Manufacturers can streamline and speed the batch release process by embracing these three digital fundamentals

As of late November 2024, the US Food & Drug Administration had recorded 46 voluntary drug recalls in the United States during the year, down slightly from previous years – an indication that pharmaceutical companies are indeed improving at quality control overall, and at batch release in particular.

But for an industry in which 46 recalls is 46 too many, given the potentially immense costs these incidents can exact, the push for better batch release continues. For too long, a reliance on siloed systems, spreadsheets, and error-prone manual processes has caused breakdowns somewhere in the batch release process, leading to recalls that can cost a company millions of dollars in direct and indirect costs.

In internal research here at SAP, we found that almost half (48%) of life sciences companies use manual processes for batch release and 35% check data in multiple siloed systems during the batch release process. In some cases, the systems that play a role in batch release — LIMS (laboratory information management system), MES (manufacturing execution system), ERP (enterprise resource planning) system, RIMS (regulatory information management system) and so on — are difficult to scale across multiple facilities because they’re highly customised.

Oftentimes these systems lack the integrations needed to create the lines of sight a company must have to efficiently manage batch release from discovery and development, through manufacturing and distribution. And, in many instances, processes that demand precision, standardisation, and accuracy lack all three and instead rely on paper-shuffling and manual data entry. All this creates inefficiencies, delays, waste, errors, difficulties with jurisdiction control, and ultimately less than optimal outcomes for companies and consumers.

There is a better way to do batch release, one that does away with siloed systems and cumbersome, inefficient manual processes in favour of a streamlined, highly automated end-to-end approach. With such a shift, batch release becomes a positive force within a company, rather than a drag on the business.

But where to start, in terms of upgrades that can provide the most bang for the buck? Here are three areas companies could target as a starting point for reinventing batch release.

1. Digitalisation of processes.

The first and most crucial step to streamlining batch release is to digitalise processes and documentation. An internal analysis here at SAP suggests that streamlining and digitising batch release processes can reduce overall batch review cycle time by more than 90%, giving companies the ability to bring more products to market, faster, with shorter order fulfillment lead times. The idea here is to create an integrated digital environment and a single source of truth for all the parties and moving parts involved in batch release.

2. A centralised hub in the cloud.

The aforementioned digital environment functions as a batch release control tower or eye-in-the-sky that ties together all the systems, processes, and teams involved in batch release. The hub affords quality managers, quality assurance teams, and qualified persons a holistic 360° view across the entire batch release landscape internally and across the supply chain, including LIMS, MES, RIMS, etc. They’re all part of a unified digital environment that enables people to rapidly analyse data to make quicker, better informed decisions throughout every step of the process.

Having such a hub gives quality assurance teams the means to more readily detect deviations early in the process, identify erroneous batches, and pinpoint the source of the error. Quality teams have all the information and tools they need, right in front of them, to rapidly analyse exceptions and make decisions about batches accordingly.

Another advantage of a centralised hub is that it enables manufacturers to bring much-needed standardisation within and across quality teams and departments, and with contract manufacturers and suppliers. Using the hub, a manufacturer can apply and enforce various automated checkpoints and standardised practices throughout the entire batch release process to ensure GxP compliance, as well as jurisdictional compliance.

There are benefits to having this batch release control tower housed in the cloud. The ability to scale all the capabilities encompassed by the hub across facilities in multiple locations is one. New analytics and modelling tools can also readily be integrated into the control tower and scaled across the business as they become available.

What’s more, because the new generation of artificial intelligence-driven capabilities to improve batch release processes require a vast amount of computing power, most of them reside in the cloud.

3. Integrating AI.

We’ve only begun to scratch the surface of what artificial intelligence can do to make batch release a faster, more automated, and less costly process. With the help of a generative AI, for example, a qualified person can quickly access and parse all the relevant jurisdictional regulations, compliance documents, and other requirements associated with a specific product and batch, saving them a massive amount of time.

Intelligent automation tools can also help quality assurance teams collect data from disparate sources (material suppliers, laboratories, manufacturing facilities, distributors, and the like), then analyse that data to evaluate exceptions and facilitate faster, more informed decisions. What’s more, intelligent automations embedded in the process can enable manufacturers to shift to a review-by-exception approach to evaluating batches.

AI-powered track-and-trace tools can also help companies fulfill their sustainability and carbon-reduction responsibilities and goals by gathering and managing data on the make-up, origin, and attributes of materials and end products, as well as the resource consumption and carbon footprint associated with manufacturing specific products. Through the control tower, manufacturers can embed sustainability-related KPIs across the business.

With these three technological cornerstones in place, batch release becomes a powerful engine for growth and efficiency. Reduced cycle times mean products get to market faster. More right-first-time releases translate into less waste and a lower carbon footprint, as well as reduced production and inventory carrying and scrappage costs, along with lower overall quality-related costs. An SAP value analysis study found that a 5% reduction in quality costs for a company with operating expenses of $80 million to $100 million can result in an average of $5 million in sustainable cost savings, while shorter order fulfillment lead times can cut inventory carrying costs by up to 25%.

All this points to a future in which, thanks to intelligent capabilities and automation, batches can be approved for release in a matter of days or even hours, with significantly lower risk of recall.