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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.

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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

How Embracing IoT Enables Business Growth
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How Embracing IoT Enables Business Growth
How Embracing IoT Enables Business Growth 700 500 Xcelpros Team

At a Glance

  • $5.5 – $12.6 trillion: The estimated dollar impact on the world economy from the Industrial Internet of Things by 2030
  • 26%: The impact of IoT in manufacturing, hospitals, and other areas
  • 10 – 14%: The impact of IoT in human health-related companies
  • 55%, down from 61% in 2020: The economic value potential of the developed world

Source: McKinsey Digital

IoT in Production

The Internet of Things is continuing to have a growing impact on all industries, including the production of medicines and other pharmaceuticals.

“The IoT enables devices to connect and exchange data. The IoT connects assets to processes, systems, and people in manufacturing. This enables better integration of plant processes, achieving higher productivity levels and taking manufacturing to the next level of transformation, Industry 4.0,” a blog post from IBM states.

“IoT for manufacturing can harness the data from machines and equipment to transform the processes and systems of the modern factory environment. By denying or ignoring the transformation that the IoT (internet of things) will inevitably bring, manufacturers risk falling behind competitors and losing clients that value speed and innovation,”

Today, the world is in the midst of the fourth Industrial Revolution following 1783’s use of water power and steam, 1870’s introduction of electricity and the 1960’s switch from analog to digital technology.

Industry 4.0 embraces cognitive manufacturing using a combination of connected sensors, big data, predictive analysis and robotics. With the industrial internet of things (IIoT) on the rise, human workers are moving away from repetitive, mundane tasks. Instead of people dipping thermometers into vats or manually counting products, sensors can monitor temperatures in real time. Barcode labels attached to everything from individual packages to pallets let handheld devices identify the contents and where they belong.

This information flows from sensors to device controllers for each machine. Each controller sends information into a plant’s internal computer network. From there, it’s passed into individual workstations that can be anywhere in the world.

Digital Controllers for IoT

Walk into any production plant anywhere in the world and regardless of what the plant produces, changes are high you’ll see controllers made by Siemens.

“Siemens is a pioneer in framework and energy arrangements, just as computerization and programming for the Industrial Control And Factory Automation Market. Being one of the world’s greatest makers of energy-effective, asset sparing advancements, this organization gives research center diagnostics, clinical imaging hardware, and clinical IT solutions,” Verified Market Research states.

VMR lists Siemens of Germany at the top of its seven industrial control and factory automation companies. The others are ABB of Sweden, Emerson Process Management of the U.S., Rockwell Automation of the U.S., Schneider Electric headquartered in France, Honeywell of the U.S. and Mitsubishi Electric of Japan.

Siemens markets the SIMATIC IOT ® gateways, which make it easy to, “implement forward-looking production concepts in your existing plant with SIMATIC IOT gateways – they’re open, versatile, and retrofittable,” the company states.

One of Siemen’s products is a controller aimed at cloud computing: the SIMATIC Cloud Connect 7. These types of controllers help companies with far-flung operations in multiple countries share information in real-time, letting workers know what’s going on in a machine a continent away. Industrial manufacturers sending this information through the Microsoft Azure cloud computing platform can easily access data from—or send commands to—devices using these controllers.

Siemens’ industrial robots “help manufacturers grow and develop new applications that were once unfeasible with previous robotics technology.” Combining different Siemens controllers and robots is one way small and medium businesses can boost their production and efficiency. By automating formerly repetitive steps, companies can run production lines longer with reduced errors. Fewer human interaction is required, allowing production runs without anyone in the building.

Information from these controllers produces what’s commonly referred to as “big data.” Terabytes of data can be routed through machine controllers into your network from individual sensors. Unfortunately, this information is almost worthless if you can’t make it work for you.

Figure: 1IoT Enterprise Spending Forecast

IoT Enterprise Spending Forecast

IoT Data

When it comes to IoT data, Enterprise Resource Planning (ERP) software is the next logical step in the flow of information. ERPs are designed to organize the data sent through your controllers and present it in useable forms such as graphical dashboards and reports.

“ERP systems bridge information gaps across different departments within a business allowing managers to see a more holistic view of a company’s finances and critical issues. With easy access to all company processes and data, managers can make quick and informed decisions to improve the productivity of the business,” according to Omniaccounts.

One important ERP feature is resource allocation. Modern sensors and controllers might be able to tell you what each machine is doing, but not which sequence of machines is most efficient. That’s where your ERP comes in.

Omniaccounts states “When ERP systems are implemented correctly across a business, they transform the financial, operational, and human resource aspects of an organization. Companies at the forefront of innovation are implementing ERP software to improve the way data is shared across an organization, reduce internal costs, increase efficiency, and improve processes across their organizations. An ERP system fits in with any industry, be it retail, corporate, industrial, and even small businesses, assisting with the day-to-day operations of the company and the ever-changing industry needs.”

Effective ERP

Picking the right ERP for your business can make a big difference in functionality. Among the many benefits of modern ERP for manufacturing is improving supply chain efficiency by helping track raw materials from the supplier to your warehouse. Once the essential items arrive, an ERP designed with labeling makes it easy to efficiently store, trace and track products throughout production and on to customers.

The right ERP also boosts production by enabling more efficient resource allocation.

