GLP Quality Audit Manual, Third Edition

✍ Scribed by Milton A. Anderson

• Publisher: Informa Healthcare
• Year: 2000
• Tongue: English
• Leaves: 405
• Edition: 3 Lslf
• Category: Library

✦ Synopsis

Designed to enable readers to plan and execute their own audits, this comprehensive guide presents discussions of and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section Ill comprises the full texts of the relevant standards and regulations along with the Priniciples of Good Laboratory Practice.

✦ Table of Contents

Cover......Page 1
GLP QUALITY AUDIT MANUAL Third Edition......Page 5
CONTENTS......Page 7
INTRODUCTION......Page 9
ACKNOWLEDGMENTS......Page 10
HOW TO USE THIS MANUAL......Page 11
SECTION I: GOOD LABORATORY PRACTICES......Page 13
A. International Development......Page 14
B. United States Development......Page 16
Observations......Page 17
Conclusions......Page 18
A. Personnel......Page 20
B. Responsibilities......Page 21
C. Standard Operating Procedures......Page 26
D. Training......Page 28
E. GLP Audit Checklists......Page 31
A. Assuring Integrity......Page 34
B. Initiation Phase......Page 36
C. In-Process Phase......Page 38
D. Completion Phase......Page 39
E. Reporting Phase......Page 40
F. Statistical Auditing......Page 42
G. Computer Applications......Page 44
A. Preplacement Evaluation......Page 49
B. Evaluation of the QAU......Page 52
C. Study Audit......Page 54
A. Effectiveness......Page 56
C. Preparing......Page 57
D. Conducting......Page 59
E. Reporting......Page 60
A. Organizations......Page 62
B. Internet Terms......Page 67
A. FDA Management Briefing and Inquiry Publications......Page 77
B. Preambles to the GLP......Page 78
C. Freedom of Information......Page 81
D. Compliance Program Guidance Manual-Good Laboratory Practice......Page 82
Control Article-b......Page 86
Person-a......Page 87
Raw Data-c......Page 88
Study Completion Date-c......Page 89
Test Facility-c......Page 90
Test Substance or Mixture-e......Page 91
Verification......Page 92
REFERENCES......Page 93
SECTION II: QUALITY AUDIT CHECKLISTS......Page 95
CHAPTER 1: GLP AUDIT CHECKLIST-COMPLETE......Page 96
PREPLACEMENT AND MAINTENANCE ABBREVIATED GLP AUDIT CHECKLIST......Page 126
INITIATION PHASE ABBREVIATED GLP AUDIT CHECKLIST......Page 144
IN–PROCESS PHASE ABBREVIATED GLP AUDIT CHECKLIST......Page 154
COMPLETION PHASE ABBREVIATED GLP AUDIT CHECKLIST......Page 167
REPORTING PHASE ABBREVIATED GLP AUDIT CHECKLIST......Page 176
SECTION III: DOCUMENT / REPORT EXAMPLES......Page 194
CHAPTER 1: QUALITY ASSURANCE DOCUMENTS......Page 195
MASTER SCHEDULE......Page 196
STUDY INSPECTION RECORD - Version 1......Page 197
STUDY INSPECTION RECORD - Version 2......Page 198
INSPECTION REPORT......Page 199
QUALITY ASSURANCE UNIT STATEMENT......Page 200
CHAPTER 2: INSPECTION REPORT EXAMPLES......Page 201
INSPECTION REPORT - Initiation Phase......Page 202
INSPECTION REPORT - In-Process Phase......Page 203
INSPECTION REPORT - Completion Phase......Page 204
INSPECTION REPORT - Reporting Phase......Page 205
AUDIT REPORT......Page 206
AUDIT REPORT (Contract Laboratory)......Page 207
SECTION IV: REFERENCES/REGULATORY TEXTS......Page 208
CHAPTER 1: Federal Register, Friday, December 22, 1978: U.S. Food and Drug Administration, Nonclinical Laboratory Studies, Good Laboratory Practice Regulations, Code of Federal Regulations, Title 21, Part 58, Effective June 20, 1979......Page 209
CHAPTER 2: Federal Register, Friday, September 4, 1987: U.S. Food and Drug Administration, Nonclinical Laboratory Studies, Good Laboratory Practice Regulations, Code of Federal Regulations, Title 21, Part 58, Effective October 5, 1987......Page 245
CHAPTER 3: The OECD Principles of Good Laboratory Practice and Compliance Monitoring, Number 1, Revised 1997......Page 261
CHAPTER 4: Guidance for Industry, Good Laboratory Practice Regulations Management Briefings, Post Conference Report, August 1979, Revised November 1998......Page 280
CHAPTER 5: Good Laboratory Practice Regulations, Question and Answers, Bioresearch Monitoring Staff, FDA, 1981......Page 327
CHAPTER 6: Compliance Program Guidance Manual, FDA, Program 7348.808, Revised 1998......Page 355
CHAPTER 7: Code of Federal Regulations, FDA. Part 58—Good Laboratory Practice for Nonclinical Laboratory Studies, Revised as of April 1, 2000......Page 388