巴西药品GMP检查条款.docxVIP

ANNEX IIIInspection Guidelines Items for the Medicinal Drugs Manufacturers.GMP检查的项目列表ESSENCIAL – E关键检查项目：对产品质量和安全性，与产品接触的员工安全以及整个生产工艺会产生关键影响。该项目是以“是”或“否”来回答。NECESSARY - N必要检查项目：对产品质量和安全性，与产品接触的员工安全以及整个生产工艺会产生较为关键的影响。该项目是以“是”或“否”来回答。如果必要检查项目在此次验厂中发现不符合要求，那么在今后的验厂中将被划为关键检查项目RECOMMENDED - R建议检查项目：对产品质量和安全性，与产品接触的员工安全以及整个生产工艺会产生非关键的影响。该项目是以“是”或“否”来回答。如果建议检查项目在此次验厂中发现不符合要求，那么在今后的验厂中将被划为必要检查项目，但不会被划为关键检查项目。INFORMATIVE – INF or I信息型检查项目：该项目是指描述性信息，不会对产品质量和安全性，与产品接触的员工安全以及整个生产工艺会产生影响。该项目可以用“是”或“否”来回答，或者描述一下。1.- MANAGEMENT AND GENERAL INFORMATION 基本信息The company should submit the required evidence documents. 厂家需提供以下基本文件No??Qualif.??Items 项目 ??YES??NO??N/A1.1??INF??What is company’s the legal name? 厂家法定名称___________________1.1.1??INF??CNPJ 税务登记号_____________________1.1.2??INF??Adress 地址: Street / Avenue: ____________________________________N0 _____________, Complement:__________________________Neighborhood:_____________________ City:_____________________State:_________________ZIP Code:________________Telephone: ______________________Fax:_________________________________Email: _____________________________1.2??INF??Inspection Period:验厂日期 ____/____/____ to ______/_____/_____1.2.1??INF??Reason for inspection:验厂原因 ______________________________________1.3??INF??Date of last inspection:上次验厂日期 ____/____/____1.3.1??INF??Reason for last inspection: 上次验厂原因_______________________1.4??INF??Does the company have a Good Manufacturing Practices (GMP) Certification? 公司有GMP证书吗??????1.4.1??INF??Date of Certificate Issue 有的话，证书颁发日期____/___/___1.5??INF??Name of the Responsible Technician: 技术负责人姓名____________1.6??E??Is the responsible pharmacist presents?负责的药剂师在场吗??????1.7??E?? Is there an evidence of his/her certification by the proper agency?有没有相关部门发给过他相关证件？??????1.8??N??Has the company presented an Organizational Chart?公司有没有出示组织机构图？??????1.9??I??Does the company have an Operating Certificate granted by the proper Agency of the National Sanitary Surveillance Agency?公司有没有国家卫生监督局所颁发的运营证书？??????1