| 查看: 4277 | 回复: 63 | ||||
| 【奖励】 本帖被评价53次，作者1949stone增加金币 42 个 | ||||
| 当前只显示满足指定条件的回帖，点击这里查看本话题的所有回帖 | ||||
[资源]
GLP QUALITY AUDIT MANUAL，Third Edition
|
||||
 GLP QUALITY AUDIT MANUAL，Third Edition Introduction Acknowledgments How to Use This Manual Section I—Good Laboratory Practices 1. Development of Regulations and Guidelines A. International Development B. United States Development 2. The Quality Assurance Unit A. Personnel B. Responsibilities C. Standard Operating Procedures D. Training E. GLP Audit Checklists 3. Quality Inspections and Audits A. Assuring Integrity B. Initiation Phase C. In-Process Phase D. Completion Phase E. Reporting Phase F. Statistical Auditing G. Computer Applications 4. Contract Laboratory Audits A. Preplacement Evaluation B. Evaluation of the QAU C. Study Audit 5. System Audits A. Effectiveness B. Scheduling Convenience C. Preparing D. Conducting E. Reporting 6. Internet Resources A. Organizations B. Internet Terms 7. Contributions to GLP Understanding A. FDA Management Briefing and Inquiry Publications B. Preambles to the GLP C. Freedom of Information D. Compliance Program Guidance Manual—Good Laboratory Practice © 2000 by CRC Press LLC Glossary References Section II—Quality Audit Checklists 1. GLP Audit Checklist—Complete 2. Abbreviated GLP Audit Checklists A. Preplacement and Maintenance B. Initiation Phase C. In-Process Phase D. Completion Phase E. Reporting Phase Section III—Document/Report Examples 1. Quality Assurance Documents Master Schedule Study Inspection Record—Version 1 Study Inspection Record—Version 2 Inspection Report Quality Assurance Unit Statement 2. Inspection Report Examples Inspection Report—Initiation Phase Inspection Report—In-Process Phase Inspection Report—Completion Phase Inspection Report—Reporting Phase Audit Report Audit Report (Contract Laboratory) Section IV—References/Regulatory Texts INTRODUCTION As we enter the 21st century and the new millennium, our experience in the Good Laboratory Practice regulations and principles has extended over more than twenty years. Initially implemented reluctantly by many, these rules are now overwhelmingly accepted by the worldwide community. They have through the years given excellent direction to developing a consistent and efficient pathway for assuring the quality and integrity of research data. This mandate has provided the multinational approving authorities a high degree of confidence in the decisions they must provide regarding the scientific research data that sponsors have submitted. This inherent system of providing “perpetual” data certification has also reduced the need for replicating studies, resulting in extensive research cost reductions and the saving of animal lives. Additionally, and perhaps most importantly, this confirmation of data quality and integrity has expedited the accessibility by consumers of deserving products, potentially benefiting and saving lives of the ultimate users—all of us. Beginning in the last years of the 20th century, we also have been assisted by the ability to rapidly access information from around the world via the Internet. No longer is it necessary to wait weeks for a mailed response from a colleague overseas or days for a voluminous regulatory document to be shipped. Now these can be immediately accessed, reviewed, and downloaded, and printed instantaneously over the Internet. This convenience is a major change that will enhance the timeline of research, and, within the quality assurance functions, will provide immeasurable improvements in inspections, auditing, archiving, and administration. The future looks bright. Milton Anderson June 2000[ Last edited by 1949stone on 2014-1-3 at 12:26 ] |
回复此楼» 本帖附件资源列表
-
欢迎监督和反馈：小木虫仅提供交流平台，不对该内容负责。
本内容由用户自主发布，如果其内容涉及到知识产权问题，其责任在于用户本人，如对版权有异议，请联系邮箱：xiaomuchong@tal.com - 附件 1 : GLP_QUALITY_AUDIT_MANUAL.pdf
2013-12-11 08:12:18, 10.25 M
» 收录本帖的淘帖专辑推荐
 科技 | 生物医药技术 |
» 猜你喜欢
WoS一区Frontiers in Genome Editing基因编辑方法与应用方向专题邀稿（影响因子4.9）
已经有0人回复
-
WoS一区Frontiers in Genome Editing基因编辑方法与应用方向专题邀稿（影响因子4.9）
已经有0人回复
-
药物学论文润色/翻译怎么收费?
已经有186人回复
-
WoS一区Frontiers in Genome Editing基因编辑方法与应用方向专题邀稿（影响因子4.9）
已经有0人回复
-
求购时间长一些的硝酸钍
已经有0人回复
-
生防菌的盆栽防效实验
已经有1人回复
-
请教大佬扩散问题
已经有5人回复
-
跪求一支AAV293细胞
已经有1人回复
-
中文投稿“肿瘤免疫”相关
已经有6人回复
-
2025年药学专业求调剂
已经有1人回复
-
292药学调剂
已经有1人回复
46楼2016-07-18 11:02:31
14楼2013-12-14 09:22:35
简单回复
iamzane2楼
2013-12-11 08:59
回复
五星好评 顶一下，感谢分享！
蔚蓝的爱恋3楼
2013-12-11 09:36
回复
五星好评 顶一下，感谢分享！
黄药师10264楼
2013-12-11 10:20
回复
五星好评 顶一下，感谢分享！
2013-12-11 14:52
回复
五星好评 顶一下，感谢分享！
2013-12-11 22:46
回复
五星好评 顶一下，感谢分享！
2013-12-12 07:21
回复
五星好评 顶一下，感谢分享！
2013-12-12 08:43
回复
五星好评 顶一下，感谢分享！
wgx11289楼
2013-12-12 11:20
回复
五星好评 顶一下，感谢分享！
work03710楼
2013-12-12 16:14
回复
五星好评 顶一下，感谢分享！
ld037111楼
2013-12-12 18:33
回复
五星好评 顶一下，感谢分享！
mzj1988110112楼
2013-12-13 11:34
回复
五星好评 顶一下，感谢分享！
sjshvdc13楼
2013-12-13 14:17
回复
五星好评 顶一下，感谢分享！