Imagine your factory is running a dozen different jobs and one of the orders is smaller than normal. When that job completes, the ERP can indicate that a machine is available. The remaining time can then be used for preventive maintenance, to run a low-volume order for one customer, or increase production for another.

On top of resource allocation, especially with IoT data, an ERP with predictive analysis helps companies.

  • It lets you know when a part is showing wear so you can replace it before having to shut down a production line
  • It helps predict where new markets will emerge through evaluating business intelligence
  • Supply chain information, coupled with business intelligence, can predict where the next Suez Canal-type fiasco might occur, giving you the option to route your shipments through other ports

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ERPs and Pharmaceutical

Today’s modern ERPs are a great way to boost the business of any small, medium or large business. ERP Research lists six ERP software makers whose products are especially good for pharmaceutical companies.

“Many pharmaceutical companies are exploring Microsoft Dynamics as their pharmaceutical ERP. The solution provides great flexibility plus a large partner ecosystem that has developed many pharmaceutical industry add-ons,” ERP Research states.

An important advantage of using Microsoft Dynamics 365 products is the company’s focus on security. Using Azure, Microsoft’s cloud computing platform provides an additional layer of data security as propriety information travels from one company site to another.

Labeling solutions that can print either barcodes or QR codes lets pharmaceutical companies embed any and every piece of required information in each label. A scan of an individual product’s label can then provide all data required in order to meet the regulations of each country or state that item moves through after leaving the factory. Even safety data sheet (SDS) information and instructions can be embedded in a label, quickly and easily.

Final Thoughts

IoT in the pharmaceutical industry is sure to be a defining factor as more use cases develop. Any company wanting to take advantage of modern technology and move to Industry 4.0 need to look at investing in at least three types of products:

  1. 1.IoT sensors to gather information at the machine level
  2. 2.Controllers to guide that data into your network
  3. 3.A modern, efficient and scalable Enterprise Resource Planning tool like Microsoft Dynamics 365 to turn that data into information for helping your company run more efficiently and profitably.

This combination gives your company an edge over competitors locked into older products and programs. Is your business IoT ready?

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Using AI & ML in the Pharmaceutical Industry – Key Considerations
Using AI & ML in the Pharmaceutical Industry – Key Considerations 700 500 Xcelpros Team

Introduction

Artificial intelligence is one of those science-fiction-sounding phrases, but what does it mean to people in the pharmaceutical industry? What is the difference between AI and its cousin, ML, which means machine learning? How can the two types of computer software make pharmaceutical companies more efficient and profitable?

The answers are in what they do and how AI and ML work together.

AI can be defined as using computer algorithms—math—to perform tasks requiring human intelligence. IBM defines AI as “leveraging computers and machines to mimic problem-solving and decision-making capabilities of the human mind.”

“It is the science and engineering of making intelligent machines, especially intelligent computer programs. It is related to the similar task of using computers to understand human intelligence, but AI does not have to confine itself to methods that are biologically observable,” John McCarthy was quoted as saying in a 2004 paper.

So if AI acts like somewhat like a human mind to solve problems, how is machine learning different?

“Machine learning is the study of computer algorithms that can improve automatically through experience and by the use of data. It is seen as a part of artificial intelligence,” Wikipedia states.

In essence, the two types of programs work together to analyze information.

For example, say the first 100 production runs of product XYZ1000 have a 70 percent success rate in terms of meeting basic quality standards. Analysis shows the difference between success and failure is one step. Every run where the temperature was kept within a 0.2-degree range succeeded. Every run where the temperature exceeded 0.5 degrees failed. Logic says that keeping the temperature within that narrow range boosts success which, in turn, improves productivity.

Machine learning tells operators, “keep the temperature within 0.2 degrees for this one step.” Artificial intelligence builds on machine learning. It says, “by keeping everything else the same and keeping the temperature in this single step within 0.2 degrees,” the company will see:

  • More efficient use of raw materials
  • Less waste
  • Greater profits
  • A host of other benefits

So how does a pharmaceutical manufacturing company benefit by using AI and ML? Let’s look at the numbers.

By the Numbers

  • $100 billion: The amount of money AI and ML can generate in the US health care industry alone.
  • $161 million – $2 billion: The estimated cost of getting a new drug through clinical trials and obtaining FDA approval.
  • 72 percent: The percentage of healthcare companies believing that AI will be crucial to how they do business in the future.
  • 62 percent: The percentage of healthcare companies considering investing in AI soon.
  • 61 percent: The percentage of companies believing that AI will help them identify opportunities they will otherwise miss.
  • 13.8 percent: A study from the Massachusetts Institute of Technology estimates the number of drugs successfully passing clinical trials.
  • 11 percent: The percentage of businesses who have not considered investing in AI.

Sources: Digital Authority Partners and PharmaNews Intel.

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How AI Helps the Pharmaceutical Industry

Add in a third element—large data sets created by Internet of Things (IoT) sensors wired into a company’s network—and the result is a technology-savvy, company that can see ways to improve efficiency. AI runs computations that estimate probabilities based on known numbers.

Going back to our earlier example, 30 percent of the production runs failed quality standards. That’s the new baseline. Having computers that can finely tune machines reduces tolerances.

Another way pharmaceutical companies are using AI is to speed up drug discovery. It sifts through large datasets from clinical studies and other sources to detect hidden patterns, performing tasks in seconds that once took months. Learning every time they perform a task, AIs run through millions of tasks.

