Author: Chandra Conzett

Here we are as an aggregate of the Rx supply chain entities and solution providers now more than 10 years out from the inception of DSCSA, and find ourselves marching through yet another year of grace as the “Stabilization Period” is slipping away. Many are at other personal milestones such as 10 cups of coffee per day wondering if we’ll ever be ready as an industry to fully meet the DSCSA requirements as mandated.

It should be noted that this is all a great paradigm against old ways of working from a data and process perspective. Change is painful – change is hard.

In the spirit of “never say never”, whilst the industry ramps up the volume of EPCIS data transactions and accompanying physical shipments, a team has been silently plodding away fighting the good fight against exception management for the benefit of all in their aspiration of sharing valuable insights and outcomes from their efforts. It’s high time their silent efforts be showcased for deserved recognition.

Being clear in the challenge presented by exceptions, they will be ever present ongoing – they are inherently within the nature of the beast of supply chain management. In order to address the DSCSA EPCIS data and physical exception challenges in a scalable and sustainable fashion – the devil is in the details.

End-to-End Testing Overview:

Antares Vision, through its subsidiary rfxcel, is embarking on a groundbreaking End-to-End Exception (E3) testing initiative, in collaboration with esteemed industry leaders, including Sanofi, Axway, Option Care Health, and Movilitas Cloud. This initiative dives into the details and aims to establish new industry protocols for exception handling by leveraging a novel collaboration mechanism and integrating physical and digital testing methodologies.

Key Innovations:

1. Establishing New Industry Process Standards: Collaborate with customers and solution providers to set transparent and accessible standards for exception handling.
2. Utilizing Novel Collaboration Mechanisms: Introduce a new collaboration mechanism and leverage an open contact list provided by NABP to access vendor and supplier contact information.
3. Efficient Error Resubmission Mechanism: Develop the ability to resubmit only the error detail, based on GS1 standards, to enhance
   efficiency and reduce redundancy in data submission processes.
4. Comprehensive Testing Including Dispensers: Include dispensers in the testing phase to identify a larger list of exceptions and ensure a thorough and comprehensive E2E supply chain testing process.

Testing Methodology:
The testing will involve a combination of physical and digital testing, facilitated by rfxcel’s provision of barcodes and coordination efforts. This multidimensional approach will enable comprehensive testing of systems’ capabilities and facilitate the identification of potential exceptions across the supply chain.

Outcome:
Through this collaborative effort, Antares Vision and its partners aim to drive industry-wide improvements in exception handling processes, ultimately enhancing efficiency, transparency, and compliance in the DSCSA supply chain.

Good luck, Godspeed, and thanks for your efforts from the Rx supply chain at-large!

The Food Safety Modernization Act, or FSMA, is unquestionably one of the most significant legal frameworks for the food supply chain. Signed into law in the early 2010s, this U.S. food regulatory framework implemented risk-based preventive controls for certain animal foods and produce to improve safety and mitigate the risks of foodborne illness outbreaks.

While the FSMA has been in effect for several years, it continues to evolve. Moreover, regulatory entities have ramped up verification activities, including FSMA compliance audits, which have raised the stakes for organizations subject to this framework.

Start on the road toward FSMA compliance by checking out this blog. In addition to  a comprehensive overview of FSMA requirements, you’ll learn practical tips for adhering to U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) guidelines.

Understanding FSMA Requirements

FSMA rules introduce several key requirements designed to prevent food hazards and ensure the safety of the food supply chain. The specific requirements that apply to your business may vary slightly depending on your position within the supply chain. However, some of the general guidelines are as follows:

• Preventive controls
• Supplier verification
• Hazard analysis and risk-based preventive controls (HARPC)
• Food defense

It’s helpful to unpack each of these stipulations. Regarding preventive controls, food facilities must develop and enforce a food safety plan, which should focus on identifying and addressing hazards that may impact consumer safety. Your strategy should be based on hazard analysis principles.

Additionally, you must establish foreign supplier verification programs to ensure that raw materials and ingredients obtained from importers meet FDA Food Safety Modernization Act requirements. As part of your HARPC efforts, you must conduct hazard analysis and implement risk-based preventive controls to mitigate identified vulnerabilities.

