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.

Chapter 1: Introduction to Part 1 - GCP; Chapter 2: The Protocol, Case Report Form & Initial Documentation - Quality Assurance Involvement & Common Problems; Chapter 3: Standard Operating Procedures in the GCP Environment; Chapter 4: Preparing for Regulatory Inspections of Company Pharmacovigilance Systems & Practices in the European Union & United States; Chapter 5: Investigator, Sponsor & Contract Research Organisation Audits; Chapter 6: Data Audits; Chapter 7: Research Ethics Committees; Chapter 8: GCP/GMP Interface, Investigational Product Accountability; Chapter 9: Monitoring & 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 & Their Audits; Chapter 16: SOPs for GLP Work; Chapter 17: Inspections - Procedural, Process & Facility; Chapter 18: Report and Data Audits; Chapter 19: Quality Assurance & Contract Research Organisations; Chapter 20: Quality Assurance & Pharmacology; Chapter 21: Application of GLP in Analytical Chemistry; Chapter 22: GLP in Drug Metabolism & 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 & 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 & GXP's; Chapter 38: QA Developing A Regulatory Compliance Training Strategy; Chapter 39: Training & Staff Records for GXP; Chapter 40: Integrating Quality Systems (GCP, GLP, GMP, ISO 9000, 14001, 18001 & 17025