Sets forth tested and proven risk management practices indrug manufacturing
Risk management is essential for safe and efficientpharmaceutical and biopharmaceutical manufacturing, control, anddistribution. With this book as their guide, readers involved inall facets of drug manufacturing have a single, expertly written,and organized resource to guide them through all facets of riskmanagement and analysis. It sets forth a solid foundation in riskmanagement concepts and then explains how these concepts areapplied to drug manufacturing.
Risk Management Applications in Pharmaceutical andBiopharmaceutical Manufacturing features contributions fromleading international experts in risk management and drugmanufacturing. These contributions reflect the latest research,practices, and industry standards as well as the authors' firsthandexperience. Readers can turn to the book for:
* Basic foundation of risk management principles, practices, andapplications
* Tested and proven tools and methods for managing risk inpharmaceutical and biopharmaceutical product manufacturingprocesses
* Recent FDA guidelines, EU regulations, and internationalstandards governing the application of risk management to drugmanufacturing
* Case studies and detailed examples demonstrating the use andresults of applying risk management principles to drug productmanufacturing
* Bibliography and extensive references leading to the literatureand helpful resources in the field
With its unique focus on the application of risk management tobiopharmaceutical and pharmaceutical manufacturing, this book is anessential resource for pharmaceutical and process engineers as wellas safety and compliance professionals involved in drugmanufacturing.