Process Optimization

Covid-19 Impacts on the Pharmaceutical Supply Chain

Covid-19 Impacts on the Pharmaceutical Supply Chain

Covid-19 Impacts on the Pharmaceutical Supply Chain 700 500 Xcelpros Team

Introduction

While the United States continues to vaccinate and protect its citizens from Covid-19, new variants of the disease continue to pop up around the world. In addition to costing millions of lives (Google states nearly 3.3 million in 220 countries and territories worldwide as of May 7, 2021, which includes 579,000 in the US alone), problems caused by the disease are wreaking havoc with the pharmaceutical supply chain.

Figure: 1Covid-19 Impacts on the companies

Covid-19 Impacts on the companies

Among the short-term effects cited in a July 3, 2020 article on Springer are:

  • Demand changes leading to shortages caused by panic-buying oral home-care medications.
  • Supply shortages of active pharmaceutical ingredients (APIs) and finished products, especially those coming from China and India.
  • Shifting communications and promotions to telecommunication and tele-health, such as 70 – 80 percent drop in visits to physician offices and clinics.
  • Changes in the focus of research and development programs to dealing with Covid-19.

Long-term effects on the pharmaceutical industry cited in the Springer article include:

  • Delayed approvals for non-Covid-related pharmaceutical product, partly caused by the closure or semi-closure of regulatory agencies.
  • Self-sufficiency and lower demand for APIs and finished products made in China and India caused by individual countries and organizations such as the European Union looking at the health needs of its citizens.
  • Slowed growth resulting from economic slow-downs in economies around the globe.
  • Ethical issues caused by poorly researched clinical therapies.
  • Consumption changes of health products by consumers.

By the Numbers

  • A 2-fold increase in investigational treatments in the U.S.
  • 100% – 700% increase in the use of medicines to treat Covid-19 in U.S. hospitals (January-July 2020).
  • 7 million excess prescriptions for hypertension, 6 million for mental health, 5 million for respiratory problems, 4 million for diabetes and 2 million for anxiety in the U.S. alone.
  • 156 clinical trials for Covid-19 in the Middle East and 140 in the EU.
  • 70%-80% reduction in patient visits to doctors’ offices in the EU.
  • 23% of patient interactions in the EU are done online.

Supply Chain Effects

Deloitte produced its “Covid-19 Response for Pharma companies: Respond. Recover. Thrive” report. Among the report’s sections is a look at Supply Chain Management.

Key risks in procurement cited by Deloitte are:

  • Quality checks of received materials. Mitigation measures include increasing warehouse space for quarantining shipments from China.
  • Shortages of raw materials, APIs and solvents due to dependency, inadequate materials to complete BOMS/batch size processing. Mitigate by boosting stocks of critical inventory, evaluating alternate sourcing of impacted materials and using government support policies when looking at investments in production plants.
  • Shutdowns of vendor plants. Mitigate by identifying shutdowns from remote (i.e., Asian) sources and pressure test supply chains for various scenarios.

Key risks for planning include:

  • Expiration of materials and monitoring for reassessments and quality certificates. Mitigate by submitting studies to the FDA with the longest agreeable expiration date.
  • Shutdowns of contract manufacturers. Mitigate though communication regarding their ability to deliver products.
  • Quality control checks at contract manufacturers or traded goods for contamination issues. Mitigate by having quality control personnel on-site and thoroughly sanitizing all in-bound products, employees and equipment.
  • Contamination after final packaging. Mitigate by disinfecting shipments before delivery and providing photographic proof.

Logistics and transportation risks cited by Deloitte include:

  • Non-availability of local transportation to move raw materials and finished goods. Mitigate by locating alternate partners and getting approval to move essential drugs should a lockdown occur.
  • Contamination issues from transport vehicles. Mitigate by disinfecting all vehicles, planning to store temperature-sensitive products and arranging warehouse space.

Export risks are:

  • Contractual compliance. Mitigate by ensuring the person(s) collecting the order is aware of any regulatory restrictions.
  • Contractual terms with domestic and export customers. Mitigate by seeking advice from insurance brokers and engaging early with clients to determine what could work if supply chain challenges or personnel issues occur.

Continuing Effects

Disposable components for single use systems are being shunted to Covid programs at the expense of other critical programs. This is one of the continuing effects on the supply chain cited by Contract Pharma in its Covid-19 Impact Report.

Kay Schmidt of Catalent said finding vaccines and target therapies for Covid-19 has boosted demand for its services. The increased demand “has led to greater collaboration and innovation between partners, regulators and throughout supply chains to meet key milestones” plus internal and external management, planning and communication to ensure resource allocation for multiple programs.