Finally, the FSMA emphasizes the importance of protecting the food supply chain from intentional adulteration and requires your facility to develop defense plans. These strategies should identify and mitigate potential hazards. Compliance with FSMA requirements is critical for your company’s ability to reduce safety risks, protect consumers, and maintain regulatory compliance.

Assessing Your Current Status

Before you can learn how to start FSMA compliance, it’s essential to know where you currently stand. You can do this by conducting an FSMA compliance audit evaluating your sanitation controls, safe food practices, and other procedures. More importantly, an audit will identify areas where your existing processes fall short of FSMA 204 final rule regulations.

Once you have identified gaps in your current processes, you can implement more stringent preventive controls for human food and take other corrective actions to ensure the safety of food products. While assessing your current compliance posture, make sure to account for other food safety laws, such as the Federal Food, Drug, and Cosmetic Act.

Most importantly, remember that meeting food safety regulations is not a one-time process. You must commit to continuous improvement to meet ever-tightening safety standards. Also, it’s crucial to develop stringent record-keeping requirements to demonstrate your adherence to FSMA regulations and food traceability requirements.

Developing a Compliance Plan

After you’ve determined your organization’s position regarding FSMA traceability stipulations, you can implement mitigation strategies to address identified hazards and ensure compliance.

Consider which specific requirements apply to your organization. The rules you are subject to will change based on your position within the food industry.

For instance, distributors, growers, and food manufacturers face a separate set of guidelines from small businesses that engage in direct-to-consumer sales. You can create a custom compliance plan after identifying which aspects of the rule apply to your company.

When crafting your plan, it’s important to set clear objectives for achieving FSMA compliance, including specific goals and milestones. Next, identify what resources you’ll need to achieve your stated aims. These include personnel, time, and budgetary resources, as well as any technologies or tools.

Develop timelines and action plans for implementing necessary changes and achieving compliance milestones. Remember, too, that most compliance dates under the FSMA have already passed, which means the act and its rules are currently in force. Therefore, time is of the essence.

Conducting FSMA Compliance Audits

FSMA compliance audits play a crucial role in verifying your adherence to regulatory requirements and identifying areas for improvement. Your business can conduct internal audits or obtain accredited third-party certifications to ensure that your current good manufacturing practices align with the provisions of the current food safety system.

The audit process involves three key components:

1. Preparation: Prepare by reviewing FSMA requirements and gathering relevant documentation
2. On-Site Assessment: Auditors will review your documents and observe processes
3. Post-Audit Activities: Address findings or non-conformities and implement corrective actions

Selecting experienced auditors and adequately preparing for audits are essential steps for ensuring adherence to FSMA preventive controls and promoting public health.

Utilizing FSMA Compliance Checklists

An FSMA compliance checklist provides a simple means of comparing your current compliance posture with the latest regulatory requirements. These checklists cover multiple aspects of FSMA regulations, including:

• Preventive controls
• Supplier verification
• Food defense
• Allergen mitigation
• Documentation requirements

Check out this free resource if you’d like to incorporate an FSMA compliance checklist into your risk mitigation strategy. There are several other downloadable PDF documents available, many of which are free to use. Take advantage of these tools to streamline your compliance process and improve adherence.

Addressing Common Challenges

Retooling your workflows and business processes can be daunting. However, you can mitigate the complexity of FSMA compliance by familiarizing yourself with the challenges that lie ahead.

One common difficulty that nearly all businesses encounter is resource constraints. Budgetary limitations, a lack of expertise, and time constraints can make it difficult to implement a compliance strategy.

Another common barrier is the complexity of FSMA requirements. The comprehensive act has different rules for each member of the food supply chain. Navigating these rules can be particularly difficult for small and medium-sized businesses with limited bandwidth.

Outdated or inadequate technology represents another challenge that you need to address head-on. Modern tracing tools can help you improve transparency and implement your food defense plan. A real-time tracking tool will also assist with labeling, product validation, and other aspects of FSMA compliance.

Training and Education

A well-trained and informed workforce is your greatest ally in the battle for FSMA compliance. Don’t just tell your staff what they need to do. Make sure they understand the “why” as well. Train them on compliance aspects, including the produce safety rule, recall plans, and general recordkeeping requirements. Also, remember to convey the implications of non-compliance.

