Pharmaceutical Regulatory Inspections
A unique and comprehensive guide to ensure regulatory compliance and success in pharmaceutical regulatory inspections.
In over 600 pages and twelve chapters this unique book provides a focussed account of regulatory issues from pre-approval inspections and the inspection itself to postinspection and maintaining compliance. This is a book that every pharmaceutical company will wish to study before and during any inspection process to ensure a successful outcome.
"The book is timely, relevant and important… it contains chapters written by a number of international experts and covers everything anyone could possibly wish to know about the inspection process and quality issues affecting pharmaceuticals and healthcare… it also covers the key points that are likely to arise during an inspection or audit. This includes documentation, electronic systems, staff training, hygiene, licencing, compliance and so forth. The quality of the explanations is high and the book is packed full of useful examples and case studies… It is an unique book… an essential item for the book shelf of anyone involved with quality inspections, audits or GMP."