James Rogers of Sterling said, “The impact of the global pandemic has exposed the fragility of the pharmaceutical supply chain.” He predicts that supply chain resilience and reliability will be given the same importance as price when developing future supply strategies.

Danita Broyles of U.S. Pharmacopeia is quoted by Contract Pharma as saying, “The decrease in on-site inspections has the potential to increase quality risks to the global supply chain,” adding pressure to manufacturers and suppliers to ensure the quality of their products.

Ben Wylie of ChargePoint Technology said that, “many governments are now pushing the industry to rethink its model to safeguard drug production.” He cited a program in India to reduce reliance on China for critical drugs and APIs.

Covid-19’s Impact on Regulatory Practices

Covid-19 will have an ongoing impact on regulations in the areas of clinical study trial design, clinical trial study development and post-clinical trial regulatory submissions, Dr. Ronan Brown of IQVIA wrote in an article on European Pharmaceutical Review.

Among the changes forced on drug makers is a more decentralized approach to collecting patient information and rapid access to regulators, Dr. Brown said. This includes pre-investigational new drug meetings with the FDA now granted in less than 30 days. The FDA has also taken steps to accelerate the review and start of new studies. Flagging potential obstacles and safety concerns during these early meetings lets pharmaceutical companies move faster into human trials, he explained.

Decentralized clinical trials, which he expects will ultimately cost about the same as the traditional versions, will offer greater diversity in terms of patient cohorts along with increased mobility and convenience.

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Top Reasons Why SMBs Need to Invest in a Robust ERP System

Top Reasons Why SMBs Need to Invest in a Robust ERP System

Top Reasons Why SMBs Need to Invest in a Robust ERP System 700 500 Xcelpros Team

Introduction

Growing small and medium businesses (SMBs) around the world continue to invest in ERP software hoping to streamline their operations and boost profits. Let’s find out why the increase in demand for an effective ERP system has risen in the past decade.

need of erp system in small medium businesses

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Leveraging Technology to Boost Profits for Chemical Companies

How chemical companies benefit from adopting newer technology

How chemical companies benefit from adopting newer technology 700 500 Xcelpros Team

Introduction

Chemical companies can face numerous problems dealing with hazardous chemicals held in inventory. More supply chain officers are turning to digital tools to transform their operations, and increase efficiency. Here are some ways that technology is helping the chemical industry by automating chemical management.

Leveraging Technology in Chemical Companies

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Moving from batch to continuous manufacturing in the pharmaceutical industry banner

Moving from Batch to Continuous Manufacturing in the Pharmaceutical industry

Moving from Batch to Continuous Manufacturing in the Pharmaceutical industry 700 500 Xcelpros Team

At a Glance

  • The pharmaceutical and life sciences sectors have relied on conventional batch manufacturing methods as a trusted model for production requirements. For faster, more dynamic manufacturing, pharma companies like CDMOs are turning to continuous manufacturing.
  • While continuous manufacturing offers more flexibility and agility, there are a number of practical and financial aspects that pharma companies need to take into consideration while making the partial or complete transition.
  • Transitioning from batch manufacturing to continuous manufacturing requires pharma companies to be equipped with the right tools and technologies. For many, partnering with experts to seamlessly drive the transition and ensure employees are well-trained is essential.

For years, CDMOs have made do with solutions focused on batch manufacturing. Fast forward to today, however, and the world is changing rapidly, with newer more efficient technologies being introduced for more dynamic process management. While the pharma sector might seem hesitant to let go of batch manufacturing, more and more companies are slowly transitioning to continuous manufacturing.

The global pharmaceutical continuous manufacturing market is predicted to grow with a CAGR of 8.2% over the forecast period of 2018-2024.– Researchandmarkets.com

With a growing number of benefits, including shorter production cycles, no equipment-stop requirements, and reduced risk for things like manual errors; continuous manufacturing is being viewed as the next big step in pharmaceutical manufacturing. In addition to the benefits, however, businesses need to expect any financial, practical, and behavioral hurdles that might arise.

This article aims to highlight these hurdles for organizations comparing batch vs. continuous manufacturing in order to gauge respective pros and cons.

Continuous Manufacturing and Its Impact on the Pharma industry

Continuous manufacturing is a highly streamlined ecosystem where multiple stages and discreet testing across various facilities are not required. For pharma companies, this can mean avoiding excessive downtime or closures of production units in the event of a faulty batch, saving manufacturers thousands of dollars previously dedicated to these types of tasks.