There are dozens of great training resources out there. The FDA provides a wealth of information that you can use to educate your staff and empower their compliance efforts. Make sure to take advantage of third-party resources as well. At rfxcel, an Antares Vision Group, we have cultivated an extensive content library with timely, relevant information to help you stay up-to-date on the latest provisions.

Don’t stop with preliminary education on FSMA, though. Ensure that you are also training your staff on how to use new tools and processes to support compliance.

For instance, if you invest in new traceability technology, support the transition to these tools by providing extensive training. If your staff is confident with the tools, they are more likely to embrace change and use the technologies you’ve provided them.

Implementing Continuous Improvement

The regulatory framework is constantly evolving, so you must also evolve. Don’t treat FSMA compliance as a set-it-and-forget-it task. Instead, view it as an ongoing process that requires continuous improvement and innovation to ensure food safety and supply chain security.

You can begin to do so by routinely analyzing your compliance posture and identifying any shortcomings. Once you pinpoint weaknesses, proactively address them by refining your policies, procedures, and technology strategies. Taking a proactive approach will mitigate the risk of fines or other penalties and help you maintain consumer trust.

Case Studies and Success Stories

Examining how one small California farm successfully implemented an FSMA compliance strategy is helpful. The farm, New Native, produces microgreens, which the FDA classifies as a “high-risk” item. Due to its revenue, New Native is subject to full compliance requirements.

Fortunately, New Native and its leadership have been proactive about compliance since day one. As such, they passed their very first FSMA audit, which was conducted in early 2020. Since then, the company has maintained an impeccable record and a strong compliance posture.

Ken Kimes, co-owner and head of compliance for New Native, provided some great tips on preparing for audits. He emphasized the importance of having all documents organized and readily accessible to the auditor. Kimes also recommended making a great first impression, not over-answering any questions, and letting the inspector “drive” the process.

Strengthen Your Compliance Posture With rfxcel

Achieving and maintaining FSMA compliance requires a concerted effort from your entire team and buy-in from key stakeholders. Now that you know how to start FSMA compliance, it’s time to implement your plan by aligning your team, processes, and technologies.

With that in mind, we invite you to explore rfxcel solutions, a modern tracing solution designed for food supply chain members.

The Food and Drug Administration’s (FDA) Food Safety Modernization Act completely changed how food manufacturing supply chain members approach traceability. To keep pace with these changes and stay prepared for audits, you need modern food traceability software.

The question is, how do you find the right food traceability systems for your organization? Here’s everything you need to know.

Introduction to Food Traceability Software

Food safety traceability software refers to cloud-based solutions designed to help the food industry comply with FSMA traceability requirements. This tool can be used to manage inventory in real-time, store product information, and share insights with other supply chain members.

The best food safety traceability software also integrates with other business tools, such as barcode scanning equipment, to provide a holistic view of the flow of goods into and out of your inventory. Adopting a modern platform will help you better monitor the food supply chain, keep track of the raw materials used in food production, and promote consumer safety.

Most importantly, food safety traceability software solutions also streamline significant batch and unit tracking processes, saving time and reducing the risk of human error. Maintaining accurate and up-to-date records is foundational to achieving end-to-end traceability and ensuring compliance with FDA regulations.

Benefits of Food Traceability Software

Adopting the right software helps you centralize traceability data and streamline workflows. With a solution like rfxcel in your corner, you can achieve benefits such as:

Improved Transparency

The FSMA outlines strict record-keeping requirements designed to support expedited product recalls in the event of a foodborne illness outbreak. These provisions are also intended to increase consumer trust and ensure real-time visibility into where food products originated.

Food safety traceability software supports these objectives by integrating with other platforms, including your ERP system, and creating a holistic view of your supply chain. The best food traceability software offers value-added management features like lot tracking and recall management, giving you even better insights into your production process.

Simplified Compliance

Adopting robust software will assist with FSMA produce safety rule compliance. Solutions that offer customizable functionality can be tailored to the unique needs of food businesses, whether they be distributors, suppliers, or retailers.

You can track expiration dates, batch numbers, and more at a glance. Should you face an audit or encounter an outbreak, you can use this data to deliver prompt notifications to the FDA and any impacted retailers.

Optimized Visibility

Quality control requires end-to-end visibility into your supply chain. With a food traceability platform, you can implement custom quality assurance protocols and maintain a holistic view of your operations to ensure that those protocols are being followed. Ultimately, these capabilities will promote better supply chain management while enhancing consumer trust in your brand.

