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

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

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

Key Considerations for Designing a System to Handle GMP Processes

Understand the Regulatory Requirements

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

Identify Critical Control Points

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

Implement a Document Management System

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

Choose the Right Equipment

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

Train Employees

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

Conduct Regular Audits

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

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

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

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

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What Features Should a Good GMP Software Have?

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

Figure 1:Essential Components of Effective GMP Software

Essential Components of Effective GMP Software

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

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

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

Conclusion

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

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

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

What Chemical Companies Can Expect from increasing their Post-Covid IT Budgets
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What Chemical Companies Can Expect from Increasing IT Budgets Post-Covid
What Chemical Companies Can Expect from Increasing IT Budgets Post-Covid 700 500 Xcelpros Team

Introduction

Chemical companies across the board have been increasing their IT and technology budgets more than ever. This increase in funding isn’t just good for consumers looking forward to new features and a better experience; it also means that your company will be safer from malware threats and cyberattacks, which can be disastrous for any type of business.

Given how focused hackers are on Chemical companies, this increased attention to cybersecurity couldn’t come at a better time! Whether your company deals with energy or manufacturing, chances are you will benefit from these new investments in IT, so what should you expect?

A great time to increase investments in your technology

Today’s recovering economy is expected to be a boom for many industries, and chemical companies are no exception.

According to Garnter.com:

“Worldwide IT spending is projected to total $4.5 trillion in 2022, an increase of 5.1% from 2021”

Figure 1:IT Spend and Growth Forecast

IT Spend and Growth Forecast

With this kind if increased demand for their products, now’s the perfect time for chemical companies looking to invest in new enterprise technology. By doing so, businesses can streamline their operations, improve efficiency, and better meet customer needs. In addition, increased investments in technology can help businesses become more agile and adapt to changing market conditions. For example, it allows for easy updates that reflect new economic developments.

Many Chemical companies who have invested in tech recently reported being able to quickly adjust during these difficult times and make necessary changes when needed. Other benefits reportedly tied to increased investments in enterprise technology include an increase in productivity, fewer errors due to human error, greater visibility into business processes and inventory levels at all times (across multiple locations), better integration with accounting software like Microsoft Dynamics 365 Finance and Operations and Business Central, improved security measures against hackers, and stronger safeguards against power outages or other environmental disasters that could impact data availability.

As any technology continues to change and evolve, investments in its latest innovations will always provide long-term advantages over outdated technologies. Considering these benefits, any company looking to thrive in this rapidly changing economy should consider investing in their technology sooner rather than later.

Bigger budgets help your business grow

Even today, the world is still uncertain, and businesses continue preparing for the worst while hoping for the best. One way that companies can set themselves up for success is by deciding to increase their IT and tech budgets. Bigger budgets mean better tools and software to help streamline processes and more resources for research and development. Additionally, increased IT spending could lead to improved customer service and support, which are essential for the chemical industry today. The companies that can adapt and grow their business will be the ones that thrive. Increased investment in IT and technology budgets could make all the difference in staying competitive in this fast-paced market.

Chemicals make up about 8% of GDP worldwide, so these companies need to stay innovative with their products to attract new customers. With an IT budget increase, these companies would have access to more reliable data systems and greater flexibility for expansion. These companies must keep investing in their infrastructure to compete against other firms like Bayer AG or Exxon Mobil Corp., which have also invested heavily in growing their technology departments.

Whether you’re a company like DuPont Co., Dow Chemical Co., or BASF SE, every penny counts for innovation. These chemical companies must maintain a healthy balance between maintaining their infrastructure and developing new technologies if they want to stay ahead of the curve.

Along with investing in R&D, there should be a plan for how your money will be spent. The introduction of cloud computing has made it easier for smaller firms to manage their cash flow; any company can now access massive computing power without paying hefty fees upfront. And not only does cloud computing allow for easy data storage, but it also allows users to remotely access applications without having any onsite hardware. Cloud computing services have reduced costs and opened the door for smaller enterprises looking to build their technological capabilities without worrying about making large capital investments upfront.

Leveraging technology to thrive

In today’s business world, technology continues to play a more important role than in the past. Chemical companies that don’t invest in modern, updated technology will be left behind, putting the future of their business at risk. The growing importance of tech is a trend that can’t be ignored, and only businesses that can keep up with changing times are likely to survive and thrive.

By increasing IT and technology budgets, chemical companies are setting themselves up for success now and in the future. From working on computerized project management systems to adapting current systems so they’re compatible with new tech, there are many ways that company leaders can start investing in their future right away—investing early in updating your systems means having access to some of the latest technology out there, not just what was available when your system was first created.

There are several cost benefits to investing in updated technology – it saves time and money by ensuring everyone is on the same page, reducing overall cost through improved efficiency, freeing up staff time by automating repetitive tasks like collecting data points or following up with suppliers, etc. With so many options available for companies looking to invest in new technologies and update their old ones (whether they have outdated software or hardware), there isn’t any excuse not to do so.

The challenges of scaling with limited resources

Scaling a business is easier with the added challenges of limited resources. With the right tools and technology in place, it is possible to overcome these challenges and scale your business successfully. In this post, we will examine some of the benefits that scaling a business with software can offer.

