GMP in Practice Regulatory Expectations for the Pharmaceutical Industry, Fourth Edition, Revised & Expanded
By James L. Vesper

As manufacturing and distribution practices become more complex and global, manufacturers cannot simply focus on one or two sets of requirements. Most multinational firms have done what national authorities have not – they have created quality systems and quality system elements that internally harmonize GMP expectations.
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Environmental Monitoring A Comprehensive Handbook, Volume 5
Edited by By Jeanne Moldenhauer

Jeanne Moldenhauer, along with fourteen expert authors discuss in-depth the requirements and establishment of an environmental monitoring program for the quality control microbiology laboratory. This comprehensive handbook address key topics such as environmental trending and the reports needed for manually trending data, how to present environmental data to both internal and external stakeholders, details regarding the development of an identification laboratory at your site, and the latest technology for performing identifications.
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The Bacterial Endotoxins Test: A Practical Guide
Edited by Karen Zink McCullough

This unique book is a collection of interdependent chapters that are part lab manual, part essay, part historical context, part consultant and part plain sage advice that provide a practical and compliant approach to the execution and use of BET. 2011.
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Quality By Design: Putting Theory Into Practice
Edited by Siegfried Schmitt

This book provides a thorough and complete treatise on the subject including potential applications beyond the original scope of QbD. It is a comprehensive reference on QbD useful to new and experienced professionals in regulated industries. Further, it is a "how-to" book with useful and practical advice. 2011.
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