Good Clinical, Laboratory and Manufacturing Practices (eBook, PDF)

Techniques for the QA Professional
Redaktion: Carson, Philip; Dent, Nigel

• Format: PDF

Produktbeschreibung

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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Produktdetails

• Verlag: RSC
• Seitenzahl: 656
• Erscheinungstermin: 31. Oktober 2007
• Englisch
• ISBN-13: 9781847557728
• Artikelnr.: 44765304

Autorenporträt

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

Inhaltsangabe

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