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[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 ]

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