Good laboratory practice: the why and the how ; with 1 table
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Berlin [u.a.]
Springer
2005
|
| Ausgabe: | 2. ed. |
| Schlagworte: | |
| Online-Zugang: | UBR01 Volltext Inhaltstext Inhaltsverzeichnis |
| Beschreibung: | 1 Online-Ressource |
| ISBN: | 9783540253488 9783540282341 |
| DOI: | 10.1007/3-540-28234-3 |
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Datensatz im Suchindex
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|---|---|
| adam_text | Table of Contents
Preface v
Preface to the second edition vii
I. What is Good Laboratory Practice All About ? i
1. Introduction 1
2. The History of GLP 7
2.1 The Early Days and the Causative Events 7
2.2 The First Regulations w
2.3 International Ripples: The OECD Principles i
2.4 The Principles and Their Interpretation 15
2.5 Closing the Circle ? The Detection of Test Item in Control Samples 17
3. The Idea Behind GLP 19
4. The Areas of Application 25
5. The Pillars of Good Laboratory Practice 33
6. Where Can GLP be Profitably Applied ? 38
7. GLP and Other Laboratory Quality Systems 53
II. How is Good Laboratory Practice Regulated ? 59
1. Introduction 59
2. Definitions in GLP 61
2.1 Good Laboratory Practice 61
2.2 Management 62
2.3 Study Director and Principal Investigator 65
2.4 Test Facility and Test Site 69
2.5 The Study 73
1.6 Short Term Studies 78
2.7 Initiation, Starting and Completion Dates 84
X
2.8 Study Plan, Amendments and Deviations 88
2.9 Raw Data 94
2.10 The Phases of a Study 97
2.11 The Master Schedule 100
2.12 Test and Reference Item 103
2.13 Additional Definitions 103
3. Responsibilities in Good Laboratory Practice 104
3.1 Management 104
3.2 Study Director and Principal Investigator 112
3.3 Study Personnel 124
3.4 The Sponsor 126
4. The Quality Assurance Programme 131
4.1 General Considerations 133
4.2 Quality Assurance Inspections 138
4.3 Quality Assurance Inspection Reports 153
4.4 Audits of Raw Data and of Final Reports 159
4.5 The Quality Assurance Statement 163
5. Facilities 170
5.1 General Requirements 170
5.2 Test System Facilities 173
5.3 Facilities for Handling Test and Reference Items 177
5.4 Archive Facilities 180
6. Apparatus, Materials and Reagents 181
7. Computerised Systems 187
7.1 Introduction 187
7.2 Basic Considerations 192
7.3 Data considerations 195
7.4 Prospective Validation 198
7.5 Retrospective Evaluation 203
7.6 Maintenance and Change Control 206
7 7 Security 208
7.8 Levels of Complexity 210
xi
8. Test Systems 213
8.1 Physical/Chemical Test Systems 214
8.2 Biological Test Systems 215
9. Test and Reference Items 219
9.1 Handling and Documentation 220
9.2 Characterisation 226
9.3 Expiry Dates 236
9.4 Sample Retention 238
10. Standard Operating Procedures 241
10.1 Introduction 241
10.2 The Format 243
10.3 Issue, Approval and Distribution 246
10.4 On line SOPs 249
10.5 The Content 251
10.6 Where are SOPs required? 255
11. Study Performance and Reporting 258
11.1 The Study Plan 259
11.2 Study Conduct 265
11.3 The Final Report 268
11.4 Re opening and Amending a Study 27s
11.5 Discontinued Studies 277
12. The Archives 278
12.1 Storage Period 279
12.2 Indexing and Retrieval 284
12.3 Security 285
12.4 Archiving of Electronic Raw Data 289
12.5 Archive location, merging and dissolution 291
Appendix II.1 294
Appendix II.II 312
Appendix II.III 329
Appendix II.IV 352
xii
III. How can Good Laboratory Practice be Introduced in a Test Facility?...36o
1. Introduction 360
2. General Aspects 361
3. A General Way to Implementation 364
3.1 The preliminaries 364
3.2 The organisation 365
3.3 Separation and distribution of facilities and equipment 36 $
3.4 Interlude: Personnel documentation 368
3.5 Distributing Responsibilities 369
3.6 The Major Task: Standard Operating Procedures 370
3.7 Second Interlude: Quality Assurance and IT 374
3.8 The Personnel: Education and Training 374
3.9 Study Plans 376
3.10 Test and Reference Item Issues 377
3.11 Study Conduct 378
IV. How is Compliance with Good Laboratory Practice Monitored ? 381
1. Introduction 381
2. National Monitoring Authorities 382
3. MOUs, MRAs, and MJVs 385
Appendix IV.1 390
Appendix IV.II 398
References 414
Useful Internet Addresses 419
Subject Index 420
|
| adam_txt |
Table of Contents
Preface v
Preface to the second edition vii
I. What is Good Laboratory Practice All About ? i
