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| 谈2010版药品GMP认证企业的档案管理 | |
| 引用本文： | 王爽. 谈2010版药品GMP认证企业的档案管理[J]. 中国药事, 2012, 26(9): 1014-1016 |
| 作者姓名： | 王爽 |
| 作者单位： | 天津生物化学制药有限公司,天津,300308 |
| 摘 要： | 目的 做好GMP认证档案的管理工作.方法 查阅相关文献,分析GMP认证档案的特点.结果 企业应明确GMP认证档案的归档范围,划分保管期限,做好收集、整理、利用等档案业务工作.结论 切实做好GMP认证档案的管理,可为下次认证工作的顺利进行打好基础. |
| 关 键 词： | 药品GMP认证 档案管理 归档范围 保管期限 |
Discussion on the 2010 Edition of Drug GMP Certification Enterprise File Management |
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| Wang Shuang. Discussion on the 2010 Edition of Drug GMP Certification Enterprise File Management[J]. Chinese Pharmaceutical Affairs, 2012, 26(9): 1014-1016 | |
| Authors: | Wang Shuang |
| Affiliation: | Wang Shuang (Tianjin Biochem Pharmaceutical Co. , Ltd. , Tianjin 300308) |
| Abstract: | Objective To promote high-quality GMP certification file management. Methods GMP certification files＇ characteristics were analyzed by reviewing related literature. Results The reviewing found that enterprises should make clear of the GMP certification file scopes, divide custody periods, and do a good job of collection, collation, and utilization of the archiving work. Conclusion A good management of archiving for GMP certification files was the foundation of next certification. |
| Keywords: | drug GMP certification file management file scope storage period |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |