Posted on Lab Informatics. 22 October, 2018
In an effort to ensure product quality and patient safety, the pharmaceutical and biotech industries are governed by strict regulations. As part of these regulations, the FDA requires that detailed production records be kept for each batch of a product produced by a pharmaceutical company. These records need to be accessible to regulators and can be used to confirm that raw material inventory is properly controlled, relevant procedures have been followed, necessary quality checks have been performed, and employee identities and training levels are verified.
Batch record documents tend to be large and complex, and many companies still use manual processes to capture this information. As these manual processes are inefficient and can lead to data integrity issues and other errors, Electronic batch record (EBR) systems have been implemented by many organizations to automate the execution and review of batch records. EBRs can provide significant compliance and cost saving benefits for pharmaceutical manufacturers.
While EBRs are a significant improvement over manual processes, integrating electronic batch record solutions with other enterprise systems (e.g., LIMS, ERP, MES, etc.) enables much better control over the capture and analysis of batch data. In this blog, we will discuss some of the benefits of EBRs, as well as benefits of integrating EBRs with other enterprise systems.
Electronic Batch Records
Producing the mountains of paperwork required for production batch records is a time-consuming and error-prone process that often extends release time. Electronic batch record systems demonstrate accountability by providing proof of proper handling for every step in the production of each batch of a drug product. EBRs help to reduce production time cycles, while improving the quality of the batch and the accuracy of the batch record.
Modern EBRs are evolving beyond paper-on-glass to provide more advanced features. Some of the benefits afforded by implementing modern EBRs in GMP-regulated industries include:
Benefits of EBR Integration with Enterprise Systems
An electronic batch record solution provides documentation that an organization has followed all applicable regulations in the production of each batch of product. These records contain data that is associated with materials, supplies, equipment, operators and the manufacturing process. It can also include data from laboratory information management systems (LIMS), enterprise resource planning (ERP), and other enterprise systems.
Integration between the batch record system and other enterprise systems is necessary to optimize batch reporting. This integration allows the EBR to be continually updated with information (e.g., test procedure execution, environmental monitoring, resource planning, manufacturing execution, etc.) that become part of the batch record.
Pharmaceutical manufacturers need to think about all of the data generated in the process of manufacturing from the perspective of the overall organizational workflow. If the EBR is thought of as the central system of record, then integration with enterprise systems allows data from the relevant system to be presented to the user in the correct context. For example, an integrated system can monitor manufacturing activity in real time, checking for anything out of specification over several batches of product. If a deviation is noted, the system can automatically send alerts so adjustments can be made before the entire batch goes out of spec.
Integration of EBR systems with LIMS is particularly important for access to quality assurance (QA) data in order to investigate manufacturing deviations. The reality in manufacturing is that one sample never represents the entirety of one batch. Additionally, batches may be processed in multiple equipment at any stage. Given that high volume processing inevitably produces product that is off-spec for a short period of time, tracking all the variables to conduct an investigation into a deviation becomes problematic without LIMS/EBR integration.
Access to QA data in the LIMS allows investigators to perform a thorough analysis relatively quickly to identify the source of the deviation, allowing for the creation of split batch sub-lots. This can help to facilitate the maximum amount of product being released for distribution, effectively minimizing waste. This kind of analysis would be virtually impossible without access to a LIMS database – the entire lot would need to be quarantined pending a lengthy investigation.
Best Practices for a Successful EBR Deployment
Selecting, implementing and integrating an EBR solution can be a challenging endeavor. In order to successfully implement an EBR solution, a comprehensive and proven methodology should be followed. This methodology should include strategic planning that leverages a workflow and business analysis to maximize business value for your organization.
Once a set of optimized future-state requirements are generated, it is it is important to design a laboratory informatics architecture that is aligned with business goals, along with a roadmap to deployment, before engaging in a proper technology selection process for your organization.
When evaluating EBR technology, a solution with a configurable business process engine should be prioritized, as this will allow the system to be integrated with various other enterprise systems to support the free flow of information across the enterprise. The project team should have knowledge of the data formats of the informatics systems to be integrated, along with experience deploying complex solutions in a validated environment.
An electronic batch record solution provides a significant opportunity for GMP manufacturers to reduce risk and improve the compliance, efficiency and flexibility of their manufacturing operations. When deploying an EBR system to replace paper, pharmaceutical companies should make the most of their investment by going well beyond a simple paper-on-glass approach. Although the considerations for such an implementation project are not trivial, the risks and expenses of not properly implementing and integrating a modern EBR solution far outweigh the costs of the project.
Astrix is a laboratory informatics consulting firm that has been serving the scientific community since 1995. If you would like to have an initial, no obligations consultation with an Astrix informatics expert to discuss your EBR project or your overall laboratory informatics strategy, please feel free to contact us.
About the Author
|Jeff Policastro is Vice President of Business Development and Strategy at Astrix, and he is responsible for the commercial growth and market strategy of the Professional Services Division. He has more than two decades of experience in Quality informatics throughout the global life sciences, chemical, and consumer goods industries. He has an extensive track record driving success and delivering value to his client’s projects.|
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