No b Pesticides herbicides 杀虫剂 除草剂No c Biologicals 生物制剂No d Steroids 激素类No e Cytotoxics 细胞毒素No f Highly active materials 高活跃性原料No 1 3 How is cross contamination avoided controlled 交叉污染如何 避免 Product protection training partition storage sanitation and cleaning training 1 4 Is the company a division or subsidiary or affiliate of another corporation 此公司是否为分公司 子公司或者隶属其他集团 NO 1 5 Proportion of customer type 厂家类型 a Pharmaceuticals 制药 57 b Foods 食品 28 c Cosmetics 化妆品 10 d Other 其他 5 2 Personnel 人员情况人员情况 No YESNODescriptions 2 1Number of staff 员工数量 a Staff in production 生产工人57 b Staff in quality assurance QA 质检工人7 c Staff in quality control QC 质控工人11 d Staff in R The last purification stage must be included 你方是否有每次验证过程的数据 最后提纯过程必须包含 Yes 10 6 Do you have a validation data on residual solvent In case that specification complies with Pharmacopoeia like EP USP JP validation only for residual solvents is required 你方是否有残留溶剂的验证数据 以保证规格符合EP USP JP 药典要求 Yes 10 7 Is it possible to send me your information like below for manufacturing facilities PV Certification of authorities for supplied products GMP 对提供的产品认证机构 GMP ISO certificates 9001 14001 ISO 国际标准化组织认证 Organization chart 组织系统图 SOP index SOP 标准作业程序指数 Quality Policy 质量方针 Process validation report or summery report 经过特殊加工处理报告 Cleaning validation report or summery report 清洁验证报告 Analytical method validation report or summery report 分析方法验证报告 Computerized system validation report or summery report 计算机系统验证报告 Thank you for your assistance 谢谢您的协助配合谢谢您的协助配合 Your information is handled confidentially This means we should take legal re sponsibility for confidential problems if you require about that 您的信息是保密处理 这意味着我们应采取保密问题的法律责任 如果您需要这一点您的信息是保密处理 这意味着我们应采取保密问题的法律责任 如果您需要这一点 Your information is handled confidentially This means we should take legal re sponsibility for confidential problems 您的信息是保密处理 这意味着我们应采取保密问题的法律责任 您的信息是保密处理 这意味着我们应采取保密问题的法律责任 This questionnaire has been f