Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing / Wiley Series on Biotechnology (ePub)

Sets forth tested and proven risk management practices in
drug manufacturing

Risk management is essential for safe and efficient
pharmaceutical and biopharmaceutical manufacturing, control, and
distribution. With this book as their guide, readers involved in
all facets of drug manufacturing have a single, expertly written,
and organized resource to guide them through all facets of risk
management and analysis. It sets forth a solid foundation in risk
management concepts and then explains how these concepts are
applied to drug manufacturing.

Risk Management Applications in Pharmaceutical and
Biopharmaceutical Manufacturing features contributions from
leading international experts in risk management and drug
manufacturing. These contributions reflect the latest research,
practices, and industry standards as well as the authors' firsthand
experience. Readers can turn to the book for:

* Basic foundation of risk management principles, practices, and
applications

* Tested and proven tools and methods for managing risk in
pharmaceutical and biopharmaceutical product manufacturing
processes

* Recent FDA guidelines, EU regulations, and international
standards governing the application of risk management to drug
manufacturing

* Case studies and detailed examples demonstrating the use and
results of applying risk management principles to drug product
manufacturing

* Bibliography and extensive references leading to the literature
and helpful resources in the field

With its unique focus on the application of risk management to
biopharmaceutical and pharmaceutical manufacturing, this book is an
essential resource for pharmaceutical and process engineers as well
as safety and compliance professionals involved in drug
manufacturing.