 |
 |
 |
 |
 |
 |
||
 |
 |
 |
 |
 |
| 查看: 3885 | 回復(fù): 63 | ||||
| 【獎勵】 本帖被評價53次，作者1949stone增加金幣 42 個 | ||||
[資源]
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 ] |
回復(fù)此樓» 本帖附件資源列表
-
歡迎監(jiān)督和反饋：小木蟲僅提供交流平臺，不對該內(nèi)容負(fù)責(zé)。
本內(nèi)容由用戶自主發(fā)布，如果其內(nèi)容涉及到知識產(chǎn)權(quán)問題，其責(zé)任在于用戶本人，如對版權(quán)有異議，請聯(lián)系郵箱：xiaomuchong@tal.com - 附件 1 : GLP_QUALITY_AUDIT_MANUAL.pdf
2013-12-11 08:12:18, 10.25 M
» 收錄本帖的淘帖專輯推薦
 科技 | 生物醫(yī)藥技術(shù) |
» 猜你喜歡
章慧等編著的《配位化學(xué)：原理與應(yīng)用》
已經(jīng)有1人回復(fù)
-
求助�。�！大佬救命�。。�
已經(jīng)有4人回復(fù)
-
藥理學(xué)論文潤色/翻譯怎么收費(fèi)?
已經(jīng)有197人回復(fù)
-
酰胺縮合
已經(jīng)有3人回復(fù)
-
藥學(xué)專碩調(diào)劑
已經(jīng)有2人回復(fù)
-
藥學(xué)學(xué)碩326求調(diào)劑
已經(jīng)有1人回復(fù)
-
105500藥學(xué)調(diào)劑，一志愿頂9，主持省級大創(chuàng)，實(shí)驗(yàn)型SCI二作，四六級已過，雙國獎
已經(jīng)有6人回復(fù)
-
藥學(xué)專碩調(diào)劑
已經(jīng)有0人回復(fù)
-
publcif的使用
已經(jīng)有0人回復(fù)
-
求調(diào)劑
已經(jīng)有2人回復(fù)
-
會計(jì)專碩求調(diào)劑
已經(jīng)有0人回復(fù)
14樓2013-12-14 09:22:35
26樓2015-01-09 13:03:06
36樓2015-10-12 21:21:12
46樓2016-07-18 11:02:31
簡單回復(fù)
iamzane2樓
2013-12-11 08:59
回復(fù)
五星好評 頂一下，感謝分享！
2013-12-11 09:36
回復(fù)
五星好評 頂一下，感謝分享！
黃藥師10264樓
2013-12-11 10:20
回復(fù)
五星好評 頂一下，感謝分享！
2013-12-11 14:52
回復(fù)
五星好評 頂一下，感謝分享！
2013-12-11 22:46
回復(fù)
五星好評 頂一下，感謝分享！
2013-12-12 07:21
回復(fù)
五星好評 頂一下，感謝分享！
2013-12-12 08:43
回復(fù)
五星好評 頂一下，感謝分享！
wgx11289樓
2013-12-12 11:20
回復(fù)
五星好評 頂一下，感謝分享！
work03710樓
2013-12-12 16:14
回復(fù)
五星好評 頂一下，感謝分享！
ld037111樓
2013-12-12 18:33
回復(fù)
五星好評 頂一下，感謝分享！
mzj1988110112樓
2013-12-13 11:34
回復(fù)
五星好評 頂一下，感謝分享！
sjshvdc13樓
2013-12-13 14:17
回復(fù)
五星好評 頂一下，感謝分享！
qxie15樓
2013-12-17 09:59
回復(fù)
五星好評 頂一下，感謝分享！
ykyang16樓
2013-12-17 10:47
回復(fù)
五星好評 頂一下，感謝分享！
younx17樓
2013-12-17 10:50
回復(fù)
五星好評 頂一下，感謝分享！
zfyzfy07070718樓
2013-12-19 09:38
回復(fù)
五星好評 頂一下，感謝分享！
huancgan19樓
2014-05-30 16:10
回復(fù)
五星好評 頂一下，感謝分享！
gaojcon20樓
2014-07-17 23:57
回復(fù)
五星好評 頂一下，感謝分享！
lovelydong21樓
2014-12-03 16:43
回復(fù)
五星好評 頂一下，感謝分享！
huliyong22樓
2014-12-03 20:45
回復(fù)
五星好評 頂一下，感謝分享！
lovelydong23樓
2014-12-06 22:01
回復(fù)
頂一下，感謝分享！
Bookaholic24樓
2014-12-11 11:48
回復(fù)
五星好評 頂一下，感謝分享！
白樺1984061625樓
2014-12-11 13:43
回復(fù)
五星好評 頂一下，感謝分享！
yyangpp27樓
2015-02-12 22:01
回復(fù)
五星好評 頂一下，感謝分享！
zhanghuaying28樓
2015-03-07 22:11
回復(fù)
五星好評 頂一下，感謝分享！
happy4me29樓
2015-07-17 23:11
回復(fù)
五星好評 頂一下，感謝分享！
zhou0430樓
2015-07-26 06:12
回復(fù)
