Pharmaceutical manufacturing processes continue to evolve, periodically embracing technological developments such as disposable
components and regulatory initiatives such as process analytical technology (PAT). These changes have improved many operations,
yet the top two causes of deviations—human error and equipment failure—remain the same. These factors create anywhere from
50% to two-thirds of manufacturers' headaches. How could companies remove them from the equation? One possible solution is
(PHOTO: COMSTOCK IMAGES, GETTY IMAGES)
Drugmakers use corrective and preventive action (CAPA) programs to address deviations, modify procedures to prevent their
recurrence, and measure the effectiveness of these modifications. Automating CAPA processes with software can help manufacturers
find the best ways to resolve production problems and, ideally, eliminate deviations altogether.
Knowledge is power
Personnel must know as much as possible about a deviation to resolve it effectively through a CAPA program. Most drug companies
have a software application system dedicated to tracking production problems and helping personnel figure out how to avoid
them in the future. To enable thorough investigations, this system must receive accurate information about the manufacturing
process. But if personnel enter data into the system manually, the opportunity for human error increases, and it becomes difficult
to categorize deviations correctly and find their root causes. These difficulties can delay a product s release for shipping.
Automation that captures data and integrated software that facilitates the tracking and trending of actions and commitments
are important tools for supporting a successful CAPA program. "With the move to at-line or on-line data-capture tools, the
capture of events and excursions during processes is achieved more readily through automation," says William (Al) Kentrup,
vice-president of manufacturing and supplier quality assessments at Pfizer (New York). Integrating the related event logs
into appropriate CAPA software allows a company to manage the manufacturing process, including product disposition and resource
Employees prepare for cell-culture transfer from a seed bioreactor into a perfusion bioreactor. (IMAGE IS COURTESY OF PFIZER)
On the other hand, sometimes data-capture tools are too effective for their own good. "In today's environment, the ability
to capture data and events can exceed the ability to assess them and react appropriately," says Kentrup. But automation or
software tools can help manufacturers convert data into knowledge easily, especially in highly automated or complex processes
such as packaging operations.
In addition to PAT tools that enable on-line monitoring, an automated, centralized quality-control system also helps address
the challenge of getting consistent, granular data, says Tim Mohn, industry principal at Sparta Systems (Holmdel, NJ). Integrating
the CAPA program with an overall quality-management solution can provide a comprehensive view of the process and facilitate
root-cause analysis and trending.
Close the loop
Trending of data, a crucial part of the CAPA process, allows a manufacturer to assess its performance in comparison with established
standards. Trending deserves more of drugmakers' attention because it allows them to determine how effective their corrective
actions are in preventing the recurrence of deviations. Over time, pharmaceutical manufacturers have become skilled at identifying
root causes and developing preventive actions for deviations. But companies often do not follow up by performing the appropriate
tracking, trending, and effectiveness checks, says Susan Schniepp, vice-president of OSO BioPharmaceuticals Manufacturing
(Albuquerque, NM) and a member of Pharmaceutical Technology's editorial advisory board. This lack of continuity can allow a deviation to recur if the preventive action did not address
the problem directly. Automation can make it easier for companies to track manufacturing operations and perform effectiveness
checks, which are crucial steps for closing the loop of the CAPA process.