包装批记录的签发跟流转.docx

GLAXOSMITHKLINE BIOLOGICALS (SHANGHAI) LTD 上海葛兰素史克生物制品有限公司 Doc. No.: VS001 编号： STANDARD OPERATION PROCEDURE 标准操作程序 Version No.: 9.0 版本号 包装批记录的签发与流转 Batch Record issuing and circulation Superseded Date: 30/10/2010 替代版本日期 Page PAGE 1 of 9 页数 Effective Date: 生效日期 SOP in use 该流程的执行人 The following person is accountable for the process implementation and output 价值流经理 Value Stream Manager Any printed copy of this document is non-controlled unless it has the blue QA Controlled stamp Last saved保存时间 SAVEDATE \@ DD/MM/yyyy h:mm am/pm 30/01/2011 4:32 PM 总页数:11页(9页＋2个附件:2页) Total pages: 11pages (9pages + 2appendicx : 2pages) 目录 TABLE OF CONTENTS: TOC \o 1-2 \h \z \u HYPERLINK \l _Toc283916863 1. 目的 OBJECTIVE PAGEREF _Toc283916863 \h 2 HYPERLINK \l _Toc283916864 2. 范围 SCOPE PAGEREF _Toc283916864 \h 2 HYPERLINK \l _Toc283916865 3. 职责 RESPONSIBILITIES PAGEREF _Toc283916865 \h 2 HYPERLINK \l _Toc283916866 4. 步骤 PROCEDURE PAGEREF _Toc283916866 \h 3 HYPERLINK \l _Toc283916867 4.0 流程图 Flowchart PAGEREF _Toc283916867 \h 3 HYPERLINK \l _Toc283916868 4.1 包装批记录的签发Batch Record issuing PAGEREF _Toc283916868 \h 4 HYPERLINK \l _Toc283916869 4.2 包装批记录的流转Batch Record circulation PAGEREF _Toc283916869 \h 6 HYPERLINK \l _Toc283916870 4.3 定期数据回顾 Periodic Process Review PAGEREF _Toc283916870 \h 8 HYPERLINK \l _Toc283916871 5. 术语 GLOSSARY PAGEREF _Toc283916871 \h 9 HYPERLINK \l _Toc283916872 6. 参考文件 REFERENCES PAGEREF _Toc283916872 \h 9 HYPERLINK \l _Toc283916873 7. 附件 APPENDIX PAGEREF _Toc283916873 \h 9 HYPERLINK \l _Toc283916874 8. 其他相关信息 RELATED FORMS AND TRAINING MATERIAL PAGEREF _Toc283916874 \h 9 HYPERLINK \l _Toc283916875 8.1 表格 Forms PAGEREF _Toc283916875 \h 9 HYPERLINK \l _Toc283916876 8.2 培训资料Training Material PAGEREF _Toc283916876 \h 9 GLAXOSMITHKLINE BIOLOGICALS (SHANGHAI) LTD上海葛兰素史克生物制品有限公司 Doc. No.: VS001 编号： Version No.: 9.0 版本号 Page PAGE 3 of 9 页数 Effective Date: 生效日期 目的 OBJECTIVE 描述开始生产操作前，包装批记录签发给生产部门的流程 To describe t