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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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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.

Streamlining Production Process in Pharmaceutical Manufacturing banner
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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

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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

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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.

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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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Key Role of ERP Systems in the Pharmaceutical Industry
Key Role of ERP Systems in the Pharmaceutical Industry 700 500 Xcelpros Team

At a Glance

  • Disruptions brought by Industry 4.0 and digitization in the pharmaceutical sector are undeniable. Thus, pharma companies must arm themselves with state-of-the-art software solutions and tools to stay ahead in the game.
  • Tracking, tracing, and serialization need the support of automated tools that can reduce manual efforts and mitigate the errors leading to stock-outs, delivery issues, and callbacks.
  • Pharma companies need to be sure they comply at all times. An ERP with Pharmaceutical and Biotech centric solutions help companies meet all the regulatory requirements.

Technology has taken over our way of life and way of work. All major and minor sectors are undergoing massive changes to adapt to these changing times; the same goes for the pharmaceutical industry. Pharma companies worldwide face various challenges, such as increasing process complexities, changing consumer dynamics, healthcare reforms, a growing abundance of data without the infrastructure to leverage it, and more. These changing tides caused pharma companies to look at ERP as a panacea to solidify their IT framework and use the latest technologies (Cloud, Big Data, Automation, Artificial Intelligence, Machine Learning, Data Analytics, etc.).

However, merely adapting an ERP system will not give pharma companies value for their money.

In fact, according to a report by Gartner, by 2021, ERP cloud enterprise application implementation labor rates will increase by 60 percent due to high demand and a lack of skilled resources.

This realization indicates that, like other sectors, the pharma industry would need to invest in skill upgrading of their employees and get expert ERP consultants on board for a smooth implementation.

Now, let’s talk about the need for an ERP software system in the pharmaceutical industry in today’s time (especially as it needs an ERP that is tailor-made for the industry’s regulations and norms). Below are some of the key reasons for pharma companies to move to ERP

Manufacturing formulation and preformulation management

The drug manufacturing process comprises strict formulation and monitoring raw material ingredients and finished product yields to produce a batch. The pre-formulation stage includes defining drug production procedures, steps, quantities, etc. With a robust ERP system, such as the Microsoft Dynamics 365 ERP, pharma companies can ensure automated management of these formulations without constantly monitoring productions and worrying about manual errors.

Effective product costing

The costing of drugs involves various factors such as raw material master management, procurement cost, supply chain tracking, vendor cost management, and so forth. In a legacy system, these departments work in silos, and changes in data or any variable take time to communicate to other branches. There’s centralized access to data with an ERP system, and an interconnected network is established between various functions to develop concurrency. Well-captured data helps in efficiently defining product costs, and any changes can reflect in the system, enabling finance to accommodate those changes appropriately.

Figure 1:Benefits of ERP for Pharmaceutical Companies

Benefits of ERP for Pharmaceutical Companies

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Meeting Regulatory Compliance

Regulatory compliance is a big one for all pharma companies. These regulations affect the brand name and consumer’s trust, but there is a factor of safety involved. Regulations and norms also differ regionally. It is essential to stay on top of safety and healthcare protocols to maintain global standards, and this is where a comprehensive system like Microsoft Dynamics 365 ERP can serve as a game-changer. Its flexible interface, centralized networking features, and automation solutions allow pharma companies to keep up with the changing rules and regulations and helps drug manufacturers to track these measures and stay compliant.

Pharmaceutical companies are also mandated to maintain CFR 21 Part 11 where it’s a statutory requirement to record (or document- either in print form or electronically) the steps and procedures that comprise complies with this FDA-regulated electronic signature and the production of a medicinal product. Microsoft Dynamics 365 Finance and Operations is compliant with this FDA-regulated electronic signature and electronic record.

Systematic and Efficient Inventory Management with Real-time Tracking

Effective inventory management for a smooth supply chain and avoiding stock-outs or bottlenecks are always concerns for pharmaceutical companies. This concern has reached the global level as governments worldwide are looking to manufacture or procure enough potential Covid vaccines and manage inventories so that the doses go to their population smoothly. An ERP system can help with a real-time track, trace, and serialization to manage inventory and avoid plausible glitches. An ERP system can also help accelerate product recall with its high-end traceability solutions.

Managing Variability and Predicting Scalability

Manufacturing of drugs involves managing supply chain variability, understanding its sources, and gaining a hand over release failures. Another aspect is predicting the scalability of product demand to alter manufacturing capabilities/capacities effectively. Both these involve strong communication between different functions and the use of data to preempt change. With a robust ERP for the pharmaceutical industry, companies can achieve these goals through predictive analysis, data crunching, and supply chain visibility.

