표제지
목차
국외 GLP 규정 4
국외 GLP 규정 목차 5
국외 GLP 규정 비교집 8
[참고] 121
(1) OECD GLP 원칙(No. 1) 원문 122
PART ONE. OECD PRINCIPLES OF GOOD LABORATORY PRACTICE(as revised in 1997) 133
SECTION Ⅰ. INTRODUCTION 135
Preface 135
1. scope 135
2. Definitions of Terms 136
2.1. Good Laboratory Practice 136
2.2. Terms Concerning the Organisation of a Test Facility 136
2.3. Terms Concerning the Non-Clinical Health and Environmental Safety Study 137
2.4. Terms Concerning the Test Item 138
SECTION Ⅱ. GOOD LABORATORY PRACTICE PRINCIPLES 139
1. Test Facility Organisation and Personnel 139
1.1. Test Facility Management's Responsibilities 139
1.2. Study Director's Responsibilties 140
1.3. Principal Investigator's Responsibilities 141
1.4. Study Personnel's Responsibilities 141
2. Quality Assurance Programme 142
2.1. General 142
2.2. Responsibilities of the Quality Assurance Personnel 142
3. Facilities 143
3.1. General 143
3.2. Test System Facilities 143
3.3. Facilities for Handling Test and Reference Items 143
3.4. Archive Facilities 144
3.5. Waste Disposal 144
4. Apparatus, Material, and Reagents 144
5. Test Systems 144
5.1. Physical/Chemical 144
5.2. Biological 144
6. Test and Reference Items 145
6.1. Receipt, Handling, Sampling and Storage 145
6.2. Characterisation 145
7. Standard Operating Procedures 146
8. Performance of the Study 147
8.1. Study Plan 147
8.2. Content of the Plan 148
8.3. Conduct of the Study 149
9. Reporting of Study Results 150
9.1. General 150
9.2. Content of the Final Report 150
10. Storage and Retention of Records and Materials 151
PART TWO : OECD COUNCIL ACTS RELATED TO GLP PRINCIPLES AND COMPLIANCE MONITORING 153
Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Cfhemicals[C(81)30(Final)] 155
Council Decision-Recommendation on the Compliance with Principles of Good Laboratory Practice[C(89)87(Final)] 157
Council Decision concerning the Adherence of Non-member Countries to the Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals[C(81)30(Final)... 161
ANNEX : PROCEDURE FOR ADHERENCE OF NON-MEMBER COUNTRIES TO THE COUNCIL ACTS RELATED TO THE MUTUAL ACCEPTANCE OF DATA IN THE ASSESSMENT OF CHEMICALS 163
(2) 다지점시험의 조직 및 운영에 대한 OECD GLP 원칙 적용(No. 13) 원문 164
INTRODUCTION 173
MANAGEMENT AND CONTROL OF MULTI-SITE STUDIES 173
QUALITY ASSURANCE 177
MASTER SCHEDULES 178
STUDY PLAN 178
PERFORMANCE OF THE STUDY 178
REPORTING OF STUDY RESULTS 179
STANDARD OPERATING PROCEDURES(SOPs) 180
STORAGE AND RETENTION OF RECORDS AND MATERIALS 181
(3) 유럽연합 비임상시험관리기준 원문 182
(4) 미국 비임상시험관리기준 원문 215
(5) 일본 의약품 비임상시험관리기준 원문 230
(6) 일본 비의료기기 비임상시험관리기준 원문 241
판권기 251