Figure: 1Batch Manufacturing vs. Continuous Manufacturing

continuous manufacturing vs batch production

Continuous manufacturing is more flexible and dynamic in nature, allowing manufacturers to introduce changes with ease and efficiency. In comparison, batch manufacturing in the pharmaceutical industry has always been highly restrictive in nature. Continuous manufacturing enables pharma companies to lower their carbon footprint, reducing any harmful emissions released into the environment and does not require the longer ‘hold times’ familiar to batch manufacturing, where between every stage materials need to be tested for quality. The transportation and storage of these samples (which are often in bulk) require both high costs and a planned holding time. These hold-ups and more can be mostly mitigated with continuous manufacturing. Companies can also significantly reduce the manufacturing lifecycle, including time to market for a drug. The single production line model found in continuous manufacturing works well to save time, leverage process flexibility, and enhance resource utilization.

3 Hurdles Implementing Continuous Manufacturing

With so many apparent benefits, it’s still a question of why the pharma industry hasn’t gone all out when it comes to continuous manufacturing. The answer lies in understanding the hurdles involved in implementing continuous manufacturing. Listed below are 3 common hurdles to consider when moving to continuous manufacturing.

1.InfrastructureContinuous manufacturing is typically considered a more advanced business model, often requiring changes in infrastructure across different functional areas. The IT framework of pharma companies and CDMO’s needs to be able to support an agile, flexible manufacturing model. Many pharmaceutical companies are still apprehensive to transition to continuous production as it usually entails a major infrastructure overhaul.

2.Regulatory IssuesPharma manufacturing is highly sensitive in terms of quality checks and regulatory approvals. After working with batch manufacturing for decades, a transition to continuous manufacturing means applying for newer approvals and altering quality check-points. For current product lines, pharma companies already have all their approvals in place for the production lines and quality check methods. Getting approvals for newer methods and production lines, like those found in continuous manufacturing, can be a costly and intimidating process.

3.Behavioural ResistanceCompared to other industries such as automotive or even chemical, the pharma sector has always been rather conventional in its approach towards newer methods and technologies. Implementing drastic changes has always been met with resistance as it can lead to numerous major shifts in processes, work methods, and operations. Employees need to be properly trained and made aware of possible hurdles when it comes to adopting a new process. For Pharma companies, this is best handled by letting change cascade from upper management, on down.

The Right Path for the Pharma Industry

With so much impact and so many possible benefits, the application of continuous manufacturing will continue to rise for businesses in the pharma sector. Going forward, precision medicine, personalized care, and agile transformation will continue to be of utmost importance for CDMOs and pharma giants. While these goals and more can be met by embracing continuous manufacturing, in order to achieve these targets, pharma companies will need to be willing to make necessary changes to their infrastructure in order to make a smoother transition to continuous production.

Key Takeaways

  • The pharmaceutical industry can take advantage of numerous benefits and opportunities with continuous manufacturing vs older batch manufacturing processes.
  • While continuous manufacturing is on the rise in the pharma sector, companies need to plan appropriately to ensure a smooth implementation/ transition.
  • Pharma companies need to be open to changes in infrastructure and mindset to take full advantage of a continuous manufacturing model.

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Microsoft Dynamics AX to Dynamics 365: A Guide to Migration

Microsoft Dynamics AX to Dynamics 365: A Guide to Migration

Microsoft Dynamics AX to Dynamics 365: A Guide to Migration 700 500 Xcelpros Team

At a Glance

  • There are multiple aspects that come into picture when a company decides to transition from Microsoft Dynamics AX to Dynamics 365. This is often a multi-pronged process that goes beyond a simple technology upgrade.
  • When businesses are preparing to move to Dynamics 365, executives need to be aware of the impact on different departments, instead of just focusing on benefits.
  • This article discusses how Dynamics 365 is different from its predecessor, Dynamics AX, and the steps organizations need to take to ensure a smooth transition.

Like most organizations looking to upgrade for better functionality, agility, enhanced digital capabilities, etc., if you’re planning to move from Dynamics AX to Dynamics 365, it’s critical to understand the difference between the two, in order to make an informed decision.

Comparing Microsoft Dynamics AX and Dynamic 365: Understanding the Differences

Aspect/ Functionality Dynamics AX Dynamics 365
User Interface Based on software Browser access (web-based login)
Infrastructure On-premise ERP/ servers Cloud-based and hybrid
Business Intelligence Limited Immense data insight generation with AI-enabled capabilities
Additional features None Power Apps
Updates Time-consuming, effort-intensive Easier, cloud-based updates (feature-wise updates)
License Yearly expense Pay-as-you-go flexible model

This simple comparison presents a decent starting point for organizations considering a shift from Dynamics AX to Dynamics 365, but decision makers in the company will want to look closely at the intricacies of Dynamics 365, and how it may affect their business. This will enable them in making an informed decision and in communicating the need for change to the organization.

Why Should Organizations Move to Microsoft Dynamics 365?

According to a recent report published by Forrester Consulting, moving to Dynamics 365 can help companies improve IT and back-office efficiency by 20-50% and 66%, respectively.

