Über die Autorinnen und Autoren

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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Written by a team of world experts, the book provides practical and detailed advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of pre-clinical safety studies, clinical trials and manufacture of drugs. It provides a framework for integrating these standards with other quality management systems. Detailed examples are provided to illustrate application of the principles. The book is targeted primarily at all those subjected to internal and external inspection and audit for compliance with the requirements of good clinical, good laboratory, and good manufacturing practices. It will be of value to chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians, and toxicologists.

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Good Clinical, Laboratory and Manufacturing Practices

Techniques for the QA Professional

The Royal Society of Chemistry

Contents

Part 1: Good Clinical Practice, 1, 
Chapter 1 Introduction: Good Clinical Practice D. Talbot and N. Downes, 3, 
Chapter 2 The Protocol, Case Report Form and Initial Documentation: Quality Assurance Involvement and Common Problems N.J. Dent, 13, 
Chapter 3 Standard Operating Procedures in the Good Clinical Practice Environment P. Charnley Nickols and J. Nickols, 39, 
Chapter 4 Preparing for Regulatory Inspection of Company Pharmacovigilance Systems and Practices in the European Union and United States E.G. Brown and S.A. Goldman, 57, 
Chapter 5 Investigator, Sponsor and Contract Research Organisation Audits P. Fitzgerald, 73, 
Chapter 6 Data Audits J.V. Birnie, 89, 
Chapter 7 Research Ethics Committees S. Eckstein, 99, 
Chapter 8 Good Clinical Practice/Good Manufacturing Practice (GCP/GMP) Interface, Investigational Product Accountability D. Bailes, 109, 
Chapter 9 Monitoring and Quality Control A. Bevan and S. Ollier, 121, 
Chapter 10 Phase I Healthy Volunteers Studies R. Cope and P. Rolan, 137, 
Chapter 11 Clinical Laboratories P.J. Ford, 147, 
Part 1: Good Clinical Practice 1, 
Chapter 12 Introduction: Good Laboratory Practice Th. Helder, 171, 
Chapter 13 Quality Assurance in GLP P.A. Carson, 183, 
Chapter 14 The Master Schedule Index J. Goeke, 199, 
Chapter 15 Study Plans and Their Audits J.R. Pateman, 209, 
Chapter 16 Standard Operating Procedures for Good Laboratory Practice Work P. Hallin and A. Wichman, 223, 
Chapter 17 Inspections: Procedural, Process and Facility A. Waddell, 235, 
Chapter 18 Report and Data Audits J. Janssens, 249, 
Chapter 19 Quality Assurance and Contract Research Organisation: GLP Studies R. Chapman, 263, 
Chapter 20 Good Laboratory Practice and Pharmacology M.J. Benton, 271, 
Chapter 21 Application of GLP in Analytical Chemistry with Cross Reference to GMP and GCP A. Anderson, J.G. Maxwell and H.M. Hill, 279, 
Chapter 22 GLP in Drug Metabolism and Pharmacokinetics N.J. Dent, 305, 
Chapter 23 Issues of Quality in Pathology K. Isaacs, 317, 
Chapter 24 Good Laboratory Practices in Ecotoxicology and Field Studies D.L. Colinese, 335, 
Chapter 25 Animal Health K. De Keulenaer, 353, 
Part 3: Good Manufacturing Practice, 
Chapter 26 Introduction: Good Manufacturing Practice J.R. Dolman, 371, 
Chapter 27 Standard Operating Procedures V. Edy and M. Gamlen, 387, 
Chapter 28 Release of Bulk and Filled Finished Product J. Sharp, 399, 
Chapter 29 Good Manufacturing Practice for Investigational Medicinal Products V. Edy and M. Gamlen, 407, 
Chapter 30 Chemical Analysis P. Newton, 419, 
Chapter 31 Good Manufacturing Practice for Sterile Products J. Sharp, 435, 
Chapter 32 Statistics for QA Auditors of GLP and GCP Studies I. Townshend, 463, 
Chapter 33 Metrics and Trend Analysis P. Carson, 473, 
Chapter 34 Supplier Auditing A. McCraight, 479, 
Chapter 35 Centralised Supplier Audits for Animal Studies P. Withers, 489, 
Chapter 36 Document Control: From Concept to Archiving J. Gumley, 497, 
Chapter 37 Computing and GXPs A. Nelms, 511, 
Chapter 38 QA Developing a Regulatory Compliance Training Strategy: An Opportunity for QA to Improve Quality and Provide Greater Value to the Business L. Brown, 529, 
Chapter 39 Training and Staff Records for GXP H. Neal, 541, 
Chapter 40 Integrating Quality Systems P. Baxter, 551, 
Glossary of Some Commonly-used Abbreviations P. Carson and N. Dent, 563, 
Appendix GLP Comparison, OECD, USA and Japan J. Somorai, 575, 
Subject Index, 599,