In 1992, the rallying cry for Bill Clinton's presidential campaign was "It's the economy, stupid!" Today, the rallying cry from consumers to manufacturers is "Its quality, stupid!" And one manufacturing segment particularly feeling the heat includes pharmaceutical manufacturers.
Globalization and the age of integrated digital technology have been both a boon and a bane of multinational pharmaceutical companies.
The supply chains of global pharmaceutical manufacturers have become increasingly complex. And while globalization has benefited manufacturers in allowing them to produce products at a more competitive price and to be closer to emerging markets, the pressure for quality is now more challenging than ever before. Pharmaceutical companies are now realizing extended supply chains in the manufacturing process -- especially the extensive use of third party manufacturers throughout the world -- also exponentially increases the risk of quality issues.
Strong manufacturing principles and standard processes allow high-performing companies to globally source and produce products efficiently with extensive internal and external collaboration and coordination. However, recent history such as some of the highly publicized quality issues within the industry shows that improvements are still required in the supply chain process.
All of this hinges of course on pharmaceutical manufacturers having a thorough knowledge of their manufacturing process, a good means of storing and analyzing the relevant production data, and a systematic corrective action plan that gets at root cause and remediation in a timely manner. However, due to a lack of integration and disparate IT systems, it is often difficult for many companies to see impending early warning signs of potential quality and compliance breaches.
The most resounding of these warning signs is an FDA Warning Letter indicating a violation of Good Manufacturing Practices (GMPs). Often manufacturing lapses originate from deviations in the related processes that escape established quality checks. The prescribed remedies are sometimes not addressed in a timely manner and the net result is a flurry of activity to determine the root cause of the problem and the execution of a hurried remediation plan. Having a thorough understanding of the manufacturing process can help immeasurably in getting quickly to the true root cause of deviations.
Awareness and Harmonization
Twenty years ago, a consumer or patient would not have had visibility into these warning signs or the globalization of supply chains in the manufacturing process at all. Their pharmaceutical insight was limited to the conversation with their physician and pharmacist, often without a thought to the actual manufacturing practice. Today a consumer's pharmaceutical prescription experience can include multiple stories on manufacturing issues from across the mass media spectrum. Recent consent decrees are well publicized and often turn viral on the internet; however, on the flip side a company's high quality manufacturing protocols or remediation steps elicits little coverage.
For a multinational company, this can be the proverbial curse of globalization and requires the industry to implement global harmonized quality processes and systems. It also requires the industry to fundamentally rethink at which points in the process it needs to focus on quality resources.
As an industry, it is important to focus quality efforts on those points in the process that are most critical in determining the final product quality. The current paradigm of inspecting for quality at the end of the process is costly and not foolproof. New ways have to be developed to ensure that quality is being built early on in the process versus back-end testing.
Building in quality requires process harmonization and a thorough understanding of the overall manufacturing. This is sometimes inconsistent from one manufacturer's site to another -- especially when factoring in external third party manufacturers to the mix. To facilitate this, pharmaceutical manufacturers need to consider creating integrated data management systems and manufacturing analytics to better understand processes. This allows them to identify the critical quality parameters, and then design real-time monitoring and controls. Accenture research finds that organizational factors that break the link between data and decisions are often the biggest obstacles to overcome.
Data availability is one of the most fundamental requirements for strong analytical capabilities. This is an area in which the pharmaceutical industry continues to struggle. Operations and quality data are typically scattered through a fragmented landscape of manufacturing execution systems, laboratory information systems, ERP systems, and a number of paper-based systems.
In addition, manufacturing organizations in the pharmaceutical industry often operate in disconnected, functional silos that encourage decision making based on tradition rather than on data. This is further complicated by the fact that the manufacturing processes are created in one organization -- often the development area -- within a limited timeline and then passed over to manufacturing. Perhaps the most critical first step toward better analytics is to design the critical input parameters that drive product quality early into the development and technical transfer processes.
In the early 2000s, the FDA began piloting a Quality by Design (QbD) initiative that was focused on integrating prior pharmaceutical knowledge and pharmaceutical development into the application review process. At Accenture, quality by design means that the integration doesnt begin with the application process but with the integration of real-time analytics and process knowledge to identify the critical to quality parameters and where to focus the quality efforts and assets.
Improved analytics for designing methodologies to improve process understanding, process optimization, and risk modeling offer the potential for greater quality and a quantum jump in robust supply chain capability for pharmaceutical companies. This means the ability to achieve the appropriate quality outcome must be designed into the process itself rather than relying solely on final product testing.
The Critical Juncture
Consumers don't know when a pharmaceutical manufacturer has addressed a quality control issue until there is a well-publicized product recall, an adverse event is reported, or the FDA issues a warning letter. The critical juncture is before the product recall, an adverse event is reported, or prior to an FDA issued warning letter where the problem can be quickly solved. All of this hinges on pharmaceutical manufacturers having a thorough knowledge of their quality processes, a good means of storing and analyzing the relevant production data, and a thorough corrective action plan that gets at root cause and remediation in a timely manner. Ideally, you want to be able to predict the potential deviations and make the small corrections before they result in the more visible recalls and warning letters. Predictive analytics allows this to take place.
Creating the complete manufacturing process requires building quality into the design and having a comprehensive quality program. This will allow a pharmaceutical manufacturer to succeed at grasping the benefits of globalization and digital connectivity while answering the rallying cry of consumers across the board.
Eugene Jones is a senior director at Accenture, a global management consulting company and leads the supply chain practice for Accenture's Life Sciences industry group. Christopher McKenna is a senior director at Accenture, and works for Accenture's Process and Innovation Performance practice.