葛兰素史克质量管理体系.doc

GLAXOSMITHKLINE BIOLOGICALS (SHANGHAI) LTD 上海葛兰素史克生物制品有限公司Doc. No.: QA004 编号：STANDARD OPERATION PROCEDURE 标准操作程序Version No.: 7.0 版本号 质量管理体系 Quality Management SystemSuperseded Date: 29/04/2010 替代版本日期Page  PAGE 1 of 13 页数Effective Date: 生效日期 Any printed copy of this document is none-controlled unless it has the blue QA Controlled stamp. Last saved保存时间 SAVEDATE \@ DD/MM/yyyy h:mm am/pm 24/10/2011 11:34 下午 总页数: 15页( 13页＋2个附件: 2页) Total pages: 15 pages (13 pages + 2 appendices : 2 pages) 目录 TABLE OF CONTENTS:  TOC \o 1-2 \h \z \u  HYPERLINK \l _Toc191312317 1. 目的 OBJECTIVE  PAGEREF _Toc191312317 \h 2  HYPERLINK \l _Toc191312318 2. 范围 SCOPE  PAGEREF _Toc191312318 \h 2  HYPERLINK \l _Toc191312319 3. 职责 RESPONSIBILITIES  PAGEREF _Toc191312319 \h 2  HYPERLINK \l _Toc191312320 4. 步骤 PROCEDURE  PAGEREF _Toc191312320 \h 3  HYPERLINK \l _Toc191312321 4.0 流程图 Flowchart  PAGEREF _Toc191312321 \h 3  HYPERLINK \l _Toc191312323 4.1 质量管理体系 Quality Management System  PAGEREF _Toc191312323 \h 4  HYPERLINK \l _Toc191312324 4.2 优良药品生产管理规范 Good Manufacturing Practice  PAGEREF _Toc191312324 \h 5  HYPERLINK \l _Toc191312325 4.3 管理原则 Management Principle  PAGEREF _Toc191312325 \h 6  HYPERLINK \l _Toc191312326 5. 术语 GLOSSARY  PAGEREF _Toc191312326 \h 13  HYPERLINK \l _Toc191312327 6. 参考文件 REFERENCES  PAGEREF _Toc191312327 \h 13  HYPERLINK \l _Toc191312328 7. 附件 APPENDIX  PAGEREF _Toc191312328 \h 13  HYPERLINK \l _Toc191312329 8. 其他相关信息 RELATED FORMS AND TRAINING MATERIAL  PAGEREF _Toc191312329 \h 13  HYPERLINK \l _Toc191312330 8.1 表格 Forms  PAGEREF _Toc191312330 \h 13  HYPERLINK \l _Toc191312331 8.2 培训资料Training Material  PAGEREF _Toc191312331 \h 13  GLAXOSMITHKLINE BIOLOGICALS (SHANGHAI) LTD上海葛兰素史克生物制品有限公司Doc. No.: QA004 编号：Version No.: 7.0 版本号Page  PAGE