Apart from the obvious benefits of Microsoft Dynamics 365 like improved interface and infrastructure, it also offers ease of use and better business intelligence with the help of Artificial Intelligence (AI). Available power-BI functionality, for instance, helps create unlimited high-end reports and dashboards.

One of the most important aspects of moving to Dynamics 365 from Dynamics AX is how straightforward the migration has become, and with reduced risks. The groundwork done by Microsoft is testament to the newer tools and applications that make migrating to Dynamics 365 products smooth and predictable.

If your mind is made up to transition to Dynamics 365 from AX, the only thing you may still be wondering about is how exactly it can be done?

Below is a simple guide for businesses starting to look at upgrading to one of Microsoft’s flagship ERPs

1.Consider the Areas of Impact While making the shift, it’s important for CTOs and CIOs to note areas, departments and processes that will be most affected. This way those areas can be prepared well in advance for the change. It’s also important to gauge the extent to which your organization is using Dynamics AX. This assessment can be done by addressing the following key questions:

  • Is your business able to adapt to changing requirements?
  • Are you able to track raw materials through the entire supply chain?
  • Are your data streams updated on a near real-time basis?
  • How many integrated systems as well as Independent Software Vendors (ISVs) are working in association with Dynamics AX?
  • How many systems (integrated and ISVs) are compatible with Dynamics 365

2.License Transfer In order to move from Dynamics AX to Dynamics 365, companies can transition the existing license for the new platform. It’s important to note that an active maintenance plan can net up to an almost 40% discount on the license purchase fee. To help ease this transition, Microsoft has included tools that can preserve customizations and ensure complete code compliance in the new Dynamics 365 ecosystem from the predecessor (in this case Microsoft Dynamics AX).

3.Ensuring Similar Transaction ResultsExperts suggest making sure that important groundwork is done in order to reduce risks and avoid hiccups when processing transactions. This groundwork can involve the continuous use of automation to run tests during the migration to ensure that you are getting similar results in Dynamics 365 as you were in AX. It’s also advisable to ensure complete documentation of use cases and business requirements for future reference.

4.Systematic Organizational Change Management (OCM)As is the case with any major software shift, change is often met with both behavioural resistance and in the form of technical glitches. Ensuring a systematic approach to change management will be key in enabling smooth transition. Companies would need to get their IT department well-acquainted with the in’s and out’s of newer Dynamics 365 environments. As well, moving from an on-premise system to a modern cloud-based, web-enabled software will require ongoing training and guidance as the system continues to evolve. Experts advise investing in OCM beforehand rather than solving the problems as they come.

Organizational Change Management: Smooth Transition from Dynamics AX to Dynamics 365

Organizational Change Management: Smooth Transition from AX to Dynamics 365

Understanding these factors goes a long way to ensuring complete preparedness, letting organizations accurately plan their transition from Dynamics AX to Dynamics 365. If you’re still unsure, it’s advisable to partner with change management experts and IT consultants experienced not only in migrations and end-to-end support, but also the industry your organization serves.

Key Takeaways

  • Like any migration, the move from Dynamics AX to Dynamics 365 has to be well-planned and well-managed for maximum efficiency.
  • Ensuring readiness- technical as well as behavioral, will help organizations in getting the expected ROI from this shift.

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ERP - Paper vs Digital

ERP – Paper vs Digital

ERP – Paper vs Digital 700 500 Xcelpros Team

Introduction

Companies today are understanding the benefits of using digital processes instead of paper-based manual processes. With up to 90% of organizations moving to paperless processes to avoid human error and improve efficiency, not deciding to make the transition can be a big mistake. Read on to learn more about paper-based vs digital ERPs- your preferred choice for technological transformation.

Paper based ERP vs Digital ERP

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Mobile Devices, WMS Work Together to boost manufacturing efficiency

How Mobile Devices & WMS Work Together to Boost Manufacturing Efficiency

How Mobile Devices & WMS Work Together to Boost Manufacturing Efficiency 700 500 Xcelpros Team

Introduction

Using cellphones, tablet computers and other mobile devices in warehouses and on the factory floor gives executives another tool to improve manufacturing efficiency, especially in terms of inventory control. Mobile devices can:

  • Adapt to changing requirements
  • Track raw materials through the entire supply chain
  • Update data streams on a near real-time basis

Mobile devices like cell phones, tablets and other specialized devices, are becoming as common in the pharmaceutical industry as they are in our daily lives. Under the supervision of today’s chief financial officers (CFOs) and chief technical officers (CTOs), employees can use these devices to improve manufacturing supply chain efficiency, especially when it comes to inventory control.

