Supplier and material qualification
Raw material quality begins with raw material suppliers, and supplier and material qualification are crucial steps for any drug manufacturing process. Quality management systems (QMS) can be useful here, says Patrick Nieuwenhuizen, senior manager and consultant at PharmaLex.
PharmaLex introduced a digital tool in November 2020 to help companies perform risk assessments of excipient interactions in the final drug product, which are required by Europe’s EudraLex Volume 4, Part III guidelines (1). “The SmartRisk tool prompts the user with a series of questions to help organize the assessment,” explains Nieuwenhuizen. He notes that the commercially available, cloud-based system complies with US Code of Federal Regulations (CFR) 21 Part 11 (2) and EudraLex Annex 11 (3), including data integrity protection.
“Having a robust quality management system with procedures and processes for raw material traceability and management supports consistency and reliability throughout the supply chain,” adds Jessica Cansler, senior quality management specialist for Nutrition & Health, North America, at BASF. “Adhering to appropriate quality standards, as well as establishing a program based on risk and application will help ensure the appropriate level of review of raw materials.”
BASF’s Virtual Pharma Assistants, introduced in 2019, are digital tools for pharmaceutical development. “ZoomLab allows formulators to predict their next starting formulation for a pharmaceutical product; RegXcellence untangles the complexity of the compliance process via instant access to regulatory and quality documentation; and MyProductWorld helps customers find the optimal excipient or API solution for their next formulation challenge,” says Valerie Van Hulle, global strategic marketing manager, Pharma Solutions, at BASF. The company continues to update the online tools, she reports.
Quality systems should not be separated in “silos” from other operations, suggests Matt Lowe, chief product officer at MasterControl, which released a new version of its life sciences QMS software on Feb. 3, 2020. “Gaining greater visibility is the first step toward ensuring traceability. Connecting your QMS with other systems and stakeholders helps provide the necessary visibility and transparency to extend a culture of quality not only across your organization, but also your supplier network. With the technology that we have today, any company should be considering a digital QMS and connecting systems in a paperless environment.”
Digitalization for raw materials handling can take many forms—from online certificates of analysis (CoAs) to electronic batch records (EBR). While the trend is toward digitalization, companies in the pharma industry are at various stages in the process, with some completely manual, others completely automated and paperless, and others in between.
Automated systems for raw materials records remove the double verification required in manual paperwork. “The system virtually does the verification for you as it can act as a ‘pass or fail’ whereby the system is working for you instead of you working for the system, which is a time savings and results in better compliance,” adds Nieuwenhuizen.
“It does take effort and time to implement digital systems,” Nieuwenhuizen cautions. He notes one example in which a company implemented a complex vendor management system that required a dedicated project team. The result, however, was the ability to link materials management and ordering with EBR, which also helped manage stock levels. Nieuwenhuizen notes that when implementing digital systems, it can be challenging and potentially counterproductive to translate manual workflows directly into digital workflows. “It may be better to embrace a new way of working and look first at how the digital tools are designed to be used,” he suggests. “The software suppliers have the knowledge about the benefits of the tool, and they can be a resource.”
Integrating digital systems
Integrating digitalized systems within a company eliminates data silos, in which data are stored in separate, unconnected digital systems. An integrated platform makes all the data in an organization accessible so that data can be analyzed to identify trends and make data-based business decisions, notes Lowe. For example, he says, if raw materials supplier data were integrated with other quality and manufacturing data, a manufacturer would have another tool to help better identify the root cause of a deviation.
Integrating QMS and laboratory inventory management systems (LIMS) is beneficial, adds Nieuwenhuizen. “Inventory control systems help with QMS. Quality control of materials can be linked to LIMS for intake, quarantine of problem batches, and release or rejection of material. An important aspect is that it gives you full traceability by batch number,” says Nieuwenhuizen. LIMS can then be interfaced to inventory control systems and to vendor management.
Inventory management and supply-chain visibility software can help with managing complex supply chains. “There are more platforms seen in the industry to alert when there is a possible supply disruption in an area due to natural disasters and other issues in the region or sourcing company,” notes Cansler.
Although data interfaces between raw materials suppliers and drug manufacturers are not yet widespread, there is a move toward sharing information so that parties can make informed decisions more quickly. Data security and confidentiality, however, are important. “Use of password protection and user vetting helps maintain confidentiality,” says Cansler. “Confidentiality can be further addressed by allowing visibility only one level up and down; [users would need to] request authorization to further review the transparency beyond their one level capability.”
Connecting supply chain management systems and QMS also improves efficiency of the supplier audit process, adds Lowe. “Manufacturing organizations need to be able to securely track and store supplier audit information, reports, deviations, supplier corrective action requests (SCARs), and more while making it easy to find suppliers that meet audit requirements.” He notes that digital audit tools within quality systems connected to supplier information allowed remote audits to take place during the COVID-19 pandemic’s travel restrictions. “A digital system can even allow you to invite suppliers to participate in tasks relevant to them, providing a secure, online collaboration space and restricted access to suppliers for collaboration and concurrent engineering efforts. For many companies, having this technology has impacted their business continuity. If there is something good that comes from COVID-19, it’s that it has illustrated the need for digitization to maintain business operations and has spurred companies to make the digital transition.”
While more companies are now embracing these well-established digital tools and systems, new data analysis tools are also being increasingly used. “Machine learning (ML) and artificial intelligence (AI) are tools that some companies are already taking advantage of, and I would expect this will be the big trend in the coming years,” suggests Lowe. “Integrating [supplier, quality, and manufacturing] systems to share information and using AI/ML and natural language processing to analyze that data will be a game-changer for companies.”
1. EC, EudraLex Volume 4, Part III, “Guidelines of 19 March 2015 on the Formalised Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use,” (Brussels, 2015).
2. CFR Title 21, Part 11.
3. EC, EudraLex Volume 4, Annex 11, “Computerised Systems,” (Brussels, 2011).
About the author
Jennifer Markarian is manufacturing editor for Pharmaceutical Technology.
Volume 45, No. 3
When referring to this article, please cite it as J. Markarian, “Digital Tools Enhance Raw Material Traceability,” Pharmaceutical Technology, 45 (3) 2021.