Final Thoughts

Pharmaceutical companies can benefit a great deal from an effective ERP implementation. This transition leads not just to accelerated production but is a massive plus in streamlining operations and managing costs.

  • A cost-effective and flexible ERP system such as Microsoft Dynamics 365 Finance and Operations enables pharmaceutical companies to take the proper steps in digitization, automation, and artificial intelligence.
  • ERP system is the need of the hour, and getting expert consultants on board can help pharma companies meet their customized financial, operational, and regulatory requirements.
  • Industrial dynamics are changing at lightning speed, and the pharmaceutical industry needs to keep up with these changes to stand the test of time.

References:

Part 11, Electronic Records; Electronic Signatures – Scope and Application

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Manufacturing Metrics and KPIs That Matter the Most
Manufacturing Metrics and KPIs That Matter the Most 700 500 Xcelpros Team

At a Glance

  • The manufacturing industry operates best by integrating people, tools, processes, and information.
  • The data generated from each of these facets needs to be quantified and analyzed.
  • In the manufacturing world, organizations that know their metrics tend to understand the tricks of the game.
  • It’s critical to focus on the metrics that matter the most; the ones that help your entire organization gain essential insights regarding different functionalities and business areas to continuously improve the manufacturing process.
  • One key that comes from knowing and managing your manufacturing metrics is the ability to systematically optimize your operations based on results.

In any industry, it’s essential to know exactly what your numbers are and what they mean to your business. While this sounds like it should be simple enough, we all know how difficult this can be in practice. When you’re able to gather numbers and metrics they still need to be collated, classified, quantified, and analyzed to add value to the business, especially for a multi-pronged industry like manufacturing. Manufacturing metrics can be diverse, and each metric has a different value throughout the manufacturing value chain. A cumulative study of a group of these metrics is a good way for manufacturing companies to gauge their performance and form strategies for continuous improvements.

Figure 1:Cycle of Continuous Improvement Methodology

Cycle of Continuous Improvement Methodology

As a manufacturing company, you always want to aim for a higher ROI which can mean a thorough analysis of manufacturing metrics and alignment of short-term and long-term business goals. Each of these metrics serves as a source of truth, representing a precise measurement of your manufacturing processes either in terms of quality or quantity (and sometimes, both). Let’s take a look at the manufacturing metrics that matter the most and how you can fortify your IT infrastructure to study and derive insights from these metrics.

1.Demand Forecasting Market research helps companies gain ideas to make estimates about demand forecasting. A manufacturer’s objective is to gauge the amount and type of raw material they will need for their upcoming business cycle. Planning, supply chain management, and operational alignment can benefit significantly from this metric’s help. It’s essential to remember that demand foreshadowing is dependent on external factors and, as such, subject to sudden changes. Take, for example, the ongoing Covid-19 pandemic. Many manufacturers found that much of their yearly estimates had taken a hit (especially sectors like automotive and luxury consumer goods). On the other hand, the demand for things like medical equipment and hygiene products increased by several fold, the world over. In this scenario, manufacturing companies can benefit from a robust enterprise resource planning system such as the Microsoft Dynamics 365 Finance and Operations that seamlessly enables change management, demand analysis, and order management.

2.Throughput & Yield of Units Produced A manufacturing company’s operational efficiency is directly proportional to its yield. Throughput is a metric that measures the average number of units produced in a particular amount of time (other coefficients being per machine, per production line, or facility). Access to the correct yield information helps manufacturers gauge their performances accurately, address bottlenecks, and develop plans for improvements.

63%

of manufacturing executives plan to get more out of what they already have invested within their manufacturing and supply chain network.

Source: Accenture

3.Inventory Turnover Properly managed inventory is a strong indicator of a manufacturing companies’ performance- after all, knowing how often inventory is sold or used in a particular timeframe is the measure of knowing its success in the market. This is precisely why decision-makers in the manufacturing industry focus on analyzing the turnover data of their inventories. To expedite the analysis and avoid data mismanagement, manufacturers still using legacy systems need to strongly consider investing in an automated ERP system that can track inventory data in real-time and facilitate seamless coordination between multiple stakeholders.

4.Quality Analysis The final quality of your product is one of the best indicators of production performance. A successful product is the best way to build your customer base, making it essential to understand applicable quality metrics- including monitoring and documenting raw material quality, incoming supplier quality, random quality checks at manufacturing plants, packaging quality, and more.

