Compliance Management

How and why Baxter International implemented an automated continued process verification program

By Marco Arocha, manager information systems, Baxter International Inc.

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OVERCOMING BARRIERS
Baxter’s CPV program is known internally as BioAnalytics, and it consists of integrating Operations Intelligence (OI) and guided input from Manufacturing Operations and Quality departments. The vision is to establish efficient manufacturing processes and enable the production of high quality products for patients. The company set out to create an automated analytical capability based on a unified view of products and critical parameters harmonized across its global manufacturing network sites to improve process knowledge and control.

Baxter defines OI as the process of bringing together operations data from many sources to generate process knowledge that will drive improved results. OI elements include automated transfer of data from the shop floor, aggregation of data from multiple sources, providing context and structure to the data and providing capabilities for standard and ad hoc analysis and reporting. All of these elements were considered essential for a collaborative CQV program.

Like other life sciences companies, the nature of Baxter’s business presented inherent barriers and special considerations for implementing a CPV program, including:

• Accessing process and quality data stored in both electronic and paper systems
• Improving data analysis/understanding process variability
• Making comparisons across global manufacturing network
• Changing the culture/adapting participants to new habits.

When Baxter began its CPV implementation program and related technology enablers, the team used an incremental approach for each product and manufacturing site to overcome short-term challenges while working toward long-term goals. It defined how technology enablers mapped to each of the three process validation lifecycle stages.

The BioAnalytics program team is responsible for implementing the global harmonization of the tools shown in Figure 2. Baxter wanted to implement a global software system that could provide access to all manufacturing data, including, but not limited to, process control systems, in-line device recordings, results of laboratory quality assays, manufacturing execution data and other batch record data. It needed analysis and reporting capabilities including the creation of control charts, product and stability trending, and other statistical analysis based upon selected data and automation or routine updates and alerts. And, last but not least, it wanted the ability to compare results across all plants and at the overall divisional level. 

The team borrowed change management methodology from author Brien Palmer who said, “All improvements to how we operate as a business require change, and all change causes a predictable resistance by those people who are affected by the change. Unfortunately, this tendency — the lack of acceptance of the change — often causes a project to fail, even if the desired change is perfectly logical and necessary.”²

To help overcome this “human” barrier, the team outlined organizational requirements, assigning each department’s role in the CPV transition and program across Quality Operations, Manufacturing Operations, Global Information Technology and Technical Services and Process experts. Individual sites were prepared for the BioAnalytics implementation by assessing the current readiness and defining actions to sustain and utilize the accompanying systems and processes.

The implementation of BioAnalytics relied on the availability of validated underlying systems that contain the data, such as online data/historians, ERP software, process control systems, electronic batch management (EBM) batch release workflow and in-process and final product quality record management software.

Among its lessons learned, Baxter’s team recommends identifying process champions to drive the project, and ensuring early on that the team is well defined and utilizes change management tools and assessments to make necessary corrections and support the implementation. Gauging realistic time commitments from SMEs helps focus resources on the project without distractions from competing priorities. SMEs who can make a difference — and who are often the key beneficiaries of the use of the product — can rally the team and follow up with consistent messages to ensure the overall vision and common goals are always present.

Integrating Baxter’s global and local teams was an important step. Local site resources were increased to ensure continuity and accommodate related, increased demands. They increased local flexibility by having a local Six Sigma Black Belt on site and an IT representative, who was empowered to support local change management activities, develop changes and adjust configurations, for example. At the global level, the team established peer reviews for configurations and directed changes through an operational steering committee on a quarterly basis.

To date, Baxter’s BioScience business has mapped thousands of parameters for product development, process monitoring or investigational purposes. It has implemented its BioAnalytics program for three of its products. Eight sites have started implementations, with three using the program for product manufacturing.

Time savings across projects and routine production have been mapped to easily available process monitoring data. Opportunities to reveal previously unknown processing elements and new CPPs, along with early trend detection that helps avoid out-of-spec (OOS) results have positively affected yields. These benefits, together with a better availability of data, time spent on investigations has been reduced by 80%, encourages Baxter to move forward along its path toward real time monitoring and control.

References
(1) FDA Guidance for Industry, Process Validation: General Principles and Practices, January 2011, CGMP, Revision 1.
(2) Palmer, Brien, “Making Change Work: Practical Tools for Overcoming Human Resistance to Change,” ASQ Quality Press, 2003.

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