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精品PPT | GXP不等于GLP、GCP或GMP,及差异比对

  • 2026-05-25 12:52:40
精品PPT | GXP不等于GLP、GCP或GMP,及差异比对

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原创：

  1. QA对试验方案的审核能不能在方案批准后？

  2. 原创：药物安全性评价GLP规范与SOP的关系及完善质量体系初探

  3. 2022年8月最新的FDA GLP警告信

  4. GLP规范与SOP的关系以及如何完善质量体系

  5. 翻译版 | MHRA对GLP/GCP相关问题的解答

  6. CFDI核查中心回复问题：拍照留存后，纸质记录还留不留？

  7. GLP vs GMP vs GCP的差异

  8. QA应具备什么样的资质能力？以及如果档案归QA管理该怎么处理？

  9. 什么叫专人负责？

  10. QAU的检查报告能提供给外方吗？

  11. GLP试验记录的受控要求和形式：散页 V.S 记录本

  12. 疫情期间仪器设备的校验和维护

  13. 疫情期间如何居家批准文件-MHRA指南

  14. 疫情期间（GxP）实验室仪器设备维护校准指南

  15. 可开展国际GLP认证的OECD成员国

  16. 已归档的试验记录还能修改吗？

  17. 试验记录中能否通过勾选代替具体数据录入

  18. 概念：GLP中主要研究者PI与贡献科学家CS的区别

  19. 知·识 | 短期试验/ Short-term Study

  20. 旧文新发 | GLP问题的解答-仪器设备检定校准

  21. 旧文新发 I 思考：什么样的人适合做GLP

  22. 释疑 | 为什么其他部门跟QA容易有摩擦

  23. QA实用指南-7 QA声明

  24. QA实用指南-8 GLP法规外QA工作的附加值

  25. QA实用指南-9 QA记录的管理及培训

  26. QA实用指南-10 多场所研究的实施及QA的作用

  27. OECD GLP规范英文单词词频

  28. FDA GLP规范英文单词词频统计

  29. GLP试验能否转为非GLP试验来终止？

  30. A级容量瓶不需要校准？

  31. GXP体系中，已作废的SOP还能重新起用吗？

  32. 浅谈GLP机构的断电

  33. 非常规的工作，需要建立SOP吗？

  34. QA的检查计划需要发给SD吗？

  35. 试验资料必须由SD去归档吗？

  36. 试验人员这样做可以减少错误

  37. 多场所试验中的人员职责和注意事项

  38. 如果委托方的实验室作为合同实验室？

  39. 谁来对试验数据的质量负责？

  40. 浅谈SD的核心体现和难处

  41. 浅谈主计划表的作用

  42. 浅谈QA工作的价值

  43. 浅谈GLP中的冲突

  44. 浅说归档的重要性和目的

  45. 可以扫描后销毁原始记录吗？

  46. 试验机构哪些变动需要上报监管机构

  47. 最终报告变更和变更最终报告

  48. 一文讲清变更与偏离

  49. 临时工也能做GLP试验?

  50. GLP培训的目的是什么

  51. GLP和非GLP试验的区别

  52. 如果不任命PI，SD如何在分场所工作？

  53. 多场所试验中一定要有主要研究者PI吗？

  54. 主场所就要承担大部分试验？

  55. 浅谈档案室的灭火器

  56. 浅谈多场所试验中SD和PI的关系

  57. SD/PI如何监督试验

  58. 检查发现的分类等级

  59. 如何预防和减少SOP偏离

  60. GLP意识是什么

  61. 小型试验机构中GLP职责的划分

  62. GLP中常见错误类型

  63. Office办公软件常用技巧

  64. 什么人适合做GLP

  65. 关于试验记录的常见问题

  66. 谁来检查、如何检查QAU的工作

  67. GLP问题的解答-4：标本和样品的概念差异分析

  68. GLP问题的问答-1

……（更多内容可在公众号界面查看或检索）

分享：

  1. 免费获取 | GLP相关书籍和规范

  2. 精品 | FDA GLP规范中文翻译-双语版-21CFR 58 非临床实验室研究的良好实验室规范

  3. 农药登记试验单位及试验范围清单-农业农村部2022年6月发布

  4. 分享 | 实验动物管理及IACUC相关指南书籍

  5. 重要发布| 关于药物非临床研究质量管理规范认证申请和检查相关问题的解答

  6. 最新药物NMPA GLP机构名单-截至2021年3月14日

  7. 你计算用的Excel如何验证？-重要信息

  8. 你计算用的Excel表格需要验证吗？

  9. GLP-NMPA药物非临床研究相关问答

  10. SD实用指南

……（更多内容可在公众号界面查看或检索）

本文来自网友投稿或网络内容，如有侵犯您的权益请联系我们删除，联系邮箱：wyl860211@qq.com 。

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  1. CONNECT:[ UseTime:0.001307s ] mysql:host=127.0.0.1;port=3306;dbname=h_sjds;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.002032s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000860s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000765s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.001704s ]
  6. SELECT * FROM `set` [ RunTime:0.000650s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.001837s ]
  8. SELECT * FROM `article` WHERE `id` = 519548 LIMIT 1 [ RunTime:0.001356s ]
  9. UPDATE `article` SET `lasttime` = 1780471896 WHERE `id` = 519548 [ RunTime:0.054571s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 64 LIMIT 1 [ RunTime:0.004255s ]
  11. SELECT * FROM `article` WHERE `id` < 519548 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.016326s ]
  12. SELECT * FROM `article` WHERE `id` > 519548 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.009578s ]
  13. SELECT * FROM `article` WHERE `id` < 519548 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.011510s ]
  14. SELECT * FROM `article` WHERE `id` < 519548 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.091300s ]
  15. SELECT * FROM `article` WHERE `id` < 519548 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.017317s ]
0.318110s