Implementing new information technologies into existing operations often takes on an air of Dickensian drama. Though decidedly not the French Revolution, two prominent companies were experiencing tough times: One challenged by managing quality to keep pace with rapid growth, and the other challenged to achieve transparency across a massive global supply chain while managing all of its complexity. Information technologies are revolutionizing Pharma operations, and attendees of Rockwell Automation’s recent user group and continuing education conference RSTechED 2014 were treated to case studies from the front-line managers of two prominent Pharma industry players — agile, competitive biotech Ferring Pharmaceuticals and world-class heavyweight Pfizer.
FERRING'S A PIONEER
Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing biopharmaceutical therapies in the fields of infertility, obstetrics, urology, gastroenterology, endocrinology and osteoarthritis.
With historical roots extending back to the 1950s, Ferring continues to be a pioneer in developing and selling pharmaceutical products based upon natural, pituitary-produced peptide hormones. Over the past few decades, Ferring has developed a strong international profile; in-house production of its award-winning therapies is carried out in Argentina, China, the Czech Republic, Denmark, Germany, Israel, Mexico, Scotland and Switzerland. Two new manufacturing sites are currently being planned and built, says the company, in the United States and in India. Ferring’s headquarters in Saint-Prex, Switzerland, is a state-of-the-art, multi-purpose site providing additional production capacity with respect to Ferring’s dry product range, as well as secondary packaging and distribution of all products.
PFIZER SEEKS KNOWLEDGE
For those working to manage geographically dispersed manufacturing assets like Pfizer, the path to operational “truth” is paved with information, that is, all the data streaming from its production equipment’s control systems and associated devices. For most enterprise, especially large complex drug manufacturing organizations, obtaining operational knowledge of its production assets is often an incredible challenge.
At $51.6 billion in revenue, global pharmaceutical powerhouse Pfizer is an undisputed industry leader. Operating in 175 markets and fielding 56 manufacturing sites, Pfizer provides consumers with a wide range of medicines and other therapies “from Advil to Zithromax,” explains José Medina, Pfizer senior analyst and intelligence manager, describing his company’s 20-location VisionPoint rollout. Characterizing the company’s product portfolio, Medina says in 2013, 10 were responsible for greater than $1 billion in sales, among them a little blue pill that most will recognize and that millions of men keep by their bedside.
GROWING STRONG AT FERRING
Growth has been especially strong for Ferring, evidenced by its burgeoning portfolio of biopharmaceutical therapies and the necessary rise in capacity required to make and supply its products worldwide. But like any company, one of the toughest things to do is manage such growth effectively — something made even more complex because of the highly regulated environment that frames the entire pharmaceutical industry and its manufacturing processes. Ferring, like most biopharmaceutical companies of its age and legacy, supported its batch processing production cycle with a paper-based batch record keeping system. This system of record keeping also formed the foundation of the company’s Quality Assurance/Quality Control (QA/QC) regime which is fundamental to the company’s ability to comply with global regulators including the U.S. Food and Drug Administration (FDA) and the European Medicine’s Agency (EMA).
As Ferring’s market success drove its growth, it became clear to the company’s executive managers that more had to be done to improve operations, accelerate its time-to-market, enhance its quality and compliance regimes, and give its employees sharper tools to manage quality and compliance all the more accurately across its international supply chain. The solution, the company felt, was to implement an integrated manufacturing execution system (MES) beginning with an electronic batch record (eBR) application. In pharma, batch records and process transparency are critical elements of regulatory compliance and managing its products’ “time in chain.”
