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Pharmaceutical

Adapting to Today's Pharmaceutical Landscape
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Adapting to Today’s Pharmaceutical Landscape
Adapting to Today’s Pharmaceutical Landscape 700 500 Xcelpros Team

In this ever-changing pharmaceutical space, it’s crucial to embrace emerging trends and address challenges that arise. From personalized medicine to digital health integration, the industry is seeing amazing transformative shifts, and is sure to see more within the next few years. The demand for enhanced patient outcomes, cost-effectiveness, and sustainability further drives market dynamics of the pharma industry.

There are, however, some challenges that come along with these industry trends. Regulatory complexities, drug pricing, cybersecurity, and sustainability pose significant hurdles that demand innovative solutions. Despite these challenges, the pharmaceutical industry continues to grow and evolve. Breakthroughs in medical science constantly expand the range of available drugs. This is, in turn, contributing to the improvement and extension of lives worldwide. By navigating these trends and addressing these challenges effectively, the pharmaceutical industry can continue to play a vital role in advancing healthcare and lengthening patient lives.

Advanced Manufacturing Technologies

Pharmaceutical manufacturers are increasingly adopting advanced manufacturing technologies such as continuous manufacturing, 3D printing, and robotics automation to enhance production efficiency, reduce costs, and improve product quality.

Supply Chain Optimization

Manufacturers are always focusing on perfecting their supply chains to ensure uninterrupted access to raw materials, streamline planning, and enhance overall operational resilience. This trend has been further emphasized by the disruptions caused by the COVID-19 pandemic.

Outsourcing and Contract Manufacturing

Pharmaceutical manufacturers are increasingly engaging in outsourcing and contract manufacturing partnerships to use specialized abilities, access new markets, and enhance agility in responding to market demands.

Quality and Compliance

Ensuring quality and compliance with regulatory standards remains a top priority for manufacturers. They are implementing robust quality management systems, embracing process analytical technologies, and adopting data integrity measures to meet stringent regulatory requirements.

Digitization and Data Analytics

Manufacturers are embracing digital technologies and data analytics to perfect manufacturing processes, improve supply chain visibility, and enhance product quality through real-time monitoring and predictive analytics.

Sustainability and Green Initiatives

Pharmaceutical manufacturers are increasingly focusing on sustainable practices, including reducing carbon footprint, implementing environmentally friendly manufacturing processes, and adopting green packaging solutions.

Regulatory Compliance and Serialization

Manufacturers are adapting to evolving regulatory requirements, including track-and-trace serialization mandates, to ensure product traceability, combat counterfeit drugs, and strengthen supply chain security.

 

Challenges Facing the Pharmaceutical Industry

Emerging trends in the pharmaceutical industry present unprecedented opportunities for growth, innovation, and improved patient lives. However, these trends also give rise to a host of complex challenges that businesses, particularly pharmaceutical manufacturers, must navigate effectively to stay competitive.

These challenges span technological, regulatory, operational, and market-related dimensions. By understanding and proactively addressing these challenges, manufacturers can position themselves for success in this ever-evolving landscape and effectively contribute to advancing healthcare for the benefit of patients worldwide.

Increasing Costs

The pharmaceutical industry continues to grapple with the relentless rise in research and development costs, According to an article by CapsCanada, as well as escalating expenses associated with raw materials and manufacturing. This upward cost trajectory places significant pressure on pharmaceutical companies to find a balance between ensuring affordable pricing for their products and sustaining profitability. This can lead to financial strains and may affect patients’ ability to afford essential medications, raising concerns about accessibility and fair healthcare.

Stringent Regulations

Pharmaceutical manufacturers face the daunting task of adhering to increasingly stringent regulations enforced by government agencies, such as the FDA (Food and Drug Administration). These regulations are designed to ensure drug safety, efficacy, and quality, but they can pose significant challenges. Compliance with complex regulatory requirements can lead to prolonged product development timelines, increased research and testing costs, and delays in product launches. Navigating the intricate landscape of regulatory compliance requires substantial resources, expertise, and meticulous attention to detail.

Changing Reimbursement Landscape

The ever-evolving reimbursement landscape adds another layer of complexity for pharmaceutical companies. Insurance companies and healthcare payers often change their reimbursement policies, formulas, and pricing structures. These changes can make it difficult for pharmaceutical manufacturers to accurately forecast revenues, effectively plan for future product launches, and navigate the shifting reimbursement dynamics. Companies must continually adapt to evolving reimbursement models to ensure market access, best pricing strategies, and sustainable financial performance.

Impact of Generics

The emergence of generic versions of drugs presents a considerable challenge for pharmaceutical companies. Generics, often priced significantly lower than brand-name drugs, can quickly gain market share and erode the sales of patented or proprietary medications. The entry of generics into the marketplace puts pressure on pharmaceutical manufacturers to stay competitive, which can include finding avenues for product differentiation, and exploring lifecycle management strategies to sustain market share and revenues.

 

Figure 1: Challenges Facing the Pharmaceutical Industry

Challenges Facing the Pharmaceutical Industry

Regulatory Compliance in the Pharmaceutical Industry

While the challenges we mention above are important, one aspect deserving increased attention is regulatory compliance. Compliance with stringent regulations is crucial for ensuring patient safety, supporting product integrity, and upholding ethical standards. It supplies a framework for navigating complex regulatory landscapes, showing commitment to quality and ethical conduct.

Regulatory compliance protects companies from legal consequences, financial penalties, and reputational harm. It is also essential for securing reimbursement and market access. Prioritizing regulatory compliance strengthens industry standing and contributes to the overall improvement of healthcare.

Non-compliance with set regulations can have a major impact on businesses in the pharmaceutical industry. An article from McKinsey discusses how in the past pharmaceutical companies didn’t put as much work into operations strategy when facing competing business pressures. Recent changes in the economy, international politics, and new therapeutics, however, have turned the focus back to strategic changes. Specifically, changes in sourcing, supply chain management, and distribution which address issues such as drug safety, pricing transparency, or supply chain management.

For example, recent legislation has made it more difficult for drug manufacturers to hike prices without justification and has needed greater transparency in advertising and promotional materials. While such changes can be challenging for companies to navigate, they are ultimately intended to protect consumer safety and improve the overall quality of pharmaceutical products. As regulations continue to evolve, it will be important for companies to stay informed and adapt accordingly.

Quality Control: Safeguarding Product Efficacy and Safety

Building upon the importance of regulatory compliance, a fundamental aspect that ensures patient safety and product integrity is quality control. In the pharmaceutical industry, stringent quality controls are essential for safeguarding the safety and efficacy of medications. Through rigorous measures and processes, pharmaceutical companies maintain the highest standards of quality throughout the entire product lifecycle, from development to distribution and post-market surveillance.

Quality controls encompass a range of procedures, including thorough testing of raw materials, in-process testing during manufacturing, and comprehensive analysis of the final product. By adhering to regulatory guidelines and Good Manufacturing Practices (GMP), companies ensure compliance with quality standards and mitigate potential risks.

Implementing robust quality controls enables companies to detect and address issues that could compromise product safety. This can include identifying contaminants, impurities, or variations in drug composition that may pose risks to patients. Ongoing quality monitoring and control ensure batch-to-batch consistency, ensuring that each dose of medication meets the required specifications.

By prioritizing quality controls, pharmaceutical companies demonstrate their commitment to patient safety and deliver reliable and high-quality medications. These controls instill confidence in healthcare providers, patients, and regulatory authorities. Through continuous improvement and adaptation of quality control processes, companies navigate the evolving regulatory landscape, contribute to patient welfare, and uphold the integrity of the pharmaceutical industry.

Conclusion – Understanding Pharma Today

The pharmaceutical industry is in flux due to various internal and external forces. With swiftly changing regulations, the advancement of technology, and rising costs, it is essential for businesses to proactively seek out strategies that can help them stay ahead. The constant and significant growth of the pharma industry within the last few years will continue showing positive results for companies who keep up to date with new technology and industry trends.

By analyzing and understanding the trends, challenges, and importance of regulatory compliance and quality controls in the pharmaceutical industry, organizations can proactively adapt to the evolving landscape. Continuously evaluating best practices and embracing innovative approaches allows companies to support their competitive edge. Thoughtful consideration of potential solutions equips organizations with the knowledge and preparedness needed to navigate industry changes effectively. By staying informed and implementing strategic measures, organizations can position themselves for success, drive innovation, and deliver high-quality products that positively affect global healthcare.

