Electronic Batch Record Design Considerations

Emerson's Heather SchwaljeLast week, the 2nd International Summit on GMP, GCP & Quality Control was held in Chicago, Illinois USA. Emerson’s Heather Schwalje, a senior Life Sciences consultant, presented Moving beyond part 11; Quality assurance considerations for translating Current Good Manufacturing Practices (cGMP) compliance into Electronic Batch Record (eBR) initiatives.

Her discussion centered around three areas: eBR definition and ISA/ANSI-95 system models, eBR strategy, and designing your process for GMP compliance through the batch records and reporting.

Electronic batch records fit in level 3, manufacturing operations management of the ISA-95 model where dispatching production, detail production scheduling, reliability assurance, and more manufacturing execution functions are performed.

Electronic-Batch-Records-ANSI-ISA-95-Level-3

Some of the specific work processes impacted by the implementation of eBR include:

  • Orders, Materials, Equipment, & Batch Execution Management
  • Batch Record Review
  • Sample & Test Management
  • Deviations Process
  • Release Process

Optimizing these processes translates into improved resource management, improved inventory management, and reduced material losses. All of these directly impact the operation’s bottom line.

Defining the strategy for how to achieve these efficiency gains begins with the organizational goals and vision. Are you seeking paperless operations? Are there opportunities to reduce non-value add activities in the workflows? Is knowledge being captured throughout the product lifecycle as part of the process, especially for manufacturers with multiple sites?

With the base-level questions to clarify the business objective and vision, it’s important to get all the key users and stakeholders involved as the design of the vision takes place. It’s important to apply risk management techniques during the process to make sure the efforts to reach the vision are commensurate with the risks.

FDA-Pharmaceutical-cGMPsHeather raised the important point of how to design for review by exception. It’s important to pre-define exception cases, perhaps based on the history of ones with the current work processes. Ensure that the handling these defined exceptions address the GMP requirements and use the integration points of a solution to eliminate errors associated with data handoffs, transcriptions, and other manual processes.

She shared two examples of GMPs for equipment and GMPs for Production and Process Control. I’ll highlight the equipment example. The requirements might be that the equipment is cleaned and maintained with written procedures including schedules, methods, equipment and materials, and responsibilities, including visual inspection of equipment for cleanliness immediately before use.

Design considerations to meet these requirements might be that the equipment and controlled room activity and events can be logged automatically and integrated with the eBR to confirm appropriate status prior to use. A second consideration might be that different equipment classes could be created based on criticality and level of cleaning, sanitization or sterilization required. Another consideration might be that the eBR workflow could include pathways for taking samples associated with cleaning validation and routine events where a dirty hold time is expired.

With these considerations fleshed out and reviewed with the stakeholders, the integrated eBR can begin to take shape. No matter how automated the process, human interactions will still be required for critical interventions, visual inspections, electronic signatures, and manual entry, and entry checks.

From a reporting standpoint, it’s important to have a clear set of end user requirement and definition. All appropriate data is defined, is accessible, and has context with what it means relative to the process and workflow. The exceptions that can be automatically dealt with should be incorporated into the eBR. The batch summary and associated batch details should be designed with the requirements of the product reviewer in mind.

Since changing work processes to a more automated approach involves people, there will be challenges in the transition to address. The first is to overcome the status quo of historical practices and attitudes, reactive programs, and the need to evolve current skill sets. A second big challenge is change management. How with the new procedures and associated training be introduced? What validation will be required and will it be an all or nothing process.

With early involvement of stakeholders and the benefits identified, this change can be successfully managed. These benefits may include decreased deviations, decreased inventory and storage levels, increased throughput, decreased batch record review and release times, and greater availability to make process improvements instead of reactive exception clearing activities.

You can join in discussions with Heather and the Life Science consultants in the Life Sciences track of the Emerson Exchange 365 community.

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