Quality Assurance Workbook for Pharmaceutical Manufacturers presents strategies for setting up and maintaining a quality management system that meets the rigors of regulatory compliance guidelines. This book shows you how your facility, through carefully planned processes, implemented at an early stage, can achieve and maintain a high production standard.
The book starts with management - outlining roles and defining responsibilities in quality assurance - and goes through the setup of contracts, documentation requirements, product identification and traceability, conducting self inspections and internal audits and, training.