BACKGROUND AND INTRODUCTION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 7

(process analytical technology), rapid microbiological analysis, and single-
use manufacturing systems offer the potential for process improvement
and risk reduction by eliminating process variation, human intervention,
and more reliable product and process testing/monitoring. However, these
technologies may bring with them new or additional risks associated with
understanding the limitations of the technology.
3. Adapting existing manufacturing methodology to new products and dosage
forms . Sometimes, tried and true approaches that have worked for older
technologies will not work as well for newer technologies. An example
may be the use of aseptic process simulations or media fill tests designed to
demonstrate aseptic technique proficiency, used to assure aseptic processing
control in relatively intervention-free automated or isolator systems.
4. The retooling of facilities and the transfer of products and technology as a
result of consolidation of plants and assets . There are likely to be physi-
cal, procedural, and cultural differences between facilities that need to be
considered in order to effectively manufacture products.
5. The loss of knowledgeable staff through attrition and reorganization .Even
the best controlled processes, with the most well-written procedures, are
subject to a certain level of “tribal knowledge.” Efficient and effective
manufacturing depends in part on the dissemination of information, much
of which is learned from experience. However, if that experience or the
people who have it are no longer with the company, then what will replace
that experience-based knowledge?
6. The need to better understand the interdependencies and variability of mate-
rials, technology, and product on more complex processes . More complex
products and dosage forms, as well as combination products, present new
process development and manufacturing challenges.
7. The need to maximize productivity and minimize cost . Quality may be the
number one factor in pharmaceutical manufacturing, but controlling cost
and resources has taken on a major level of importance in most mod-
ern manufacturing operations. This often leads to LEAN manufacturing
methods, doing more with less, automation, and streamlined operations
and workforces. All are for the good, but established methods of quality
assurance may also need to adapt to this new business environment.
8. The need to control processes to achieve consistent quality and maintain
product supply from and across multiple plants and locations . As seen in
the 2009 heparin issue, where products and supplies originated in emerg-
ing growth countries, there may be a need to examine the effectiveness of
existing methods and procedures for quality control and quality assurance
including audit, training, monitoring, and testing regiments [15]. In addi-
tion, more complex products and inspection techniques may result in or
uncover quality issues with critical supplies, such as glassware and product
contact containers. Improved methods of identifying and addressing these
issues may be necessary. Where inspection is not enough, quality by design