FDA检查清单.pdf

This e mail will serve to officially introduce myself I am Jos E Mel ndez US FDA Investigator that will be conducting the cGMP Inspection from 08 26 2013 to 09 03 2013 以此邮件正式介绍下我自己 我叫 Jos E Mel ndez 是美国 FDA 的检查官 在 2013 年 8 月 26 日至 9 月 3 日 我将对贵公司进行 cGMP 检查 Due to a limited time of inspection and in order to make a more efficient use of my time I ll provide you a list of documents that I need to be ready and available upon arrival to your firm This information will be also reviewed and discussed with your staff during the course of the inspection I hope that by providing this request in advance it will facilitate the logistic of the inspection and the access to the required documentation in order to speed up the inspectional process 由于有限的检查时间 和为了更有效地利用我的时间 我将提供一个在我达到你公司之 前需要准备好的文件清单 这些信息我也会在检查过程中与贵公司员工进行回顾和讨 论 我希望通过提前发出过个需求会有助于检查的安排 完备的必需资料可以加快检查 的过程 1 Copy of current electronic drug registration FDA and drug products listing 一份当前 FDA 电子注册和产品清单 2 General company administrative information Normally this information is provided as a power point presentation and hand out copy 总体公司管理信息 通常这些信息以通常这些信息以 PPT 介绍加一份纸质复印文件的形式介绍加一份纸质复印文件的形式 a Hours of operation shift breakdown 生产时间 倒班 b Scheduled facility closures e g scheduled maintenance holidays etc 工厂停产计划 如维护计划 假期等 c Number of employees at inspected facility 工厂人数 3 History of Business summary to include but not limited to Normally this information is provided as a power point presentation and hand out copy 公司历史的介绍 包括但不限于 通常这些信息以 PPT 介绍加一份纸质复印 文件的形式 a Legal status e g sole owner corporation etc 法律地位 如 独资企业 团体法人 有限公司 股份公司等 b General description of buildings and operations to include a layout map of facility 总体描述工厂的建筑和运行 包括设施的图纸 c List of company changes if any and corresponding dates e g ownership change name change mergers product introductions or deletions major facilities or operations changes etc 公司的变更清单 如果有的话 和相应的变更日期 如 所有者变更 公司名字变更 公司的兼并 产品引入和下线 主要设施或操作变更 等 d Details of any future proposed changes 未来可能变更细节 e Website Phone and Fax numbers 网站 公司电话和传真 4 Current organizational chart s to demonstrate reporting structure of inspected facility also include reporting structure to corporate facility r headquarter Please include all departments 组织结构图 以展示被检查工厂的报告结构 也包括到合作公司或总部的报告结构 请提供所有部门的 5 Summary of roles and authorities of key responsible personnel such as Plant Manager QA and or QC Director 介绍关键责任人的背景和职责 如工厂总经理 QA QC 总监等 6 Related companies and facilities e g US agent importer broker parent company sister facilities distribution centers address phone fax and contact person contract manufacturers contract laboratories contract customers etc if any 相关连的公司和工厂 如美国代理 中间商 母公司 姐妹公司 配送中心 地 址 电话 传真和联系人 合同制造商 合同实验室 合同客户等 如果有 a Name of company 公司名称 b Address 地址 c Telephone number 电话 d FAX 传真 e E mail 邮箱 f Contact person 联系人 g Relation to the inspected facility 与被检查工厂的关系 7 List of all drug products and or APIs manufactured by the firm and the manufacturing process flow charts or layout 列出工厂生产的所有制剂和原料清单 生产流程图或布局图 8 For each products and or APIs exported to the United States in the last 2 years 近两年内每个出口到美国的制剂和原料 a Name of product and or API 产品名称 b Specific lot numbers 批号 c Consignee s with name and address 承销人的名字和地址 d Quantities shipped to each consignee 运给每个承销人的数量 e Frequency shipped to consignee 运给每个承销人的频率 9 Complete product labeling for all products being or plan to be exported to the US 所有已经或计划出口到美国的产品标签 10 Current list of SOP s Manufacturing and Laboratory operations SOP 清单 生产和实验室 11 Documentation submitted to FDA if there were previous deficiencies in NDAs for any drug product 递交给 FDA 的文档 如果之前所有新药有缺失的话 12 List of any significant changes not filed submitted or reported in NDA for any drug product manufactured in your facility 列出所有新药 NDA 中没有递交或报告的所有重要变更 I will appreciate if the above requested information could be available in English and presented together in a binder 如果上述需求信息能以英文表述并订成一本的话 将会非常感激 