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. - Case studies and examples make the book of direct practical relevance to the professional in the pharmaceutical industry - Find the answers you are looking for quickly and easily with clear indexing and referencing - Reference to international standards and practice mean this book will be useful wherever you are working
Autorentext
Dr. Kate McCormick is a pharmaceutical manufacturing consultant and trainer who has worked extensively with both regulators and companies in more than 50 countries. She is the author of a number of textbooks, and she was an editor of GMP Review and International Education Advisor for ISPE. Dr. McCormick has a degree in biochemistry, a doctorate in microbiology, and is also a Master of Business Administration.
Klappentext
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.
- Case studies and examples make the book of direct practical relevance to the professional in the pharmaceutical industry
- Find the answers you are looking for quickly and easily with clear indexing and referencing
- Reference to international standards and practice mean this book will be useful wherever you are working
Inhalt
Quality Life Cycle
Quality Assurance and Quality Control
Quality Systems
Good Manufacturing Practice
Management of Quality
Cost of Quality
Qualified Person
Technology Transfer
Calibration
Auditing/Inspections
Pharmaceutical Microbiology
Quality Improvement Programmes
Quality Tools and Techniques