Current handheld devices, ‘can provide full functionality and access to a company’s business systems without any sort of limitations’– Redwood Logistics

How do mobile devices help? By providing:

  • Increased productivity and responsiveness to customer requests by adapting on the fly to changing needs.
  • Regular Real-time data exchanges between workers and managers.
  • Geographic flexibility allows raw materials like active pharmaceutical ingredients and finished products to be stored closer to areas experiencing increased demand while moving materials from areas with decreased requirements.
  • Accurate location tracking on the road and inside a warehouse using smart devices’ built-in global positioning system (GPS) functions.
  • Reduced overhead through accurate, real-time, inventory tracking using barcode scanners to track everything from individual batches to large containers.
  • Reduced employee downtime.
  • Simplified training through consistent use of similar handheld devices and software that work regardless of the location. Employees working in Sudan and Southern California share the same devices and software.

Connected Mobile Devices vs. IIoT in Manufacturing

Mobile devices allow workers and managers to gather massive quantities of data but they lack one major function the industrial internet of things (IIoT) has: the ability to physically react to the information the sensors gather.

While mobile apps gather data, they can’t physically react to it. An employee needs to interpret that data and then react with the new information in mind. However, the IoT creates a proactive supply chain rather than a reactive one’ | Triskele Logistics

If, for example, a warehouse worker notices a critical active pharmaceutical ingredient (API) is at critical stocking levels, the worker must let a manager know, who then places an order for the product. An IIoT-equipped mixer, for example, may track the API storage level and place a reorder before the quantity drops to a critical level. Unlike with a mobile phone, human intervention is not required.

Mobile devices working with IIoT enabled machines permit the best of both situations: workers can remotely monitor machines and respond quickly when a problem occurs.

Using WMS with Mobile Devices

Some warehouse management software (WMS) works on mobile devices like phones and tablets, not just desktop and laptop computers. These systems help pharmaceutical manufacturers logically and effectively keep track of everything from raw materials to finished products, including the state of a given production run (e.g., finished).

When using the mobile app version of a WMS, warehouse workers can:

  • Print new barcodes and text labels and reprinting existing labels.
  • Start production orders and issue reports when a production process is finished.
  • Look up information on products stored elsewhere.
  • Perform one task that triggers a second. One example from Microsoft Dynamics 365 Warehouse Management System is receiving a purchase order that automatically generates a put-away order.
  • Perform a task triggered by a previous task, such as putting away the received materials listed on the purchase order.
  • Change batch disposition codes.
  • Transfer products from one location to another using the license plates.
  • View work available to specific users (requires a tablet).
  • Split work between two license plates when one is full.
  • Pick and pack items from a sales order into a single shipment.
  • Pick the oldest batches using configurable app software that can be set to Warn workers listing the oldest expiration dates or Force telling them there is an older batch to pick.

Using a Cell Phone or Tablet Camera

Warehouse workers need to input information into their mobile devices. Workers can painstakingly input product numbers into a keypad, risking problems when an error occurs, or they can scan barcode and QR codes.

Some firms prefer using dedicated handheld scanners. However, these devices may be restricted to proprietary WMS software that may offer limited functionality.

Cameras built into cellphones and tablets can be enabled for use as scanners. Users simply position the barcode within brackets on the screen and take a picture, automatically and accurately inputting the information into the portable device.

Improving Worker Efficiency With Barcodes and Scanners

A common scenario where mobile devices improve manufacturing efficiency is when a worker has a purchase order and receives several items with different quantities and warehouse locations. The worker scans the barcode. The mobile device, either cell phone or a tablet, tells them the quantity of each item and location where it goes, such as a warehouse section and bin number.

Depending on the WMS software configuration, the worker inputs the quantity and selects the measurement unit. They have the option of clicking ‘OK’ when everything matches up or clicking ‘Cancel’ when spotting a deviation.

Managers can also have the software configured to have workers confirm the required quantity is in the correct location. They have the option of confirming the purchase order or updating it to reflect a different quantity.

By the Numbers

Figure: 1Advantages of an Inventory Management System

 Advantages of inventory management system

The connected logistics market – an interdependent set of communication devices and the internet of things (IoT) permitting the sharing of data, information and facts with supply chain partners – was expected to grow by a factor of four from 2016 to 2021.

$10.04 billion – the connected logistics market in 2016.

$41.33 billion – the forecast connected logistics market in 2021.

32.7% the connected logistics market Compound Annual Growth Rate from 2016 – 2021.