5.Overall Equipment Effectiveness (OEE) Whether it’s a single piece of equipment or an entire production line, knowing how effective every piece of equipment is, has become essential to a timely yield that matches quality and quantity requirements. This metric is recognized by the manufacturing industry worldwide as one the most important to assess agility, downtime, and overall production quality.

Book a demo today to learn how Microsoft Dynamics 365 helps you achieve manufacturing KPIs.

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The metrics above are just a few in manufacturing that often generate mountains of data through multiple sources that are constantly subject to changes. The answer to managing all this information is a data pool – a single source of truth for multiple manufacturing metrics that can help companies track, manage, and analyze the data against their KPIs.

Figure 2:Role of Sophisticated ERP in Managing Manufacturing

Role of Sophisticated ERP in Managing Manufacturing

Implementing Microsoft Dynamics 365 ERP and Power BI lets you optimize your IT infrastructure to systematically allow real-time data access, multi-level visibility, and artificial intelligence-backed insight generation. This allows you to visualize and track the progress of your manufacturing metrics, along with a cumulative awareness of your production line.

Final Thoughts

For every manufacturing company operating today, metrics and KPIs have become among some of the most important things to understand and track. How you view these metrics moving forward, how accurate the information is, and how you’re able to leverage it will be the deciding factor in your success.

  • Every company needs to reinvent its best practices with the help of manufacturing metrics for a profitable business.
  • Investing in a fortified IT infrastructure to track and manage manufacturing metrics is the need of the hour for manufacturing companies.

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Gen-Next Serialization in the Pharmaceutical Supply Chain: Improving Track & Trace
Gen-Next Serialization in the Pharmaceutical Supply Chain: Improving Track & Trace 700 500 Xcelpros Team

At a Glance

  • Worldwide pharmaceutical companies are dealing with drug counterfeiting, adulterations, supply chain thefts and packaging glitches.
  • Serialization is much more than just applying barcodes to personalized medicines.
  • This modern age of fast-paced digitization calls for modifications and improvements in serialization techniques.
  • To better strengthen the supply chain, loopholes need to be identified and closed.
  • Transparency needs to be maintained for every drug dose.
  • Pharmaceutical companies and their supply chain vendors should use of advanced analytics, cloud computing and the Internet of Things (IoT) to get a grip on modern serialization techniques.

Introduction

Traceability in pharmaceuticals is now very much seen as a global mandate. With laws differing from country to country, major pharmaceutical companies are looking for ways to improve how they track and trace their products in the supply chain to always remain in compliance.

Struggling to meet those requirements continuously is causing pharmaceutical companies to develop and implement new serialization techniques. Supply chain security, battling counterfeit and altered drugs, better product traceability, and overall cost-savings are chief among the motivations.

Reports suggest that by 2023, more than 90% of the global drug supply will be scrutinized under track and trace regulations. The program will enhance patient safety measures by combating drug counterfeiting.

Serialization is no longer restricted to global compliance mandates either. It’s helping more and more pharmaceutical companies add transparency, accountability and integrity to their supply chains.

Serialization is proving to be more effective at reducing shrinkage (i.e., errors and theft) than other solutions such as sturdy packaging and traceable 3D hologram models.

Figure: 1Common Loopholes in the Pharmaceutical Supply Chain

Common Loopholes in the Pharmaceutical Supply Chain

Innovation is the key to improving trace and track in any supply chain model, including the frequently complex pharmaceutical supply chain.

Companies worldwide are investing millions of dollars in maintaining product integrity.

Assigning unique identification numbers or barcodes to individual items (such as a strip of tablets or a bottle of medicine) for computerized serialization and tracking is becoming among the best ways to maintain product integrity.

Among newer innovations and latest trends in serialization in the pharmaceutical supply chain.

Data Encryption and Data Security

The ultimate aim of pharmaceutical supply chain serialization is to ensure consumers get the right drugs at the right price and quality. At the same time, companies that trace and track their products end up knowing where each shipment is at any given moment.

Verification for this requires very strict data management and security. One way to get it done is through computerized encryption that lets only designated people read the data.

The pharmaceutical industry loses on average 4.5% of its potential revenue because of supply chain inefficiencies.Source: Interactive Data Corporation

Recalling Individual Products

The pharmaceutical industry is highly susceptible to recalls caused by poor packaging, leading to contaminated products that could harm patients.

