Quality Magazine

Learning Quality from Pharmaceuticals

April 1, 2010
The quality processes used in pharmaceuticals can help other manufacturers learn quality processes and ways to further improve efficiencies.



The discovery of contaminated blood thinner from China in commercial Heparin was a wake-up call for many in the pharmaceutical industry. The 2008 incident, which spanned nine countries and caused at least 21 deaths and 305 allergic reactions in the United States alone, illustrates the complex challenges pharmaceutical companies face in an increasingly competitive, global market.

Because of the nature of the products they provide, pharmaceutical companies, which operate squarely in the category of process manufacturing, must produce products that are safe for the consumer and are of the utmost quality. They must strive to produce products at the lowest cost, in the least amount of time-while still ensuring quality and compliance.

Risk management tools must be integrated into every facet of the development and manufacturing process. Executives at these companies constantly look for ways to build efficiencies into the product cycle, while quality managers are tasked with making sure a host of strict procedures are followed to maintain product quality, safety and compliance with regulations from many countries. Though manufacturers in other industries might not be held to the same strict standards legally, the quality processes used in pharmaceuticals can definitely help other manufacturers learn quality processes and ways to further improve efficiencies.

Balancing quality and compliance with speed has become particularly challenging in a market where outsourced manufacturing and global supply chains are increasingly common. To maintain quality in a global outsourced market, companies must accomplish countless major tasks, only some of which include:

  • They must track and manage their global suppliers, keeping careful tabs on which suppliers consistently offer the highest quality raw materials, and prioritizing procurement accordingly.

  • They must implement effective Corrective and Preventive Action (CAPA) processes that can trace manufacturing deviations to their root cause, address those deviations quickly, and put measures in place to prevent future deviations.

  • They must put rigorous change control procedures in place that can track change requests, approvals, pre-authorizations and implementations, and accurately assess regulatory and other quality-related impacts across the organization.

    Most pharmaceutical companies have these processes in place, but they’re often hampered by a lack of consistency and effective tools to manage multiple moving parts. Even in many of the largest companies, supplier, audit, change management and other processes are tracked on a fragmented, departmental level using rudimentary tools such as Excel spreadsheets, disparate manual systems and databases and even paper-based documentation. It’s not unusual for companies to have different systems in place at different locations and different parts of the supply chain. This can be said for manufacturers across all industries.

    This fragmented approach inevitably slows down quality operations and product time-to-market for several reasons:

  • The disparate spreadsheets, databases and other systems employees use are often simplistic, and not optimized for intended use. They require time-consuming workarounds to accomplish their quality control tasks.

  • Each siloed system has its own quirks, limitations and user interface, requiring a considerable amount of maintenance, user training and support.

  • The use of multiple parallel systems leads to unnecessary redundancy, with many departments implementing the exact same processes different ways.

  • Lack of integration and visibility across diverse quality systems and departments makes CAPA, change control and regulatory audits unnecessarily painful and time-consuming.

  • Extensive customization inevitably means difficult software upgrades, which often have to be re-customized from scratch.



  • The Right Solution for Quality Management

    Current market conditions are forcing many pharmaceutical companies to take a much more holistic approach to quality management. By consolidating multiple quality control systems into a single enterprise solution, manufacturers can achieve a holistic view of quality across departments and functions that can help them accelerate and enhance quality management processes.

    Companies are also seeking to integrate quality management with other relevant enterprise and manufacturing systems, including ERP, CRM, laboratory information management systems (LIMS), manufacturing execution systems (MES), and enterprise document management-and make them accessible to all groups involved in quality control, including regulatory affairs, lab operations, and environmental health and safety staff.

    Because no two companies are alike, identifying the right solution for quality management requires careful analysis of all relevant quality control processes and the parts of the organization that touch those processes. Inevitably the type of products the company manufactures and its manufacturing and distribution model will have substantial effects on the design of the company’s quality management processes. It’s also important to analyze how the company’s other core applications interact with quality to understand the level of integration necessary to achieve a seamless user experience. Companies should use this information to map out a solution that can work for the long term across all their quality control functions, and minimize total cost of ownership. They can then simplify their initial deployment by focusing on one or two critical needs in the organization with the goal of covering other quality control processes over time.

    There are many ways to achieve this enterprise view. Many companies expand existing ERP solutions with quality control functionality. Such a solution is possible, but often requires a significant amount of customization, which can complicate future upgrades and cause many of the same problems companies were seeking to correct.

    Other manufacturers look to purpose-built enterprise quality management solutions (EQMS) that bridge enterprise document management, ERP, LIMS, MES, and other core systems, overlaying workflow functionality for CAPA, supplier management, change management and other quality management functions. EQMS also provides accessibility to relevant processes, documents and information across departmental boundaries and maintains accountability through automated notification and escalation procedures, and centralized on-demand reporting.

    An example of EQMS in action was seen recently when a global biopharmaceuticals company that develops, manufactures and distributes injectable pharmaceuticals, replaced its manual systems for managing deviations with an enterprise-wide quality management software solution. With the proper planning the company was able to extend the system to additional quality management functions over time.

    The benefits have been considerable for the company: It can use provided software templates to investigate manufacturing deviations, easily finding and surveying all relevant information from its enterprise document management and training systems to determine what caused them. The EQMS also streamlined supplier quality management and compliance activities and eliminated more than half of the custom functionality the company had built into its existing document management system. And, perhaps most importantly, the solution has allowed the company to slash the time-to-release of injectable lots from as long as 90 days to 30 days, reducing costs and enhancing the company’s competitive advantage.



    Another Example

    Another example concerns a contract development and manufacturing organization for pharmaceutical, biotechnology and healthcare companies that also achieved this holistic view with an enterprise level quality management system. The EQMS centralized the logging and tracking of events, reducing confusion and time delays across company departments. Centralization made it easy to make all pertinent information accessible across departments when necessary as well as determine root cause and develop an effective CAPA strategy.

    Implementing a holistic quality management system obviously requires a significant investment in systems, infrastructure, training and implementation time. Pharma companies have found, however, that return comes quickly when they focus the solution on their biggest quality control pain points first, then use what they learned to extend the solution gradually. This holistic, enterprise-wide approach, already widely used in the pharmaceutical industry, can also be applied by companies working in discrete manufacturing industries, such as medical device, to enable production of better-quality products and, ultimately, a safer consumer.