Increasing visibility will also support your company’s long-term health and success. You can use real-time insights to identify inefficiencies in your entire supply chain and improve inventory control strategies. By combining the information from your food safety traceability modules with data from your ERP software, you can transform your business into a flexible and resilient organization.

Enhancing Food Safety With Traceability

Food traceability software isn’t just great for regulatory compliance and supporting your stakeholders. It’s also an excellent tool for promoting safety. With robust software, you can achieve the following:

Streamline Recalls

Tracking down the origins of allergens and contaminants represents one of the toughest parts of issuing a recall. Historically, food manufacturers have been forced to “cast a wide net,” which can lead to unnecessary panic and tremendous product waste. However, with the help of food traceability software, you can issue more targeted recalls without compromising safety.

Accelerating the recall process will help curb the spread of food borne illnesses and minimize the risk of reputational damage. By quickly disseminating important information about affected products, you can also collaborate with retailers and the FDA.

Enforce Quality Control Standards

Quality management requires real-time visibility and accurate inventory records. The right tools enable you to monitor everything from when goods arrive to how long they sit at your warehouse. Increasing visibility will help improve freshness and reduce spoilage, both of which are great for your bottom line.

Mitigate Risks

Food safety traceability software is a risk mitigation tool. It allows you to safeguard your business, trade partners, and customers from the dangers of spoiled food or lax quality control processes.

By increasing your understanding of key workflows, you’ll achieve unprecedented oversight of business operations. This has become increasingly important amid supply chain disruptions and other uncertainties.

Key Features of Food Traceability Systems

Leading food traceability software offers numerous features, including the following:

Barcode Labeling

Labeling represents one of the fundamental requirements of the FSMA. You must label each unit and track goods as they progress through your segment of the supply chain. More importantly, you are required to maintain records of these transactions for auditing and quality control purposes.

Top software solutions collect and store this data, and the best platforms also streamline label creation.

Batch Tracking

The FDA has also implemented batch-tracking requirements. These help trace food from manufacturers to distributors and retailers. If a batch is contaminated, regulators will use this information to track down and recall products that may pose a consumer risk.

Solutions like rfxcel facilitate custom batch tracking. We allow you to track every shipment and maintain flawless digital records.

Real-Time Monitoring

Thanks to integrations with your ERP software, rfxcel’s food safety traceability solution offers real-time monitoring capabilities. You can track inbound and outbound shipments as they progress through the supply chain.

Reporting Tools

Creating a lean supply chain requires actionable insights. With that in mind, leading food safety traceability software includes robust reporting tools that provide both high-level and granular data about your business.

Technological Innovations in Traceability

Several advancements have accelerated the development of food safety traceability software, including blockchain and the Internet of Things (IoT). Blockchain provides a tool for creating accurate, immutable records of transactions, thereby ensuring transparency and trustworthiness. The IoT includes frontline internet-connected tools like barcode scanners and RFID devices.

Cumulatively, these tools have helped to promote a more nimble and reliable food tracing infrastructure. As you explore traceability solutions for your business, make sure to prioritize platforms that embrace these and other advancements.

Compliance and Regulatory Requirements

U.S. food traceability regulations primarily focus on items found on the FDA’s Food Traceability List. If you manufacture, process, hold, distribute, or pack any items on the FTL, the FSMA applies to your business.

Among other regulations, you must document critical tracking events (CTE) and retain key data elements about these occurrences. Some CTEs include harvesting, cooling, initial packing, and receiving. This is a partial list of requirements. You’ll need to review the entire FTL and FSMA final rule to understand your organization’s obligations under the act entirely.

Implementation Strategies and Best Practices

Successfully adopting food traceability software requires a three-stage approach. First, be transparent with your team about what’s happening and why you are implementing a new platform. Get them involved in the process early on to reduce change resistance.

As you begin the rollout, offer comprehensive training to ensure your team members are confident using the new tech. Put additional support staff in place to assist with any challenges that may arise and ensure that the technology can be scaled out across your entire supply chain.

Additionally, it’s crucial to consider compatibility with your existing technology, specifically your ERP software. Integrating your food tracing platform with your ERP will provide optimal efficiency and transparency.

