BACKGROUND AND INTRODUCTION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 14

of risk management in critical areas of biopharmaceutical production, such as raw
material supply, cell banking, fermentation, cell culture, purification, scale-up of
production process, and distribution issues associated with cold chain.
Finally, Chapter 13 provides a risk-based approach to controlling processes
and process-related changes. Integrating QRM into the change control system is
essential to maintain risk management as a “living” process, but it can be espe-
cially challenging because change control covers many areas in manufacturing
and most of the product life cycle. Chapter 13 provides some practical methods
and tools that can be used to integrate QRM into an existing change control
system.

1.4 FINAL THOUGHTS

Risk management can be a useful tool in controlling processes, assuring product
quality, prioritizing resources, and understanding processes. Risk assessment can
be helpful for obtaining the information needed to make manufacturing deci-
sions in a challenging business environment. The consideration of risk in making
product-quality-related decisions is not only a logical business practice but also
a regulatory expectation.
Effective quality risk management can facilitate better and more informed
decisions, can provide regulators with greater assurance of a company's ability
to deal with potential risks, and might affect the extent and level of direct regula-
tory oversight. Proper documentation is important to achieve this goal. However,
the level of effort, formality, and documentation of the quality risk manage-
ment process should be commensurate with the level of risk. The application of
risk management practices enables manufacturers to design processes that proac-
tively identify, mitigate, and/or control risks. Risk management practices may be
implemented via a well-designed risk assessment plan and activities.
The use of risk management, when properly planned and implemented, can
provide valuable information. That information, when properly considered, can
then lead to better product quality-related decisions. Those decisions, if prop-
erly implemented, can assure product quality and improved processes. Process
improvement can better ensure patient safety, which is the objective of quality
risk management.

REFERENCES

1. Department of Health and Human Services, U.S. Food and Drug Administration,
Code of Federal Regulation, Title 21, Chapter 211, Section 100 (CFR 211.100 of
cGMPs), 2008.
2. Medical Device Directives, Annex

1—Essential Requirements, European

Commission.