19 GMP文件格式模板（布局选择“水平居中”） Version/版本：01 Expiry Date/有效期：2022/04/29 Distributing Numbers/分发数量：15份 Documentation No./文件编号：SMP-QA -XXX Effective Date/执行日期：2019/04/30 Initiation Department/文件发起部门：QA Distributing Dept./收文单位：总经理办公室、人事处、仓管处、采购处、总务处、财务部、工程部、QA、QC、环保部、安全部、生产部、研发和转化部、法规部、商务部 Author起草/日期： Checker审阅/日期： Reviewer审核/日期： Approval批准/日期：
1. Purpose 目的
The SMP is to define the proper procedures for all APRO’s document draft, review, approval, issuance, training, abolish and periodic-review and maintenance for correlative GMP files which include Standard Management Procedures, Standard Operational Procedures. The approval of the SMP will indicate authorization to adhere to the new procedure until the SMP being updated. This SMP also defines the numbering system in APRO.
本SMP规定了关于江苏君若医药有限公司相关文件的格式如何设定，在设定前，首先调整页边距“上、下、左、右”均为2cm，设定完毕方可进行内容格式的设定。具体要求见备注或直接使用格式刷。另注意：不设置页眉，表头直接为正文内容，格式中只设置页脚，如无必要，不要使用分页符分页和分节符分节。
2. Scope 范围
The regulatory, format, numbering system defined in the SMP is applied in all GMP files. When the files are drafted and revised, the format regulatory refers to attachment 5.
应用于公司所有GMP文件，从此文件生效之日起，公司所有新制定或修订的GMP文件，都需要按照此文件要求的格式书写。具体要求格式参照：附件1。
3. Responsibility 职责
A GMP file is drafted by those personnel authorized as authors of GMP files. A GMP file is reviewed by those personnel authorized as Reviewers of GMP files. A GMP file is approved by those personnel authorized as Approvers of documents. This SMP is drafted, reviewed and approved by quality department.
GMP文件由被授权的作者来起草，经被授权的审核者来审核，最后经由受权批准者来批准。本文件由QA起草，经QA相关主管审核和批准。
GMP文件，未经允许，不得复印 第 1 页 共 5 页 SMP-QA -001 The Department Heads are responsible to ensure that all compliance concerns are addressed and that the procedure accurately describes the process for which the document is created and revised.
部门领导有责任强调所有应遵守的相关事项, 并在GMP文件系统的建立和修订时，准确地描述这个过程。
3.1 The Quality Assurance department is responsible to lead all GMP file building and perfecting, review
and approve all drafted and revised GMP files. Other department supervisors are responsible to check the self-department’s GMP files suitability and integrality periodically and initial the creation, revise and obsolescing action corrective with self-department.
3.2 QA负责主导公司GMP文件系统的建立和完善，审核并批准公司各部门起草或修订的GMP文件。
各部门主管有责任随时审视本部门GMP文件系统的完整性和适用性，并负责在必要时发起与本部门有关的文件的建立/修订/废止。
3.3 The Quality Assurance document Coordinator is responsible for format checking and tracking a
document during the Review and Approval processes, and making document effective based on the training period required for the document.
4. Definition 定义 4.1 Author 起草
The author of a document is the individual who drafts the initial document or new draft version of an existing document, the author must be experience at the procedure operation. The author is responsible to training, evaluating and assessing for the file.
GMP文件起草是指起草文件初稿或现有文件新版本草稿的人。起草人必须有一定的资质和经验，并对其起草的文件内容非常了解。起草人负责对其起草的文件进行培训，培训效果评估等。
5. Content 正文
5.1 GMP File Category GMP文件层次 Category 层次 First 第一层文件 Second 第二层文件 Name 名称 Policy 公司政策 Standard Management Procedures 标准管理规范 Validation Master Plan 验证主计划 Third 第三层文件 Standard Operational Procedures 标准操作程序 Validation Protocol 验证方案类 General Method GMP文件，未经允许，不得复印 第 2 页 共 5 页 Code 代号 POL SMP VMP SOP VP GM SMP-QA -001 通用分析方法 The directive of batch production 产品批生产指令 Fourth 第四层文件 Validation Report 验证报告类 Form and Record 表格记录类 Analytical Origin Record 分析原始记录类 Others Record 其他记录报告类 The record of product batch production 产品批生产记录 Note/注意:
POL, SMP and SOP categories will be performed complied with this SMP. POL类、SMP和SOP类文件的格式参考本文件执行；
And the other categories will be performed complied with defined requirement in individual files. 其余文件格式按照各文件具体要求的格式执行。
QRR、APR、QS、MOA、IR(Investigation Report)、CAPA、CS、RS、SD、AMD BPR/BDR/IPC AOR DOC VR MPI/IPC/MDI
5.2 GMP files numbering system GMP文件编码系统
5.2.1 Department code 部门代号 Code 代号 Department 部门 PS WH MS PU PE RD CEO Office总经理办公室 Warehouse 仓管处 Commercials 商务部 Purchase 采购处 Personnel人事处 Research and Development 研发转化部 LR Regulatory Affair法规部 ARD Code 代号 Department 部门 QC IPC PL PD IT CS Quality Control分析处 In Process Control 中控 Plan Department 计划统计部 Manufacture 生产部 IT网管 Calibration Section 验证计量处 Analytical Research Development 分析方法开发 QA EP GA Quality Assurance质保处 Environmental Protection环保部 General Affair 总务处 MA HS FD Engineering 工程部 Health Safety安全部 Finance Department财务部 GMP文件，未经允许，不得复印 第 3 页 共 5 页 SMP-QA -001
SMP-QA-001 GMP文件格式模板(1)