What pharma challenges do you face? Connect with us today to find a solution.

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Designing a GMP System: Key Considerations and Benefits of Implementation
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Designing a GMP System: Key Considerations and Benefits of Implementation
Designing a GMP System: Key Considerations and Benefits of Implementation 700 500 Xcelpros Team

Good Manufacturing Practices (GMP) ensure that products meet quality standards and are safe for use or consumption. A GMP-compliant system is essential for companies that must adhere to regulatory requirements to produce safe and effective products. A GMP system involves guidelines and procedures regulating the manufacturing process, including product design, production, and testing. Regulatory bodies, such as the FDA, set these guidelines, and compliance is mandatory for companies operating in industries like pharmaceuticals, biotech, and food and beverage. Implementing a GMP system can be complex, but the right design can help companies streamline processes, minimize errors, and maintain compliance.

A study published in the Journal of Pharmaceutical Innovation found that implementing an electronic GMP system resulted in a 15% reduction in product defects and a 20% reduction in manufacturing time.

Key Considerations for Designing a System to Handle GMP Processes

Understand the Regulatory Requirements

The first step in designing a GMP system is understanding the regulatory requirements for your industry. GMP guidelines are detailed and can be complex, so it is essential to have a clear understanding of the expectations and standards. FDA regulations, for example, require documentation of every step in the manufacturing process, from raw material selection to final product release. A GMP system must also ensure products are produced in a controlled environment that minimizes contamination risk. Once you clearly understand the regulations, you can design your GMP system to ensure compliance.

Identify Critical Control Points

Critical control points (CCPs) are points in the manufacturing process where control can be applied to prevent, eliminate, or reduce a significant hazard to product quality or safety. In a GMP system, CCPs are identified and monitored to ensure the process operates within acceptable limits. Designing a system that identifies CCPs and monitors them is critical to ensuring product quality and safety.

Implement a Document Management System

Document control is an essential part of any GMP system. The FDA requires companies to maintain accurate records of every step in the manufacturing process, including raw material and component receipt, manufacturing and packaging, and product testing. A document management system can help ensure that all documents are accurate, up-to-date, and easily accessible. The system should provide version control, document tracking, and secure storage to maintain the integrity of the records.

Choose the Right Equipment

Equipment selection is critical in designing a GMP system. All equipment used in the manufacturing process must meet certain standards, including being designed for easy cleaning and maintenance. Equipment must also be calibrated and validated to ensure it works correctly. Choosing the right equipment can help streamline the manufacturing process and minimize the risk of product contamination.

Train Employees

GMP compliance requires that all employees involved in the manufacturing process are adequately trained in GMP guidelines, procedures, and practices. A GMP system should include employee training and ongoing education to ensure employees know their responsibilities and can effectively execute the strategies. Employee training should also include instruction on identifying and reporting potential quality issues.

Conduct Regular Audits

Regular audits of the GMP system are essential to ensure that the system is functioning as intended and that compliance is maintained. Audits should include reviewing all documentation and records, verifying equipment calibration and validation, and observing employees performing their tasks. Audits should be conducted at regular intervals and documented to provide a record of compliance.

Designing a system to handle GMP processes requires careful planning and attention to detail. Understanding regulatory requirements, identifying CCPs, implementing a document management system, choosing the right equipment, training employees, and conducting regular audits are all essential components of a successful GMP system. By implementing a well-designed GMP system, companies can streamline processes, minimize errors, and maintain compliance, ultimately improving product quality and safety.

In a case study conducted by UL, a pharmaceutical company that implemented an electronic GMP system reported a 50% reduction in batch review time and a 70% reduction in product release time.

Book a consultation with our technology experts to learn more about considerations for maintaining GMP processes.

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What Features Should a Good GMP Software Have?

Here are some important features that good GMP software should have:

Figure 1:Essential Components of Effective GMP Software

Essential Components of Effective GMP Software

  • Electronic signatures: GMP regulations require documentation of all activities related to the manufacturing process, and electronic signatures provide a secure and traceable way to authenticate these records.
  • Audit trails: The software should have a comprehensive audit trail that tracks all changes made to the system, including who made the changes, when they were made and the reason for the change.
  • Role-based access control: The system should have a robust access control mechanism that ensures users access only the information they need to do their job.
  • Electronic batch records: The software should provide a centralized location to store all batch records electronically, allowing for real-time tracking and analysis.
  • Validation and compliance: The GMP software should be validated according to regulatory guidelines. The vendor should provide ongoing support to ensure the system complies with any regulation updates or changes.
  • Risk management: The system should have features to manage and mitigate risks associated with the manufacturing process. This includes the ability to perform risk assessments and track corrective actions and preventive actions (CAPA).
  • Integration with other systems: The software should integrate with other methods, such as ERP systems or LIMS systems, to provide a seamless end-to-end manufacturing process.
  • Reporting and analytics: The software should provide comprehensive reporting and analytics capabilities to enable companies to analyze and optimize their manufacturing processes.
  • Training and support: The vendor should provide comprehensive training and support to ensure that users can effectively use the software and comply with regulatory requirements.

Electronic GMP software can enhance the implementation of a GMP system, providing features such as electronic signatures, audit trails, role-based access control, electronic batch records, validation and compliance, risk management, integration with other systems, reporting and analytics, and training and support. By using good GMP software, companies can further optimize their manufacturing processes and ensure ongoing compliance with regulatory requirements.

Overall, companies prioritizing implementing GMP practices and investing in a well-designed GMP system and software can benefit from improved product quality and safety, increased efficiency, and reduced costs. By maintaining compliance with regulatory requirements and prioritizing quality and safety, companies can build a strong reputation and gain the trust of customers, regulators, and stakeholders.

Conclusion

In conclusion, the implementation of Good Manufacturing Practices (GMP) is crucial for companies operating in industries such as pharmaceuticals, biotech, and food and beverage to ensure product quality and safety. Designing and implementing a robust GMP system requires careful planning and attention to regulatory requirements, critical control points, document management, equipment selection, employee training, and regular audits.

XcelPros has decades of experience helping build and implement GMP practices as a Microsoft Gold Partner. Our team understands the importance of implementing the right system and can guide your business every step of the way.

With electronic GMP software, companies can further enhance their GMP system and optimize their manufacturing processes while ensuring ongoing compliance with regulations. By prioritizing GMP practices, companies can benefit from improved product quality and safety, increased efficiency, and reduced costs, building a solid reputation and gaining the trust of customers, regulators, and stakeholders.

Benefits Of Batch Traceability in Pharmaceutical Manufacturing
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Benefits Of Batch Traceability in Pharmaceutical Manufacturing Company
Benefits Of Batch Traceability in Pharmaceutical Manufacturing Company 700 500 Xcelpros Team

Introduction

In a previous article: Batch traceability in pharmaceutical manufacturing, we talked about GS1 traceability standards, the DSCSA, and why the pharmaceutical industry has to be prepared for item-level traceability by the end of 2023. Now let’s go over the benefits of traceability that the industry should not ignore.

Benefits of Pharmaceutical Track and Trace

The pharmaceutical industry relies on several workflows, and the ability to track and trace batches are one of the most important. With traceability slated to be mandatory by the end of 2023, it will help to understand the benefits that will come along with this change.

  • Reduced counterfeits Counterfeits are still a significant challenge for the industry, accounting for nearly 7% of all medicines globally. These fakes can replace high-quality treatment anywhere in the supply chain.

    With real-time lot tracking and tracing, it’s easy to fully follow the journey of a batch to ensure it hasn’t been misplaced or replaced at any point in the supply chain. This is a crucial step in reducing the number of counterfeit medicines.

  • Streamlined recall processes Despite paying mandatory diligence, specific errors are bound to happen. There are as many as 1200 recalls on medicine every year. But remembrance can be difficult when the manufacturer isn’t aware of the exact position of finished goods and raw materials in their supply chain.

    After implementing a traceability solution, manufacturers have much more control over finished goods and raw materials as they move through their supply chain. This means more opportunities to recall or even stop defective medicines from reaching the public.

