Data and the Supply Chain

The COVID-19 pandemic has highlighted the challenges and complications of sourcing, tracking, and testing materials for pharmaceuticals. Pharmaceutical Technology spoke with Joe DiMartino, Luminata solution manager at ACD/Labs about the impact COVID-19 is having on the pharmaceutical supply chain and how companies can prepare for these challenges.

PharmTech: The COVID-19 pandemic has highlighted potential gaps in the pharmaceutical supply chain. What changes must the pharma industry make in the short-term—and in the long-term—to ensure the quality of APIs, excipients, and final drug products?

DiMartino:Many stakeholders are traditionally challenged with accelerating clinical testing and commercialization timelines. This is especially pertinent today, when considering the aspirational goal of reducing the clinical trial and regulatory submission/approval timelines to support the COVID-19 infected patient’s needs.

Modern informatics technologies are needed to reduce both the reliance on document-driven decision making and human effort-dependent decision/approval points.

PharmTech: What steps should sponsor companies and contract manufacturers take to ensure they have a sufficient supply of API and raw materials to sustain production during a potential regional or global disruption to the supply chain?

DiMartino: To ensure that the sponsor company and contract manufacturer are meeting sufficient supply, they need a communication plan. Particularly, with what has been completed and the ability to measure what they have done with the data-driven documentation. Things have arisen in the past where a contract manufacturer has changed a step in the sponsor’s process and this had global consequences to the supply chain. These issues could be prevented by using software that focuses on all analytical data associated with the batch material.

PharmTech: What measures should sponsor companies take to ensure an appropriate supply of materials during fluctuations in demand of certain types of drugs?

DiMartino: Currently, there are supply chain systems that focus on production planning, demand planning, and location of batches. When we think of appropriate supply we shouldn’t be thinking only quantity of material but also quality. While the systems I mentioned earlier may help organizations with quantity, the way batch data [are] currently managed means there is a disconnect with the analytical data that can speak to quality of batches, which is equally important.

Manufacturers need to know if all batches are consistent in their content, and this becomes a crucial element when there are multiple contract manufacturing partners.

PharmTech: Do you foresee changes in global regulations of the supply chain to address complications that can be caused by a crisis similar to a pandemic?

DiMartino: Global regulations already have measures in place for fast track, priority review, and accelerated approval. These digital systems capture all of the pertinent data used in preparing the human readable reports, which supports the QA [quality assurance] review-and-approval release step.

I do believe that storing and managing ‘structured’ datasets in persistent data management systems would help QA staff perform any type of follow up queries to create any further reports.

PharmTech: How does a company track the chain of materials from the original manufacturing site?

DiMartino: There are systems that currently track the chain of materials from the original manufacturing site to the sponsor company site. Luminata offers a ‘manufacturing process-to-data’ association that is missing today. The ability to view the supply chain in one place, where not just meta data [are] associated to a batch, but also all analytical data [are] associated to prevent any issues from arising. For example, the genotoxic impurity that caused the recall of Valsartan.

PharmTech: Do virtual inspections of API, excipient, and materials suppliers impede the ability to ensure a safe, secure supply chain?

DiMartino: It becomes quite difficult if the sponsor company is doing virtual inspections. They would need to have experienced group members and an informatics platform that they can easily access and identify if any batches have unexpected impurities in the supply chain.