A digital supply chain helps ensure API quality

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Accessing supply chain data in real time or near real time through digitization can help branded and generic drug manufacturers monitor the quality of materials throughout the supply chain and ultimately the active ingredients they use to manufacture their end products.

The benefits of an interoperable supply chain are extensive, and the potential for speed and efficiency gains along the value chain is enormous, said Valerie Van Hulle, Global Strategic Marketing Manager for Digital at BASF. “The process will be much more efficient, faster and with real-time data access,” agrees Selwyn Lustman, Senior Vice President Global Sourcing and Procurement at LGM Pharma.

Instead of waiting for emails, phone calls, and even paper mail, companies can instantly share high 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, explains Van Hulle.

For example, according to Lustman, the pre-shipment Certificate-of-Analysis (CoA) approval carried out within a day and digitized documents that reach the freight forwarder before the goods arrive at the port in order to pre-dispatch the goods are just two Examples of the faster flow of information made possible by digitization.

In addition to the ability for companies to collect and analyze data in real time in order to make quick decisions, according to Lustman, digitization can also facilitate traceability and transparency. This is achieved, according to Van Hulle, by exchanging data via Electronic Data Interchange (EDI), application programming interfaces and other software.

“The receiving organization can embed [these] Data directly into their own systems, supports their internal processes and opens the door to big data analyzes, ”observes Van Hulle. “When it comes to quality,” she notes, “such advances can help companies maintain much higher levels of transparency, traceability and accuracy throughout the manufacturing and supply chain process.” Data allow greater flexibility, she adds.

Connecting data across the supply chain creates a single source of truth, claims Van Hulle. “Connectivity requires a common language, and key 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 says. This consistency would further increase efficiency and increase data quality throughout the value chain.

Still too early

However, the digitization of API manufacturing is still premature and it’s hard to say if this process can be fully digitized, according to Lina Cogan, senior director of global sourcing and procurement at LGM Pharma. In comparison to other high-tech industries, the pharmaceutical industry has a lot to do, agrees Van Hulle.

“While there is some digital know-how (e.g. modeling, advanced analytics), digital solutions have not yet been widely used,” says Van Hulle. Even leading API manufacturers still produce drugs in a more “manual” environment, Cogan adds, with batch logs that are most of the time handwritten and maintained by on-site operators who track every single activity in accordance with current Good Manufacturing Practice (CGMP.) document) regulations. “Active ingredient manufacturers still work manually both in production and in various laboratories, relying on their employees to document every single step in compliance with GMP regulations and requirements,” she says.

Progress is being made

However, Van Hulle notes that businesses and people are quick to see the benefits of digitization and understand that customers, regulators and partners are demanding higher levels of connectivity. As an example, she refers to the research into the use of virtual and remote audits of production facilities for active ingredients and excipients by BASF, which was made possible by digitization and represents a major innovation during the COVID-19 pandemic to ensure high-quality supply.

Many processes in the supply chain have been digitized in the last 10-15 years, adds Lustman. At LGM Pharma, for example, orders are sent digitally and CoAs are digitally provided for approval before shipping so that customers can ensure that the material meets their quality requirements before shipping. He also notes that most of the shipping documents from contract manufacturers are sent digitally to customers in order to make them available to freight forwarders and authorities for customs clearance.

Another example of growing importance for biological agents and vaccines is the use of advanced digital trackers for cold chain deliveries, according to Lustman. The trackers provide downloadable data throughout the shipment so that drug manufacturers know that their products are being shipped in good condition. In the past, data loggers had to be sent back to the manufacturer to download the information, which delayed the release of the API on the client side. The new technology also enables the more efficient release of goods through government agencies, he adds.

Multiple challenges

The fact that some suppliers and manufacturers have advanced digitization while others are still working manually makes it difficult to exchange data across the entire value chain of the pharmaceutical supply chain. “Some companies use cloud systems and have completely digitized their operations, while others are still dependent on paper documents. It is extremely difficult to exchange data across systems that are not ready, let alone between different systems, ”comments Van Hulle.

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

Some regulations may also need to be changed. A challenge in digitizing supply chain data that LGM Pharma has observed is the need for certain types of active ingredients, such as planned products, to have original documentation. “Original documents have to be sent by the customer to the contract manufacturer, and they can only be sent after approval by the authorities. This process can take several weeks, ”explains Cogan.

Strategic approach required

According to Van Hulle, digitization should not take place for the sake of “going digital”, but with the focus on eliminating pain points. “There is a plethora of new technologies available to support the digitization of the supply chain. Trying to implement any digital solution can be overwhelming and lead to less effective investments, ”she observes.

Companies should examine how digital solutions can make their care easier.
Chain challenges and address changing customer requirements 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 introduction of its PCI | Bridge platform in Fall 2020 was one of many initiatives PCI has taken to incorporate digital transformation as a core part of its business strategy, the company said (1). The digital solution makes real-time information easily accessible to customers, including inventory, production, sales and shipping data, presented in organized, customizable formats. The platform also has a document repository where electronic records can be stored and accessed in one place, and signatures can be secured on the platform.

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

References

1. PCI Services, “First digital platform of its kind to provide real-time supply chain data and analysis to customers,” 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. Challenger, PhD, is co-editor of Pharmaceutical technology.

Item details

Pharmaceutical technology
vol. 45, No. 8
August 2021
Pages: 22–23

citation

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


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