Analysis & Pharmaceutical Quality

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance...

This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for ha..

Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on..

Due to the increase in the consumption of herbal medicine, there is a need to know which scientifically based methods are appropriate for assessing the quality of herbal medicines. Fingerprinting has emerged as a suitable technique for quality estimation. Chemical markers are used for evaluation of ..

Written in simple, clear, and concise language that cuts through the regulationese, this book covers the basics of validation, planning process equipment design and construction, documentation requirements, avoiding validation pitfalls, and the types of services the supplier should provide. The book..

Considered the "industry bible," this text provides a practical guide to microbial limit methodologies. Presenting microbial limit tests and bioburden testing mandated by USP-NF, the comprehensive second edition reflects current industry standards, regulatory expectations, and critical technical and..

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 system has to be built. Beginning with explanations of key terms and concepts, this book covers ISO 9000 and GMP and how to combine them, and includes..

More than just a checklist of audit questions, this guidebook contains proven methods and techniques for performing effective audits. Completely covering the four key competencies essential for successful GMP audits, the book explores the rationale behind using audits as a quality tool and explains ..

A valuable tool for chemists and analysts working in Quality Control laboratories, this book provides technical solutions that fulfill training requirements and build skilled manpower. The text is written for practitioners in quality control laboratories, product development laboratories, and stabil..

Written by the founders of the Institute of Validation, this introduction to validation cuts through all the jargon and focuses on the essentials. Valuable to novices and experienced validators alike, this book helps readers understand validation fundamentals and how these principles can help build ..

Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. The second edition is fully revised, updated, and expanded to include new chapters addressing postapproval changes, te..

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. Wi..