This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutica..
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities an..
Due to the increase in the consumption of herbal medicine, there is a need to know which scientifically based methods are appropriate for assessing th..
A valuable tool for chemists and analysts working in Quality Control laboratories, this book provides technical solutions that fulfill training requir..
Considered the "industry bible," this text provides a practical guide to microbial limit methodologies. Presenting microbial limit tests and bioburden..
Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance wi..
More than just a checklist of audit questions, this guidebook contains proven methods and techniques for performing effective audits. Completely cover..
Written by the founders of the Institute of Validation, this introduction to validation cuts through all the jargon and focuses on the essentials. Val..
Written in simple, clear, and concise language that cuts through the regulationese, this book covers the basics of validation, planning process equipm..
When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guidelines defining exactly how such a ..
Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Act..