  • Increased quality throughout production To ensure continual production, and an adequate supply of raw materials is essential. By adopting the practice of advanced track and trace for pharmaceuticals, these companies can maintain quality tracking at every production stage.

    The right pharmaceutical tracking system can record critical data like quantities in pounds or gallons, products consumed, remaining stock, quality throughout production, finished goods quality, and more. This data ensures only the best products are produced and quality requirements are upheld.

  • Maintaining supply chain integrity Another benefit of a system offering traceability is maintaining a higher level of supply chain integrity.

    Traceability solutions like D365 let manufacturers closely track the quality and pedigree of every batch from raw materials to finished goods.

  • Increased compliances As a pharma industry player, adherence to certain compliances and regulations is fully necessary. Achieving full compliance is one of the most important benefits of having item-level traceability.

    Full traceability helps you track the journey of a lot from manufacturing units to the pharmacies which is crucial for things like the Automation of Reports and Consolidated Orders System (ARCOS), GS1 traceability standards, and more.

Figure 1:Benefits of Pharmaceutical Track and Trace

Benefits of Pharmaceutical Track and Trace

  • Easy lot number tracking Traceability solutions like Microsoft D365 help departments assign specifics like a package, serial, and lot numbers to any outbound or inbound finished medicines. This makes tracking whole batches quick, easy, and accurate.

    Traceability solutions also help post tracking details as ledger entries – where there is a dedicated page for managing the workflow. This dedicated page even shows the total sums of traced items throughout production.

  • Item availability Lot traceability with Microsoft Dynamics 365 Finance and Operations helps calculate and report an item availability in real-time.

    It’s not just about tracking, though; D365 also helps by providing a wide range of accurate item information on the tracking page so that it’s easy to find out how much of the product is consumed and what remains.

    You can check the lot availability per lot number and serial number. It also prevents the double allocation of items in a lot or batch.

    Some of the critical metrics D365 offers visibility on include things like:

    • Total Quantity
    • Current Requested Quantity
    • Total Requested Quantity
    • Current Pending Quantity and
    • Total Available Quantity
  • Lot or serial number allocation for inbound transactions Not likely to change anytime soon, seamless purchase order management is essential for inbound transactions, and D365 F&O makes it possible. D365 helps manufacturers process real-time lot code tracking from the moment they are part of the organization.

    This tool can automatically transfer the lot/serial number in the transaction documents and keep the warehouse team updated.

  • Lot/batch sales Whether you want to block a lot in the sales lines or control its entire journey, D365 F&O makes it possible.

    This solution enables manufacturers to freeze or partially dispatch specific lots before they’re sold. This plays a crucial role when it comes to managing recalls, especially important when you’re dealing with expired or defective lots.

    The job is done by clicking on the Items and selecting the Sales Blocked options.

  • Complete control of the track and trace items The real-time lot control and traceability abilities of Microsoft D365 Finance and Operations enable manufacturers to find out where a tracked item is used and how. This makes it easy to follow the present instances of a specific lot/batch.

    Regarding quality control, these features are significant as they help you understand which customer received which item. In case of defective product delivery, immediate actions can be taken to minimize damages.

Final thoughts

Regarding the pharmaceutical industry, we know accurate items and batch-level tracking will soon be a requirement – not just a nice to have. With advanced lot control and traceability capabilities, Microsoft D365 F&O is here to make everything more accessible than ever.

With that in mind, the effective implementation of solutions like D365 F&O will deliver the promised outcomes. The task is often a massive challenge as it is a comprehensive tool with multiple modules and features.

A seasoned Dynamics expert that understands your industry is the best way to keep the hassles to a minimum while extracting the maximum potential of a system like Microsoft Dynamics.

For more information or to find out how we can help, schedule a call today.

Batch traceability in pharmaceutical manufacturing
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Batch Traceability in Pharmaceutical Manufacturing
Batch Traceability in Pharmaceutical Manufacturing 700 500 Xcelpros Team

One of the oldest in the world, the pharmaceutical industry has had to face many challenges over the years. One of the biggest challenges that still presents itself today is how to address batch traceability when it comes to pharmaceutical manufacturing.

The importance of Pharma batch traceability

For a multitude of reasons, pharmaceutical manufacturers need the ability to maintain traceability throughout their entire batch process. This means being able to identify every single ingredient and process step that was involved in creating a production batch. When an issue arises, this information can help determine which action caused the problem and where it may have originated.

Batch traceability will help identify what went wrong and provide critical data for addressing any resulting challenges. A manufacturer should be able to provide an audit trail for every batch manufactured and retrieve this information quickly when needed.

When combined with other quality systems, such as an SOP manual or cGMP guidelines, batch traceability becomes more potent.

DSCSA (Drug Supply Chain Security Act)

Brought to life by the FDA and Congress in 2013, the DSCSA was designed to change how pharmaceutical products and raw materials are treated throughout the supply chain, including prescribing ways to trace the movement of products when packaged and distributed. The goal of the DSCSA was to increase the security of pharmaceutical products and patient safety using pharmaceutical finished goods. This then new law offered:

  • 1 Single federally supported solution to replace requirements that might have been different for every state
  • A simplified, consolidated view of supply chain regulations that focus on enhanced patient safety and security
  • Higher standards for distributors in the U.S.
  • Streamlined processes for identifying the suspect or counterfeit goods in the supply chain

As we approach the 10-year deadline set by the DSCSA, where partners in the supply chain will need to provide item-level traceability when products move from one party to another, stakeholders must make sure they’re in full compliance.

The longer you need to implement a track-and-trace solution, the more at risk you face things like heavy fines, loss of licensure, and even imprisonment.

For more information about the act – see FDA DSCSA 

GS1 traceability standards

With so much more data getting captured every second, GS1 standards are a way to focus on what’s important – with a set way to manage your supply chain data to make sure important data is always available, understandable and 100% accurate.

GS1 traceability standards are part of a larger global framework used in over 100 countries to ensure the systems they use for traceability are designed for interoperable collaboration and sharing information for the entire supply chain using the following.

  • Critical Tracking Events (CTEs) Actual events that occur throughout the lifecycle of a traceable product or raw material. This includes things like packing, shipping, and receiving.
  • Key Data Elements (KDEs) Important information and data regarding the specific pieces of Critical Tracking Events.
  • Global Trade Item Numbers (GTINs) and Global Location Numbers (GLNs) Unique identifiers for finished goods and raw materials as they move through the supply chain.

According to GS1, four key events should be given the most attention as finished goods, and raw materials move through the supply chain:

  1. 1.What product(s) were impacted?
  2. 2.When did the event occur?
  3. 3.Where did the product(s) come from? Where are they now?
  4. 4.Why was this process observed?

For more information about GS1 traceability standards – see Supporting the Pharmaceutical Supply Chain for DSCSA

Pillars of batch traceability

Figure 1:Pillars of Batch Traceability

Pillars of Batch Traceability

With the law already written, it’s up to partners to figure out how they’ll meet the requirements. To ensure this compliance can be met, four underlying pillars of batch traceability should be implemented one way or another.

  1. 1.Serialization – The ability to create unique identifiers for a product with multiple packaging options. This typically includes serial numbers, lot numbers, and expiration dates.
  2. 2.Track and trace – Like Serialization, track and trace is all about where a product has been and where it is now. This helps highlight any ownership changes, determine the original manufacturer, or track all movement throughout the supply chain, even if it hasn’t changed ownership.
  3. 3.Verification – The ability to verify where a product is or has been in the supply chain. This includes requirements to confirm specifics like serial and lot number, movement and transaction history, and more.
  4. 4.Reporting – The ability to report accurate information about serialization, track and trace, and verification to regulatory bodies as needed and required.

The ability to report accurate information about serialization, track and trace, and verification to regulatory bodies as needed and required.

These pillars are designed to work together to give you a more detailed view of the products in your supply chain, and lets you share that data with your partners, customers and more.

Final thoughts

Batch and item traceability doesn’t just help protect consumers from harm and keeps your company in compliance with regulatory bodies like the FDA. Batch traceability software lets manufacturers and distributors easily track every batch of product manufactured during a specific timeframe.