“Drug discovery is being transformed through the use of AI, which is reducing the time it takes to mine the vast amounts of scientific data to enable a better understanding of disease mechanisms and identify new potential drug candidates,” says Karen Taylor, director of the Centre for Health Solutions at accounting and consultancy group Deloitte. “Traditional drug discovery has been very fragmentary, very hit and miss,” she adds in The Guardian article.

The rapid creation of effective Covid-19 vaccines is a direct result of AI and ML in the pharmaceutical industry, Taylor states.

Figure: 1 Funding in Artificial Intelligence in the Pharmaceutical Industry

Funding in Artificial Intelligence in the Pharmaceutical Industry

How valuable is AI to big pharma? Britain’s two largest drug makers—AstraZeneca and GSK—recently funded the Cambridge Center for AI in Medicine at the prestigious university. GSK already opened a £10 million (roughly $13.5 million) in central London. This lab is near Google’s DeepMind AI lab.

DeepMind founder Demis Hassabis recently unveiled Isomorphic Labs, which intends to use an AI-first approach to discovering new drugs. DeepMind’s AlphaFold2 AI system solved the 50-year-old challenge of protein folding. AlphaFold is capable of predicting the 3D structure of protein directly from its amino acid sequence to atomic-level accuracy, Hassabis said in a recent Isomorphic blog post.

“One of the most important applications of AI that I can think of is in the field of biological and medical research, and it is an area I have been passionate about addressing for many years,” he said.

Hassabis considers biology an extremely complex and dynamic information processing system, making it a perfect match for AI.

“But just as mathematics turned out to be the right description language for physics, biology may turn out to be the perfect type of regime for the application of AI,” he said.

The Guardian article also looks at the money: Using older methods, nine of every 10 drugs in development will fail. The average drug development time is 10-12 years. With AI, the success rate is expected to at least double and possibly boost success from 1:10 to as high as 1:2.

How Can SMBs Benefit from AI?

While having $13 million in labs devoted to research is a great idea, many companies don’t have that large of an R&D budget. At least one well-known company has enterprise resource planning modules that integrate AI: Microsoft.

Figure: 2 AI Powered Insights by Microsoft

AI Powered Insights by Microsoft

AI Powered Insights by Microsoft

One example is Microsoft Dynamics 365’s Customer Insights is one of several modules that has AI built in. When pharmaceutical companies combine Dynamics’ Business Intelligence module with its Integrated Chemical Management (iCM), the two work together to mine your pharmaceutical data.

iCM is specifically designed to handle tasks like System of Record (SOR) for chemical and regulatory data plus compliance with cGMP regulations.

Add in Dynamics’ Supply Chain Management module and pharmaceutical manufacturers and suppliers can know to the second how much of any given product they have. Using AI and other information mined from a thorough inventory review, companies can accurately predict how much of any given precursor chemical they need to meet forecast demands. With this information, companies can place orders when costs are low or keep just enough on hand.

The Bottom Line

Pharmaceutical companies already create mountains of data. Instead of losing valuable nuggets of information such as trends and insights, artificial intelligence can sort through it. AI can:

  • Perform comparatively mundane tasks extremely fast
  • Provide your company with ways to create new products at lower costs
  • Produce new drugs much faster than before
  • Reduce the number of new drug failures

Using Microsoft Dynamics 365 modules equipped with the power of AI will ultimately help boost your bottom line.

How Sustainable Operations Helps Manufacturers Grow
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How Sustainable Operations Helps Manufacturers Grow
How Sustainable Operations Helps Manufacturers Grow 700 500 Xcelpros Team

Introduction

Every business leader has heard the term “sustainable manufacturing,” but not all know that practicing methods that help the environment can also grow their business.

“Sustainable manufacturing is the creation of manufactured products through economically-sound processes that minimize negative environmental impacts while conserving energy and natural resources,” the United States Environmental Protection Agency states. These same practices enhance employee, community and product safety in part by producing less waste that pollutes the air, water and soil.

According to the EPA, companies that use a methodical, planned approach to sustainable manufacturing processes:

  • Increase operational efficiency by reducing costs and waste
  • Respond to or reach new customers and increase competitive advantage
  • Protect and strengthen brand and reputation and build public trust
  • Build long-term business viability and success
  • Respond to regulatory constraints and opportunities

Fostering Growth

These environmentally friendly sustainable manufacturing practices help companies grow by reducing production costs long term. For example, instead of paying thousands of dollars each month to an electric company to light and cool a 300,000 square-foot manufacturing plant, consider covering a flat roof with efficient solar panels.

The average payback time for a home solar electric installation (industrial estimates were not available) is roughly 6-10 years, though it varies depending on the climate and other factors. Solar panels also tend to last 25-40 years meaning roughly three-quarters of their useful lives is spent generating free electricity. The most recent designs are much more efficient, producing more power in a smaller size, than those made 10 years ago. The result is greater efficiency, allowing manufacturing facilities to cover less of their roofs while producing as much or more power than the older models.

Production plants can also reduce their massive electrical bills with skylights. The waterproof domed coverings help illuminate work areas, reducing the need of electric lighting. Extended exterior shelves can reduce sunlight, cutting cooling costs.