Source: Markets and Markets Connected Logistics Market Report

Challenges to Using Mobile Devices

Off-the-shelf mobile devices used for supply chain management offer a host of potential benefits. They also come with some challenges. The main risks associated with them are:

  • Different designs: Cellphones are not designed with supply chain management (SCM) uses in mind.
  • Data Security: Data sent over the air using a wi-fi or Bluetooth connection is not as secure as when the data flow is done through a wired connection.
  • Durability: The majority of modern cell phones and tablets are not designed for the rugged, dangerous conditions of many factory floors.
  • Interoperability: Some smart devices may not be compatible with the company’s preferred WMS.
  • Obsolescence: Computer technology is constantly evolving. Today’s fastest device is tomorrow’s paperweight.
  • Cost: CFOs must budget for new devices and replacements for those damaged or destroyed in the course of business.

Summary

Cellphones and tablets are becoming increasingly popular tools alongside WMS on factory floors and in warehouses, offering businesses numerous benefits as the technology continues to mature. When combined with mobile versions of warehouse management software, these products:

  • Let workers stay on task and on target in terms of inventory control.
  • Provide workers guidance on picking the oldest items first.
  • Give managers an additional tool to improve manufacturing efficiency.

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Advantages of material requirement planning

Advantages of a material requirement planning system (MRP) vs. manual planning

Advantages of a material requirement planning system (MRP) vs. manual planning 700 500 Xcelpros Team

Introduction

While it wasn’t a strong consideration for chemical production in the past, today’s plants are realizing the need to know where they stand in terms of meeting their customer’s needs. Some key demands being placed on the chief financial officer by different departments include questions like.

  • Can we fulfill my customer’s regular orders on time?
  • Are we able to deliver a client’s last minute rush-order?
  • Do we have enough inventory to stay on schedule without impacting other projects?

The only way for a plant to know exactly where they stand in terms of its raw materials, packaging, production and delivery schedules is through proper planning.

The benefits of effective materials requirement planning starts with understanding each product’s formulas, which dictate the required bills of materials (BOMs) in terms of raw or previously refined ingredients along with up-to-date instructions on how to safely use them.

A manufacturing BOM is essential in designing enterprise resource planning (ERP) systems and materials requirement planning (MRP).-Investopedia

Difficulty with Conventional Methods

A conventional method of making sure you’d have all the information required to answer the CFO’s questions was by using Microsoft Excel spreadsheets for production planning. One spreadsheet might list all of the required chemicals for a specific formula from the BOM in the first column followed by others showing the quantities required for each batch and the quantities on hand. Other sections of the spreadsheet might be what is on order, which supplier is shipping it, when it is due and other similar information.

In this format however, ensuring the information on the BOM is accurate usually requires additional diligence and effort to be put forth. This could mean verifying inventories, making phone calls and sending emails when numbers in the warehouse don’t match. It might mean having one manager call another when a shipment arrives with less than the ordered quantity, or rarely, more than what was ordered.

Once the BOM is completely built out and the CFO knows what materials are available, they can schedule labor and resources to produce the products. This can be tricky when the same distillation equipment is to be used for multiple products, with downtime in manufacturing required between batches for cleaning and device maintenance.

Ideally, production teams have a planner who creates a schedule similar to the one in the image below (see Production Planning PPT slide from Xcelpros).

The Downsides to Downtime

You may have heard it before “Poor planning produces poor performance.” When it comes to business however, poor planning can also mean unexpected costs, and unexpected downtime. Downtime is often defined as time when production is scheduled to run but for some reason is not. Unplanned downtime or production stoppages however can seriously impact a businesses bottom line. These include disruptions in the form of reputational damage and customer churn by not delivering products on time. This unplanned lack of production also causes revenue losses, reduced employee productivity, reduced end-user productivity and stressed employees. Stressed employees can result in employee turnover. An HRDive brief puts the cost of replacing an employee at one-third of an employee’s annual salary or roughly $15,000 per worker.

Direct Costs of Downtime

The direct cost of downtime in production across all industries, not just chemical——varies. According to Atlassian and Garvey, downtime costs add up to

 

$247per minute for small businesses

$9,000 per minute for medium and large businesses

$260,000per hour across all businesses in a 2016 study

800 hours of downtime per year on average in manufacturing alone as cited by Garvey

Source: Atlassian & Garvey.com

Tracking Downtime in the Chemical Industry

According to an article by Accruent, unplanned downtime in the chemical industry appears in

  • Reduced production
  • Losses caused by quality issues
  • Costs for equipment repairs
  • Decreased customer satisfaction

One example cited was the quality drop off when a High-Density Polyethylene (HDPE) plant restarts. The plant can take from hours to days to produce right-first-time materials. The transitional goods are either scrapped or sold as reduced quality.