三星好評 頂一下，感謝分享！
pumcnsy31樓
2015-07-28 07:53
回復(fù)
五星好評 頂一下，感謝分享！
yyangpp32樓
2015-07-31 22:04
回復(fù)
頂一下，感謝分享！
ienjoysun33樓
2015-08-01 12:43
回復(fù)
三星好評 頂一下，感謝分享！
bluesky999934樓
2015-09-19 20:54
回復(fù)
五星好評 頂一下，感謝分享！
xuxiao6435樓
2015-09-20 10:00
回復(fù)
五星好評 頂一下，感謝分享！
juwairen37樓
2015-10-12 21:23
回復(fù)
頂一下，感謝分享！
haofeng080438樓
2015-10-13 11:32
回復(fù)
五星好評 頂一下，感謝分享！
yicaoting39樓
2016-01-28 21:08
回復(fù)
五星好評 頂一下，感謝分享！
常倪40樓
2016-02-19 11:36
回復(fù)
五星好評 頂一下，感謝分享！
pumcnsy41樓
2016-04-11 08:24
回復(fù)
頂一下，感謝分享！
ienjoysun42樓
2016-04-11 18:22
回復(fù)
頂一下，感謝分享！
summers198543樓
2016-04-11 18:27
回復(fù)
五星好評 頂一下，感謝分享！
qiute62144樓
2016-04-11 20:08
回復(fù)
五星好評 頂一下，感謝分享！
cpu084511745樓
2016-07-17 22:42
回復(fù)
五星好評 頂一下，感謝分享！
quaicun47樓
2016-07-18 13:55
回復(fù)
五星好評 頂一下，感謝分享！
cpu084511748樓
2016-07-23 22:39
回復(fù)
頂一下，感謝分享！
magic012a49樓
2017-05-04 10:25
回復(fù)
五星好評 頂一下，感謝分享！
Jindongzhang50樓
2017-05-04 16:53
回復(fù)
頂一下，感謝分享！
相關(guān)版塊跳轉(zhuǎn)
我要訂閱樓主 1949stone 的主題更新
| 最具人氣熱帖推薦 [查看全部] | 作者 | 回/看 | 最后發(fā)表 | |
|---|---|---|---|---|
|
[考研] 0856求調(diào)劑 +3 | 劉夢微 2026-03-15 | 3/150 |
|
|---|---|---|---|---|
|
|
[考研] 材料工程327求調(diào)劑 +3 | xiaohe12w 2026-03-11 | 3/150 |
|
|
|
[考研] 復(fù)試調(diào)劑 +3 | 呼呼？~+123456 2026-03-14 | 3/150 |
|
|
|
[考研] 復(fù)試調(diào)劑 +4 | z1z2z3879 2026-03-14 | 5/250 |
|
|
[考研] 290求調(diào)劑 +4 | @將就將就看 2026-03-10 | 8/400 |
|
|
|
[考研] 331求調(diào)劑（0703有機(jī)化學(xué) +5 | ZY-05 2026-03-13 | 6/300 |
|
|
|
[基金申請]
有必要更換申報(bào)口嗎
 20+3
|
fannyamoy 2026-03-11 | 3/150 |
|
|
|
[考研] 調(diào)劑 +3 | 13853210211 2026-03-10 | 3/150 |
|
|
|
[考研] 一志愿湖師大化學(xué)289求調(diào)劑 +6 | XMCMM3.14159 2026-03-10 | 6/300 |
|
|
|
[考研] 材料371求調(diào)劑 +9 | 鱷魚? 2026-03-11 | 11/550 |
|
|
|
[考研] ［0860］321分求調(diào)劑，ab區(qū)皆可 +4 | 寶貴熱 2026-03-13 | 4/200 |
|
|
|
[考研] 315求調(diào)劑 +9 | 小羊小羊_ 2026-03-11 | 10/500 |
|
|
|
[考研] 求b區(qū)學(xué)校調(diào)劑 +3 | 周56 2026-03-11 | 3/150 |
|
|
|
[考研] 302求調(diào)劑 +6 | 負(fù)心者當(dāng)誅 2026-03-11 | 6/300 |
|
|
|
[考研] 求調(diào)劑 +3 | 程雨杭 2026-03-12 | 3/150 |
|
|
|
[考研] 土木第一志愿276求調(diào)劑，科研和技能十分豐富，求新興方向的導(dǎo)師收留 +3 | 土木小天才 2026-03-12 | 3/150 |
|
|
|
[考研] 274求調(diào)劑0856材料化工 +12 | z2839474511 2026-03-11 | 13/650 |
|
|
|
[考研] 求調(diào)劑 資源與環(huán)境 285 +3 | 未名考生 2026-03-10 | 3/150 |
|
|
|
[考研] 283求調(diào)劑，材料、化工皆可 +8 | 蘇打水7777 2026-03-11 | 10/500 |
|
|
|
[考研] 290求調(diào)劑 +3 | 柯淮然 2026-03-10 | 8/400 |
|