Figure: 1 Sustainable Manufacturing – a Big Picture

Sustainable Manufacturing - a Big Picture

Turning Trash Into Treasure

Other sustainable methods look at ways to reduce waste, especially by converting some “trash” into new products or using it for new methods.

One website alone lists 35 artful ways homeowners can recycle wooden pallets. These new uses include making tables, bed frames, stairs, mounting frames for heavy electronic display monitors and a host of other uses. Many of these same methods work for industrial companies in terms of outfitting conference rooms and other non-work areas.

From an industrial perspective, worn pallets can be repaired, cleaned and reused. They can also be sold, recouping some of the cost. Other uses for worn pallets include chipping them, turning them into wood pellets. The pellets can then be burned, generating heat and electricity.

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Cascading Chemicals

Recycling is a large part of the sustainable “green” economy. Industrial chemicals can be recycled. They can also be reused through a process known as “industrial symbiosis,” greenbiz.com states. One example cited uses ferric chloride, which is a byproduct of steel pickling in hydrochloric acid, to treat water.

“Frequently, recycled chemicals are not only cheaper than newly produced ones, but they also reduce resource consumption, waste generation and greenhouse gas emissions. The carbon emissions through solvent recycling are 46 percent – 92 percent lower than those of new solvent production,” the website states.

When the article was written in 2019, industrial giants Siemens and Evonik were conducting research to convert the most common greenhouse gas—carbon dioxide (CO2)—into common industrial chemicals such as ethylene.

Other methods used to reduce chemical and industrial waste cited by greenbiz include swapping what might be one manufacturer’s trash with a different nearby business. That business can use these materials in its products.

Another environmentally friendly industrial method is “leasing” chemicals. In this model, a manufacturer sells the functions performed by the chemical using functional units, not the chemicals themselves.

Large manufacturers with their own wastewater treatment plants can redesign those facilities in ways that help the company turn a profit and grow. Companies interested in practicing sustainable manufacturing practices can modify existing equipment to produce energy, clean water and chemicals because, “the future of sewage is power and profits.”

The greenbiz.com article ends with a quote made in 1848 by the former president of the London Royal College of Chemistry, R.W. Hoffmann: “In an ideal chemical factory there is, strictly speaking, no waste but only products. The better a real factory makes use of its waste, the closer it gets to its ideal, the bigger is the profit.”

Technology Can Spot Opportunities

One way a company can practice sustainable operations management is by using its data wisely. Especially in forward-thinking firms that use internet of things (IoT)-enabled devices, they have access to mountains of information.

Combining a well-thought plan with the right software lets these firms look at everything coming into their warehouse—including packaging—as potential profit sources. Enterprise resource planning (ERP) products such as Microsoft Dynamics 365 and its Supply Chain Management Module let companies of any size keep accurate track of their inventories. Add in the Integrated Chemical Management component and chemical manufacturers have an accurate label management solution that also produces safety data sheets.

By understanding the chemicals involved and working with sustainability experts, plant managers can evaluate their current conditions.

Executives interested in sustainable production and consumption—and being more competitive—will want to ask questions similar to these: What current waste products and materials can we use for secondary purposes or repackage and sell to someone in a different industry? Can we reuse packing materials we receive to pad and protect outgoing shipments? Are we using our raw materials effectively or are there ways we can become more efficient? How much power do our plants use? Are there affordable ways of reducing that consumption while also generating some of our own power all while meeting our long-term business goals?

Asking questions like these, and then using powerful software to find the answers, help innovative firms generate more money. That in turn can use sustainable practices to fuel growth.

The Bottom Line

Sustainable manufacturing involves looking at everything a company has, from a different angle. More office employees are working from home, freeing up space. Can we use that space for a different purpose instead of looking at empty desks? Can we move items around and expand our production facilities or our warehouse without having to build or buy new facilities?

Operations managers wanting to fuel growth by reducing power consumption can use ERP software to find ways to save money and new ways to make money. All it takes is a little outside the box long-range thinking.

The Road to Success Implementing Microsoft Dynamics 365
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Jump-starting resilient and reimagined operations
Jump-starting resilient and reimagined operations 700 500 Xcelpros Team

Jump-starting resilient and reimagined operations

Based on a wonderful piece from our friends at McKinsey, describing the effort needed by businesses moving forward after COVID disruptions. A reminder that businesses able to maintain a certain level of speed during the transition can create a significant long-term advantage.

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mistakes that slow the growth of a chemical manufacturing company
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Mistakes that slow the growth of a chemical company
Mistakes that slow the growth of a chemical company 700 500 Xcelpros Team

7 Quotes

Companies need to grow if they wish to flourish and prosper. There are many quotes already related to business growth you might have heard before, including:

  • “Conformity is the jailer of freedom and the enemy of growth,” President John F. Kennedy
  • When you stop growing, you start dying,” author William S. Burroughs
  • “Every problem is a gift —without problems we would not grow,” motivational speaker and author Anthony Robbins
  • “Out of your vulnerabilities will come your strength,” neurologist Sigmund Freud
  • “Strength and growth come only through continuous effort and struggle,” author Napoleon Hill
  • “The only way you are going to have success is to have lots of failures first,” Google co-founder Sergey Brin
  • “The journey of a thousand miles begins with a single step,” Chinese philosopher Lao Tzu

Introduction

What do you consider growth for your business? How this is measured is up to each individual organization. Data points that highlight company growth includes:

  • Sales
  • Revenue
  • Profits
  • Company Value
  • Number of customers
  • Number of Employees

The next question to ask is, “Are you growing in a way that is sustainable and lets you achieve all of your company’s goals?” As they grow, companies can make several mistakes that doom their opportunities for growth.

