A Digital Supply Chain Helps Ensure API Quality

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Ensuring API quality is essential to the safety of drug products based on small-molecule
drug substances. That includes the quality of generic and branded APIs produced in-house or outsourced from contract manufacturers. The quality of raw materials, the quality culture and systems of API manufacturers, and other factors determine API quality.

Access to real-time or near-real-time supply-chain data through digitalization can help formulators of branded and generic drugs monitor the quality of materials across the entire supply chain and ultimately the APIs they use to produce their final drug products.

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

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

For instance, says Lustman, pre-shipment certificate-of-analysis (CoA) approval carried out within a day and digitalized documents reaching the forwarder before goods arrive at port so preclearance of goods can be reached are just two examples of the faster flow of information made possible with digitalization.

In addition to enabling companies to collect and analyze data in real time, allowing for decisions to be made quickly, Lustman also says that digitalization can facilitate traceability and transparency. That is achieved, Van Hulle says, by sharing data via electronic data interchanges (EDI), application programming interfaces, and other software.

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

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

Still premature

API manufacturing digitalization is, however, still premature, and it is hard to say whether this process can fully be digitalized, according to Lina Cogan, senior director of global sourcing and procurement at LGM Pharma. Compared to other high-tech industries, the pharmaceutical industry has much work to do, Van Hulle agrees.

“While there are pockets of digital expertise (e.g., modeling, advanced analytics), digital solutions have not yet been broadly deployed,” says Van Hulle. Even leading API manufacturers still produce drug substances in a more “manual environment”, adds Cogan, with batch records handwritten most of the time and handled by operators on the spot who document each and every activity as required according to current good manufacturing practice (CGMP) regulations. “API manufacturers still work manually both in production and various labs and rely on their people to document each and every step to comply with GMP regulations and requirements,” she says.

Progress is being made

Van Hulle does note, however, that organizations and people are quickly realizing the benefits of digitalization and understand that customers, regulatory authorities, and partners are demanding a greater level of connectivity. As an example, she points to BASF’s exploration of the use of both virtual and remote audits of API and excipient manufacturing sites, which was enabled through digitalization, and an essential innovation during the COVID-19 pandemic to ensure high quality supply.

Many processes in the supply chain have be digitalized over the past 10–15 years, Lustman adds. For instance, at LGM Pharma, purchase orders are sent digitally, and CoAs for pre-shipment approval are provided digitally, so clients can ensure that material meets their quality requirements before shipment. In addition, he notes that most shipping documents from contract manufacturers are sent digitally to clients, so they can be provided to forwarders and authorities for release of the goods from customs.

Another example of increasing importance for biologic drug substances and vaccines is the use of advanced digital trackers for cold-chain shipments, according to Lustman. The trackers provide downloadable data throughout shipment so drug manufacturers know their products are delivered in good conditions. In the past, data loggers had to be sent back to the manufacturer for downloading of the information, delaying the release of the API on the client side. The new technology allows more efficient release of goods via government agencies as well, he adds.

Several challenges

The fact that some suppliers and manufacturers have progressed with digitalization while others still operate manually makes sharing data across the pharma supply value chain difficult. “Some companies are leveraging cloud systems and have fully digitized their operations while others are still relying on paper records. It is extremely challenging to share data across systems that are not prepared to do so, let alone between different systems,” Van Hulle comments.

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

Some regulations may also need to change. One challenge to digitalization of supply-chain data that LGM Pharma has observed is the need for certain types of APIs, such as scheduled products, to have original documentation. “Original documents have to be sent from the client to the contract manufacturer, and only once government authorities approve them can shipments take place. This process can take several weeks,” Cogan explains.

Strategic approach needed

Digitalization should not be done for the sake of “going digital” but with a focus on addressing pain points, according to Van Hulle. “There is an abundance of new technologies available to support supply chain digitalization. Attempting to implement every digital solution can be overwhelming and lead to less-than-impactful investments,” she observes.

Organizations should look at how digital solutions can alleviate their supply-chain challenges and address evolving customer demands that can be met through digitalization. “Ultimately,” Van Hulle concludes, “digitalization of the supply chain is a great answer to many of these challenges and the first step in a company’s digital transformation.”

Two digitalization examples

Industry suppliers that have recently announced digital supply-chain solutions include PCI Services and MilliporeSigma.

The launch of its pci | bridge platform in the fall of 2020 was one of many initiatives that PCI has undertaken to incorporate digital transformation as core to its business strategy, according the company (1). The digital solution makes real-time information readily accessible to clients including inventory, production, distribution, and shipping data, presented in organized, customizable formats. The platform also features a document repository where electronic paperwork can be stored and accessed in one place and signatures secured on the platform.

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

References

1. PCI Services, “First-of-its-Kind Digital Platform to Provide Clients with Real-Time Supply Chain Data and Analytics,” Press Release, Sept. 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 a contributing editor to Pharmaceutical Technology.

Article Details

Pharmaceutical Technology
Vol. 45, No. 8
August 2021
Pages: 22–23

Citation

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