Synopses & Reviews
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.
Review
Quality AssuranceGood clinical, laboratory and manufacturing practices: techniques for the QA professional
P.A. Carson and N. Dent (Eds.)
Cambridge, UK: RSC Publishing | 2007 | 692p | ISBN 9780854048342
Reviewed by J.A. Day
Carson and Dent remove much of the jargon and mystique often associated with quality assurance (QA) by drawing on the experience of a number of specialists in GxP (quality guidelines within pharmaceutical and clinical practice, including good laboratory practice (GLP), good clinical practice (GCP) and good manufacturing practice (GMP)).
Those involved in quality assurance and control could use the book as a reference guide and as a source of best-practice methodology to set up, operate, monitor and interpret a quality system. The exceptionally well-presented chapters on the role of quality assurance, computing, inspections and standard operating procedures (SOPs) are particularly important in the modern laboratory.
Although meant for the GxP laboratory, it could easily be interpreted for ISO 17025 and ISO 9001 laboratories as well.
Many quality assurance manuals do not cover the subject in sufficient depth. Not this one. In over 600 pages, the authors cover purpose, control, documentation, history and training, as well as risk assessment, fit-for-purpose issues and the essential fundamentals of GxP systems, including the roles and responsibilities of those involved.
In summary, this is a well-structured, comprehensive and easy-to-read book on the individual parts of a GxP, aimed at quality managers and newcomers to quality assurance. In nearly 30 years as an analytical chemist and quality professional, I have not come across a book that is a must-read, but this certainly is.
Chemistry World, 2007.
Both auditors and auditees in R and D will become aware of what is expected of them to help ensure compliance with legal and industry standards when developing new drugs and related chemicals
Operations and regulatory compliance managers be able to assess opportunities to harmonise management quality systems to simplify the bureaucracy whilst retaining compliance with quality requirements
Review
"This book should be essential reading for all those working QA"
Review
"This book should be essential reading for all those working QA" Pharmazie in Unserer Zeit, Markus Veit, Kaufering.
Review
Those involved in quality assurance and control could use the book as a reference guide and as a source of best-practice methodology to set up, operate, monitor and interpret a quality system....exceptionally well-presented.....s a well-structured, comprehensive and easy-to-read book.In nearly 30 years as an analytical chemist and quality professional, I have not come across a book that is a must-read, but this certainly is. Chemistry World, November 2007, 74 (J A Day)
Synopsis
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.
Synopsis
This 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 and offers detailed examples to illustrate application of the principles.
Synopsis
Spanning chemical, cosmetic and manufacturing industries, this book is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists.
About the Author
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
Table of Contents
Chapter 1: Introduction to Part 1 - GCP; Chapter 2: The Protocol, Case Report Form and Initial Documentation - Quality Assurance Involvement and Common Problems; Chapter 3: Standard Operating Procedures in the GCP Environment; Chapter 4: Preparing for Regulatory Inspections of Company Pharmacovigilance Systems and Practices in the European Union and United States; Chapter 5: Investigator, Sponsor and Contract Research Organisation Audits; Chapter 6: Data Audits; Chapter 7: Research Ethics Committees; Chapter 8: GCP/GMP Interface, Investigational Product Accountability; Chapter 9: Monitoring and Quality Control; Chapter 10: Phase I Healthy Volunteer Studies; Chapter 11: Clinical Laboratories; Chapter 12: Introduction to Part 2 - Good Laboratory Practice; Chapter 13: Quality Assurance in GLP; Chapter 14: The Master Schedule Index; Chapter 15: Study Plans and Their Audits; Chapter 16: SOPs for GLP Work; Chapter 17: Inspections - Procedural, Process and Facility; Chapter 18: Report and Data Audits; Chapter 19: Quality Assurance and Contract Research Organisations; Chapter 20: Quality Assurance and Pharmacology; Chapter 21: Application of GLP in Analytical Chemistry; Chapter 22: GLP in Drug Metabolism and Pharmacokinetics; Chapter 23: Issues of Quality in Pathology; Chapter 24: GLP in Eco-toxicology and Field Studies; Chapter 25: Animal Health; Chapter 26: Introduction to Part 3 - Good Manufacturing Practice; Chapter 27: Standard Operating Procedures (Specific to GMP); Chapter 28: Release of Bulk and Filled Finished Product; Chapter 29: Good Manufacturing Practice for Investigational Medicinal Products; Chapter 30: Chemical Analysis; Chapter 31: GMP for Sterile Products; Chapter 32: Statistics for QA Auditors of GLP and GCP Studies; Chapter 33: The Use of Statistics in Research Quality Assurance; Chapter 34: Supplier Auditing (GMP); Chapter 35: Centralised Supplier Audits (GLP); Chapter 36: Document Control from Concept to Archiving; Chapter 37: Computing and GXP's; Chapter 38: QA Developing A Regulatory Compliance Training Strategy; Chapter 39: Training and Staff Records for GXP; Chapter 40: Integrating Quality Systems (GCP, GLP, GMP, ISO 9000, 14001, 18001 and 17025