A digital supply chain helps ensure the quality of APIs


Accessing real or near real-time supply chain data through digitization can help formulators of branded and generic drugs monitor the quality of materials throughout the supply chain and ultimately of account, the APIs they use to produce their final pharmaceutical products.

The benefits of an interoperable supply chain are enormous and the potential gains in speed and efficiency along the value chain are enormous, according to Valerie Van Hulle, global strategic marketing manager for digital at BASF. “The process becomes much more efficient, faster and with access to real-time data,” confirms Selwyn Lustman, senior vice president of global sourcing and purchasing at LGM Pharma.

Instead of waiting for emails, phone calls, and even paper mail, businesses can instantly exchange regulatory and quality content, supply chain data, and other critical data. This capability leads to better collaboration between suppliers and manufacturers and,
ultimately, better API quality assurance, explains Van Hulle.

For example, according to Lustman, the approval of the Pre-Shipment Certificate of Analysis (CoA) done within the day and the scanned documents reaching the freight forwarder before the goods arrive at the port so that preclearance of the goods can be achieved are only two examples of the faster flow of information made possible by digitization.

In addition to allowing companies to collect and analyze data in real time, which enables decisions to be made quickly, Lustman also says digitization can facilitate traceability and transparency. This is achieved, says Van Hulle, by sharing data through electronic data interchange (EDI), application programming interfaces and other software.

“The host organization can integrate [these] data directly into their own systems, supporting their internal processes and opening the door to big data analysis, ”observes Van Hulle. “When it comes to quality,” she notes, “such advancements can help companies maintain a much higher level of transparency, traceability and precision throughout the manufacturing process and supply chain. . Companies also recognize that methods of sharing data allow for greater flexibility, she adds.

Connecting data throughout the supply chain creates a single source of truth, says Van Hulle. “Connectivity requires a common language, and essential content such as application programming interface terms and metrics would be spoken in a single language, eliminating the need to compare ‘apples and oranges’,” she asserts. This consistency would improve efficiency and improve data quality throughout the value chain.

Still premature

The digitization of API manufacturing is still premature, however, and it’s hard to say whether this process can be fully digitized, according to Lina Cogan, senior director of global sourcing and purchasing at LGM Pharma. Compared to other high-tech industries, the pharmaceutical industry has a lot of work to do, Van Hulle admits.

“Although there are pockets of digital expertise (eg modeling, advanced analysis), digital solutions have not yet been widely deployed,” says Van Hulle. Even major API manufacturers still produce drug substances in a “more manual environment,” Cogan adds, with batch records mostly handwritten and managed by on-site operators who document every activity in accordance with good manufacturing practices. current (CGMP) regulations. “API manufacturers still work manually both in production and in various laboratories and rely on their staff to document every step in order to comply with GMP regulations and requirements,” she says.

Progress is underway

Van Hulle notes, however, that organizations and people are quickly realizing the benefits of digitization and understand that customers, regulators and partners demand a higher level of connectivity. As an example, she cites BASF’s exploration of the use of virtual and remote audits of API and excipient manufacturing sites, which has been made possible through digitization, and a key innovation. during the COVID-19 pandemic to ensure a high-quality supply.

Many supply chain processes have been digitized over the past 10 to 15 years, Lustman adds. For example, at LGM Pharma, purchase orders are sent digitally and certificates of authorization for pre-shipment approval are provided digitally, so customers can ensure that the material meets their requirements. quality before shipping. In addition, he notes that most of the shipping documents from contract manufacturers are sent digitally to customers, so that they can be provided to freight forwarders and authorities for customs clearance of goods.

Another example of growing importance for biologic drugs and vaccines is the use of advanced digital trackers for cold chain shipments, according to Lustman. Trackers provide downloadable data throughout the shipment so drugmakers know their products are being delivered in the right condition. In the past, data loggers had to be sent back to the manufacturer for downloading the information, delaying the release of the API on the client side. The new technology also enables more efficient release of goods through government agencies, he adds.

Several challenges

The fact that some suppliers and manufacturers have advanced in digitalization while others still operate manually makes it difficult to share data throughout the pharmaceutical supply value chain. “Some companies are leveraging cloud systems and have fully digitized their operations, while others still rely on paper documents. It is extremely difficult to share data between systems that are not prepared to do so, let alone between different systems, ”comments Van Hulle.

“If the pharmaceutical industry is to achieve real-time data sharing, companies must first examine their end-to-end IT structures and ensure that they are ready for exchange,” says Van Hulle. Greater connectivity also requires the adoption of data sharing standards. “Common standards could speed up the connectivity process and encourage companies to invest in compatible electronic solutions,” she says. BASF is, for example, studying how ASTM and other existing standards can help make data sharing possible.

Some regulations may also need to be changed. One of the challenges of digitizing supply chain data that LGM Pharma has observed is the need for certain types of APIs, such as programmed products, to have original documentation. “The original documents must be sent by the customer to the contract manufacturer, and only after government authorities have approved them can shipments take place. This process can take several weeks, ”explains Cogan.

Strategic approach needed

According to Van Hulle, digitization should not be done to ‘go digital’, but with an emphasis on problem solving. “There is an abundance of new technologies available to support the digitization of the supply chain. Trying to implement all digital solutions can be overwhelming and lead to low impact investments, ”she observes.

Organizations should consider how digital solutions can lighten their supply.
supply chain challenges and respond to changing customer demands that can be met through digitization. “Ultimately,” concludes Van Hulle, “digitizing the supply chain is a great answer to many of these challenges and the first step in a company’s digital transformation.

Two examples of digitization

Industry vendors who recently announced digital supply chain solutions include PCI Services and MilliporeSigma.

The launch of its PCI | Bridge in fall 2020 was one of several initiatives PCI took to embed digital transformation at the heart of its business strategy, according to the company (1). The digital solution makes real-time information easily accessible to customers, including inventory, production, distribution and shipping data, presented in organized and customizable formats. The platform also has a document repository where electronic documents can be stored and accessed in one place and signatures secure on the platform.

MilliporeSigma’s eMERGE program is a standardized platform solution for data exchange via machine-readable XML format based on an existing ASTM industry standard (ASTM E3077-17), including certificates of authenticity and certificates quality (2). It is compatible with existing process monitoring and analysis systems, allowing end users to integrate raw material data directly into their internal knowledge management systems and process analysis tools for monitoring and improved analysis of production performance, better understanding of the impact of raw materials on processes and products. variability and a more efficient investigation process for out-of-specification situations.

The references

1. PCI Services, “First-of-its-Kind Digital Platform to Provide Customers with Real-Time Supply Chain Data and Analytics,” Press Release, September 28, 2020.
2. S. Wing, “Setting the Stage for Electronic Data Exchange”, MilliporeSigma White Paper, February 2021.

About the Author

Cynthia A. Challener, PhD, is Editor-in-Chief of Pharmaceutical technology.

Item details

Pharmaceutical technology
Flight. 45, n ° 8
August 2021
Pages: 22–23

Quote

When referring to this article, please cite it as C. Challener, “A Digital Supply Chain Helps Ensure API Quality”, Pharmaceutical technology, 45 (8) 2021.

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