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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Implementing a Continued Process Verification (CPV) program requires overcoming obstacles manufacturing companies typically face when they evolve their traditional systems. Leveraging technology solutions can help break through such barriers to ultimately make it easier to access and use process data for trending, automated alerts and improved process understanding and business benefits.

For the past few years since the FDA updated its guidance for process validation, many life sciences manufacturers have been adopting new programs. Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

Process validation involves a series of activities taking place over the lifecycle of the product and process. The FDA describes the process validation activities in three stages: process design, process qualification and CPV, which is the “ongoing assurance (that) is gained during routine production that the process remains in a state of control.” The FDA emphasized in its document that process validation should not be thought of as a singular event, but as a program requiring ongoing demonstration that a process remains in control.¹

The products and processes of Baxter International Inc.’s BioScience business are varied, but they share the common connection of improving the lives of patients with rare conditions, chronic diseases or limited treatment options. Commissioning its Global Information Technology team to lead the charge, Baxter knew it could capitalize on the following business benefits through an automated CPV program:

• Improved Data Access – Access to data is generally achieved through a few subject matter experts (SMEs) who know where and what the data is and how it relates to a process. CPV programs formalize this knowledge so that more people have self-service access to the data with a common “data dictionary” used for reference and to guide access to the data.
• Better Control – Data is frequently extracted into multiple spreadsheets or data and sources. A CPV program can reduce the number of data sources and formalize control processes by creating a single point of self-service access to data that provides a single version of the truth.
• More Integrated Data – Data must be integrated with its context (e.g., data type, genealogy, lot number, date, batch number, process step, etc.) to be understood as information that drives action. Most frequently this context is provided personally from the knowledge of SMEs. CPV can formalize and automate this data contextualization so that scarce and expensive SME time can be allocated to more value-adding activities. Additionally, there is a desire to relate the information from different sites and systems, and CPV can optimize this type of integration through one point of access.
• Automation of Routine Process and Product Monitoring – In-process and final product parameters can be monitored automatically rather than manually. This provides a high assurance of product safety with evidence from every batch that all parameters are operated within their desired manufacturing limits, not just the final product specifications.
• Automated Alerts for Review-by-exception – Monitoring by exception through an automated CPV program provides operating staff and support teams with automated out-of-trend (OOT) alerts, so they can take action before batches begin to fail. This allows technical experts to spend their time only on those process parameters that are trending outside of pre-set limits rather than reviewing hundreds of trend charts to catch just those few that require immediate attention.
• Validated Environment – Baxter’s CPV program included systems that conformed to the FDA’s 21 CFR Part 11 requirements and Good Automated Manufacturing Practices (GAMP) to ensure its electronic record data capture, as well as the rest of the software systems, are validated and, therefore, trustworthy and reliable for decision-making without the need for the additional expense and risks of second person verification tasks.
• Data More Easily Re-used – Data is frequently extracted for a single use, and each time the data is needed by different people it is extracted again and calculations/derivations are made repeatedly. Through CPV programs, data and key calculations/derivations can be stored for more efficient re-use.

Baxter wanted to implement a global management approach across multiple sites, to improve process understanding and control process variability across its entire network of manufacturing assets. With its new automated CPV program in place, the company expected to identify yield improvement opportunities through process comparison within a site and/or across different manufacturing sites. It wanted to better understand the correlation between process parameter and quality indicating outputs, especially the Critical Process Parameters (CPP) and Critical Quality Attributes (CQA). This would allow trending of parameters, so teams could take action before a specific factor became a problem, thereby avoiding costly deviations and product discards. 

Ultimately, Baxter could switch from a data collection and reconciliation mode to an analyzing and decision mode of operation. For the future, Baxter knew its CPV program could enable real time process monitoring and control as Figure 1 illustrates.

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