According to Growthink, the most common growth-related mistakes are:

  1. 1.Ignoring the Ansoff Matrix—also known as the Product/Market Expansion Grid—that details ways to increase sales.

Figure: 1Ansoff Matrix: Product-Market Expansion Grid

Ansoff Matrix: Product-Market Expansion Grid

  1. 2.Failing to conduct market research, such as a SWAT (strengths, weaknesses, opportunities and threats) assessment.
  2. 3.Developing weak financial models showing the impact of each growth opportunity.
  3. 4.Forgetting what worked in the past for your company.
  4. 5.Starting at the wrong place and lacking a clear vision of where you want to go.
  5. 6.Lacking focus, which can occur when a company lacks a clear growth plan.
  6. 7.Ignoring the human factor by not having the right people.

Chemical Industry Mistakes

The previous items apply to all companies wanting to grow, regardless of industry. The heavily regulated pharmaceutical and chemical industries face additional challenges when they want to grow.

According to Global Safety Management, these unique challenges include:

  1. 8.Ignoring jurisdictional regulations.
  2. 9.Costly errors from operations.
  3. 10.Failing to evolve into an intelligent enterprise.
  4. 11.Delivering products, not business outcomes.

Ignored regulations often result in hefty fines. For example, if your pharmaceutical company sells its products in Europe, and then decides to expand into the U.S., not following FDA labeling regulations is a major no-no. Violating Section 21 of the Federal Food Drug and Cosmetic Act (aka, title 21, section 331) mislabeling a prescription drug for interstate commerce is expensive. Penalties include prison sentences up to 10 years, fines of up to $250,000 and civil penalties up to $10 million, the law firm of Wallin & Klarich states.

Problems often result from manufacturing errors and omissions. Many of these can be traced to the supply chain. For example, inaccurate inventory counts lead to starting a production run only to discover a key ingredient is missing, stopping production.

Evolving by using available technology as a way of moving forward can be done when company leaders are looking toward the future. Tools exist today—such as the Industrial Internet of Things (IIoT) coupled with modern enterprise resource planning (ERP) software—to let small and medium-sized businesses grow. They also let larger companies get even bigger.

Having total control over your inventory and an ever-changing grasp of your supply chain lets you reduce raw materials and shipping costs while still delivering products on time.

Translation Errors Can Prove Fatal

The final error in our “devils’ dozen” is:

  1. 12.Translation Mistakes.

Let’s face it: many American chemical manufacturers purchase materials from suppliers outside the U.S. and ship finished products overseas. That means labels must not only be in the languages used by your customers and others in the supply chain, they must also meet safety regulations at their destination.

If, for example, a formula using imperial measurements (i.e., pounds and ounces) is incorrectly translated into its metric equivalent or instructions are unclear, the resulting product may fail safety and purity tests. Poorly translated labels could cause regulators to deny a shipment until the products are relabeled correctly. Translation errors could even result in a large batch failing its tests, wasting the materials, time and equipment.

“If the mistakes are severe enough, the resulting chemical combinations could be dangerous or deadly for staff members who follow mistranslated instructions to the letter,” GLTaC states.

Under terms of the European Chemicals Agency’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) act of 2006, dossiers are required on each substance produced or imported weighing more than one metric ton.

“Inaccurate information due to translation mistakes could result in regulatory action by the European Chemicals Agency that could prove financially crippling,” GLTaC, a translation services provider, warns.

Technology Helps Reduce Mistakes

ERP software like Microsoft Dynamics 365, especially when paired with something like Xcelpros’ Integrated Chemical Management (iCM), helps companies better manage their growth.

Figure: 2Integrated Chemical Management with Microsoft Dynamics 365 Supply Chain Management

Integrated Chemical Management with Microsoft Dynamics 365 Supply Chain Management

ERPs can work with IIoT sensors, gathering large quantities of data. Dynamics 365 Finance helps turn the raw numbers into actionable data. Using this data, and the charts and graphs created from it, executives can spot areas operating inefficiently. For example, machines are down and staff is doing make-work while waiting for earlier cycles to complete.

Having access to real-time numbers lets these leaders know where changes can occur, boosting overall production.

iCM helps chemical companies hit their growth targets. It integrates seamlessly into D365’s Finance module, providing impeccable security. Among iCM’s value propositions are:

  • Built-in labeling and safety data sheets (SDS)
  • Fully integrated SDS management
  • Real-time SDS data sheets are consistent and compliant with Global Harmonization System requirements

These SDS features reduce the total cost of ownership (TCO) by removing the need to maintain product safety documentation and data in-house.

iCM becomes the repository of record for all regulatory data while making it accessible to authorized D365 users. It also integrates SDS authoring at the formula/item level, embedding workflows for authoring and approvals.

Xcelpros’ product adds to one of D365’s many strengths: its labeling prowess. The Supply Chain Management module lets companies track products from the moment raw materials arrive in their warehouse to the instant a customer receives them. iCM builds on the existing technology, further focusing on the chemical industry.

