变化管理规程 Procedures of Change Management
文件编号：JTYC/ZL?FJ15-001-2 Serial No. of Document: JTYC/ZL?FJ15-001-2
新 订：√ Updated: √
替代：TYC/ZL?FJ15-001-1Replaced by: TYC/ZL?FJ15-001-1
生效日期： Effective date： 年 月 日 year month day
复印份数： Copy numbers：
颁发部门：地点1、2、5、6、 Department of delivery: site 1, 2, 5 and 6.
起草人/日期： Draftsman/date：
审核人/日期： Assessor/date：
批准人/日期： Ratifier/date：
1．
目的：生产过程中的各种变化都会对药品生产质量产生影响，为使变化得到有效控制，建立一个变化控制的管理规程，从而保证产品质量。 Objective: All changes taking place during the production could have impact on the quality of medicine production, and to get these changes under efficient control, management procedures of the change control should be set up to ensure the product’s quality.
2．
范围：生产过程中的各种变化。 Scope: All changes during production.
3．
职责；公司质量经理、科技质量部、各地点主管厂长本规程的实施负责。 Responsibility: The quality manager in the company, the department of technology and quality, and heads of different sites should be responsible for the implementation of the procedures.
4．
内容 Task
4.1
影响产品质量变化的分类。 Classification of changes having impact on product’s quality
分 类 Classification
变化对象 Object of change
生产场所 Production site
其它区域、同一区域内或临近区域内的其它建筑 Other buildings in other areas, the same areas or neighboring areas
质量标准（制剂） Quality standard (preparation)
质量标准内容 Content of quality standard
原料、辅料 Raw materials and accessories
生产厂商、等级、生产方法、生产设备 Manufacturer, grade, method of production and production equipment
批号规模 Scale of batch number
扩大规模，缩小规模 To extend the scale; to shrink the scale
生产设备/仪器/保管设备 Production equipment/devices/equipment keeping
新机能?新功能设备、设备改善、设备更新、零件更换 equipment with new functions, equipment improvement, equipment update and change of parts华译网北京翻译公司翻译过大量有关变化管理规程文件的文件资料,Beijing Chinese Translation Service Company has translated many technical documents Procedures of Change Management
生产的辅助系统 Supplementary system in production
（生产用水） (Production-used water)
(空调系统) (Air-conditioning system)
生产方法 Method of production
工程参数、触媒?溶媒（原药）程序 Engineering parameters; procedures of accelerants and solvents (original medicine)
试验方法 Method of experiment
试验方法、试验机器Method of experiment and machine for experiment
包装 Package
保管容器，包装形态 Container for safekeeping and form of package
清洗 Cleaning
清洗方法，清洗剂 Method of cleansing and cleaning agent
生产操作人员，检验操作人员 Production operator and testing operator
4.2
公司控制变化项目及方法： The company should control the projects and methods for changes:
4.2.1
生产场所、质量标准（制剂）变化由公司批准后执行。 Changes in production sites and quality standard (formulation) should be implemented after the approval of the company.
4.2.2
生产场所、质量标准变化由公司或各地点主管厂长填写“变化申请审核书”，上报科技质量部，科技质量部作出是否变化的评估，报公司主管经理批准。 As for changes in production site and quality standard, the company or heads of different sites should fill in the “Application for Approval of change” and submit it to the department of technology and quality; then the department should make an evaluation on whether the changes should be made and report it to the related manager in the company for approval. 批准的变化监控报告发放给每个单位并记录。 The approved change monitoring report should be delivered to each unit and recorded.
4.2.3
各生产地点依据“变化申请审核书”的决定执行变化。 Different sites should carry out the changes according to the decision on the “Application for Approval of change”
4.2.4
公司每年应对所发生的变化汇总。 The company should make summary of the changes that happen each year.
4.3
各生产地点控制变化项目及方法： Different sites should control the projects and methods for changes:
4.3.1
原料、辅料、批号规模、生产设备/保管设备、生产的辅助系统（生产用水）(空调系统)、生产方法、试验、包装、清洗、操作人员由各地点主管厂长批准后执行。 The following items should be carried out with the approval of heads of different sites: raw materials, accessories, scale of batch number, production equipment/keeping equipment, supplementary system of production (production-used water and air-conditioning system), method of production, and operators of experiment, package, and cleansing.
4.3.2
各地点必须建立变化管理规程，变化控制程序应确保产生足够的支持性数据来说明变化后可生产出预期质量的药品。 Different sites should have procedures of change management established, and the process of change control should guarantee the production of adequate supportive data to prove that medicine with expected quality could be produced after the changes. 变化的执行要依据管理规程执行。 The implementation of changes should be made according to the management procedures.
4.3.3
按时间做好变化的汇总工作。 Summary should be made on the changes according to their timings.
