The ultimate goal of any life sciences company is to produce accurate, high-quality products to save patients’ lives and implement sustainable practices to reduce resource consumption and address climate change. Therefore, proper quality processes must be in place to control possible manufacturing issues, chemical contamination, the presence of impurities, and beyond.
The batch release process is one such process – a necessary stopgap to ensure life sciences products were produced according to manufacturing requirements and meet the closely controlled regulations around distribution. During batch release, quality assurance and operations teams can identify deviations before the product is released to the market.
A non-compliant batch can have an irreversible and unforgiving impact on valuable human lives and the environment. A faulty product can cause physical harm or even death. Because people’s lives are at stake, the life sciences industry needs to be strictly regulated.
In 2021, there were 78 product recalls reported to the Food and Drug Administration (FDA). Failure to effectively manage this process is not only critical to protecting lives but can introduce a potential health hazard to patients, requiring a batch recall. According to McKinsey, a single warranty or recall process can cost the manufacturer up to US$600 million. This does not include other recall-related costs like lawsuits.
A product recall can cause consumer and investor confidence to fall, resulting in a decline in revenue and stock prices. For example, the same McKinsey study estimated a 13% drop in stock prices across the industry, triggered by product recalls. In fact, the total annual cost for the life sciences industry can exceed $5 billion. That doesn’t even consider the credibility costs.
Such recalls can have huge costs to a life sciences company and its brand reputation, in addition to inflicting harm to patients and damage to the environment due to waste.
Based on SAP working with leading pharmaceutical companies, it takes a working group of quality control professionals around 40 hours to determine the release decision for one single batch. While vital to protect consumers, this process requires a significant amount of time, can impact a business’ overall supply chain, and requires consistent manual collection and evaluation of cumbersome data from different siloed systems. This slows down the overall supply chain performance and order fulfillment lead time, resulting in higher levels of inventory carrying costs.
With growing market trends demanding faster supply chains, highly personalized batch-size-one types of products, and more tightened regulations, it is critical to take steps to de-risk, speed up, and scale up the batch release process and do so without compromising quality or safety.
SAP has undertaken the development of an industry standard together with two leading global pharmaceutical companies. SAP realized that the process deserves not only closer scrutiny, but an end-to-end re-engineering to replace the inefficient, legacy, labor-intensive manual process with a digital platform, eliminating manually pooling information from non-integrated systems.
In this context, SAP has launched the SAP Batch Release Hub for Life Sciences solution, which helps address life sciences organizations’ unmet market need for transparent, flexible, integrated, and efficient batch release management.
SAP Batch Release Hub for Life Sciences is an innovative cloud solution developed on SAP Business Technology Platform. It is designed to semantically integrate with existing heterogeneous SAP and third-party solutions – both on premise and in the cloud – with a unique integration data model that can help make faster and more secure batch release decisions.
It receives the release check data required to release a batch from various source systems, automatically evaluates it against predefined criteria, and visualizes the results into a cockpit to enable a faster and more intuitive decision-making process.
Based on SAP’s leading technology, the solution is a digital hub that helps provide qualified persons and release-responsible persons with the intelligent tools to streamline and simplify the full batch release procedure to make fast and accurate batch usage decisions. The reduction of review cycle times enables scalability through data collection and evaluation automation while retaining compliance. Digital batch release supports preventive actions to enable a life sciences company to produce the right product the first time, minimizing the CO2 footprint associated with replenishment and recall of a non-compliant batch.
With the solution, life sciences organizations can:
- Reduce the risk of quality non-compliance by standardizing and simplifying the batch release process, reducing the risk of human errors.
- Reduce compliance and risk management costs by automating and simplifying the time-consuming and labor-intensive legacy batch release activities.
- Reduce order fulfillment lead time by enabling a faster batch release cycle time, thanks to automation and standardization.
- Reduce inventory carrying costs and the environmental impact of excessive inventory by reducing the required level of inventory with lower order fulfillment lead times.
The SAP Batch Release Hub for Life Sciences solution is the latest life sciences innovation from SAP and serves as an important pillar in the SAP for Life Sciences solution portfolio. SAP Batch Release Hub for Life Sciences helps extend the enablement of the Intelligent Enterprise by bringing software intelligence to the core process of batch release for life sciences products.
Aladdin Mandishah is global industry solutions manager for Life Sciences at SAP.