For example, iCM becomes the system of record for all labels, integrating them into operational workflows like production and shipping. To learn more, download the iCM brochure.

Figure: 3Translation Service Process in Dynamics 365

Translation Service Process in Dynamics 365

Customers using D365 also have access to the Dynamics 365 Translation Service (DTS). Hosted in Microsoft Dynamics Lifecycle Services (LCS), it uses a machine translation system to maximize translation output quality. It also recycles linguistic assets from D365 and partners, such as Xcelpros. DTS is compatible with D365 Finance, Commerce and CRM modules among others.

Summary

Chemical companies face potential mistakes common to all growing businesses. In addition, they also face certain hurdles that other industries do not. Regulation is a major issue for chemical companies, especially those who rely on raw materials and finished products made outside the U.S. or shipped overseas.

Taking advantage of technology like Microsoft Dynamics 365 and Xcelpros’ unique Integrated Chemical Management software can help prevent these mistakes and let executives continuously grow their companies.

Get a consultation to learn how to resolve critical problems in your chemical company.

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References: Distribution Of Mislabeled Products In Interstate Commerce

latest trends in pharmaceutical manufacturing industry banner
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Latest Trends in Pharmaceutical Manufacturing Industry 2021
Latest Trends in Pharmaceutical Manufacturing Industry 2021 700 500 Xcelpros Team

By the Numbers

In a July 2021 report, Grand View Research estimated the 2020 global pharmaceutical manufacturing market value at $405.52 billion. Key metrics include:

  • 11.34%: The industry’s expected compound annual growth rate (CAGR) from 2021 – 2028
  • $957.59 billion: The revenue forecast for 2028
  • 77.95%: The retail segment market share in 2020

The IQVIA Institute for Human Data Science used a five-year estimate from 2018-2023 in its 2019 report. This report estimated spending on medicine to top $1.4 trillion by the end of 2021. Looking ahead to anticipated global medicine spending and growth in 2023 shows the top individual regions in terms of spending and 5-year CAGR as being:

  • United States: $625 – $655 billion, + 4% – 7%
  • Pharmerging: $355 – $385 billion, + 5% – 8%
  • Top 5 Europe: $195 – $225 billion, + 1% – 4%
  • Japan: $89 – $93 billion, – 3% – 0%

“Pharmerging” is a term given to emerging nations in areas such as Africa and parts of Asia.

Figure: 1Estimated medicine spending by companies in 2023

Estimated medicine spending by companies in 2023

Figure: 2Estimated growth rate of medicines by 2023

Estimated growth rate of medicines by 2023

5 Topics to Ponder

Despite all the problems and deaths caused by Covid-19, along with its impact on pharmaceutical manufacturing and the U.S. trade war with China, the market for medicines and related products is staying strong.

Looking several years out, one question CEOs and CFOs must ponder is what changes can we make now to prepare for a profitable future?

According to The Medical Futurist, the Top 5 trends for leaders to consider in the coming years include:

  1. 1.Using artificial intelligence to speed research & development. Spending on AI in healthcare alone is expected to hit $31.3 billion by 2025.
  2. 2.Empowering patients to aid in drug design and advisory boards. TMF notes the Food and Drug Administration has its own patient engagement advisory committee. The FDA states the committee considers different topics including the design of clinical investigations, communicating device benefits and risks, digital health technology and more.
  3. 3.Conducting experiments using computer simulations or “in silico,”. This is another digital trend in pharmaceutical manufacturing. This method eliminates animal testing and side effects on humans and animals. So far, this technology is less than halfway to becoming a reality, though.
  4. 4.Boosting the supply chain with technology such as blockchain to enhance security and improve inventory tracking. “Counterfeit drugs might make a cheaper alternative but are the cause of tens of thousands of deaths worldwide while the fake drug trade continues to be a profitable multi-billion dollar business,” according to TMF.
  5. 5.Using technology to appeal to more providers and payers. TMF mentions a wearable monitoring device and an app for feedback from doctors plus the app itself. Another technology is 3D printed pills such as Spritam that gained FDA approval in 2015.

Another topic mentioned in a different report is using real-world-evidence (RWE). A 2018 report by Deloitte defines RWE as, “clinical evidence about a product’s usage, potential benefits and risks derived from real-world data.”

However, Deloitte’s survey also highlighted three potential barriers to RWE adoption by pharmaceutical companies:

  • 75 percent: Major lack of receptivity by external stakeholders
  • 70 percent: Lack of understanding by internal stakeholders
  • 65 percent: Lack of access to necessary external data

AI and ERPs

Enterprise Resource Planning (ERP) software such as Microsoft Dynamics 365 Finance can support different AI modules, as needed. Depending on a business’ requirements, AI can help conduct research more efficiently, automate manual processes and perform other repetitive tasks.

AI benefits researchers through natural language processing and reasoning, learning from data and optimization addressing problems. One example cited by the Royal Society is using “deep” neural networks to identify features required to solve problems. Another uses reinforcement learning to examine many scenarios and assigning credit to different moves—such as chemical combinations—based on performance.

When it comes to research and manufacturing of pharmaceutical products, AI helps researchers use genomic data to predict protein structures, improving diagnosis and developing new treatments. Using machine learning—one part of AI—to predict the three-dimensional structure of proteins from DNA sequences is another example. This is quickly becoming one of the biggest trends in the pharmaceutical industry in 2021.

