Biomedical Engineering Reference
In-Depth Information
Mitigation of risk involves taking action and making changes. These changes
may not mitigate all risk and may add other risks—or residual risks. Residual
risks are risks that remain after mitigation changes are made. It is important to rec-
ognize and address these residual risks. This does not mean avoiding mitigation
changes because of residual risk.
Choose the risk assessment method that best fits the complexity and impact
of the decision to be made. One method may not fit all applications. Avoid
unnecessarily complex or burdensome methods when simple ones will accomplish
the same result. However, choose a method that will provide enough information
and is as objective as possible.
1.3 OVERVIEW OF THE BOOK
Companies have struggled with the best way to effectively use and demon-
strate the use of risk-based information gathering, evaluation of information,
and decision-making processes, often doing too little or too much. In an effort to
assist the reader with the development and use of effective risk-based approaches
for pharmaceutical and biopharmaceutical product manufacturing, this topic will
provide guidance, including some divergent views on practical and pragmatic
ways to incorporate risk into their operations. While the contents of this topic
are not meant to include all of the methods and areas where QRM can and should
be incorporated, it provides several approaches and examples that can be used
as a framework for developing and implementing risk-based decision-making
methods for other processes and process steps.
The first chapters are designed to familiarize the reader with the subject of risk
management in the context of pharmaceutical and biopharmaceutical manufactur-
ing and present basic concepts and ideas for developing and utilizing an effective
risk management program. To that end, Chapter 1 provides an introduction and
background to risk management for pharmaceutical and biopharmaceutical prod-
ucts and processes. Chapter 2 introduces the reader to general information on the
development and use of a risk management program. It shows widely used risk
assessment tools and methods, many of which are used in subsequent chapters.
Chapter 3 provides additional insight into the nuances of the risk management
program, including regulatory expectations, a high level overview of the cogni-
tive and social aspects of risk, as well as thoughts on developing an objective
risk management program and an effective organizational culture. Chapter 4
presents views and a commentary on the use of statistical analysis to assist with
the planning of risk-based approaches and with useful analysis of the resulting
information.
The next chapters present specific, yet not exclusive, areas of pharmaceutical
and biopharmaceutical product development and validation where risk manage-
ment techniques can be used, along with programs and approaches for doing so.
As such, Chapter 5 discusses the use of QRM in QbD aspects of product and
process development. The QbD approach is where quality is designed from the
Search WWH ::




Custom Search