All said and done, a properly implemented track and-trace solution will allow you to fully trace finished goods and raw materials as they move through your supply chain from start to finish. Being able to track your products helps to prevent theft and counterfeit copies and makes sure your products remain safe for use. Tracing your products lets you closely follow and monitor every product in your supply chain, leading to fast, efficient returns and recalls, confidence in your products, protection of your brand, and more. A solution like Microsoft Dynamics 365 makes this all possible by providing a customizable system tailored to your specific business needs.

After 2023, track and trace won’t be an option – this will be a requirement if you want to keep doing business in the pharmaceutical industry. The sooner you have a system in place, the better.

Not sure where to begin? Contact us today to see how we can help.

The Importance of Supply Chain Visibility for Pharmaceutical Companies
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The Importance of Supply Chain Visibility for Pharmaceutical Companies
The Importance of Supply Chain Visibility for Pharmaceutical Companies 1449 1036 Xcelpros Team

Introduction

Today, many businesses rely on the supply chain to fill their shelves with products ready to sell, and pharmaceutical companies are no exception. To provide the fastest response time possible, pharmaceutical companies must have full visibility of the products in their supply chain, from when they are manufactured until they reach the store shelf. This can be a challenge, especially as many products come from outside sources and other countries. How can supply chain visibility help your business? Read on to find out!

The Modern Supply Chain

The supply chain has become more complicated and sophisticated with pharmaceuticals being regulated. Using an efficient, reliable supply chain directly impacts customer satisfaction, cost containment, and competitive differentiation. This is because customers want consistent quality drugs that work every time they are administered to patients. Pharmacists want to give their customers the cheapest possible medication while meeting their needs.

Pharmaceutical supply chains have changed in recent times to make this happen. For example, products go through various manufacturing phases, including research and development, before becoming end products. There are also numerous checkpoints along the way that include inspections by regulators.

Manufacturers need an accurate grasp of current production costs to accurately predict new drug pricing and minimize any additional expenses associated with these phases. The supply chain needs to be flexible enough to accommodate sudden changes in demand, raw material prices, and regulatory requirements. They also need to monitor operational metrics such as fill and inventory turnover rates so that all stakeholders know what is going on.

3 of the key features that define the modern supply chain are proximity, visibility, and sustainability.

  1. 1.Proximity – Proximity means cutting out middlemen who add cost and complexity to transactions.
  2. 2.Visibility – Visibility means being able to know where every product is at any given time.
  3. 3.Sustainability – Sustainability means paying attention not only to the natural environment but also how our supply chains interact with other industries (e.g., manufacturing) as well as social issues (e.g., food security).

One of the most important aspects of a modern pharmaceutical supply chain is visibility. If it was difficult or impossible to see where products were and how fast they were moving, there would be too much room for error. That is why good tracking systems are necessary for companies in this industry. One common solution includes scanning barcodes to keep track of items, but there are other ways as well depending on each company’s needs. Some solutions allow for locating materials anywhere in a warehouse using a radio frequency identification system (RFID). An RFID reader sends out radio waves from its antennae which causes tags attached to objects within range to reflect certain frequencies, causing them to stand out against other objects not tagged with an RFID tag.

Benefits of Supply Chain Visibility

Pharmaceutical organizations have found that supply chain visibility provides several important benefits, including greater data accuracy, lower inventory costs, reduced compliance risk, and increased business agility. With the help of insights from better visibility, they can identify potential problems before they happen. With this information, pharmaceutical industries can proactively solve problems before they cause severe damage to their organization. It has even been shown that well-managed supply chains lead to higher customer satisfaction scores and product reliability.

Increasing supply chain visibility offers a wide range of benefits for organizations today, including:

  • Increased data accuracy.
  • Improved process efficiency.
  • Lower inventory costs.
  • Reduced risks associated with compliance.
  • Enhanced agility to meet the needs of changing markets quickly.

That last point may be especially critical for pharmaceutical companies given the fact they stand to incur substantial penalties if violations occur during the supply chain process. All these factors make visibility an essential component not only to reducing risks but also to success overall.

With so many benefits, improving supply chain visibility should be a top priority for any company, regardless of its size or industry. The initial investment in implementing these changes will pay off handsomely in terms of financial benefits, brand protection, and positive impacts on both customers and employees.

Improving Visibility

Companies that maintain a high level of visibility throughout their supply chain will benefit from increased safety, lower risk of errors, reduced cost, and improved customer satisfaction.

In today’s digital world, there are many ways to implement visibility measures into your business practices. This can be done through computerized systems that track inventory and orders, barcodes, radio frequency identification (RFID) tags on products, or other innovative modern technologies. These systems can not only keep you informed on the location of your products but also allow you to detect theft, tampering, or defects in packaging before they get shipped out.

A proactive approach such as this is necessary to reduce the risk of having issues with faulty goods or health and safety hazards that could affect customers. It is crucial for businesses in the pharmaceutical industry where an error may result in death, injury, or permanent disability because it is important to ensure every step has been taken to provide quality assurance along the way.

Figure 1:Steps to be taken to ensure quality in the supply chain

Steps to be taken to ensure quality in the supply chain

  1. 1.Identify customer supply chain activities – Track customer shipments as soon as they are picked up and shipped in real time. Always have visibility on what has been delivered, where it is currently located, and any delays.
  2. 2.Utilize location-based technologies – Utilize the latest in GPS technology to monitor transportation so you can track deliveries from start to finish with ease. This will give you full control of your supply chain and alert you to any discrepancies immediately instead of having to search through multiple records manually later.
  3. 3.Use big data analytics tools – Leverage automated tools that provide a complete view of all activity across every part of your supply chain.
  4. 4.Share accountability with everyone involved – Make sure that everyone who handles or touches the product throughout its life cycle knows their responsibility at every step and is held accountable if there’s a problem somewhere along the way.
  5. 5.Understand global dynamics – Achieving visibility means understanding what is happening locally and globally and how international events may affect local ones (and vice versa).
  6. 6.Keep customers informed – Be transparent about what is happening throughout the entire process by keeping customers informed about shipping schedules and any issues that arise during shipment.

Finding the Right Solution

One of the biggest challenges in managing supply chain visibility is coordinating all parties involved. Creating and executing a plan can often be complicated with multiple stakeholders, especially when crossing borders or distributing products from different geographic locations.

Various software solutions and cloud-based platforms are available to help with these challenges, but companies must choose the right technology for their needs.

The following benefits should be considered before choosing a solution:

  1. 1.A single solution that integrates data across the entire supply chain.
  2. 2.An accurate view of each vendor’s location and inventory levels.
  3. 3.Work seamlessly with one another regardless of location or platform.

When considering which solution is best for you, it is important to evaluate your company’s goals and make sure that your decision will support them.

Your business may have specific needs related to planning and forecasting, inventory management, asset tracking or other capabilities. By determining what you want to achieve through supply chain visibility, you will be better equipped to decide about which product or service fits your company’s unique situation best. In some cases, implementing an ERP (Enterprise Resource Planning) system is ideal for connecting diverse systems, tracking assets on a global scale, and organizing all activities from sales orders to invoices.

Microsoft Dynamics 365, through its a combination of big data and analytics that are continuously updated, can provide valuable insights to help pharmaceutical companies achieve more supply chain visibility by assisting with inventory tracking, forecasting, customer insights and trade spend. By having these features readily available, a business can get the real-time visibility they need to gain insight into market fluctuations and improve their order fulfillment rate.

Microsoft Dynamics 365 offers benefits in automating complex processes such as invoicing, accounting, and sales analysis.

Some of the software’s inventory management capabilities make it an efficient way to manage many aspects of supply chain visibility. It is also good for tracking inventory distribution across multiple warehouses or stores in order to gain greater supply chain visibility. Plus, Microsoft Dynamics 365 offers deep insights into customer behavior which helps track competitive offerings and measure performance success by channel. Finally, Dynamic’s manufacturing features provide details critical to maintaining safe working conditions while reducing manufacturing costs.

In addition to providing information on order fulfillment rates and logistics processes, this type of system also improves control over manufacturing process timescales and provides alerts if any disruptions occur in any part of the system.

What’s Next?

The next step for most companies should be meeting with your partner to discuss supply chain visibility. At this point, an organized and ongoing audit process must be in place so you know what needs improving and where to go next. Once a plan has been created, it should be revisited at least once a year or when processes change, or the latest information becomes available.

