Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA Professional

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Phillip A. Carson, Nigel J. Dent
Royal Society of Chemistry, 2007 - Science - 622 pages
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Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
 

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Contents

Good Clinical Practice
3
Quality Assurance
13
Appendix A
25
Standard Operating Procedures in the Good Clinical Practice Environment
39
Further Reading
54
Investigator Sponsor and Contract Research Organisation Audits
73
Data Audits
89
Research Ethics Committees
99
Issues of Quality in Pathology
317
Good Laboratory Practices in Ecotoxicology and Field Studies
335
Animal Health
353
Good Manufacturing Practice
371
Standard Operating Procedures
387
Release of Bulk and Filled Finished Product
399
Good Manufacturing Practice for Investigational Medicinal Products
407
Chemical Analysis
419

Good Clinical PracticeGood Manufacturing Practice GCPGMP Interface
109
Monitoring and Quality Control
121
Phase I Healthy Volunteers Studies
137
Clinical Laboratories
147
Good Laboratory Practice
171
Quality Assurance in GLP
183
The Master Schedule Index
199
Study Plans and Their Audits
209
Standard Operating Procedures for Good Laboratory Practice Work
223
Procedural Process and Facility
235
Report and Data Audits
249
GLP Studies
263
Good Laboratory Practice and Pharmacology
271
Application of GLP in Analytical Chemistry with
279
GLP in Drug Metabolism and Pharmacokinetics
305
17
424
Good Manufacturing Practice for Sterile Products
435
Statistics for QA Auditors of GLP and GCP Studies
463
Metrics and Trend Analysis
473
Supplier Auditing
479
Acknowledgements
487
From Concept to Archiving
497
Computing and GXPs
511
References
527
Training and Staff Records for GXP
541
Integrating Quality Systems
551
Glossary of Some Commonlyused Abbreviations
563
Subject Index
599
Copyright

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About the author (2007)

Dr Carson trained as an organic chemist (PhD) and safety and health expert (MSc). He was formally employed by Unilever as research scientist and Head of Science Support Services at their Research and Development Laboratory, Port Sunlight. Responsibilities included, occupational health, safety and environment; consumer safety; ethics of animal and human testing; Quality Assurance (GCP, GLP, GMP, ISO 14001/17025/OHSAS 18001); Project Risk Management and member of the Management Committee. Current posts include Quality Director (4-Front Research Ltd), a H&S consultant, Chairman of CIREC (a research ethics committee recognised for reviewing Phase 1 studies on healthy human volunteers) and member of a local hospital clinical ethics committees. Since 1983 he has been a member of the Institution of Chemical Engineers 'Loss Prevetion Panel' and is a member of the Association of Reserach Ethics Committee. He is past member of the Chemical Industries Association Health Advisory Group and past Chairman of their Hygiene Working Group. Bewteen 1990-2000 he was visiting lecturer in chemistry at UMIST and was PhD examiner for Aston University Chemical Engineering Department. He has over 60 technical publications including The Safe Handling of Chemicals in Industry (3 volumes), Longman The Hazardous Chemicals Handbook (2 editions), Butterworth Heinemann Good Clinical, Laboratory and Manufacturing Practices (2 editions), Royal Society of Chemistry He is also coauthor of 'Silver Screens of Wirral' (2 volumes), Countyvise Ltd

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