3_变更控制管理规程
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
变更控制管理规程
Change Control Management
1 目的/Purpose
建立变更控制管理体系，对与产品质量有关的变更进行控制、评估和管理，从而保证产品的质量、有效性和安全性。
This document describes the procedure to control, evaluate and manage the changes that have an impact on product quality in order to assure the quality, efficacy and safety product.
2 范围/Scope
2.1 本规程适用于可能影响产品质量的所有变更，但不仅限于：
This procedure applies to all changes that may affect product quality, including but not limited to the following:
●主要原辅材料Key Raw Materials.
●设备和分析仪器Equipment and Analytical Equipment.
●设施Facilities.
●公用系统（如水系统、压缩空气系统等）
Utilities (e.g. water system, compressed air system, etc.)
●产品生产工艺Manufacturing Processes
●清洁工艺Cleaning Methods
●质量标准Specifications
●检验方法Analytical Test Methods
●计算机硬件和软件Computer Hardware and Software
●生产地址Manufacturing Site
2.2 本规程不包括文件变更。文件变更按照《文件管理规程》执行。
This procedure excludes the Change Control of documents which is described in “Document Management”.
2.3 本规程不包括供应商变更。供应商变更按照《供应商评估与选择管理规程》执行。This procedure excludes the changes in suppliers which is governed under “Supplier
Evaluation and Selection”.
2.4 本规程不包括标签和包装材料变更。标签和包装材料变更按照《产品包装设计、印刷管理规程》执行。
This procedure excludes the changes in labels and packaging materials which are governed under “Management of Packaging Material Design & Printing”.
3 职责/Responsibilities
3.1 变更申请人/Applicant of Change
●提出变更申请Raise the change application
●提供变更申请和变更实施所需的支持性材料
Provide supporting materials for application and implementation of change.
●拟定变更的实施日期Propose the implementation date
●参加与所提交变更相关的评估会议
Participate in the assessment meeting regarding the change
●编写风险评估报告（如需要）Generate a risk assessment report if required
●制定变更实施计划，跟踪变更进度
Establish the change implementation plan, track change schedule
3.2 生产车间/Workshop
●评估变更对产品质量的影响Evaluate the impact on product quality
●评估变更对本部门GMP文件的影响
Evaluate the impact on the associated department’s GMP documentation
3.3 国际部/International Dept.
a) 评估对国外客户的影响Evaluate the impact on foreign customers
b) 评估对国外注册资料的影响Evaluate the impact on the foreign registration
file
3.4 物流部/Logistics Department
●评估对物料/产品存储、发运的影响
Evaluate the impact on storage and distribution of Material/product
●评估变更对本部门GMP文件的影响
Evaluate the impact on the associated department’s GMP documentation
3.5 研发中心/Research& Development Center
●评估对注册资料的影响Evaluate the impact on the registration file
●执行注册补充申请工作（如需要）
Prepare and submit the supplementary registration document to the competent authority where applicable
3.6 公共支持部/Utilities Support
●评估对变更设备运营和维护保养的影响
Evaluate the impact on the operation and maintenance of equipment to be changed
●评估变更对本部门GMP文件的影响
Evaluate the impact on the associated department’s GMP documentation
3.7 销售中心、销售部/Sales Center& Sales Dept.
评估包装变更带来的市场影响性
Evaluate the impact on the market caused by the change of packaging material or label
3.8 安全环保部/EHS Department
评估安全隐患和废弃物带来的环境污染的影响性
Evaluate the potential safety risk and impact on the environment caused by wastage resulting from change
3.9 生产运营部/Production Department
评估对产品的工艺规程和生产计划的影响
Evaluate the impact of the change on the process instruction and production plan
3.10 质量控制部/Quality Control
●评估变更后的检验方法、质量标准的适用性
Evaluate the suitability of analytical test methods and specification if the change is implemented
●评估是否需要附加的试验
Evaluate whether need additional experiment or not
3.11 质量管理部/Quality Management
●发放变更编号Issue an official number for the change