Proper Planning Produces Peak Performance

Figure: 1Production Planner’s View on Manufacturing: Planning & Execution in a Chemical Company

Features Of MRP System

Much of this downtime in manufacturing can be avoided by proper planning, especially when using a Master Plan. Managing master planning processes using software such as Microsoft Dynamics 365 Supply Chain Management can complete a number of critical tasks including

  • Calculates net requirements for the master plan based on actual current orders. This permits day-to-day inventory management.
  • Forecasts gross requirements for long-term planning of materials and production capacity.
  • Calculates net requirements across legal entities, such as different companies providing supply and demand.

The Master planning module determines the supply (materials) and capacity (resources) needs that will meet current demand (net requirements),” which includes the longest lead times.-Microsoft

The Master plan setup includes coverage settings and defining coverage rules for items.

Using a Master plan includes creating a constrained plan, handling safety stock and dealing with delays.

When used with multiple sites, the Master plan creates site schedules, site plans and coverage, the BOM version and other functions.

In terms of intercompany planning, the Master plan lets CFOs and project planners view the outbound intercompany demand and collaborate with internal supply chain customers.

Demand forecasting functions include importing historical data, generating, adjusting and approving a baseline forecast and then monitoring the forecast for accuracy.

Demand Forecasting in Microsoft Dynamics 365

Figure: 2Basic flow in Demand forecasting

Basic flow in Demand forecasting

Having an idea what to order in advance is a “top of the mind” issue for many CFOs. Microsoft Dynamics 365 Supply Chain Management can perform demand forecasting, though it requires the Microsoft Azure Machine Learning Studio, which has limited availability.

  • Predict independent demand from sales orders and dependent demand at any decoupling point
  • Customize it for industry-specific requirements
  • Visualize demand trends, confidence intervals and make forecast adjustments based
  • Remove outliers
  • Authorize the adjusted forecast for planning

Final Thoughts

Proper planning helps CFOs cut costs and reduce downtime in manufacturing at the same time. One way to ensure production facilities have enough of what they need to keep factories rolling is by using an MRP system. These systems are

  • More efficient
  • More accurate
  • Better for long-term planning

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Top Reasons Why Companies Are Actively Moving to The Cloud

Top Reasons Why Companies Are Actively Moving to The Cloud Computing

Top Reasons Why Companies Are Actively Moving to The Cloud Computing 700 500 Xcelpros Team

Introduction

Cloud computing has remained a hot topic for quite some time now and businesses are rapidly shifting their processes to the cloud for streamlined workflows and increased productivity. With cloud efficiency saving millions of dollars, companies are eagerly coming forward to reap its benefits. Let’s find out how moving to the cloud is helping companies transform themselves.

Top Reasons Why Companies Are Actively Moving to The Cloud

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Pharmaceutical inventory management challenges and solutions banner

Pharmaceutical Inventory Management: Challenges and Solutions

Pharmaceutical Inventory Management: Challenges and Solutions 700 500 Xcelpros Team

Introduction

In the pharmaceutical industry, the task of keeping track of inventory is a critical process where large investments can either make or break a company. There are so many different things to consider that have a significant impact on an organization’s bottom line.

When it comes to pharmaceutical inventory management there are a certain questions that need to be answered for full accountability, including

  • What products or raw materials do we have in inventory?
  • Where is it being stored – both physical location and in the production process
  • Does the physical inventory on hand match what each department is supposed to have?
  • Are there any discrepancies?
  • Are any raw materials or products either approaching, at, or past their expiration dates?

If just a few of these questions are left unanswered, the damages to a company can quickly begin to pile up. This can result in a loss of revenue, fines, or worse, risk to human life. Understanding exactly what issues could arise, and how, is the best first step to approaching inventory management in the pharmaceutical industry.

Understanding common causes

With rapidly rising costs for things like materials, transportation, and fines associated with non-compliance, understanding the most common causes of the issues plaguing the industry, and more, is critical to the operations and success of organizations in the pharmaceutical industry.

This lets businesses plan more carefully to be able to successfully manage their inventories down to the smallest detail. Some of the most widely seen causes of pharmaceutical inventory management errors include

  1. 1.Human error resulting in misinformation being entered into an organization’s enterprise resource planning (ERP) system.
  2. 2. Improper or incorrect storage of finished goods or raw materials.
  3. 3. Waste and/or shrinkage (i.e., theft) resulting in incorrect inventory counts and undocumented loss of revenue.
  4. 4. Errors caused by incorrect measurements or from using inaccurate equipment.
  5. 5. Discrepancies between ordered, shipped and the received quantities.
  6. 6. Failures to properly account for expired, damaged or destroyed items including raw materials and finished goods.

Inventory Management Systems

Efficient, accurate inventory management is critical because it controls the amounts of raw materials, work in progress and finished products available at any given time. More companies are taking advantage of today’s modern solutions to achieve a number of functional benefits along with enhanced visibility of their inventory levels. These new systems all support three major goals, including

  1. 1.Making sure there are enough raw materials to meet current and anticipated demand.
  2. 2.Using working capital on other needs, such as replacing outdated equipment, opposed to buying or storing additional inventory.
  3. 3.Balancing the above goals while allowing the company to make a profit.