如果上述需求信息能以英文表述并订成一本的话 将会非常感激 In addition to the above requested information there are some documents and or procedures that will be reviewed discussed and or may be copied during the course of the inspection 除此之外 对于上述需求 还有一些文件或规程在检查过程中需要一起回顾或讨论 也有一些可能需要复印过去 For example 例如 Quality System 质量系统质量系统 1 Lots manufactured from 08 2011 to present including status Mfg date approved release reject dates or others 从 2011 年到现在的所有批次 包括的状态 生产日期 批准放行或报废的日期 或其他信息 2 Annual Products Reviews 产品年度回顾 SOP APR s highest volume product Most recent approved 年度回顾 最高销量产品 最近批准的产品 3 Complaints investigations and Re call 投诉调查和召回 Current SOP English 当前执行的SOP 英文版 List from 08 2011 up to now list containing complaint product event description date received dated closed and category 从 2011 年到现在的清单 列出投诉编号 品名 事件描述 接受日期 关闭日 期和类别 4 Investigations process manufacturing deviations sterility failures 调查 工艺 生产偏差 无菌阳性 Current SOP English List from 08 2011 up to now including Inv description date discovered date closed and category 从 2011 年到现在的清单 包括调查编号 描述 发现日期 关闭日期和类别 5 CAPA Corrective and Preventive Actions 纠偏和预防措施 Current SOP English List from 08 2011 up to now 从 2011 年到现在的清单 6 Change Control requests 变更控制 Current SOP English List of critical change control requests from 08 2011 up to now 从 2011 年到现在的关键变更控制清单 7 Validation Status from 08 2011 to present including completion and proposed dates 从 2011 年到验证状态 包括已完成和计划验证时期 8 Training 培训 Firm training program SOP English 公司培训管理SOP 英文版 9 Reprocessing Reworking 返工和重做 SOP English List from 08 2011 up to now including description and category 从 2011 年 8 月到现在的清单 包括描述和类别 Facilities and Equipment System 设施和设备系统设施和设备系统 1 Plant Physical Layout 工厂布局图 2 Water Systems description of each Drawings 水系统 描述 图纸 Status of qualifications Last qualification of the water system 确认的状态 最后一次水系统的确认 3 Manufacturing Equipment dedicated or not 生产设备 专用或非专用 4 SOP for cleaning general equipment English 总体设备的清洁 SOP 英文版 5 Holding time for cleaned and dirty equipment 清洁设备和待清洁设备 脏的 的置存时限 6 SOP for validation of cleaning procedures English 清洁程序的验证 SOP 英文版 7 Status of cleaning validations 清洁验证的状态 8 Layout of Room classifications 房间洁净级别布局图 Production System 生产系统生产系统 1 Executed Media fill studies for 2012 2013 2012 2013 年之间的培养基灌装实验 2 Media fill Program SOP English 培养基灌装 SOP 英文 3 Smoke Studies for filling line 灌装线的烟雾测试 4 Smoke Studies program SOP 烟雾测试 SOP 5 Personnel flow in production area 生产区域的人流图 6 Aseptic technique SOP English 无菌操作技术 SOP 英文 Materials System 物料系统物料系统 1 Inventory system for raw materials APIs components and others 原材料 活性成份 组份和其他的存储管理系统 SOP English 2 Sampling Area 取样区域 SOP for sampling including sampling plans English 取样 SOP 包括取样计划 英文 3 Storage conditions 仓储条件 Environmental Monitoring of the warehouse and sampling areas 仓库和取样区域的环境监控 4 Rejection of components SOP Quarantine English 不合格品的拒收 SOP 和待验 英文版 5 Distribution of the materials to production areas and finished product to warehouse 发料到生产区域和成品到仓库的管理 Materials and Product Flow diagram 物料和产品的流程图 Packaging and Labeling System 包装和标签系统包装和标签系统 1 Receiving and storage of the packaging materials 包装物料的接收和储存 Material flow and storage areas Labels control 物流和存放区域 标签控制 Type of evaluation and acceptance operations 评估的类别和接受操作 Visual examination for labels 标签的目检 2 Label Controls 标签控制 SOP for this control English 标签控制 SOP 英文 Area designated 指定区域 Spacing between different labels 不同标签的空间距离 3 Container Controls 容器控制 SOP for control 容器控制 SOP 4 Packaging records 包装记录 5 Line Clearance SOP and documentation 生产线的清洁 SOP 和记录 6 SOP for expiration dates 失效期管理的 SOP Laboratory System 实验室系统实验室系统 1 List of Laboratory Standard Operating Procedures English 实验室 SOP 清单 英文版 2 Product Specifications for drug products 制剂产品的质量标准 3 The Impurity Profile for drug products 制剂的杂质概况 4 List of Laboratory Investigations Out of specifications for Analytical and Microbiology from 08 2011 to present 实验室调查 OOS 清单 从 2011 年 8 月到现在的理化分析和微生物 5 Cleaning Valid