A third party can play a role in this continuous improvement by bringing impartiality and objectivity. Continuous improvement will keep your company ahead of evolving regulations such as GDPR (General Data Protection Regulation), which means maintaining compliance and staying ahead of potential requirements by gaining valuable insights through accurate supply chain visibility.

Better supply chain visibility will also help you identify trends that lead to additional revenue opportunities, such as inventory obsolescence or potential overproduction. For example, if your sales team told you about reduced demand for certain products and gave feedback on how to address the problem, these insights could come from supply chain visibility. Ultimately, working with the right partner to achieve greater supply chain visibility will enable your company to thrive despite external pressures or changes to industry standards. Contact us today for more information to see how we can help your business grow.

Get the Most Out of Your Business with Microsoft Power BI
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Get the Most Out of Your Business with Microsoft Power BI
Get the Most Out of Your Business with Microsoft Power BI 700 500 Xcelpros Team

Introduction

In highly regulated industries like Chemical, Pharmaceutical, and Life Sciences – being able to analyze your data quickly has become critical for everything from ensuring a good customer experience to understanding changes in the market.

Microsoft Power BI connects your data to all the tools you use daily, from Excel and Outlook to Microsoft Dynamics 365 and dozens of applications in between, aiding collaboration and the generation of actionable insights. Compared to older manual processes, Power BI doesn’t just save you time—it helps you get the most out of your business, so you can focus on moving your company forward. Learn how Power BI Connectors can help you today by giving your business access to the data it needs to grow faster and reach new heights.

The future of analytics

Data and analytics have become increasingly important for a wide range of businesses, especially in recent years where adoption is growing.

Figure 1:Worldwide BI & Analytics Growth

Worldwide BI & Analytics Growth

Source: Apps Run the World; Statista 2022

While regulations have traditionally been enforced by a group of people inside a company, these regulators expect to see evidence-based decision-making from businesses at all levels. Maintaining visibility into data from various sources is essential to comply with certain regulations. Because of the number of data sources and systems that companies can use today – often including disparate technologies or providers – it can be not easy to extract data across platforms for analysis purposes.

In the Chemical, Pharmaceutical, and Life Sciences industries, where regulatory oversight has always been a top priority, the need for reliable analytical tools has significantly increased over time.

Immediately, you may not know what would make a difference in terms of driving customer behavior or improving customer experience without proper analytical tools, without data showing trends like customer purchases about prices and features offered by competitors, or where customers spend most of their time within your site, or which pages result in the highest bounce rates?

Data collected from marketing campaigns are used to help answer questions about customer engagement, usage habits, and preferences to improve engagement throughout the user journey. Understanding the general pattern of what makes your customers tick is necessary to gain insight into their behaviors and needs – even if they don’t give you direct feedback! Regular monitoring through powerful analytic solutions like Power BI makes this type of feedback easier than ever.

Where does Power BI fit in?

Power BI is a Microsoft cloud-based business intelligence and analytics platform that helps businesses run on multiple systems to get the most out of their data. Power BI has a growing library of connectors that helps businesses connect different sources to analyze data and create unique reports and role-based dashboards. Power BI can track key performance indicators (KPIs), monitor sales and marketing campaigns, and understand customer behavior.

Power BI can help businesses in the Pharmaceutical, Chemical, and Life sciences industries use their data more efficiently to make better decisions. For example, a company that manufactures chemicals for use in other products could run simulations based on different product characteristics and use Power BI to analyze the output from these simulations. If one type of product were found to be more profitable than another under certain conditions, they would know which products to produce more or discontinue producing altogether.

Additionally, a company that produces vaccines needs to know exactly how much demand there will be for their vaccine before it’s released into production; with Power BI, they can plot a forecast for where demand might be higher or lower than expected, letting them adjust their production accordingly. As Microsoft grows its library of Power BI connectors, companies will have easier access to all sorts of valuable data and insights.

What Are Power BI Connectors?

Power BI connectors are a part of the software that allows you to connect different data streams in one location – perfect for any business that runs on multiple systems. For example, suppose you’re a chemical manufacturer offering consulting or testing services. Power BI connectors could link the two systems together to generate automatic reports and analyses.

This lets you import data from one system into another system or export data into another. This makes it possible to see all your information at once without going back and forth between systems. Power BI connectors link data sources based on predefined rules and patterns. They also come pre-built with smart visualizations and customizable dashboards, allowing you to view all your information at once without switching between each company’s app or website.

Once you implement Power BI, you can use available connectors for free! The library of power bi-connector options continues to grow as more businesses find the value in using them for their purposes. These days, you can use Power BI connectors to do anything from importing bank statements into payroll management software to analyzing customer sentiment over time. There are many benefits to using power bi connectors.

One major benefit is the ability to analyze your company’s data in-depth without ever having to step outside of Microsoft Office 365. This makes it easier for employees who don’t normally share responsibilities related to finance or sales reporting, for example, because they know they can stay within their comfort zone while still getting the job done efficiently.

In addition, those employees will always know what needs to be done because they’ll always have access to relevant information and charts and graphs that provide additional context around certain trends.

What about security, privacy, and compliance

Regarding business data, security, and privacy are always top concerns. Microsoft is aware of this and has taken steps to ensure that the data it collects with Power BI is secure and in full compliance. For starters, all data is encrypted both in transit and at rest.

Power BI complies with major industry standards like HIPAA, SOC 2, and GDPR. It’s easy to see why so many companies trust their data to Power BI for their analytics needs. Data is processed on an isolated instance, ensuring there’s no possibility of a breach from a compromised network server.

To stay on top of any potential breaches that could arise from malware infections or unauthorized access attempts, administrators can monitor the system for any suspicious activity. They can also set up alerts and audit logs to track who accessed what data, when and where they did it from. If something happens, the company will have information about how it happened and what was lost, as well as how they could mitigate the damage.

Power BI works hard to keep your data safe by having dedicated security features designed specifically for businesses including:

  • A dedicated infrastructure architecture separates workloads into individual virtual machines and prevents cross-contamination.
  • Several built-in protections against SQL injection attacks.
  • Protection against cross-site scripting (XSS) via double validation tokens.

These protections help make sure you’re safe while you work on your dashboards!

Next Steps

While it’s true Microsoft’s Power BI is a powerful tool that can help businesses gain insights into their data, even across different systems, to get the most out of it you need an experienced partner who can implement Power BI seamlessly and connect it to your other systems. Working with a partner that understands your industry means less time is spent trying to figure it out on your own.

An experienced partner will help you maximize the value of Power BI and ensure that you are getting the most out of your investment. With an experienced partner, you’ll also have a strategic advisor who can advise on addressing your needs through customizations and integrations. Plus, they’ll help you keep your system up to date so that you’re always maximizing the value of your investment in power bi.

Maintaining an enterprise-wide analytics platform requires expertise from partners who understand not only what software does but how to use it as well. For instance, if a company has never used SQL before or has no knowledge about R scripting, you’ll want to investigate more experienced support.

Xcelpros offers hands-on industry experience implementing Microsoft Power BI analytics with custom extensions and connectors that provide customers with deep insight into their data and seamless integration between disparate business systems.

Schedule a call today to see how we can help you meet your business goals.

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Streamlining Production Process in the Pharmaceutical Manufacturing
Streamlining Production Process in the Pharmaceutical Manufacturing 700 500 Xcelpros Team
  • There’s a consistent demand to scale capacity when it comes to pharma manufacturing as healthcare demand continues to rise globally.
  • Cost-savings, shorter turnaround time, and enhanced productivity are some of the key criteria for top executives in pharma manufacturing companies.
  • Automation of production lines, minimizing raw material wastage, stakeholder synchronization, optimized resource allocation, etc. are some of the ways with which pharma manufacturing can be streamlined.

Around the world, we continue to see rising demand for access to quality healthcare. Side-effects of the recent pandemic significantly added to this demand. This has placed a lot of pressure on pharma and biotech manufacturing companies, who are finding it difficult to:

  • Streamline research and development (R&D) processes.
  • Reduce overall costs and improve time to market.
  • Ensure 100% safety and regulatory compliance.
  • Enhance production capacity.
  • Expand market reach.