Along with achieving these goals, these systems let business perform much of the following

Tracking Production Lots

Unlike other industries that track raw materials and finished products by part numbers, many existing pharmaceutical factories tend to produce medicines and other drugs in lots.

The lot method uses various machines to create various lot and batch sizes of a particular drug or product in common increments such as gallons or pounds. Each lot should then be marked with a pedigree serial number as required by the US FDA Safety and Innovation Act (FDASIA). All drugs distributed by wholesalers, repackagers or distributors must have a pedigree serial number for tracking purposes.

The manual and electronic (ePedigree) versions allow for tracking individual drug production lots from start to sale. Lot numbers let healthcare providers know if a particular batch of product:

  • Is ready for sale
  • Is expired
  • Is part of a recall

Lots have codes unique to each batch, making it easy to learn when problems occur. For example, if Batch A is perfect but Batch B has a problem, the manufacturer can use lot codes to narrow down where the problem occurred and correct it.

Pharmaceutical Lot tracking and the Supply Chain

Lot tracking increases supply chain integrity by tracing the pedigree of each batch of drugs manufactured.-2014 article by Lowry

Figure: 1Pharmaceutical Drugs Management Life Cycle

Banner: Pharmaceutical Drug Management Life Cycle

Specific to pharmaceuticals, lot tracking ensures tracing of each ingredient, dosage units, product family, national drug code (NDC) number, strength, schedules and other information for each batch. Lot numbers permit tracing throughout the production, processing and distribution processes.

Each lot is given an expiration date that determines its shelf life. This lot can be tracked through the supply chain to determine:

  • When it was made
  • Where the lot is at any given moment such as production shipping or a storage warehouse
  • Which customers received it
  • When the customers received their shipment of a specific lot

Typically, batches nearing their expiration date undergo a quality control test. The quality control lab either extends the expiration date or scraps the batch.

The Drug Supply Chain Security Act (DSCSA) plus the FDA and Drug Enforcement Agency (DEA) are constantly updating regulations related to lot and batch labeling.

Enhanced Tracking Methods

A stand-alone inventory management system, or the more robust ERP offerings in products such as Microsoft Dynamics 365 – Supply Chain, uses lot or batch numbers in the pharmaceutical industry, and/or product codes for internal tracking. Many wholesalers use the FDA-assigned NDC number, which is unique to a specific product. These systems can also track products by brand, brand description, strength and dosage as required by the DSCSA and for suspicious order monitoring.

The Global Trade Item Number (GTIN) is a 12-digit number used with a barcode for tracking purposes in the US and Canada. It is also known as a universal product code (UPC). The first 6-9 digits are the company prefix. The next digits reflect the product while the last digit is a check digit based on a calculation of the first 11 digits. An European Article Number (EAN) is similar to a GTN except it has 13 digits. EANs are used everywhere in the world except in the US and Canada.

Modern Inventory Management Systems

An pharmaceutical inventory management system that works with accounting, such as Microsoft System Dynamics 365 – Supply Chain, allows pharmaceutical companies to track, manage and organize inventory levels plus order, sales and deliveries.

The purpose of inventory management software is to maintain an optimal inventory level, track goods during transport between locations, receive new items, manage pharmaceutical warehouse processes such as picking, packing, and shipping, prevent product obsolescence and spoilage, and ensure your products are never out of stock.-Microsoft

Other advantages of using an inventory management system include

  • Inventory optimization
  • Product identification and tracking
  • Asset tracking
  • Reorder point determination

Inventory Management in ERP Systems

When included from the beginning as part of an ERP system, Inventory Management provides a number of additional benefits, such as

  • Direct integration into a company’s Supply Chain Management operations
  • Tracking of individual lots and batches using barcodes
  • Insights from real-time tracking using a cloud-based system, visible on mobile devices at any time
  • Artificial Intelligence (AI) recommendations for determining optimal inventory levels
  • Quicker, easier software updates for cloud-based systems compared to standard on-premise programs

Final Thoughts

The adoption of modern inventory management systems helps businesses reduce the likelihood of having either too little or too much in terms of raw materials or finished goods. For the pharmaceutical industry, inventory management is critical, offering accurate, continuous tracking of batches and lots. This ensures the company meets stringent federal and state regulations and helps ensure that only current—not expired—products are available to customers. To achieve the best results, businesses need to understand the issues and perform enough research to determine how beneficial adopting a modern inventory management system would be.

Looking for effective ways to manage your pharmaceutical inventory? Get started today with XcelPros!

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