ABSTRACT: Aging facilities have become a concern in the pharmaceutical and biopharmaceutical manufacturing industry, so much that task forces are formed by trade organizations to address the topic. Too often, examples of aging or obsolete equipment, unit operations, processes, or entire facilities have been encountered. Major contributors to this outcome are the failure to invest in new equipment, disregarding appropriate maintenance activities, and neglecting the implementation of
modern technologies. In some cases, a production process is insufficiently modified to manufacture a new product in an existing process that was used to produce a phased-out product. In other instances, manufacturers expanded the facility or processes to fulfill increasing demand and the scaling occurred in a non-uniform manner, which led to non-optimal results.Regulatory hurdles of post-approval changes in the process may thwart companies’ efforts to implement new technologies.
As an example, some changes have required 4 years to gain global approval. This paper will address cases of aging processes and facilities aside from modernizing options.
Aging processes and facilities are not a rarity. Many examples, supported by regulatory citations, can be
found. A major culprit for aging facilities and processes is the widespread belief that improvement activities will only increase costs without any incremental benefit.
Woodcock and Wosinska elaborate on the fact that lowmargin drug products make investments into aging processes unattractive. For this reason, older process equipment is utilized, even when it may mean manual interventions or breakdown. Examples of continuous improvement
activities, however, show just the opposite.
Proper improvement and modernization planning supports the efficiency and productivity of the processes and therefore financial gains (5). In addition to productivity, processes run at a higher quality and safety level without interruptions, regulatory scrutiny, and frequent human interventions.
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