STADA + Celonis

The batch release process helping STADA deliver life-saving meds, fast

Quality and speed sometimes feel like opposites. But when you’re delivering life-saving medicine, the two must go hand-in-hand.

While the quality of their product was exemplary, pharmaceutical company STADA’s processes for batch-releasing their life-saving medicines to market were fragmented, slowing down throughput and release times.

Knowing the importance of getting vital medicines into market quickly for patients, STADA’s batch release process had to be smoother to be faster. They started with the root cause of the problem – disconnected departments and scattered data.

Fragmented processes obscured potential batch release process improvements

Batch release is the final stage of the pharmaceutical manufacturing process: when the entire batch of medicine has met quality, safety, and regulatory standards before its release.

“[It’s] a cross-functional effort, meaning many stakeholders – from quality assurance and global quality teams to supply chain and logistics – are involved,” says Marijana Panic, STADA’s Director of Global Quality EU Release.

The process requires multiple teams to compile and review all the documentation generated during the manufacturing and analytical processes, ensuring everything is correct. After that, the Qualified Person will certify the batch and approve it to be put on the market.

Further complicating matters, “We were working with different text files, different documentation systems, and compiling the documentation and the information from different parts,” adds Monica Aragoneses, STADA’s Cluster Quality Head of Eastern Manufacturing Operations.

With multiple stakeholders in various departments using a variety of documentation systems, it was a challenge for the STADA teams to pinpoint where the disconnects and slowdowns were occurring in their batch release process. And because each documentation step and departmental handoff was manual, prioritization was slow.

Unified data, automations, and increased collaboration

STADA needed a better way for departments to collaborate, for more people within those departments to have visibility into the batch release process, and for slow manual processes to be automated – all while maintaining high standards.

Having brought the Celonis Platform into STADA’s operations in 2021 teams were already using process mining to tackle their most standard transactional processes, such as Accounts Payable.

Gathering “golden nuggets” – proving value and showing quick wins – STADA took their learnings and expanded the use of Celonis across several departments.

“Prior to Celonis, we relied on manual data entry into spreadsheets. Now with Celonis, we have a full digital dashboard with real-time insight into various parameters, and we can organize our processes and resources to release our product faster to patients,” Monica says.

The result has been improved visibility and a more streamlined batch release process thanks to automation.

“Colleagues were working in a manual way – sending emails, requesting missing information – this has now been almost fully automated. With the click of a button, emails or requests are being automatically sent out from the system,” says Vladimir Grad, STADA’s Center of Excellence Director.

With unified data, greater visibility, and a single source of truth, Vladimir sees other opportunities for automation in the batch release process, delivering more value to the business in the future, especially as they explore AI.

“My goal is to work on rolling out the successful solution we have for quality to further countries and further clusters. Then also to work on diversifying our use case portfolio, identifying and working together with other teams to deliver high-impact use cases.”

Process Intelligence improves batch release process by 20%

Today, STADA is no longer using spreadsheets or relying on other manual operations to get products approved and into the market.

“We managed to shift from a manually fragmented process to a digital twin of this process. All manual steps have been eliminated and we have over 100 users working together on a daily basis,” says Vladimir.

As a result, throughput times are down 44%. Additionally, STADA has seen on-time batch releases improve by 20%.

While metrics like these always matter, they’re crucial when working with medicine. Especially when results become personal.

When Monica’s own father became ill, the improvements STADA was making in their processes became even more real for her.

“Years ago, my father needed oncological medication,” she says. “Sometimes, we are just reviewing documentation, clicking something in the system, and putting the product in the market. We are not always aware of how important that is. But having access to the medicines on time is super important.”

While urgency varies among common OTC products to life-saving medicine, Monica’s personal story drives home how timely access to medicine is paramount for all patients. Thanks to Celonis, STADA is achieving this crucial speed, ensuring STADA is living up to its mission.