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Quality (Pharmaceutical Engineering Series)
Dr. Kate McCormick
The Pharmaceutical Engineering Series is a comprehensive reference for the pharmaceutical professional covering all aspects from quality, documentation and validation through manufacturing processes to facility design and management. In 'Quality', Dr Kate McCormick provides the reader with comprehensive coverage of this vital subject, including the quality life cycle, management and cost of quality, GMP, auditing and inspections. This book with the others in the series will become a unique source of reference and educational material for the readership.
Quality Life Cycle, Research and development, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Drug Registration in the European Union, Drug Registration in America, Unlicensed medicines, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP); Quality Assurance and Quality Control, Relationship between Quality Management, QA, GMP and QC, Definition of Quality Management, Definition of Quality Assurance, Definition of Quality Control, Responsibilities of QA, Responsibilities of QC; Quality Systems, ISO 9000 Series, ISO 14000 Series, Use of the Quality Systems Approach within the Pharmaceutical Industry, Case study; Good Manufacturing Practice, Definition of GMP, Different versions of GMP, Comparisons of different GMP guidelines, Responsibilities under GMP, Rule vs. Guidelines, Application of GMP, Case studies; Good Distribution Practice (GDP), Principles of GDP, Quality system, Personnel, Documentation, Premises and equipment, Deliveries to customers, Returns, Self-inspections, Provision of information to Member States, The role of the responsible person, Case studies; The Management of Quality, Evolution of Quality Management, The role of the Quality Manager, The Quality Management System; The Cost of Quality, Definitions of Cost of Quality, Using the Cost of Quality tool, Establishing a system for calculation of costs of quality, Case studies; The Qualified Person, The qualified person in the European Union, The Equivalent role in USA, Other parts of the world; Technology Transfer, Reasons of technology transfer, Choosing the receiving site, Evaluating the hardware and software issues, Validation and registration, The Technology Transfer Guide, Planning for a successful technology transfer, Maintaining quality during factory closure; Calibration, Objectives of calibration, Calibration programme, Different types of standards, Different types of calibration equipment, Maintenance of calibration equipment, Categorisation of instrumentation, Purchase of new instruments, Review of calibration programme, Training of calibration technicians, References to calibration in International Standards; Auditing/Inspections/Auditing, Types of inspections, Mutual recognition of inspections, Guidance in participating in inspections, GMP Certification in the Developing World, Case Studies; Pharmaceutical Microbiology, Overview of micro-organisms, The microbiology of raw materials, Non-sterile products, Sterile products, Sterile manufacturing, Risks of contamination of their control, Validation and environmental monitoring, Sterilisation; Water for Pharmaceutical Uses, Types of Water, Design of water treatment systems, Biofilm, Common problems and troubleshooting, Wastewater treatment; Quality Improvement Programmes, History - the key figures, Prerequisites for successful quality improvement programmes; Quality Tools and Techniques, Tools for identification of problems, Tools for analysis of problems, Benchmarking, Using the tools and techniques; World Class Manufacturing in the Pharmaceutical Industry, Areas for improvement; Glossary; Bibliography; Index