Future Trends and Emerging Technologies

Emerging tech like artificial intelligence and predictive analytics will undoubtedly reshape the food supply chain. AI can automate key tracing protocols, save time, and promote better efficiency. Predictive analytics will shed light on threats to food safety and help you proactively mitigate them to reduce waste.

While you don’t have to be the first adopter of these and other emerging technologies, it’s important to keep your operations modernized and agile. Otherwise, you risk giving up ground to the competition.

Choosing the Right Traceability Solution

Generally, there are three factors to consider before selecting a food traceability software: customizability, vendor reputation, and scalability. The best platforms can be tailored to align with your unique needs. They also offer nearly limitless scalability by leveraging cloud-based infrastructure and a flexible architecture.

Perhaps most importantly, you need to find a vendor who understands the nuances of the Food Safety Modernization Act. Organizations like rfxcel specialize in helping our clients meet traceability regulations via dynamic, industry-specific solutions. When your organization’s future is on the line, rfxcel delivers.

Partner With rfxcel

Partnering with rfxcel today means joining a network dedicated to excellence in supply chain management. With our advanced solutions, you can ensure the highest standards of traceability and transparency. Would you like to learn more about the benefits and capabilities of food safety traceability software? Our experts are ready to demonstrate how our platform can enhance your operations. 

Contact us to book a demo and take the first step toward transforming your supply chain.

In the complex and tightly regulated world of pharmaceuticals, ensuring safety and traceability is paramount. The Drug Supply Chain Security Act (DSCSA) is a critical piece of legislation aimed at enhancing the security and traceability of pharmaceutical products throughout the supply chain. DSCSA exception handling represents a key component of this regulatory framework. It involves managing deviations from standard procedures to maintain the supply chain. In the following, you can explore the importance of DSCSA exception handling guidelines for maintaining the quality and safety of physical products in the pharmaceutical industry.

Key Concepts and Definitions

Before delving into the nuances of DSCSA 2023 provisions, examining some critical terms associated with this process is helpful. Exceptions refer to instances where deviations from standard procedures occur within the pharmaceutical supply chain. These deviations may include:

• Discrepancies in transaction information
• Product identifier records
• Chain of custody between distributors and dispensers
• Errors in transaction statements

Deviations are specific instances of exceptions that require investigation and resolution. In contrast, a waiver is an official exemption granted under certain circumstances that relieves you from specific DSCSA requirements.

Generally speaking, exception handling applies to all authorized trading partners — entities involved in the pharma supply chain — such as the following:

• Wholesale distributors
• Repackagers
• Third-party logistics providers
• Dispensers

The Food and Drug Administration (FDA) holds these entities accountable for adherence to the DSCSA and specific exception-handling guidelines.

Understanding DSCSA Exception Handling Guidelines

Throughout the DSCSA timeline, which featured a phased rollout of the regulatory framework, exception handling has remained a fundamental component of the act. The Healthcare Distribution Alliance (HDA) has helped affected entities keep pace with the latest changes and updates to exception handling by publishing a comprehensive list of guidelines.

These guidelines include processes for identifying, documenting, investigating, and resolving exceptions promptly. As part of your exception management strategy, you must maintain master data for prescription drugs. This database needs to include package-level product data as well as transaction data.

You can use this information to track the flow of goods along the supply chain and to identify discrepancies that deviate from your standard processes and workflows. Additionally, you are required to maintain accurate records of exception-handling activities, including investigation findings, corrective actions taken, and methods used to keep stakeholders in the loop.

For instance, you might identify a suspect product that may have been compromised. In that case, you will have to determine which pallets of goods were impacted and take appropriate action (e.g., initiate a recall or notify the FDA).

Compliance with DSCSA exception handling guidelines is essential. It allows you to uphold product traceability, prevent counterfeit products from entering the supply chain, and protect patient safety.

Types of Exceptions in Pharmaceutical Traceability

Within your pharmaceutical traceability framework, you may encounter several types of exceptions. Each situation requires a specific response.

For instance, product recalls necessitate immediate action to remove affected products from circulation and notify relevant stakeholders. Suspected counterfeit products must be reported and investigated thoroughly to ensure that they are not distributed to patients.

Discrepancies in product documentation, such as incorrect product identifiers or expiration dates, pose risks to your supply chain integrity and patient health. You must carefully investigate these exceptions to prevent misidentification and mitigate expiration risk.