A CHALLENGE AS LARGE AS PFIZER ITSELF
A company the size of Pfizer has enormous challenges, says Medina, largely due to its complexity, due mostly to the fact that it manufactures pharmaceuticals, and not just one kind, but several — both patent protected like Viagra, and biologics — as well as over-the-counter medications which have an entirely different economic/production model dictating their profitability. Regardless, since the introduction of the U.S. Food and Drug Administration’s “Pharmaceutical GMPs for the 21st Century – A Risk-Based Approach” 11 years ago, the pharmaceutical industry has been faced with a regulatory regime based on Good Manufacturing Practices (GMP). In his article “Coming of Age” (Pharmaceutical Manufacturing, April 2013) author Angelo DePalma, noted “GMPs for the 21st Century have profoundly influenced how drug companies manage risk, particularly but not exclusively with regard to manufacturing. The risk-based approach becomes particularly challenging given the backdrop of merger and acquisition activity and a heavier reliance on outsourcing for manufacturing and R&D. For manufacturing, this means negotiating the moving targets of productivity and supply chain demands.”
It’s within this context that Pfizer has steadily structured and refined its manufacturing assets to support and implement GMPs integrating them into to Pfizer Global Supply (PGS), the internal organization tasked with supplying the company with the products it develops and markets around the world. According to Pfizer Global Supply’s John Kelly, VP sourcing & network strategy and transitioning operations, “Pfizer Global Supply [is] a critical element of Pfizer’s success … We’ve always been a very vision-focused organization … Our purpose is to supply quality products for a healthier world.”
Fulfilling PGS’s mission and vision, as Kelly succinctly described, is entirely dependent on managing its production assets as efficiently as possible, a task that is even more dependent on the operational truth derived from the Enterprise Manufacturing Intelligence (EMI) it derives from the vast amounts of data streaming from its control devices and production and processing equipment and the subsequent reports Medina’s department provides to PGS executive management. But, according to Medina, until recently its reporting processes were clunky, slow and riddled with inefficiencies that were preventing PGS from obtaining, in a timely fashion, the critical KPIs and associated production metrics and statistics it needs to manage its production assets effectively, and globally.
FERRING’S LEAD TIMES TOO LONG
Jerome Repiton, Ferring’s associate director of its Lean Six Sigma program, offered his audience a table revealing that manufacturing lead times for the pharmaceutical industry were between 120 and 180 days — a long period relative to other industries due to the demands regulators place on drug producers. Regardless, says Repiton, Ferring’s lead time was “very long,” especially relative to its competitors, and the company felt that implementing an eBR and integrating it into a contemporary MES would “help us eliminate steps in the chain.”
Repiton explains that within frame of product manufacturing lead times, Ferring’s manufacturing step is one of the shorter elements of the process. What takes the most time is the QA/QC qualification testing and review that can take weeks and often occurs after the product is made: “You can’t manage a product without information, and compliance is impossible without information,” he says. The rub for Ferring was that all of its batch information was generated via paper-based methodologies, embedded in standard operating QC procedures which extended the time from batch manufacture to release to some 44 days or more. In 2010, Ferring began its journey by implementing at its premier facility in Saint-Prex an eBR/MES solution based on Rockwell Automation’s Factory Talk Pharma Suite.
According to Repiton, paper-based systems are full of “hitches” and that no matter how well organized, a paper-based system might be, it could never deliver the real-time process transparency Ferring needs to manage its supply chain effectively. “An eBR solution,” says Repiton, “is the GPS of manufacturing operations. It guides the user to the desired destination, finds the shortest trip, alerts one to dangers, and feeds them back in real time.”
Repiton explains that Ferring understood that eBR was the key to process transparency. If one has process transparency, he says, one can understand process trends in the same time frame and know immediately if there has been an excursion that might affect quality. With Rockwell’s technology providing process data that is characterized by the batch recipe — the “destination” in Repiton’s GPS analogy — any deviation becomes known virtually instantaneously via the application’s dashboard. “When you work with paper,” notes Repiton, “you have to wait for someone to review the paper.” Armed with real-time process information, qualified personnel can conduct batch quality review during manufacturing rather than after and manage by exception: “If nothing’s wrong, then it is OK to press the button,” says Repiton.
