验证的组织和实施.docVIP

Validation Organization and Implementation 验证的组织和实施 Distribution List: 分发清单： QA、QC、PD生产部、Lo.物控部、TD技术部、EN工程部、EQ设备部 Role 责任人 Draft 起草人 Review 审核人 Review 审核人 Review 审核人 Review 审核人 Review 审核人 Review 审核人 Approve 批准人 Dept. 部门 QA QC PD Lo. TD EN EQ QD Name 姓名 Signature 签名 Date 日期 1 Objective目的 Validation organization and system are introduced, and responsibilities for validation is defined in this SOP to ensure that the implementation of validation is systematize and standardized and meet the requirements of Chinese and foreign GMP. 该规程介绍了本公司的验证组织机构，规定了各部门在验证中的职责；描述了验证文件体系，以确保验证工作系统化、规范化及符合国内外GMP的要求。 2 Scope范围 This SOP applies to all validation/qualification activities relevant to cGMP: 该程序适用于本公司工厂 GMP 相关的验证活动： Premise and Equipments 厂房和设施 Utilities system公用系统 Equipment Qualification 设备验证 Analytical Method Validation 检验方法验证 Process and Packaging 工艺与包装 Cleaning Validation 清洁验证 Related Computerized Systems Validation 相关的计算机系统验证 3 Responsibilities 职责 3.1 QA is responsible for drafting, revising, training, implementing and supervising this SOP. QA负责本规程的起草、修订、培训、执行及监督。 3.2 This SOP should be reviewed by the heads of relevant departments and approved by Quality Director. 相关部门负责人审核本规程 ，质量总监负责批准本规程。 3.3 This SOP should be correctly understood and carried out by all the relevant personnel of all departments. 所有部门相关人员应充分理解本规程，并按此执行。 4 Definition 定义 4.Change － any planned change against approved protocol that may affect validation or qualification purpose. 变更－任何与已批准的验证方案不一致的有计划的改变，这些改变可能会影响最初的验证目标。 4.Re-qualification: the qualification on a production process, a system, a equipment or a kind of starting material which has already been qualified, and the re-qualification is carried out at certain time period after putting use, aim to prove that there is no drift to the “Qualified Status”. 再验证－指一项生产工艺、一个系统、设备或者一种原材料经过验证并在使用一个阶段后，旨在证实其“验证状态”没有发生漂移而进行的验证。 4.3 Annual validation i