Moving Batch Release Into the Fast Lane

May 16, 2025 | Mike Edwards

Speeding products to market requires a precise balance between efficiency and compliance. By streamlining complex workflows, a centralized and automated approach to batch release will improve patient access to innovative treatments.

Novel therapies offer the exciting prospect of treatments for previously incurable diseases. Since many of these are greenfield, life sciences companies must grapple with new suppliers and processes for manufacturing and testing while ensuring continuous control and visibility.

Speed is critical for patients waiting for innovative treatments. However, complex supply chains challenge organizations to keep efficiency and compliance in constant equilibrium. Quality leaders are responsible for delivering products to market that meet the required standards, but typically make batch release decisions by pulling electronic records from several disconnected systems. This fragmented approach is counterproductive to revenue goals, introducing regulatory and data integrity risks that lengthen overall time to market.

Better outcomes are achievable when data aggregation and review are automated and centralized. A more effective approach is to ensure that the disposition owner can collate and view all relevant content and data in one place. Reducing the number of steps in the batch release process would result in fewer errors and more batches being processed each month. By moving away from manual activities, quality leaders will improve the likelihood that batches go to the right markets at the right time — and with fewer deviations.

Novel science, new problems

Life sciences companies are broadening their remit to new modalities, such as cell and gene therapies, which introduce complexities including variable materials, limited batches, and shorter shelf lives, to name a few. These factors significantly increase regulatory scrutiny and operational challenges, making oversight critical to timely patient access.

Whether key activities happen in-house or are undertaken by external partners, quality leaders are responsible for their outcomes. They must ensure that each batch of medicinal product is manufactured and tested in accordance with Good Manufacturing Practice (GMP). Even virtual companies that don’t own manufacturing facilities and heavily outsource are ultimately responsible for their products. As supplier processes vary significantly, comprehensive oversight is critical to the disposition owner’s decision on accepting the batch.

Revenue goals out of reach

Once a product is patented, the countdown begins on its exclusivity. Any delay in post-manufacturing batch release lengthens the time to market and could impact financial metrics.

Until recently, companies lacked an efficient in-house option to bring together quality control (QC) testing, batch documentation review, quality assurance (QA) assessment, and regulatory compliance. Some relied on application programming interfaces (APIs) to overcome silos in their technology landscape. Larger biopharmas often customized their on-premises solutions with embedded digital forms that pulled data into their enterprise resource planning (ERP) system.

The risks of these fragmented batch release methods are now apparent. Disconnected systems introduce compliance risks due to human error: teams complete batch dispositions in one system, manage deviations in another, and then check against a digital report. Given unclear processes and obscure turnaround times, it’s difficult to identify who is responsible for fixing problems if something goes wrong. Relying on integrations for data aggregation and review undermines data integrity, as disposition owners cannot be sure they are reviewing the latest data.

Slower batch release undermines the return on investment (ROI). Without visibility of the end-to-end batch release process, quality leaders won’t know which improvements to prioritize.

An end to batch release bottlenecks

An automated and centralized approach to data would result in fewer errors and delays. For example, access to real-time data from regulatory information management systems and other quality applications (such as document management and laboratory information management systems) means quality leaders can make faster batch release decisions [Figure 1].

Figure 1: Automating end-to-end batch release

Source: Veeva Systems

With better visibility, quality leaders can scale their activities compliantly. First, a centralized system saves significant time when querying. Once manufacturing is complete, batches are pulled from the ERP into the system for disposition, and then a plan is populated with checks for that specific batch [Figure 2]. In theory, there are hundreds of variations of checks, but because of the connections to other applications, the disposition owner will know exactly what to look for. They can automatically retrieve the right content and data: for example, from Veeva QMS for deviations and change control, Veeva QualityDocs for certificates and reports, Veeva LIMS for lab testing, and Veeva RIM for market approvals (as well as external systems through APIs).

 

Figure 2: Saving time during querying

Source: Veeva Systems

Second, being able to trace decisions to source data removes a key driver of uncertainty and delay. Disposition owners used to monitor batch release status until regulatory and quality completed all their activities to license products in different markets (i.e., managing change controls in QMS and regulatory impact assessments in RIM that required reapproval in every country). Under this approach, the change control remained open, and all batches were held at the figurative ‘Stop’ sign until health authority (HA) approvals had been received from all countries.

With traceability to source data, companies can make shipping decisions efficiently and compliantly by following a ‘traffic light’ approach for each batch. They can implement change orders and release automatically once a batch meets the necessary criteria.

Greater control, faster delivery

Any delay to batch release impacts patient access by lengthening the time to market and undermining ROI.

Digital solutions reduce compliance and data risks, empowering quality leaders to make quick and correct decisions. Through real-time data and full visibility of the batch disposition process, they can ensure every batch goes to the right market at the right time.

Join us at Veeva R&D and Quality Summit to learn practical strategies and solutions to optimize your batch release processes, accelerate time to market, and deliver better patient outcomes.