BACKGROUND AND INTRODUCTION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 5

verification of equipment used to manufacture and test pharmaceutical products.
It was an effort to use risk to product quality and patient safety as important
factors when deciding what to qualify, how to qualify, when to qualify, and
who should be involved in the qualification and approval effort [14].
When the ASTM committee E55 was assembled to create and review what
would become E2500-07, they discovered that while many, companies recog-
nized that quality risk management was an important tool for making product
manufacturing decisions, few, had real experience or input into practical means
to accomplish this in an effective manner. As such, the committee was faced
with creating desired state approaches rather than reflecting tried and true best
practices. Throughout related meetings and discussions, it appeared that most
companies had some appreciation for the need to manage risk to product quality
and as a part of that to take steps to assess and document the assessment of that
risk. However, it also appeared that companies did not always utilize risk man-
agement techniques optimally or effectively in making decisions. One is reminded
of a company visited not long after the 2005 PDA meeting. The company had a
vigorous risk management program, complete with corporate directives, policies,
procedures, and a risk management department. They had volumes of carefully
filled out risk assessments, which were placed in binders and displayed. When
asked what these risk assessments were used for, the response was to assess risk.
The assessment forms were meticulously filled in, reviewed, and approved. After
that, they were placed in binders and placed on a shelf. Whether the informa-
tion was used to help make any decisions was not apparent. This illustrates the
misconception that the objective of risk management is to merely assess or cat-
egorize risk, rather than using it to provide information to help make informed
decisions and improve the process.
The objective of risk management should be to improve the process by reduc-
ing or mitigating risks. There needs to be a clear link between risk management
principles as described in guidances such as ICH Q9 and other guidances and
practical manufacturing activities. The topic offers the reader multiple perspec-
tives and approaches to risk management and assessments. The chapters in this
topic emphasize that quality risk management of pharmaceutical manufacturing
processes is an important topic because of the following:
1. It is a regulatory expectation, in that it helps to assure product quality
and ensure patient safety. The FDA, European Medicines Agency (EMA),
and many other regulatory agencies strongly recommend the use of risk
assessment and the consideration of risk to patient safety and product qual-
ity in making decisions related to product development, manufacture, and
distribution.
2. It is a good business practice. Properly used, risk management should help
assure product quality as well as promote efficient utilization of resources
and prioritization of efforts. It should help companies reduce redundant and
non-value added efforts, while allowing them to focus on efforts that have
optimal impact on product quality.