Pharma manufacturers must constantly upgrade their game regarding R&D, operations, production, and distribution with newer technologies and strategic business moves. With signs indicating the industry is poised for extraordinary growth, it’s becoming a given that manufacturers will need to invest in leaner, more agile production processes.

According to the 2020-2027 Pharmaceutical Market Size Report, by Grand View Research, the global pharmaceutical manufacturing market size was valued at USD 324.42 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 13.74% from 2020 to 2027.

These growth stats put focus on the need for ramping up production without compromising on safety, all while ensuring consistent profitability.

Key Factors in Pharma Manufacturing

Before we look into how manufacturing in pharma companies can be streamlined, we must consider some key processes involved.

1.Robust R&D: For pharma and biotech companies, continued investment in laboratories is essential in ensuring long-term success. With Robust R&D comes increased chances for innovation, which can define a pharma company’s overall market position in terms of being the first to manufacture a ground-breaking formula. The strategic movement towards streamlined manufacturing begins with ensuring superior, quality research in the labs.

2.Raw Material Acquisition and Distribution: Whether it’s small-molecule or biological drugs, pharma companies typically depend on an intricate network of raw material manufacturers and distributors to acquire safe and superior-quality products. In addition, complex formulations require compounds manufactured across multiple facilities to be stored and transported in optimal conditions. Manufacturers could be dependent on multiple different suppliers for raw materials globally.

3.Managed Production Lines: Today, pharma companies are more dependent than ever on fast-paced production lines backed by technology-enabled batch manufacturing, serialization, and traceability. Bridging the gap between hardware and software for streamlined drug production can make a huge difference in speed to market.

Manufacturing Process Issue/ Roadblocks How Technology Can Help
R&D Prone to human error, slower processes Automated data integration and analysis, AI for molecular identification
Supply Chain Highly complex, data discrepancies or duplication, missing information, stock-outs Centralized SCM for real-time visibility, centralized data access, real-time stakeholder communication, inventory management in ERP
Drug Manufacturing/ Production Shop floor to top floor communication glitches, communication time-gaps, human errors in reporting/ record maintenance Automated production lines, report generation in ERP, real-time communication between shop floor and top floor
Quality Control Counterfeits, fake drugs, human errors, formulation errors Computerized serialization, use of blockchain to ensure drug safety

4.Competent Supply Chains: Healthcare is a global business and, now more than ever, pharma manufacturers are dealing with complex supply chains involving multiple stakeholders spread worldwide. Ensuring that these supply chains are competently managed is critical to ensuring the overall streamlining of pharma manufacturing.

5.Quality Checks: When it comes to drug manufacturing, anything less than 100 percent is often unacceptable. Pharma companies are well aware of the perils of lawsuits, license cancellations, and other dire consequences regarding quality management. At every stage of pharma manufacturing, quality checks are paramount to ensuring drug safety and compliance with all required healthcare regulations.

Schedule a call to learn more about how to streamline your pharmaceutical manufacturing production process

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How Can Pharma Manufacturers Streamline Their Production Processes?

Pharmaceutical companies are embracing newer and newer technologies for quicker results, better process management, and enhanced productivity. Still, there’s a lot more that pharma manufacturers and their CDMOs can do to enhance the overall pharmaceutical production process for significantly better results.

  • Integrating new technology in the lab is proven effective in accelerating research and innovation. Leveraging Big Data and Analytics for data collation, integration, and insights generation from clinical trials can expedite the process and ensure accuracy and transparency. Similarly, computational permutations are effective in molecule identification for a particular drug. Gene sequencing, digital record maintenance, computerized medical equipment, etc., are becoming game changers in strengthening R&D and the production process typical in pharma manufacturing.
  • Pharmaceutical shop floors can and should be well-integrated with the IT infrastructure on the top floor. By embracing software-managed production lines, manufacturers can leverage automation for faster and error-free processes. Similarly, production supervisors can benefit from the automated data flow from an Enterprise Resource Planning (ERP) system to and back from the production lines. This software can manage tasks like reporting and serialization to save time and cost.
  • Newer technologies and software for SCM are becoming pivotal in helping pharma companies stay on top of complex supply chains and distribution networks. IoT solutions are leveraged in pharma manufacturing and distribution for real-time monitoring and communication. Better shipping times and inventory management become possible through effective data analysis. Many companies also use blockchain to ensure data security and encryption while managing complex supply chain networks globally.
  • The use of blockchain and comprehensive ERP software (for serialization) are also helping manufacturers ensure drug safety. Since these tools and technologies provide the option of complete traceability (from production to patent), drug counterfeits become extremely difficult, if not impossible. Drug quality and safety are major concerns for manufacturers, and optimal use of technology can ensure quality checks, thereby saving efforts, costs, and time.

Final Thoughts

Pharmaceutical manufacturers are embracing newer technologies for better production and profitability. With these technological advancements, companies could achieve their manufacturing goals without compromising quality and safety.

  • Newer technologies and software such as IoT, Artificial Intelligence, Data Analytics, SCM, and ERP play important roles in streamlining manufacturing processes in pharma.
  • Pharma companies need to reinvent themselves technologically to keep up with the complex and ever-expanding canvas of global healthcare.

Resources: Workflow Software for Improved Healthcare Solutions

streamlining-the-label-management-process
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Streamlining the Label Management Process
Streamlining the Label Management Process 700 500 Xcelpros Team

At a Glance

  • $10 million: The average cost of recalls to food companies that can are caused in part by inaccurate labels.
  • $65,000: The average cost of incorrect labeling based on a 2020 survey. Of that group, 61 percent said mislabeling costs exceeded $50,000.
  • 10-26%: The number of products mislabeled every year according to a survey of 300 IT directors in the U.S., UK, France and Germany.

Introduction

Labels serve three primary purposes in a consumer’s eyes. Labels help to:

  1. 1.Identify the contents of a product
  2. 2.Identify the product name
  3. 3.Promote the brand image

In combination with well-designed packaging, certain label parts could be considered one component of an effective marketing campaign. From a business perspective, though, labels need to do much more than tell consumers what is inside. Efficiently labeling and tracking is the best way to monitor a product’s performance, along with ensuring customer safety is the best it can be. This is especially true when it comes to certain industries like pharmaceuticals.

Packaging and Labeling

There are many key points to note when it comes to packaging and labeling, including the following:

Definition:

Labeling refers to the text, design, symbol, logo, instructions and use suggestions printed on the product package. Labels are designed to inform and attract customers by providing information.

Objective:

Labeling provides all information required by the governments in the geographical location where the product is marketed, sold and used.

Focus:

While exterior packaging is about appearance, labeling focuses on what’s inside. For example, products are required to accurately list the primary ingredients and their nutritional value when it comes to food. Labels on medicines must include active and inactive ingredients, allergic reactions, and harmful side effects.

Label designs are usually simple and formal. They may follow a government or company template. These can require a set list of data fields such as country of manufacture and expiration or “use by” date. Hazard information is typically posted where a customer can see it before making a purchase.

Effective label designs also include inventory tracking options while also meeting government requirements.

Inventory Tag Controls

“When paired with a competent asset or warehouse management system, inventory tags can be scanned to inform your supply chain of changes in your current inventory. This practice helps build end-to-end visibility among all parties, from supplier to customer, as your inventory moves through your warehouse,” according to a blog post by CamCode.

Inventory tags can be integrated into a product’s label design. The most common inventory labels we see doing this are bar codes. Barcode are a series of vertical lines—generally black—of varying widths interspersed with white gaps. QR (i.e., quick response) codes are a form of bar code generally in a square or rectangular format with black blocks and white spaces.

Speed is the main advantage of using a barcode or QR code label. Handheld and machine scanners can read the barcode information, sending it to inventory tracking software. That software can then automatically update inventory counts, eliminating the need for manual checks. The result is a fast, more accurate inventory update. A critical part of inventory tagging with barcodes is using the right type. Before creating any labels, companies should ensure they understand any regulatory or equipment-based requirements for the barcode type, label size, and label material type.

