SUMMARY
Proper handling of data is essential to the future of the pharmaceutical supply chain. With deadlines for complying to the DSCSA looming, packaging producers in the pharmaceutical industry need to create alignment of data and product. The Eli Lily debacle serves as a warning against the specter of non-compliance. By automating critical processes like data collection, data traceability, data management and quality control, a pharma packaging manufacturer can stay ahead of audits and be worry-free.
Are you prepared for the November 2024 deadline for the Drug Supply Chain Security Act (DSCSA)?
The most important event of the year for the packaging industry will be the Drug Supply Chain Security Act (DSCSA) compliance deadline in November.
As the pharmaceutical industry and the industry’s contract packagers gears up for the final phase of compliance with the Drug Supply Chain Security Act (DSCSA), packaging stakeholders find themselves at the forefront of ensuring adherence to track-and-trace regulations. With the November 2024 deadline looming, it’s crucial for pharma packaging companies to assess their readiness and implement necessary measures to meet compliance requirements.
What is the DCSCA?
The DSCSA mandates that all stakeholders involved in the creation, packaging, distribution, or dispensing of prescription drugs comply with stringent regulations aimed at enhancing drug supply chain security. This includes serialization of prescription drug products at the unit level, maintaining detailed transaction records, and establishing a robust product tracing system.
DSCSA Requirements
The act established the following requirements:
1. Every organization must ensure that all prior transaction information is provided at each ownership transfer.
2. If a recall takes place, or for the purpose of investigating a suspect product or an illegitimate product, all organizations must provide the applicable transaction documentation upon request.
3. Manufacturers and packaging companies must affix or imprint a product identifier on each package and homogeneous case intended to be introduced in a transaction into commerce except for products that must have a standardized numerical identifier.
4. Every organization must ensure that each of their trading partners is authorized. Every organization must implement systems to: Investigate suspect products; and handle illegitimate products, including through quarantine, disposal, & proper notice.
5. Manufacturers, wholesale distributors, and packaging companies must verify returned products before further distribution.
In a few months from now, the pharmaceutical packaging ecosystem must be ready to provide data on origin, destination, and movement through the supply chain of any pharmaceutical product. The Partnership for DSCSA Governance (PDG) recently released new guidelines that provide insight into how DSCSA regulations will be implemented, with specific information on compliance requirements.
Ensuring the accuracy and accessibility of data in the pharmaceutical supply chain is critical not just for today, but also for the future. DSCSA guidelines require all supply chain partners to maintain a complete electronic record of the transaction history for each drug product they handle, including the product’s ownership and movement through the supply chain.
All stakeholders in the drug supply chain must adopt robust data management systems and processes to ensure the accurate and timely sharing of critical information and to minimize the risk of data transport failures or data corruption. What’s needed is the deployment of a configurable, scalable process built to meet compliance requirements.
What does this mean for pharma packaging companies?
Meeting DSCSA requirements poses several challenges for packaging companies, particularly in terms of data management and reporting. However, solutions such as implementing advanced IT systems, training personnel, and enhancing data collection and reporting practices can help streamline compliance efforts and mitigate risks of fines, product recalls, and reputational damage.
Data accuracy and accessibility is paramount
Stakeholders must adopt robust data management systems and processes to facilitate timely sharing of critical information and minimize the risk of data transport failures or corruption to comply with DCSCA guidelines.
Deploying configurable and scalable data management solutions tailored to meet integration and compliance requirements is essential for navigating the complexities of DSCSA compliance. By leveraging technology, packaging companies can enhance data accuracy, streamline reporting processes, and ensure seamless communication across the supply chain.
As the deadline for DSCSA compliance approaches, packaging companies must prioritize readiness and implementation of necessary measures to meet regulatory requirements. By understanding DSCSA guidelines, addressing compliance challenges, and leveraging technology solutions, pharma packaging stakeholders can navigate the regulatory landscape with confidence, ensuring the security and integrity of the drug supply chain.
An MIS/ERP Helps Achieve Regulatory Compliance Goals
The ramifications of non-compliance with regulatory standards in the packaging industry can be severe. Suppose one batch of a product is contaminated or unsafe; swift and accurate identification of distribution channels becomes paramount to mitigate risks and protect consumer health. Failure to comply with product tracing regulations not only invites fines but also triggers product recalls and tarnishes a company’s reputation.
This is exactly what happened in 2022—and again in 2024—to Eli Lilly.
In January 2024, Eli Lilly’s beleaguered manufacturing site in Branchburg, New Jersey, was back in the U.S. Food and Drug Administration’s crosshairs. Reuters first reported on the pharma company of incidents that focused on non-compliance in 2022. Then the company was found to have inadequate “control of computer systems.” The findings included deleted data on the company’s manufacturing processes and failed quality control over audit paper trails.
Among the problems uncovered during the FDA’s 2023 summer inspection was inadequate protection of electronic records on Lilly’s manufacturing process, which could leave the company vulnerable to data manipulation, Reuters pointed out. The U.S. Food and Drug Administration inspection in July at Lilly’s Branchburg, New Jersey, plant detected eight separate deficiencies. They included problems in tracking manufacturing process and quality controls, lapses in its equipment calibration and failure to properly maintain.
Solving the problem of compliance with technology
Can those involved in regulatory environments – pharma, food & beverage, cosmetics, and now, cannabis–avoid problems like those described above? Can stake holders choose management systems that not only ensure quality control and compliance, but also provide efficient solutions for business and manufacturing management?