Other slightly less severe exceptions may include shipping errors, packaging defects, and deviations from temperature control requirements. Though these issues are not as severe, they require prompt attention. You must also document any corrective actions that you took to remedy the problem.

Best Practices for Managing Exceptions

The DSCSA delay to late November 2024 has provided organizations with extra time to ensure compliance. However, this window is rapidly closing, so you must act now to capitalize on this added grace period, as the FDA is unlikely to offer another extension. Do you need help determining where to begin? We recommend implementing a few exception-handling best practices.

First and foremost, be proactive when communicating with stakeholders and trading partners. Reiterate the importance of rapid response and discuss ways to minimize exceptions’ impact on your supply chain. Establishing clear escalation procedures and designated points of contact will accelerate your resolution capabilities and lower the risk of response delays.

Moreover, it is crucial to create a detailed paper trail of your efforts. Whenever you encounter a discrepancy, you must protect the supply chain by documenting the scope of the problem and how you responded to it. Additionally, note the outcomes you achieved.

Thorough documentation enables your business to track the status of exceptions and identify trends or patterns. You can also use your records for auditing purposes and to help prevent minor issues from becoming more prominent, recurring problems.

Perhaps most importantly, you must collaborate with trading partners and regulatory agencies. Don’t view the DSCSA as a source of contention between supply chain members. Instead, acknowledge its intended purpose: to promote unity and optimize patient safety.

Implementing Exception Handling Processes

As you implement DSCSA exception-handling processes in your company, it’s crucial to establish open lines of communication between key stakeholders. Define clear roles and responsibilities for each entity. You and other organizational leaders should create procedures for identifying, categorizing, and prioritizing exceptions based on their severity and potential impact.

Next, develop a training strategy to promote a practical understanding of your policies and procedures. Conducting what-if scenarios can help your staff move from theoretical concepts to practical applications.

Investing in automation and other technology solutions can streamline exception management by facilitating real-time monitoring. With the right tools, you’ll gain actionable insights into deviations, enabling you to remedy them more effectively before they have a major impact on your operations.

Lastly, prioritize continuous evaluation and improvement. After you’ve met the minimum standards, explore ways to become more efficient at handling exceptions.

Ensuring Compliance With DSCSA Requirements

The FDA continues to provide updated guidance on DSCSA exception handling requirements. While the regulatory landscape is still evolving, a few ways exist to build a strong compliance posture and stay ahead of the learning curve.

Start by reevaluating your record-keeping and documentation strategies. Ensure that your team maintains detailed records of all exceptions and your response to these deviations.

Furthermore, conduct regular internal audits to assess your compliance status and identify areas for improvement. Taking compliance into your own hands will help you breeze through FDA audits and avoid regulatory penalties.

Additionally, adopting standardized processes for exception handling is vital. Creating and educating your team on a set of standardized responses enables you to promote consistency and efficiency in dealing with deviations from “business as usual.”

Collaborating with industry associations like the HDA can further strengthen your compliance posture and help promote alignment between your business and its trading partners.

Training and Education for Stakeholders

Implementing robust protocols and automation-centric technologies represents a huge step toward DSCSA compliance. However, the efficacy of these efforts hinges on your team’s knowledge and skills. With that in mind, investing in training and education for stakeholders is vital.

As you design your training programs, move beyond theoretical concepts and focus on practical applications. Explain what DSCSA exception handling is, why it matters, and how your team can contribute to a strong compliance posture. By teaching team members the “why” behind your initiative, you can promote better buy-in and increased adherence to the new policies.

Don’t rely on a single training delivery method, either. Instead, provide your staff with multiple educational resources, such as online courses, webinars, and in-person training, to maximize information retention.

Challenges and Considerations

Whether you have stayed apprised of the latest DSCSA regulatory requirements or are playing catch-up, you must familiarize yourself with the challenges you’ll likely encounter on your compliance journey. The biggest hurdle is change management.

Adopting new processes, technologies, and workflows is challenging for everyone. Therefore, it is essential to keep your team in the loop from day one.

Another common barrier to exception-handling compliance is the need for the right technologies and tools. You need end-to-end visibility into your supply chain to efficiently identify and remedy deficiencies in your compliance posture. Otherwise, significant problems may go unnoticed for weeks, resulting in reporting issues and compliance violations.