Figure: 1Components of a Barcode

Example of a Barcode

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Different Types of Barcodes

Barcodes primarily come in three different types:

  • Numeric only with a row of numbers beneath the bars
  • Alpha-numeric with a row of letters and numbers
  • Two-dimensional (QR is one example) using a series of small dots arranged in a unique pattern

The type of barcode a company chooses often depends on its industry and how the product will be used. For example, the Postnet format encodes destination information using long and short lines. Retail items often use the Universal Product Code (UPC).

The U.S. Food and Drug Administration (FDA) has several requirements for barcodes. While the FDA does not require a specific code format, it mandates the barcode include the drug’s national drug code (NDC) number. Machine-readable information on blood and blood components must be on those labels.

“This new system is intended to help reduce the number of medication errors that occur in hospitals and health care settings,” according to the FDA.

These FDA rules apply to manufacturers, repackers, labelers, and private label distributors of human prescription drug products, biological products, and over-the-counter (OTC) drug products to protect consumers from dangerous side effects or worse.

Labels alone are not enough. However, companies need to be able to accurately track their inventory as well as safely manage any recalls or other issues with products. This only works when you have the right software in place.

Inventory Tracking Software

Software like Microsoft Dynamics 365’s Supply Chain Management includes several powerful inventory management features helping these businesses thrive today. For example, Supply Chain Management can automatically assign serial numbers based on manually entered (or scanned) batch numbers.

Dynamics 365 Supply Chain Management also makes creating and tracking barcodes for released products easy. This modern inventory management software also works with the GS1 bar code and QR formats for use on shipping labels.

Microsoft says, “Unlike older bar codes, GS1 bar codes can have multiple data elements. Therefore, a single bar code scan can capture several types of product information, such as the batch and the expiration date.”

With a system like Microsoft’s Dynamics 365 Supply Chain Management, you can use a predefined list of application identifiers to define the meaning of your data and connect it with GS1 codes. Microsoft suggests, “The setup of the application identifiers defines how the system should interpret a bar code and save it as a value in the system.”

The Bottom Line

With today’s focus on consumer safety, proper labeling and tracking of products, especially when it comes to pharmaceuticals and medicine, will continue to be of utmost importance, including efficiently dealing with government regulations. Today’s businesses need to ensure they’re taking advantage of inventory tracking software that lets them easily create labels that help track the flow of raw materials, from work in progress to finished goods.

Programs like Microsoft Dynamics 365 Supply Chain Management can create unique QR codes that contain a list of ingredients, allergy information, serial and batch numbers, hazardous warnings, and safety data sheets. Solutions like these let your warehouse staff scan products and send information wirelessly to any device on the network more efficiently than ever before. Is your labeling solution up to speed?

Resources: Packaging vd Labeling

Warehouse management challenges in the pharmaceutical industry banner
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Warehouse Management Challenges in the Pharmaceutical Industry
Warehouse Management Challenges in the Pharmaceutical Industry 700 500 Xcelpros Team

At a Glance

The pharmaceutical industry faces some unique warehouse management challenges. Many of these issues can dramatically impact medications, even though they may not exist in industries such as general retail.

Key issues facing warehouse managers include:

  • Keeping portions of their facilities at the correct temperatures to prevent medications from spoiling.
  • Following federally-mandating good manufacturing process rules.
  • Security issues for products and intellectual property.
  • Inventory controls.

Warehouse issues specific to the pharmaceutical industry include:

  • Temperature control: Active pharmaceutical ingredients (APIs), precursor chemicals, and manufactured drugs frequently require controlled temperatures. A general temperature range for a cool, dry place is between 59-77° F (15-25° C). Some products, such as vaccines, may require freezing. Exposing drugs to the temperature outside their effective ranges can cause chemical changes and reduce a drug’s effectiveness. For example, Baystate Health states that medications containing hormones do not work as well when exposed to colder or hotter temperatures.
  • Humidity control: Moisture condensing inside packages can impact a medication’s effectiveness. Baystate Health states that blood glucose strips exposed to humidity will give inaccurate readings.
  • Light exposure: Exposure to ultraviolet light from the sun and other sources can change the chemical structure of some medications. The light exposure causes photodecomposition, reducing the medication’s potency. Light exposure can also cause side effects after administration, such as phototoxicity and photoallergy, a 1997 post in PubMed states.
  • Adhering to the Food and Drug Administration (FDA) Current Good Manufacturing Process (CGMP) standards for warehouses, processes, and drugs: Includes keeping careful track of item locations within the warehouse.

According to Kanban, the FDA’s CGMP warehouse standards include the following:

  • Contamination prevention: Storage must allow inspection and cleaning.
  • Identification: Each drug must have a unique, traceable code that identifies the lot’s status, such as approved, quarantined or rejected.
  • Distribution Procedures: Written procedures describing the distribution process for each drug including recalls.
  • Storage Procedures: Written procedures describing the storage conditions for each drug are required.

Some pharmaceuticals require only temperature controls for specific ranges. Other medications require climate-controlled environments affecting temperature and humidity.

Figure: 1Pharmaceutical Warehouse Management Challenges

Pharmaceutical Warehouse Management Challenges

Planning on transforming your pharmaceutical warehouse to get over operational challenges? Get started with a assessment!

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Following GMP Rules

GMP SOP states that following the Good Manufacturing Process (GMP) rules enables manufacturers to:

  • Protect medicines and raw materials for medicines during storage
  • Prevent finished product degradation
  • Avoid contamination from other materials
  • Prevent damaged or expired products from being shipped

Warehouse managers also face the challenge of keeping track of three types of items appearing on the packaging bill of materials governed by GMP procedures. Each of these item types requires unique lot numbers:

  • APIs, precursor chemicals and other starting materials
  • Packaging materials
  • Printed materials

All warehouse managers face inventory control requirements. Those in the pharmaceutical sector also deal with intense government scrutiny.

Receiving Shipments

Other GMPs in the pharmaceutical industry require materials arriving from suppliers to be reviewed based on their use. For example, it’s important to check starting chemicals to confirm they are:

  • From a source approved by the company
  • Free of damage and defects
  • Labeled with all required information
  • Have a unique identifier
  • Registered in the company’s inventory database
  • Quarantined until quality control tests are performed
  • Stored appropriately and safely, such as in a temperature-controlled section or “Dangerous Goods” area for flammable and toxic materials

Unlike retail goods warehouses, pharmaceutical warehouse managers should also set aside an area for raw materials to be tested and confirmed to meet all required standards. A similar section should exist for any materials that fail these tests, GMPSOP states.

Sampling and Testing

Sampling and testing should be done in a room having sections with positive air pressure (i.e., the air pressure is higher than that outside, preventing contaminants such as dust, microbes, pollen, cleaning agents and lubricants from entering) and negative air pressure (i.e., the pressure is lower than that outside to prevent materials from inside the room going outside). An airlock with positive pressure keeps out external contaminants. With the airlock sealed, the inner testing can have negative air pressure to keep chemicals from contaminating the larger warehouse.

Other sampling room requirements include clean instruments and appropriate personal protective equipment (PPE) as required by the federal Occupational Health and Safety Act (OSHA) and the FDA. OSHA has a downloadable brochure on warehouse safety.

Storage and Tracking Inside the Warehouse

“Lack of control over material movement in the warehouse can, and has, led to defective products,” GMPSOP states.

General warehouse practices (GWP) require that:

  • Received unused goods and finished products are quarantined until approved for release.
  • Items have correct status labels (e.g., current, expired, etc.)
  • Unique identifiers are visible.
  • Products are stored by type when appropriate.
  • Access to toxins and addictive drugs or chemicals is stored separately. Access is limited only to approved personnel.
  • Materials are tracked as they move through the production facility from the Receiving area to Production and then to the Shipping.

When possible, warehouse managers should have separate sections to store damaged or returned goods, recalled items, “not for sale” samples and when identified, counterfeit materials.

Labeling

Another challenge for pharmaceutical warehouse managers is accurate labeling. GMP rules require labels to include a familiar name and Unique Identification Number that must be different from the supplier’s lot number. The UIN must be recorded in the lab, on the facility’s computer system, and in production. GMP SOP suggests not referring to the IUN as a batch number.

Other requirements unique to pharmaceutical labeling include:

  • Expiration dates
  • Barcodes for additional tracking options
  • Status indications, typically in the form of a color code
  • Quarantined products
  • Items being held for investigation
  • Rejection labels when an item fails to meet required standards
  • Approval and/or release labels indicating the item can proceed to the next step in the supply chain

Security Challenges

Medicines and other pharmaceutical products are in high demand, making them tempting targets.