PFIZER’S UPHILL BATTLE
Like Sisyphus rolling the boulder up the mountain only to watch it roll back down, then pushing it back up again ad infinitum, Medina and his department’s two other staff were responsible for the hundreds of reports Pfizer’s PGS managers were demanding at every turn of each of its 56 location’s business cycles. Medina explains that although the company implemented a core application that is the same at each location, each location’s application is naturally adapted and localized to each site, which in turn thwarted the departments’ ability to provide the operational transparency to a central authority. Maintaining commonality to create a unified reporting structure became an incredible challenge, says Medina.
What came next was a litany of administrative issues associated with the logistics of connecting to each site to generate reports, meeting manager’s informational needs locally then translating those globally, etc., all in an effort to maintain report continuity across all of Pfizer’s production assets. “So, the three of us have to cope with the fact that we have to keep maintaining those reports, keep those reports up-to-date among the sites, and if one site has a special requirement … do that change, and when we do that change we have to ensure that we do the same change on every site. So we have to connect to each site globally and redeploy the report … and redeploy the report … and redeploy the report … and at the end of day redeploying for each site takes us three or four days — perhaps a week to redeploy the entire suite of reports.”
Reporting issues didn’t stop there, either. Medina said it was virtually impossible for executive managers to obtain a common, centralized view of all the production assets in one take (and in a timely fashion) because it still meant connecting to each site to obtain individual site reports. Even though Medina’s team maintained report commonality, a common aggregated view or line-to-line comparisons were not available without more time-consuming manual intervention.
It became evident that because of the company’s incumbent reporting system, not only were Pfizer’s data analysts being effectively stymied from efficiently delivering actionable information to the organization, no matter how much managers insisted, they also were not getting the information they needed for critical decision support up the chain of command. A true, unifying solution was needed. Rockwell Automation’s VisionPoint EMI was ready to step in, creating the right solution at the right time for PGS.
For Ferring, implementing Factory Talk Pharma Suite was both a process quality and quality assurance process improvement program. Working with Rockwell, Ferring is now able to track “time in process” and that includes time spent in QA/QC review. According to Repiton, with Factory Talk, time in process has been essentially halved — a dramatic improvement and one of the primary goals of the whole endeavor. Since the eBR/MES program began in 2010, the number of batches processed by the company has jumped from 7,000 to 11,000; a 56 percent leap in just five years, accomplished, says Repiton, with the same amount of staff, “representing a real return on investment.”
With Factory Talk well implemented and pervasive process data available to key operations, Repiton said Ferring created a solid basis to integrate the system with its IT infrastructure including Laboratory Information System (LIMs) and ERP to provide an MES that supports the organization’s compliance and competitive agility goals. Characterizing it as an operational excellence project, Repiton finds that Ferring is much better equipped to cope with the complexities associated with biopharmaceutical manufacturing and to proactively comply with demanding regulators around the world.
PFIZER IMPROVES INFO ACCESS
Medina says they had two goals: Business Goals and Technological goals for its VisionPoint solution. “What we wanted to provide [PGS],” says Medina, “was a scalable, dynamic and value-adding information portal across the range of Pfizer core and manufacturing systems.” Adding that for business goals “we needed to improve access to information; we needed to provide better understanding of the information; we needed the ability for users to create their own report scenarios; and we needed the ability for users to run trends for line and historic data.”
In terms of technical goals, says Medina, his department needed centralization and rapid deployment. “Previously it might have taken us one or more days to deploy a report. Of course, that meant we would have to ensure that report was copied over to all the sites. We wanted to be able to deploy reports to all the sites in one shot.” Ultimately, says Medina, through VisionPoint, his department was able to create a platform in which to deliver standardized reports globally, remove the administrative work associated with variances and customization demanded by users, and supply critical metrics and other knowledge when and where it is needed — on demand — ready to support data-confirmed regulatory compliance, product quality and the operational excellence mandatory for competitive success in the 21st century.