Partner with Rfxcel

Remedying this problem requires strategic technology investments. Focus on traceability solutions like rfxcel, an Antares Vision Group, which help you improve information visibility and accessibility. With rfxcel and other traceability tools, you’ll be able to rapidly identify and resolve any threats to business continuity while preserving the integrity of your supply chain.

Contact us today to see how our tailored solutions can help you!

The Drug Quality and Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA) forever changed pharmaceutical warehouse management. Today, logistics professionals in the pharmaceutical industry face a host of new challenges, including stringent regulatory frameworks, shifting consumer expectations, and increasing pressure from downstream trading partners and healthcare providers.

The question is, how can you adapt your pharmaceutical warehouse inventory strategy to align with these new challenges and thrive in the global prescription drug ecosystem? This blog explores the hurdles you’ll face and provides practical solutions for overcoming them by using refined strategies, employing enhanced technologies, and taking a proactive approach to innovation.

Introduction to Pharmaceutical Warehouse Management

Overseeing the daily running of a facility that stores prescription medications might as well be called “chaos management.” After all, keeping up with pharmaceutical compliance rules, meeting the ever-changing needs of your trading partners, and maintaining a real-time account of inventory is nothing if not chaotic.

As a member of this vital supply chain, you have to navigate all of the typical order processing and inventory tracking challenges of other storage facilities while simultaneously mitigating the liabilities associated with handling prescription drugs and biologics.

The good news is that there are solutions that can make your life simpler and help you stay ahead of Food and Drug Administration (FDA) regulations. The key is to identify what you are up against and mobilize your entire team toward tackling those challenges.

Key Challenges in Pharmaceutical Warehouse Management

Three of the major difficulties you’ll face on your journey toward better efficiency and improved resilience are as follows:

Storage Constraints

If you want to maintain product integrity, you’ve got to invest in high-quality, climate-controlled pharmaceutical warehousing. Optimizing your inventory control processes and engaging in safe material handling is critical to preventing product waste and ensuring patient safety.

However, due to the high costs of storing medications, it’s important to stay lean and avoid carrying too much inventory. This is where things become challenging, as carrying too little stock leads to stockouts and supply shortfalls. If you overorder, you’ll encounter spoilage issues, waste, and excess expenses.

Regulatory Compliance

The DSCSA imposed stringent regulatory requirements on members of the pharmaceutical supply chain, including warehouses and distributors. In response, you must adapt your workflows to ensure ongoing compliance. Otherwise, you’ll face severe penalties and may even be restricted from participating in the U.S. pharmaceutical supply ecosystem.

As part of this process, you must implement security measures geared toward promoting transparency and guarding against fraud. Furthermore, you have to meet all labeling and packaging requirements as laid out in the DSCSA. These labels should include expiry dates, the names of the pharmaceutical companies that made the drugs, and other key information.

Inventory Accuracy

Maintaining real-time visibility of your stock plays a pivotal role in order fulfillment and the meeting of regulatory standards. At any given moment, you should know which medications you have in stock, where they are stored, and the quantity of each item. Due to the fast-paced nature of this industry, it’s nearly impossible to achieve this level of visibility using manual processes.

You can remedy your inventory woes with a pharmaceutical warehouse management system. The best solutions offer up-to-the-minute insights into stock levels, allowing you to avoid shortages while meeting your clients’ needs.

Regulatory Compliance and Good Distribution Practices (GDP)

Good distribution practices (GDP) are established minimum standards that your organization should follow to ensure medication integrity and quality. Make sure to familiarize yourself with both domestic and international GDPs, including those published by the FDA and the European Medicines Agency.

Additionally, you need to adopt the rules laid out in federal acts like the DSCSA. These regulations apply to key members of the prescription drug sector, including manufacturers, distributors, and suppliers. You cannot treat these regulations as an afterthought. Instead, you must integrate them into the company culture and your standard operational procedures.

It’s also important to train your staff on the legal requirements that apply to your company. Equip them with the tools and resources they need to meet these regulations, such as barcode scanners, user-friendly software, and efficient workflows.

Inventory Management Systems and Technologies

Adopting automated tech tools can drastically reduce the likelihood of costly human errors in your supply chain. Start by assessing the quality of your current software. Is it cloud-based and nimble, or are you due for an upgrade?