1. Introduction 1
2. The History of GLP 7
2.1 The Early Days and the Causative Events 7
2.2 The First Regulations w
2.3 International Ripples: The OECD Principles \i
2.4 The Principles and Their Interpretation 15
2.5 Closing the Circle ? The Detection of Test Item in Control Samples 17
3. The Idea Behind GLP 19
4. The Areas of Application 25
5. The Pillars of Good Laboratory Practice 33
6. Where Can GLP be Profitably Applied ? 38
7. GLP and Other Laboratory Quality Systems 53
II. How is Good Laboratory Practice Regulated ? 59
1. Introduction 59
2. Definitions in GLP 61
2.1 Good Laboratory Practice 61
2.2 Management 62
2.3 Study Director and Principal Investigator 65
2.4 Test Facility and Test Site 69
2.5 The Study 73
1.6 Short Term Studies 78
2.7 Initiation, Starting and Completion Dates 84
X
2.8 Study Plan, Amendments and Deviations 88
2.9 Raw Data 94
2.10 The Phases of a Study 97
2.11 The Master Schedule 100
2.12 Test and Reference Item 103
2.13 Additional Definitions 103
3. Responsibilities in Good Laboratory Practice 104
3.1 Management 104
3.2 Study Director and Principal Investigator 112
3.3 Study Personnel 124
3.4 The Sponsor 126
4. The Quality Assurance Programme 131
4.1 General Considerations 133
4.2 Quality Assurance Inspections 138
4.3 Quality Assurance Inspection Reports 153
4.4 Audits of Raw Data and of Final Reports 159
4.5 The Quality Assurance Statement 163
5. Facilities 170
5.1 General Requirements 170
5.2 Test System Facilities 173
5.3 Facilities for Handling Test and Reference Items 177
5.4 Archive Facilities 180
6. Apparatus, Materials and Reagents 181
7. Computerised Systems 187
7.1 Introduction 187
7.2 Basic Considerations 192
7.3 Data considerations 195
7.4 Prospective Validation 198
7.5 Retrospective Evaluation 203
7.6 Maintenance and Change Control 206
7 7 Security 208
7.8 Levels of Complexity 210
xi
8. Test Systems 213
8.1 Physical/Chemical Test Systems 214
8.2 Biological Test Systems 215
9. Test and Reference Items 219
9.1 Handling and Documentation 220
9.2 Characterisation 226
9.3 Expiry Dates 236
9.4 Sample Retention 238
10. Standard Operating Procedures 241
10.1 Introduction 241
10.2 The Format 243
10.3 Issue, Approval and Distribution 246
10.4 On line SOPs 249
10.5 The Content 251
10.6 Where are SOPs required? 255
11. Study Performance and Reporting 258
11.1 The Study Plan 259
11.2 Study Conduct 265
11.3 The Final Report 268
11.4 Re opening and Amending a Study 27s
11.5 Discontinued Studies 277
12. The Archives 278
12.1 Storage Period 279
12.2 Indexing and Retrieval 284
12.3 Security 285
12.4 Archiving of Electronic Raw Data 289
12.5 Archive location, merging and dissolution 291
Appendix II.1 294
Appendix II.II 312
Appendix II.III 329
Appendix II.IV 352
xii
III. How can Good Laboratory Practice be Introduced in a Test Facility?.36o
1. Introduction 360
2. General Aspects 361
3. A General Way to Implementation 364
3.1 The preliminaries 364
3.2 The organisation 365
3.3 Separation and distribution of facilities and equipment 36\$
3.4 Interlude: Personnel documentation 368
3.5 Distributing Responsibilities 369
3.6 The Major Task: Standard Operating Procedures 370
3.7 Second Interlude: Quality Assurance and IT 374
3.8 The Personnel: Education and Training 374
3.9 Study Plans 376
3.10 Test and Reference Item Issues 377
3.11 Study Conduct 378
IV. How is Compliance with Good Laboratory Practice Monitored ? 381
1. Introduction 381
2. National Monitoring Authorities 382
3. MOUs, MRAs, and MJVs 385
Appendix IV.1 390
Appendix IV.II 398
References 414
Useful Internet Addresses 419
Subject Index 420 |
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| title_auth | Good laboratory practice the why and the how ; with 1 table |
| title_exact_search | Good laboratory practice the why and the how ; with 1 table |
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| title_full | Good laboratory practice the why and the how ; with 1 table Jürg P. Seiler |
| title_fullStr | Good laboratory practice the why and the how ; with 1 table Jürg P. Seiler |
| title_full_unstemmed | Good laboratory practice the why and the how ; with 1 table Jürg P. Seiler |
| title_short | Good laboratory practice |
| title_sort | good laboratory practice the why and the how with 1 table |
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