Cleanroom management: Information technology offers a compliant roadmap for quality

By James Pace and Chris Funck

Pharmaceutical manufacturing organizations face the challenge of balancing resources to meet and maintain current good manufacturing practices (cGMPs) compliance expectations with their need to continually improve the efficiency of operations. With proper planning and attention to core business objectives, information technology (IT) solutions can help organizations achieve a proactive and sustainable approach to:

  • Compliance with cGMP mandates and validation requirements, with particular attention to Part 11 requirements.
  • Timely and targeted information and feedback systems for Decision Support.
  • Increased operational effectiveness & productivity.

However, these three criteria quickly become competing forces as manufacturing operations deploy IT solutions. If investments in technology and automation are not balanced appropriately, manufacturing organizations may not be able to remain competitive while meeting quality mandates.

FDA's emphasis on integrated quality systems

Pharmaceutical companies are experienced with adapting to and complying with regulations governing how they conduct business.

In the last 10 years, Information Systems (IS) have become pervasive in pharmaceutical companies and are finding their way into manufacturing facilities. Systems such as enterprise-wide laboratory information management systems (LIMS) and enterprise resource planning (ERP) systems are being upgraded and implemented to capture information that was originally captured on paper.

Recently, the Food and Drug Administration (FDA) has been placing renewed emphasis on compliance with cGMP expectations and on quality of manufacturing information. For example, the FDA is focused on identifying high-risk areas of the drug manufacturing process. As such, manufacturers must take appropriate measures to mitigate those risks.

While a focus on high-risk areas in itself is nothing new, the method of analysis and mandated remedies have changed dramatically. FDA inspections now go beyond identification of specific problems, and instead place emphasis on the manufacturer to:

  • Identify the root cause of the regulatory incident and provide process improvements for resolution.
  • Provide an audit trail demonstrating the validity of the compliance data presented and the steps taken for resolution.
  • Demonstrate the ability to proactively analyze, predict and correct incident trends based upon a facility and organizational view of compliance data.

cGMP organizations can no longer afford to take a reactive approach to quality and compliance of operations and support systems. Companies must quickly and proactively address the quality and consistency of cGMP operations to avoid the costs of legal action and manufacturing disruptions.

Pharmaceutical manufacturers are forced to embrace and adopt information technology solutions that go well beyond LIMS and far beyond mere data acquisition to stay current with cGMP expectations. However, if these solutions are not designed and implemented within the context of the FDA's Integrated Quality System framework, then these solutions have essentially no compliance value add.

IT's place in pharmaceutical manufacturing

There are three primary areas where IT can provide significant value for a manufacturing area, including: compliance with cGMP mandates and validation requirements, with particular attention to Part 11 requirements; increased operational effectiveness and productivity; and timely and targeted information and feedback systems for decision support.

cGMP compliance: Comprehensive, proactive compliance depends upon a holistic view of data capture, retention and management. Beyond LIMS enhancement, applying information technology to compliance means managing, capturing and auditing data throughout the manufacturing process with information systems that are fully integrated with one another. Some examples are:

  • Specialized electronic data capture (EDC) devices, spanning the gamut from continuous monitoring devices, to wireless-enabled tablet PCs for data acquisition and operating procedure management, to integrating existing devices, provide for real-time data acquisition and monitoring, and continuous submission to LIMS and ERP systems.
  • Validated enterprise database platforms, such as specialized document management systems and data warehouses, provide for secure, yet accessible, storage of electronic records for the required record retention period.
  • By migrating business processes from paper-based to electronic-based, such as master product records, laboratory results and FDA submittals, it becomes easier to retain and retrieve these records. It also enables consistent and reliable means to manage, retrieve and present information for communication to the FDA.

Improve operation effectiveness and productivity: Existing investments in technologies and systems investments for regulatory compliance do not preclude you from using these investments to streamline your business processes simultaneously.

A compliance process fully optimized through automation, by definition, should be complementary to the production process and existing technology investments. It is important that new investments add value to the production process and are fully integrated with other information assets. This enables the organization to achieve a return on investment in productivity and efficiency by leveraging existing systems. Some examples are:

  • Capture of an electronic signature at the time of data capture that identifies the person executing the process and a record of any changes to an electronic production record. The electronic signature can be integrated with an organization's central directory or security information repositories for use with ID card and biometric scanning devices for complete, unobtrusive and convenient security management.
  • As products are manufactured, it becomes critical to monitor the environment to ensure that it is within acceptable guidelines for the manufacturing of the specific product. Real-time data on the environment can be used to quickly remediate problems, saving substantial dollars in otherwise lost product and resolution after the fact. This data can be transmitted to LIMS and ERP systems the moment that it is captured.
  • Compliance systems designed with total integration in mind allow a single point of entry for both the compliance process and the LIMS or ERP system, increasing productivity by avoiding dual data entry and redundant system vs. paper data capture. Additionally, since direct access to LIMS and ERP systems is often limited in sterile and production floor environments, there is a delay between capture of compliance data on paper and entry into the system of record. Integration of wireless mobile data capture devices with these systems substantially reduces the risk of data entry errors.
  • Provide electronic real-time guidance such as standard operating procedures (SOPs) and daily scheduling for production, environmental monitoring and product tracking. Beyond systems integration, this requires a thorough analysis of how software can be used to integrate the functional processes of compliance requirements with the task-level business process of pharmaceutical manufacturing.

Improve decision support & intelligence: A deluge of reports presently exists to aid in the management of pharmaceutical manufacturing operations. Unfortunately, the reports are often generated by the major individual information systems—LIMS, ERP, departmental databases, notes databases—without regard to the business relevance of the data itself or the value in combining the information from these systems for specific management functions. As a result, “analysis paralysis” takes hold, limiting the actionable value of the information.

Several approaches exist that emphasize less data with more targeted value to the management function in question. As a result, a careful mapping of the information to the business process, regardless of the system it comes from, can provide customized views of the organization over time that allow management decision-makers to plan, schedule and act before compliance and productivity issues become costly problems. Some examples are:

  • Manufacturing and quality portals: A single desktop view of several information assets, bringing a customized view of daily progress and tasks for each user.
  • Management dashboard: Can be delivered within a portal initiative or as standalone software, allowing quick, real-time access to information that is specifically targeted to the role of the manager in the organization.
  • Compliance workflow systems: While the quality of information is important, it is of equal importance to demonstrate the ability to proactively solve compliance problems to the FDA. Workflow systems that are carefully mapped to the business process and provide both a high-level and drill-down view of in-process compliance investigation and resolution activities aid in both quality business intelligence and decisive, timely action.

Every minute of every hour of every day that a pharmaceutical manufacturing plant is not producing product, there is a potential for lost revenue. Therefore, an effective process for implementing IT solutions must be followed if business goals are to be attained.

James Pace is responsible for pharma/bio-pharma business development for The Sycamore Group, a software and integration services provider based in Fort Washington, Pa. Pace can be contact at [email protected].

Chris Funck is practice manager for The Sycamore Group. Funck can be contacted at [email protected].


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