By creating a highly-detailed computer model that replicates a human organ, pharma companies can see the effectiveness of different drug therapies on specific diseases.

When it comes to pharmaceutical manufacturing technology, which versions work? What are the side effects? What changes can we make to reduce the side effect’s severity? These are some of the questions AI can help answer quickly and efficiently without experimenting on humans or animals.

In terms of business, “artificial intelligence technology allows businesses to automate a variety of processes, frees up employees’ time and helps improve productivity.” The result is greater output in less time at lower cost, according to Intellspot.

AI also helps capture competitive research and analysis. One tool with that capability is Microsoft Power Bi. This software has three types of AI transformations:

  • Text analytics tags images and extracts key phrases
  • Vision analyzes images
  • Azure ML helps generate insights and predictions

ERPs and Regulatory Compliance

A major obstacle unique to technology in pharmaceutical manufacturing is dealing with FDA regulations. Many of these rules require strict recordkeeping. Modern ERPs, which share data between departments, allow companies to keep more accurate documentation and inventory. ERPs allow executives to review data for accuracy, ensuring that information from Inventory Control matches what Finance says it should report.

A key feature of sharing information between different departments such as Inventory Control and Finance, companies can spot areas for improvement. Are FDA documentation requirements being met? A simple query can give a CEO the answer for any department anywhere in the world.

ERPs can also ensure that product communications meet the FDA’s stringent requirements for truth under the Federal Food, Drug and Cosmetic Act (FD&C Act). These laws can result in severe fines for conveying important information the FDA considers misleading.

Labelling is another major part of FDA rules, one where D365’s Inventory Control Module for Dynamics Supply Chain Management stands out. This lets businesses generate barcodes and other labels, tracking products and batches from the moment they arrive through production to their delivery to customers.

Summary

Pharmaceutical manufacturing technology, like the use of AI or ML in research & development, are quickly becoming leading pharmaceutical industry trends since 2020, helping make pharmaceutical companies leaner and more efficient. Modern software like tier 1 ERPs lets them gather, sort and analyze information obtained from the continuous manufacturing of pharmaceuticals much more rapidly than ever before.

Keep up with the Pharmaceutical Manufacturing trends. Get an obligation trial of Microsoft ERP tailored for the Pharma Industry.

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Formula Management Scales Up Process Manufacturing
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Formula Management Scales Up Process Manufacturing
Formula Management Scales Up Process Manufacturing 700 500 Xcelpros Team

Introduction

Formulas are at the core of process manufacturing and managing them is a critical function in the product development cycle. However, we see manufacturers show little effort in how they store and access their formulas, often keeping them siloed. However, today’s connected world makes sharing information across business units critical.

Seldom are formulas managed with any regularity. We find them in manual logs or at best, Microsoft Excel files. Companies spend years perfecting a single formula, ensuring it is scalable and able to maintain consistent quality across all batches and then restrict access to it.

At Xcelpros, we help our clients modernize their formula management. Keeping these formulas updated and secure from prying competitors results in higher productivity. That translates into a stronger bottom line.

Enterprise Resource Planning (ERP) software such as Microsoft System Dynamics has the ability to manage formulas. An ERP brings consistency, product scalability and improved efficiency to formulas while achieving better compliance scores.

Formula management (FM) includes the ability to optimize formulas. It also creates and manages workflows, creates formula variants, manages labeling content, plans inventory for scaling up production and validates the formulas to meet regulatory requirements.

An essential part of electronic batch processing, FM helps modernize the product development process. The resulting efficiency increase results in shorter times to market.

Automating formulas ensures consistent products. It removes manual calculations of ingredients, their properties and costs, thereby removing a source of error.

This process also causes better regulatory compliance. It reduces the chances of recalls, rejections and fines. Each of these actions costs your firm money while negatively impacting brand value.

The Downstream Impact of Formula Management

As discussed above, formula management is at the core of process manufacturing. Using the chemical industry as an example, formulas are at the center of each company’s assets. The research and development (R&D) section likely has an “n number” of formulas and variations. When each formula is processed, it delivers a unique product. Having related formulas scattered across multiple locations increases the compliance hazard, reducing efficiency.

An integrated FM system gives top executives control of:

  • Transparency in terms of cost – An integrated business application such as an ERP includes ways to control formulas. The software also shows costs associated with the manufacturing process. ERPs give you a holistic picture. They provide the downstream impact of a formula from raw materials procurement to setting end product pricing.
  • Visibility of formula properties – ERPs let you analyze the change in physical properties of key ingredients in real-time. For example, you can vary the quantity or substitute one raw material for another. Making these changes in the ERP lets you see the impact on areas such as the nutritional value of products.
  • Authentication and formula protection – This security feature helps an organization define access rights to each formula. It allows you to limit modification rights to a select few while giving master control to the administrator. The administrator can reverse any changes to the formula.

Your business deserves the power of a unified system for formula management.

ERPs are the Way Ahead

ERPs provide an effective solution with the ability to unify production processes with research and development formulation in a common, secure platform. ERP systems can transform the way formulas are managed by players in industries such as chemical, pharmaceutical, food & beverages, etc.

Keeping formulas confidential is critical for every manufacturer in every industry. Managing formulas efficiently can be a competitive advantage, especially when a company is growing.