Don’t stop there, though. Shift your attention to frontline tools like RFID or barcode scanners and automated picking systems. Streamlining these key parts of your workflows will make the organization more flexible and resilient to shifting regulatory frameworks.

Temperature-Controlled Storage and Cold Chain Management

Not all drugs can be tossed on a shelf. Temperature-sensitive pharmaceuticals are often particularly challenging to manage and store. You must keep these goods within established temperature thresholds during every link in the delivery process, including storage and transportation.

As part of these efforts, ensure you partner with reputable carriers that understand the stringent temperature constraints associated with transporting such medications. Even a temporary change in storage conditions can cause raw materials in certain substances to spoil.

Also, implement strict quality control protocols that include ongoing monitoring and alerts. The sooner you identify issues with temperature management equipment, the better your odds of resolving them before it leads to a greater problem.

Risk Management and Security

Product tampering and theft represent the two most prominent threats facing your pharmaceutical warehouse. By implementing robust monitoring and access control protocols, you can track every person who enters your facility and ensure that they are authorized to be there.

You can begin to do so by implementing multiple layers of security and monitoring, including keycard-based door controls and camera systems. It’s also a good idea to enact physical measures such as:

• Fencing around your facility
• Multiple layers of access control
• On-site security personnel

Cumulatively, these deterrents will drastically reduce the likelihood of theft or tampering while also protecting your reputation.

Optimization Strategies and Best Practices

Pharmaceutical warehouse management is an expensive endeavor, but taking certain steps can reduce your expenses and make the organization leaner. First, make sure to optimize your warehouse’s layout. Organize your shelving and storage systems in a way that promotes easy access to products, and take advantage of vertical space.

Where practical, adopt lean principles like just-in-time ordering. Use analytics tools and inventory management software to monitor consumption trends and set optimal reorder points. These tactics will reduce overordering while preventing stockouts and decreasing your storage costs.

While you need to retain a healthy inventory of vital medications, it’s important to stay nimble and leave yourself room to adapt to shifts in consumption habits.

Quality Assurance and Traceability

Under Title II of the DQSA, members of the pharmaceutical supply chain must work toward interoperability and facilitate the electronic tracing of prescriptions. These provisions are designed to promote visibility, quality assurance, and end-to-end traceability.

As a member of the pharmaceutical supply chain, your organization must adhere to these regulations. Specifically, you must comply with labeling requirements, engage in batch tracking, and relay this data to downstream members of your trading network.

In the event of a safety concern, you are also required to provide batch tracking data to the FDA so that it can oversee recalls. Failing to adhere to these requirements can compromise public health. Additionally, the FDA can impose sanctions and monetary penalties.

Collaboration With Supply Chain Partners

Your business doesn’t operate alone. It relies on an interconnected ecosystem of trade partners, all of which are interdependent on one another. While all warehouse management optimization initiatives must begin and end internally, you cannot realize your long-term goals without the support of your industry partners.

Explore opportunities to refine relationships with distributors, manufacturers, and logistics providers. Where possible, integrate your technologies with theirs to accelerate the flow of information and enhance overall visibility.

Remember, this should be a two-way process. Ask the organizations that are immediately upstream and downstream from you how your business can better support their goals. Cumulatively, your companies can achieve unprecedented levels of efficiency and flexibility.

Future Trends and Innovations

Pharma global compliance represents the next great leap in drug supply chain management. Nations are already collaborating to create safer prescription medication supply chains. Ultimately, this will lead to the creation of international standards, which will certainly be more stringent than current frameworks.

On the technological side, artificial intelligence and warehouse automation represent two of the most exciting developments. These solutions will expand your bandwidth and help you continuously meet productivity goals while adapting to changing regulatory frameworks.

Blockchain technology is another promising tool for promoting traceability and transparency. With the help of blockchain, your company can create immutable records of batch origins and ensure compliance with FDA requirements.

Connect With rfxcel

Are you ready to revolutionize the way you approach pharmaceutical warehouse management? If so, rfxcel can help. Our pharma supply chain visibility software provides real-time insights into your stock levels, automates redundant administrative processes, and empowers your team to get more done. If you’d like to learn more about rfxcel and our adaptable software, schedule a demo today.