An MIS/ERP for those in packaging, label and flexographic businesses can be that all-in-one answer to ensure companies which operate in a regulated environment won’t encounter problems for the brand owner after hitting the market. In today’s regulatory driven market, technology, like the automation in an MIS/ERP, MES and IoT can assist manufacturers not just on the plant floor, but also in quality control, data collection, reporting and accuracy. Perform audits, inspections, and assessments with ease and effortlessly report and track findings.
HiFlow offers industry-specific tools that ensure compliance with FDA, ISO, USDA and other major regulatory agencies.
Data management is critical to compliance
– is your system up to par?
Proper handling of related data is essential to the future of the pharmaceutical supply chain. The goal of total alignment of data and product is in reach with the deployment of a configurable, scalable process built to meet the integration and compliance requirements of today and tomorrow. By automating critical processes like data collection, data traceability, data management and quality control, a pharma manufacturer can stay ahead of audits and be worry-free.
When evaluating whether your current system adequately manages data for the new regulations, consider the following areas – the collection of data, the traceability of data and whether the data is properly documented.
DATA that is CAPTURED
Industries that are subject to regulatory compliance by necessity require data to be captured throughout the entire product life cycle. What data is collected? How often? Where is it stored? Is it seamlessly integrated into your quality management system? Is it reliable?
Consider the ways to capture data, such as smart sensors (MES) on machines and the Internet of Things (IoT), that will record information in real time and funnel the data back to one central database of an MIS/ERP where all job information and updates are stored.
DATA that is TRACEABLE
FDA has stringent “Track and Trace” validation requirements. The Drug Supply Chain and Security Act (DSCSA), suggests that digital record keeping tools which integrate shop floor data collection, such as machine sensors, are especially important to modern pharma manufacturing. An ERP/MIS needs to offer traceability, inspection, and integrated data management and a central repository
It means requiring total accuracy in matching every pallet and everything it carries to the electronic record sent to other distributors.
Because all records must be traceable and easily retrievable, they must be managed and controlled. An MIS/ERP will enable a pharmaceutical manufacturer to offer smart data management solutions to intelligently track & trace to provide product tracing documentation.
DATA that is COMPLIANT
CAPAs. Batch records. Electronic records. Audit trails. Regulated products generate an endless stream of data that needs to be documented and stored. For example, from the FDA’s point of view, if it is not documented, it did not happen. Proper documentation is imperative. An MIS/ERP can offer quality control, batch traceability, raw material and product testing, and it can:
- Automate processes and document management.
- Offer connectivity with other electronic applications.
- Offer EDI connections to supply chain connections
- Report and analyze to provide predictive insights into quality events.
- Scale to accommodate various user groups, locations, and operations.
- Provide continuous validation.
Case Study in Compliance:
Pharma Manufacturer MTC and HiFlow
MTC is headquartered Vienna, Austria with manufacturing based in Pruszków, Poland. It supplies Poland and exports to over 25 countries including Europe, Scandinavia, as well as the US. The factory in Pruszków employs a staff of 85. MTC Delivery high-quality packaging for pharmaceutical brands and laminates and specialized foils for cosmetic packaging.
“We are family-owned company with a modern equipped production site with quality certificates implemented—BRC IoP, HCCP, and GMP,” says Lukasz Szczepanski, CFO, MTC Poland. They also meet ISO standards – ISO9001, ISO15378, ISO14001, and the stringent EU standards for pharma.
Quality control is key
MTC chose HiFlow because of the quality control and compliance features it offered and that it was configurable to exactly what the pharma manufacturer needed. Every single batch of raw material has the option of being tested and approved. If a given batch of raw material does not meet the standards, it can be sent to the complaint warehouse or for destruction. The warehouse employee receives the appropriate disposition in the warehouse module and on the barcode reader with the operating system.
“HiFlow provides MTC with comprehensive service of orders, from the acceptance of the order to the departure of the finished product to the customer,” Szczepanski offers. All of its processes are currently supported by the system, enabling the company to have easy access to them. This allows MTC to have control over their costs, as well as having 100% compliance with EU regulatory requirements.
Batch Traceability in HiFlow
The scope of tests is fully configurable by the user within HiFlow and depends on the supplier and stock classification (type, assortment, or group). A batch may be subject to many tests; to release it for production, it must pass all the tests and only then will the system automatically approve it.
HiFlow MIS offers a complete identification process for each batch used in the production process (raw material, semi-finished product, product). The tests of raw materials, semi-finished products and products are fully configurable, and can be adapted to various regulatory systems. The manufacturer can set up any tests and define acceptable ranges according to regulations such as FDA, USDA, or EU MDR.
The results of all tests and the generated documents are stored in dedicated areas of the system (Material Quality Tests, Product Quality Tests), so they are easy to present. Batch tracking reports and batch details allow you to instantly view the entire order flow from raw material receipt to product shipment. “Analysis of the entire process is now much easier,” Szczepanski concludes.
The package printer selected HiFlow because it had the functionalities required by its demanding clients from the pharmaceutical industry. “Not all software vendors were able to meet these requirements,” states Szczepanski.
Choose a robust solution to manage compliance
In the ever-evolving landscape of pharmaceutical manufacturing, staying ahead of regulatory changes and industry challenges is imperative. By making strategic investments in technology, such as MIS/ERP and MES solutions, pharmaceutical companies can not only satisfy sophisticated regulatory requirements but also drive cost efficiencies and operational improvements across the organization.
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