The New Biopharmaceutical Blueprint: Service-Oriented Architecture in Manufacturing - Pharmaceutical Technology

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The New Biopharmaceutical Blueprint: Service-Oriented Architecture in Manufacturing
More than ever, drug makers need to be fleet and flexible—and they need their software to be the same.

Pharmaceutical Technology

SOA is easier to understand through real-life examples. Below, the authors examine an industry-specific critical issue within the manufacturing organization to show where SOA approaches enhance information sharing for internal systems and support tighter integration with manufacturing business partners.

Manufacturing: Improving the product-release process

Today's regulatory agenda demands "quality by design"—a proactive approach that addresses compliance issues before they occur. Customers and regulators want nothing less than continuous supply, reliable product safety controls, and the ability to track issues efficiently. More parties are involved in manufacturing, as more complex products require more communication, which exposes the industry to risk from local variations and monitoring procedures managed by global partners. The authors will focus the discussion on a real-life scenario of getting manufactured products released into the market.

BioPharma manufacturing is striving to create tighter integration among all the players: suppliers, technical development, manufacturing facilities, comarketing, logistics, and markets. At the same time, manufacturing is an inherently changing environment. The authors will look at one part of the release process and examine the many systems supporting this process. Companies often experience integration challenges when there is:
  • One enterprise resource planning (ERP) application with many instances internally or externally at manufacturing sites
  • Many ERP instances with many best-of-breed applications
  • Different systems for each department discipline involved in the manufacturing process
  • A reliance on paper being generated from these different systems, with the legal requirement to retain the paper and show an audit trail for each released batch
  • Loosely enforced global IT standards within the organization or with partners.

Managing the product-release process today

Figure 1: Today's release process involes many manual, iterative processes.
The release process is complex and involves massive amounts of information from various sources. All compliance-based processes must come together at this point before a batch is released to the market. Staff is involved across the organization and outside the company that includes quality control, in-house or third-party manufacturing, engineering, quality assurance, and supply-chain operations. Figure 1 shows how a typical release process occurs today.

This process is triggered as a batch is completed. Today, the process is slow and inefficient because it is still largely paper-based, with many applications. It relies on humans to push the paper to its next step, or to transfer the information manually from one system to the next. Documents can become lost and can be difficult to trace during critical stages. Stand-alone applications may only have partial information, and the manual entry of information into multiple systems can lead to redundant or even conflicting data. Each discipline has its own reports to document the manufacturing of the batch. It is the collective set of documents from all activities and departments that comprises the information and basis to know whether or not the batch should be released. There are many document-related activities and issues that can occur as documents are collected. What Figure 1 does not depict is the iterative nature of document generation and collection loops that can prolong the process if no triggers exist to alert staff about ongoing issues or corrective actions. The result is a process that is difficult to measure and manage.


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