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.”