BACKGROUND AND INTRODUCTION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 2

customers, and be competitive. Companies have struggled with balancing
regulatory requirements, scientific elements of product development and
manufacture, and maintaining a productive business situation.
The pharmaceutical and biopharmaceutical industries are facing financial pres-
sure because of the high cost of drug development and manufacturing as well
as generic competition. There are business drivers and regulatory expectations
for innovative approaches to speed up pharmaceutical product development and
licensure, optimally use resources, and to assure continued product quality and
patient safety. The industry must apply comprehensive risk management and
innovative approaches to product life cycle not only to enhance patient safety but
also to improve business outcomes. Hence, it is critical to understand appropriate
risk management tools and approaches that would be acceptable to regulatory
agencies. Other industries, including closely related ones such as the medical
devices and food industries, have adopted a more structured approach to this
subject than we have traditionally used. The application of risk management to
medical devices is expected by medical device regulatory bodies [2-4]. Hazard
analysis and critical control points (HACCP) is used in the food industry to iden-
tify potential food safety hazards, so that key actions, known as critical control
points (CCPs), can be taken to reduce or eliminate the risk of the hazards being
realized [5].
In the summer of 2002, the FDA announced an initiative to “enhance and
modernize” pharmaceutical regulation. In the fall of 2004, it published the final
report on Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach .
This paper represented an attempt to “enhance and modernize” pharmaceutical
regulation. It not only speaks of product quality and patient safety but also of
the need for innovation and the cost of drug development and manufacture [6].
The paper offered initiatives and recommendations with the following
objectives in mind:
1. Encourage the early adoption of new technological advances by the phar-
maceutical industry.
2. Facilitate industry application of modern quality management techniques,
including implementation of quality systems approaches, to all aspects of
pharmaceutical production and quality assurance.
3. Encourage implementation of risk-based approaches that focus the attention
of both industry and agency on critical areas.
4. Ensure that regulatory review, compliance, and inspection policies are
based on the state-of-the-art pharmaceutical science.
5. Enhance the consistency and coordination of FDA's drug quality regu-
latory programs, in part, by further integrating enhanced quality systems
approaches into the agency's business processes and regulatory policies
concerning review and inspection activities.
The reference to risk-based approaches mentioned in (3) is of particular inter-
est to the subject of this topic. Facing limited resources, the agency recognized