Warehouses should have secure physical storage areas for raw materials and finished products.

In addition, Avcostar states that the formulary, drugs, and drug components are expensive and prone to theft. It suggests performing a risk analysis audit that includes where known security breaches occurred. “The company can then focus on identifying and eliminating the most vulnerable posts and systems against malicious access, modification or deletion of data, enhance access control to systems and data and implement new cybersecurity best practices,” Arecont Vision Costar VP of Marketing Jeff Whitney states.

The code of federal regulars 21 CFR Chapter 1 requires control of all production stages, including system validation and audit trails. Refer to this article from Cornell Law School for detailed information.

Solving Challenges

Effective use of warehouse management computer systems, such as the warehouse management module in Microsoft Dynamics 365’s Supply Chain Management, can help track inventory management in pharmaceuticals accurately and manage these challenges.

The module “has a wide range of features to support the warehouse facility at an optimal level at any time,” according to Microsoft. Among the warehouse module’s functions are:

  • Workflow support
  • Using mobile devices
  • Full batch and serial item support
  • Label printing and routing
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Pharmaceutical Analytics and Business Intelligence using Power BI
Pharmaceutical Analytics and Business Intelligence using Power BI 700 500 Xcelpros Team

Introduction

Modern pharmaceutical companies are undergoing a significant transformation with new opportunities from digitization, big data, and analytics. In response to COVID-19, businesses are seeing an increased need for an agile enterprise Business Intelligence (BI) architecture to leverage these opportunities in order to grow. Successful Pharmaceutical companies are looking beyond standard operational and statutory reports to implement more powerful Analytics and AI-driven solutions. These new solutions provide actionable insights and useful KPIs to help make better decisions. This leads to more empowered teams and new engagement that drives additional revenue.

Pharmaceutical companies generate massive information every day through their day to day operations. But the data is not always being put to the right use. Some companies tend to look at reports with a traditional eye that doesn’t drive a ‘call to action’ to grow the business.

The strength of any analytics software lies in its ability to help users easily create quick insights, especially for an agile business like pharmaceutical manufacturing. Creating reports in days instead of months frees up hundreds of hours in unnecessary spend to gather these hidden insights. This allows business leaders to repurpose cost savings towards other operational improvements and growth.

There is a right and wrong way of reporting – one provides overwhelming numbers, while the other means to understand those numbers and make them actionable.

As the pharmaceutical industry continues to undergo significant adjustments to new opportunities presented by digitization, big data, and analytics, more enterprises continue to see the need for an agile enterprise Business Intelligence (BI) architecture to leverage these opportunities & seamlessly deliver business-critical insights to executives.

The Strength of PowerBI

Power BI, Microsoft’s business analytics solution, lets you visualize your data and make it accessible to your Organization. Insights can be easily shared through various platforms of your Organization by embedding them in your app, portals, or website, collaborating on Teams, and integrating them into your ERP or CRM applications. Microsoft’s Power BI makes it easy to combine these numbers from different sources, streamline analytics onto a single dashboard, act on newfound insights, and enhance visibility to other teams in your organization.

Leveraging PowerBI interactive reports in a few quick and easy steps

  • Onboard
    • Access PowerBI either from powerbi.com or any of the Microsoft ERP/ CRM applications.
    • Connect to your data wherever it lives.
    • Explore your data with interactive visuals.
  • Collaborate & Share
    • Publish reports and dashboards.
    • Collaborate with your team.
    • Share insights inside and outside of your Organization.
  • Access insights from anywhere
    • Act with seamless access to data insights from your desk or home.
    • Access on the go with Power BI visual reports built rapidly.

Book a demo to learn how Power BI can boost your pharmaceutical analytics.

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Turning Industry Data into Smart Decisions

Leading Pharmaceutical companies who are transforming into agile organizations need 360-degree insights for business-critical functions such as manufacturing execution, sales productivity, financial management, purchasing raw materials from approved suppliers, quality assurance & quality control.

Today’s pharmaceutical organizations collaborate, monitor, and communicate on available live data to achieve operational excellence. Pharmaceutical business intelligence enables these organizations to monitor real-time data from multiple sources and combine them into one pharmaceutical dashboard with the ability to drill-down into the report to identify issues, as necessary.

Figure 1: Pharmaceutical Analysis using Power BI

Pharmaceutical Analysis using Power BI

Usage in the Pharmaceutical Industry

01.Interactive Reports

Power BI is an analytics software that brings to the table a strong background in delivering end-to-end BI analytics to modern Pharmaceutical companies such as

  • Efficiency Reports On Lot Production
  • Trending And Analysis Of Quality Control Data
  • Recommendations Based Clinical Trial Reporting
  • And Financials Per Batch Produced For Each Product
  • Product Go to market assessments (how much spend and types of activity is involved, expected and actual results)

02. KPI Reporting

Accurate decision making occurs when reporting provides clarity on both good and bad data points on prime KPIs. With business analytics in the pharmaceutical industry, companies can acquire intelligence in real time and can track key performance indicators like:

  • Machine utilization
  • Process efficiency
  • Cost of Sales
  • Inventory levels
  • Batch Losses and cycle times
  • Quality standards of a product line
  • Customer engagement and customer experience

03.Real-Time Analytics

One of the essential requirements for agile Pharmaceutical companies is to have real-time analytics of overall operations, and to be able to make quick corrections and proactively handle situations before they turn into risks. Especially for manufacturing execution and pharmaceutical inventory management, knowing the work is progressing and inventory is turning around helps production supervisors to manage batch production processes much faster and make on the fly corrections. This real-time reporting on screens throughout a production plant gives needed visibility to both the managers and operators who can be alerted and fully aware of any issues.

Figure 2:Real-Time Data Tracking with Power BI

Real-Time Data Tracking with Power BI

Benefits of PowerBI enabling business improvements

  1. 1. This information gives the ability to make changes to processes based on how well resources are functioning to increase productivity, and how each product lot produced is performing in the market.
  2. 2. Getting real-time alerts with Power BI mobile apps makes your operations more efficient, allowing you to achieve a higher level of organizational agility and minimize response times.
  3. 3. Power BI enables monitoring of your supply chain end-to-end, letting you identify problems and potential bottlenecks before they can affect critical processes.
  4. 4. Monitoring quality inputs and outputs from all sources, including your customers, allows you to make quick and meaningful decisions that will improve the quality of batches that are manufactured.
  5. 5. The ability to share your dashboards with suppliers and partners is a plus and accommodates adjustments to the latest information available to work towards making your processes leaner and smarter.
  6. 6. Microsoft’s Power BI is a full-featured BI solution that offers a number of benefits to many different organizations on their path to success such as –
    • Global Scale – Local Speed
    • Agile Business Processes
    • Predictive Analytics
    • Machine-to-Machine
    • Employee Onboarding

Basic analytics used by the Pharmaceutical Industry

  • Products & Inventory
    • Full Track & Trace Functionality
    • Enhanced Global Marketability
    • Customer Requirements
    • Product Quality
    • Product Recalls
  • Sales
    • Quotes & Order analysis
    • Pricing and Cost reporting
    • Available-to-Promise reporting
    • Order Profitability
  • Supply Chain Management
    • Match demand and supply
    • Improved Supply Chain Responsiveness
    • Updated and efficient Logistic analysis
  • Financial
    • Product Profitability reports
    • Batch costs
    • A full audit of transactions
  • Manufacturing
    • Safety and sustainability analysis
    • Realtime production data reports
    • Equipment failure predictions
    • Production rescheduling

Final Thoughts

A big step towards change today comes from enhancing visibility across all operations including manufacturing execution, sales force productivity, procurement, and financials. Power BI brings to the table a strong background in end-to-end BI services for modern pharmaceutical companies – covering BI strategy, managed services, implementation & support, and even more. From the moment you start considering a BI solution for your growing Pharmaceutical company, the benefits of Microsoft’s Power BI become evident very quickly. Microsoft’s Power BI will continue to be a must-have product for leading Pharmaceutical companies by delivering a 360-degree insight of operations.

References: Advantages of Using Power Bi

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