Previously, these recalls were made at batch-levels, causing massive revenue loss as well as disrupting the supply chain. Narrowing defective medicines to individual units makes it possible for companies to limit recalls to specific products. The same serialization can then be used to determine when and where the product was altered or contaminated.

Figure: 2 Serialization to Improve Track and Trace

Serialization to Improve Track and Trace

Use of Advanced Analytics

By studying buying trends, life sciences organizations and their research groups constantly work to understand what consumers need and want. Using advanced analytics applications like Microsoft Power BI to create in-depth business intelligence reports is becoming the best way to help realize and act on these patterns. Power BI’s dashboards take advantage of interactive visualizations to help users make informed decisions about if and when they need to alter their production schedules to keep up with market demand.

Enhanced Visibility at Every Level of Supply Chain

Serialization is a good way for companies to provide accountability regarding compliance with government regulations. It’s also an excellent way to enhance visibility and improve monitoring at every level of the pharmaceutical supply chain. Knowing how much you have and where to reduce stock-outs improves the overall distribution and ensures your products are available when and where the consumers want them.

Barcoding and Labeling

Barcodes can provide a lot more information than just a serial number alone. You can include electronic links to product information sheets, safety data sheets, ingredients, storage requirements, shipping requirements, dosage levels, and other information. All a worker needs to scan a code made with advanced label-making capabilities using a barcode reader or cellphone to access this data on the spot.

$200 billion (10%): that is the global monetary cost of counterfeit drugs according to the World Health Organization.
One million: That is the annual cost in human lives each year from fake and altered medicines according to Interpol.

Serialization’s Impact on Companies

In the United States, the serialization of all drugs at the sealable unit and case level became a requirement with the passage of the Drug Supply Chain Security Act (DSCSA) in November, 2017. This requirement had an impact on pharmaceutical companies and their supply chain vendors that had to ensure serialization of all drugs at an individual container or dose level with barcodes for better tracking and tracing.

Ultimately however, this has led to a number of benefits including:

  • Better market visibility down to individual drug demand. This helps by allowing for more efficient drug distribution.
  • Warehouses and inventories need to be equipped with a fortified drug distribution plan.
  • Better understanding and communication among cross-functional teams. Since serialization provides an inflow and outflow of different information, life sciences researchers, packaging personnel, IT experts, and distributors alike can share any data available for a particular drug.

Challenges in Serialization

Like any other change across the supply chain, serialization has its own set of challenges, including:

  • Hardware Setup and Updates
    Companies need to ensure they have the right equipment and supplies on hand at all times to print the labels, barcodes and seals required for serialization.
  • Steady Flow of the Production Line
    Introducing serialization and the training required to understand the process might have an impact on the production line early on as labeling each and every product may initially slow down the process.
  • Higher Costs
    Adding serialization to an existing process often means adding costs in terms of hardware, software, and people. These costs can be reduced by using pooled investments and sustainable hardware and software applications.
  • Skilled Personnel Shortage
    Newer, digital methods of serialization require a workforce that understands what needs to be done. Companies are facing a lack of a skilled, technically sound employee base to implement their serialization strategies.
  • Technical Glitches
    Serialization should ultimately require minimal human intervention, aiming to significantly reduce manual errors. With anything else so integrated, you will need to make sure any technical issues can be identified and addressed in a timely manner to avoid any major disruptions to production.

XcelPros’ Microsoft Dynamics 365 solutions enable pharmaceutical companies to seamlessly implement serialization for better compliance and enhanced track and trace.

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Key Benefits of Serialization in Operations

Pharmaceutical companies able to take advantage of advanced digital serialization processes for their supply chain operations often realize a number of benefits, including

  • Easy end-to-end implementation across the supply chain
  • Efficient sealing of supply chain loopholes to combat drug counterfeiting and packaging mistakes
  • Minimal human intervention required, making serialization a fool-proof, effective way to ensure brand authenticity and reduce batch recalls
  • Full compliance with government traceability regulations
  • Reduction of counterfeit drugs and compromised quality.

Final Thoughts

Overall, serialization in the pharmaceutical supply chain plays a significant role in avoiding drug theft, counterfeiting, batch recalls, and other potential hazards. Every pharmaceutical company needs to have a unique serialization process to meet its requirements. Newer serialization software uses advanced analytics for better drug distribution and fewer stock-outs.

With government mandates requiring pharmaceutical companies and their supply chain vendors to understand and master the technical details of implementing serialization at batch and case levels in an effort to fortify their supply chain and enhance visibility, these companies need to be prepared to overcome any challenges that arise. Is your track and trace solution ready?

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