Instead of making FM a daunting task, using an ERP ensures your manufacturing processes are standardized across your production units regardless of their location.

ERPs are Transformational

Modern businesses generate gigabytes of data every single day. That number continues to increase as handheld devices and connected systems add to it. ERP software is designed to handle massive volumes of data. It generates insights letting top executives gain deeper understanding of core business functions. Using an ERP, top leaders can see the data behind critical decisions.

Looking at batch processing, which includes FM, leaders have a centralized information source covering all products that being processed, manufactured or stored. Having access to this data in one spot lets leaders generate important business insights.

Batch size, quality, quantity and components are essential items captured by ERPs. The system allows organizations to set security controls ensuring only authorized personnel can access the firm’s trade secrets and formulas. The ERP also maintains a version history of all changes made to the formula, letting authorized people go back to a previous version in case of unauthorized access.

Connecting Silos

In many businesses, data is captured and stored in stand-alone “silos.” A problem with this approach is its inability to share data. This is especially true when data from multiple business functions is captured in different systems.

Siloed data is not easily accessible from systems outside that area. It doesn’t give key executives enough variables to make informed decisions. The silo approach causes inefficiencies and lower returns on investments from technology assets.

Today is the age of connected business ecosystems, not stand-alone silos. Collaboration is the key to efficiency, transparency and easier operations. Sharing data means quicker and informed decision making, all of which eventually leads to success. Only an ERP can break the silo walls, connecting your data to provide a complete 360-degree view of your production process.

A connected system helps you calculate formulas and break down the costs of each product, percolating down to provide improved competitive and operational advantages.

ERP Software Systems and Formula Management

Some areas where ERPs are instrumental in formula management include:

  • Versioning formulas
  • Scaling formulas to create larger batches
  • Determining and establishing coproducts or byproducts
  • Categorizing active ingredient formulas by
    • Weight
    • Percentage
    • Operations related to ingredient consumption
    • Approvers
    • Batch sizes

Figure: 1ERP Software For Process Manufacturing

ERP Software For Process Manufacturing

Versioning Formulas for Compliance

Process manufacturers are continually updating and improving their formulas. Updates are driven by changing industry trends, customer demand and most importantly, ever-changing regulations.

Keeping up with rule changes is a constant task, especially for companies with multinational manufacturing and distribution operations. They must be compliant with the laws in each country where they operate.

Compliance impacts formulas directly, making keeping different versions a “must have” feature. For example, formaldehyde is a chemical agent dangerous to humans at levels of 100 parts per million. It is banned for use in cosmetics across the European Union but is found in hair-straightening products and nail polish in the US. Atrazine is used as an herbicide in the US, but was banned in the EU since 2003 over concerns of it polluting water bodies.

Differing regulations requiring different formulas—even with minor alterations—can be intimidating. Formulas must be managed properly to meet the regulations in each country or region.

Scaling Formulas for Consistency

Another formula function ERPs automate is scaling. When a customer changes its order size, the quantity of raw materials varies. Formulas do not.

To the uniformed, the impression of an ERP at a manufacturing location is like taking a widget, adding some gadgets plus a few man hours and presto, you have a finished product. This is at best oversimplification and at worst a mathematically challenging extrapolation.

Why is scalability a challenge? Consider a scenario where you are preparing soup for a family of four. Something happens. Now you need to make soup for your neighborhood, maybe your city or even your county. Most people realize your raw materials will increase as you add people, but what about making your soup look and taste the same or ensuring your serving quantity is right?

To accomplish all of this requires software that can scale production while maintaining consistency in product composition. An ERP solution such as Microsoft Dynamics 365 for Finance and Operation can help categorize all your formulas based on parameters such as: weight, percentage, ingredients, production size, approvers, etc. Top executives have complete control of their manufacturing operations regardless of how many customers one product serves.

Creating New Efficiencies

In addition to providing consistent products regardless of batch size or manufacturing location, ERPs can help manage your formulas to create new levels of efficiency by:

  • Ensuring changes made to a formula have real-time implications to raw material procurement, production, inventory management and planning.
  • Scaling formulas regardless of production size.
  • Adjusting user fields to suit current requirements and configurations.
  • Keeping tabs on production costs such as raw materials, labor and other variables based on changes to your formula.

Conclusion

Most chemical manufacturers have a legal pre-defined volume to weight ratio for using certain ingredients. The process becomes more complex when using multiple measurement units of such as dry and wet volumes. Adding to the complexity are when different measuring systems are used, such as imperial in the US compared to metric elsewhere. The complexity increases when adding storage temperature or acidity of the ingredients into the mix. How will a particular chemical or ingredient react when it comes in proximity or contact with another agent? Will it lose effectiveness at a specific temperature?

An ERP’s formula management function allows companies to automate the production process. The integration process also means firms can publish relevant labels. These labels are pasted on the products providing required information.

Using FM in an ERP lets companies concentrate on the business of selling products. They can avoid the costs and headaches caused by an inefficient formula management process. Powered by a self-sustained connected ecosystem hosting a universe of business applications, Microsoft Dynamics 365 offers a secure and holistic formula management suite. Dynamics 365 ensures your formulas are secure, scalable, compliant and most importantly, strategically placed to elevate your organization to the next level of efficiency.

Scale up your manufacturing process with formula management, book a consultation with our expert to learn more.

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