成品混合验证方案.docVIP

XXXXXX—成品(XX)混合验证方案 同步验证ConcurrentvalidationBlending validation protocol for XXXXXX 同步验证 Concurrentvalidation 方案编号/File no.: XX-VP 04 版本/修订号 version/ revision no.: A/0 本次验证性质： Validation nature : 职责 Responsibility 部门/职务 Department/position 名字 Name 签字/日期 Signature/date 起草 Drafted by 车间主任 Workshop director 质管部QA QA dept. 审核 Checked by QC经理 QC Manager QA经理 QA Manager 生产负责人 Production director 批准 Approved by 质量负责人 Quality director XXXX有限公司 XXX CO.,LTD?2015年10月 Oct, 2015 XXXXXX—成品(XX)混合验证方案 Blending validation protocol for XXXXXX 目录 Contents TOC \o 1-5 \h \z HYPERLINK \l bookmark6 \o Current Document \h 0 简介Summary 1 HYPERLINK \l bookmark8 \o Current Document \h 2.0 验证的方法和 目 的 Validation method and purpose 1 HYPERLINK \l bookmark10 \o Current Document \h 3.0 验证范围 Validation scope 1 4.0 验证小组主要人员及其职责 Main personnel and corresponding responsibility 1 HYPERLINK \l bookmark12 \o Current Document \h 5.0 验证相关文件 Validation relevant documents 1 6.0 验证过稈控制稈序 Validation process control program 2 》昆合前物米斗准备 Materials preparation before blending 2 混合方法 Blending method 2 混合过程取样方法 Sampling method of blending process 2 样品检测项目及结果汇总 Testing items and results summary 3 混合后混批样品检测标准 Testing method of samples after blending 3 XX 三批混批质量统计表 Quality statistics of three blending batches for XX 4 7.0 验证可接受标准 Acceptance criterion of validation 4 HYPERLINK \l bookmark14 \o Current Document \h 0 偏差报告 Deviation report 4 HYPERLINK \l bookmark16 \o Current Document \h 9.0 验证失败的处理 Handling of validation failure 4 HYPERLINK \l bookmark18 \o Current Document \h 10.0 验证产品的处理 Handling of validation products 4 HYPERLINK \l bookmark20 \o Current Document \h 0 再验证周 期 Period of re-validation 4 HYPERLINK \l bookmark22 \o Current Document \h 12.0 验证结论 Validation conclusion 5 验证结果的汇总分析 Summary and anylysis of validation result 5 验证结果评价 Evaluation of validation result 5 验证报告的审批 Approval of validation result 5 附件一/Annex 1: XX 混合验证取样点图 Chart for sampling points of XX blending validation 6 附件二/Annex 2:验证方案修