At the heart of successful cGMP and QBD-based pharma manufacturing is real time operational data generated by highly networked control, sensing and analytical technologies across the process continuum. The volume of data generated by pharma enterprise information and manufacturing technologies is immense, but the availability of data is not the issue — what is at issue is the ability to generate high-quality data then extracting and shaping meaningful, relevant information from it, then delivering it to the organization in forms that serve business and process decisions.
The efficient flow of data and information from process to executive suite and back is dependent on a well-organized, modern data/informatics infrastructure. But for many organizations basic data input and information handling remains haphazard and antiquated, relying on paper records, subject to human-induced error. Similarly, access to decision-supporting information continues to be problematic, with knowledge kept in silos and behind other artificial barriers that ultimately impinge on efficient, cost-effective operations.
To gain clarity on IT-related issues facing the industry today, Pharmaceutical Manufacturing sought input from leading IT suppliers and consultants; convening a virtual panel to discuss trends in Pharma information technologies and reveal insight into how companies can better manage this aspect of their operations in pursuit of operational excellence and business success.
Pharmaceutical Manufacturing: In spite of commercial realities prompting closer alignment between functional executive ranks (i.e. facility/manufacturing managers) and higher order business intelligence IT operations, it’s perceived a gap still exists. In your experience, what has been effective at closing this gap and creating the alignment pharma enterprise needs to be successful?
K.R. Karu, industry solution director, Sparta Systems Inc.: “Closing the gap and aligning information within the pharmaceutical enterprise is best accomplished by globally harmonizing processes and identifying which systems will manage which subset of data. These systems should then be integrated so master data can be stored in one system and consumed by all. When global data is harmonized in a strategic group of systems, the data can be used by many for their particular function within the company.”
Dino Busalachi, practice director, Unified Manufacturing, Applied Group: “The gap exists and unfortunately, in our experience it is all too often the ‘norm.’ For many years, the executive suite dictated its information priorities for the overall organization and IT served those interests: hoever, corporate IT and manufacturing have generally not possessed an intimate understanding of each other’s needs and concerns, leaving the operations/facility leadership to their own devices to collect, deliver and leverage valuable operational intelligence.
However, the need for alignment between IT and manufacturing IT, supported by an integrated IT and analytics infrastructure, is critical — especially when it comes to the FDA and compliance. Owning and implementing an enterprise-wide intelligence solution has historically been capital intensive and challenging; it requires a close, ongoing relationship between corporate IT and manufacturing to deploy and sustain the solution. Given the often tenable relationship btween corporate IT and manufacturing, many executive boards have chosen not to invest the significant capital necessary to build the required infrastructure and implement manufacturing intelligence solutions.
Ken Rapp, managing director for Analytical, Development, Quality and Manufacturing, Accelrys: “During the course of our work with Pharma industry leaders, Accelrys has identified two specific pain-points — the independence and isolation of standalone vendors / applications and the inability to connect the data from separate application to separate application. This hinders new product innovation and decreases efficiencies because information valuable to new product development cannot be accessed and shared up and down the value chain. Information never becomes knowledge. We think addressing these two problems is the core to closing this gap in Pharma. Technology that effectively connects data and provides valuable knowledge up and downstream from product development through commercial applications is needed. We believe applying technologies that provide the ‘scientific platform’ to allow communication between disparate applications is the most effective way to close the gap in the Pharma industry.”
PhM: Most will agree that process data and record keeping is not managed as well as it could be in the Pharma space. Paper-based systems remain pervasive and record-keeping lapses have been identified as a major factor in compliance issues with regulators. But in spite of the obvious risk, it is feared that change will lead to tremendous expense associated with process revalidation and fresh exposure to regulatory scrutiny. Are these fears justified? And how might they be overcome?
Trish Meek, product strategist, Informatics Business, Thermo Fisher Scientific: “No, those fears are not justified. I think these fears are born out of experiences that happened in the past, but the technology has improved greatly over the past five years. The reality is that the cost of maintaining paper processes far exceeds the cost of integrating systems. The other fact to consider is the potential cost to quality [that stems from] not removing manual, paper based processes. The best a human being can achieve is four sigma for transcription activities. That means that for every 1000 results someone transcribes from an instrument they will make 3-6 mistakes. This error increases drastically to 3 per 100 if there is math or stress involved. If just one of these mistakes results in a batch being approved and then later recalled, or a failed FDA audit, the cost of this one mistake would far exceed the cost of the IT system that would have prevented it.