BACKGROUND AND INTRODUCTION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 6

3. It is a logical and effective means of obtaining useful information needed
to make sound quality and business decisions. Risk management represents
an organized method for obtaining, analyzing, and communicating useful
information.
The regulatory environment emphasizes the use of enhanced knowledge of
product performance over a range of material attributes, manufacturing process
options, and process parameters to identify risks to patient safety and product
quality. Risk analysis and risk management are acceptable and effective ways to
minimize patient risk and determine appropriate levels of validation and controls.
The use of quality risk management does not obviate company obligation to com-
ply with regulatory requirements. However, effective quality risk management
can facilitate better and 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 regulatory inspections. The effective and consistent analysis of
risks associated with manufacturing processes and quality systems typically leads
to more robust decisions and yields greater confidence in outcomes. The ultimate
goal of the risk management process of an organization is to bring focus and
effort to the issues that impart the highest risk to product quality and/or patient
safety. Risk management outputs will potentially serve as reference documents
to support product development and control strategy discussions in regulatory
filings.
1.1 RISK MANAGEMENT OF PHARMACEUTICAL
AND BIOPHARMACEUTICAL MANUFACTURE
The efficient manufacturing of quality pharmaceutical products presents a chal-
lenge in the present day business environment. If not properly controlled, these
challenges can represent risk to product quality and in turn patient safety. There
are several reasons why the business environment presents unique challenges,
including the following:
1. The need to understand and comply with evolving regulatory requirements
and expectations . In the past, the FDA represented the benchmark or stan-
dard source for drug product and manufacturing regulations. Most foreign
regulators utilized the principles presented by the FDA in their own reg-
ulations. However, as European and other non-U.S. markets developed,
companies faced unique interpretations and presentations of regulations
and requirements from other regulatory bodies. At times, as one regula-
tory body would attempt to modernize its regulations or guidance, other
countries would lag behind, creating the potential for misinterpretation and
misalignment of regulatory expectations or focus.
2. The use and integration of innovative technologies with existing manufac-
turing methodology . New technologies such as automated processes, PAT