There are three main areas where new technology can provide an advantage over traditional methods:

  • Inventory Management.
  • Manufacturing.
  • Marketing.

These areas are all integral parts of running a successful business, and when they are handled properly, they can help you keep pace with the competition.

Inventory management is often a challenge for businesses of any size. But with effective inventory management software like our own S&OP application, which allows you to set alerts and schedules for orders and track purchases and sales at every level of the supply chain – raw materials through finished goods – managing your inventory becomes infinitely easier.

New technology simplifies complex processes like scheduling production orders, handling multiple batches simultaneously or even tracking job progress on production lines by integrating process data such as manufacturing flow sheets or operating instructions into one system. Thirdly, marketing has always been about creativity but unfortunately marketers don’t always have the time for creativity because their days are filled with tasks that don’t require creativity at all!

Things you should invest in first

As the world starts to come out of the Covid-19 pandemic, many businesses are looking at their budgets and wondering where to invest their money. For chemical companies, investing in IT departments and new technology is a smart move that will help them thrive in the post-pandemic economy.

For chemical companies to survive it’s becoming clear they need two things:

  • Reliable production lines.
  • A loyal customer base.

Modern technology can provide both. With new CRM systems, you can manage your client base precisely and ensure you’re keeping customers happy by providing them with what they want – when they want it. With the rise of e-commerce, this means being able to work remotely and deliver orders quickly via delivery drones or on foot. The software also helps ensure your production line stays running smoothly through alerts when there are any problems, so you don’t have to worry about bottlenecks or shortages.

If you want to empower your business with plenty of potential for growth and success, there’s no time to invest in an IT department and new technology!

Using your increased investment in enterprise tech wisely

There are many ways businesses have used their increased investment in technology wisely.

  • One way is using it to improve communication and collaboration within the company. This can be done through video conferencing, instant messaging, and document sharing platforms.
  • Another way businesses have used their increased investment in technology is by using it to improve customer service. This can be done through online chatbots, live chat, and automated customer service platforms.
  • Finally, businesses have also used their increased investment in technology to improve their marketing efforts. This can be done through social media, search engine optimization, and content marketing.

It’s important for business owners to make sure they don’t just focus on what they need now but instead plan for future needs as well. With an increase in spending on enterprise tech comes an increased need for cybersecurity experts as well. It’s also critical that a business not only invest in cybersecurity solutions but also in training for their employees so that they have a full understanding of how these solutions work. The most successful businesses will see the value of investing in all these areas no matter what because with every new change come new opportunities for growth and innovation.

Final thoughts

As the Covid-19 pandemic continues to lighten, it’s grasp more, and more businesses are seeing the value of increasing their IT and technology budgets. This is especially true for chemical companies, which have been hit hard by the pandemic. What’s the outlook for chemical companies looking to increase their technology budget? The answer depends on your situation, but there are some general things you can expect.

Firms already dealing with ongoing IT challenges will likely see their problems worsen as they attempt to cope with increased security risks, increased regulatory compliance costs, and more complex product development cycles.

In this case, it may be best to implement strategies like employee retraining programs and process automation that help decrease reliance on human labor in certain business areas.

On the other hand, if you’re currently on solid footing regarding tech advances in your company – or if you’ve just started out – then an increased budget could be just what you need.

Schedule a call today for more information or help to define your new technology budget.

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

Get a consultation to discover more about Embracing IoT powered applications.

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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?

Best Practices in Quality Management and Control
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Quality Management and Control – Best Practices
Quality Management and Control – Best Practices 700 500 Xcelpros Team

Introduction to Quality Management and Control

Reducing the amount of defective products saves manufacturers money. Cutting raw materials waste, using labor and equipment more efficiently, and reducing returns from unhappy customers are all ways to save money when product defects are reduced. Boosting quality control in manufacturing can also lead to an enhanced customer experience, supercharging your brand while lowering the need for extra raw materials to replace anything wasted.

Three ways any industry can improve quality control include:

  1. 1. Reducing human mistakes by automating repetitive actions. Automation also improves accuracy and increases visibility. Combined with internet of things (IoT) sensors, automation creates data that can be analyzed for hidden incremental improvements.
  2. 2. Inspecting, testing, and comparing products to defined standards. Products that meet those standards are shipped. Those that don’t are recycled. Adding computerized sensors in the inspection and quality control phase also provides an opportunity for insights into ways to create and build quality control standard operating procedures (SOPs).
  3. 3. Tracking inventory from the material supplier through warehouses and production to the end customer’s door. Accurate labeling lets manufacturers trace everything from essential ingredients to sub-assemblies and completed products. Using barcodes combined with automated and hand-held scanners provides a third data entry point into your firm’s network, ensuring most of what goes in comes out as salable products.

Using these three quality control methods in production can help your company create an efficient production cycle that reduces machine downtime, defects, and waste rework. The result is better merchandise and less waste, benefiting customers and manufacturers alike.

Quality Control Starts with Quality Planning

For many, focusing on quality control, or QC, means creating an efficient, consistent manufacturing process that gives the same results every time the process is repeated. The only way to ensure this consistency is with a well-formulated quality plan.

As a manufacturer or company who uses contract manufacturers, you likely focus on two critical elements: quality and cost. The best way to deliver the highest quality at the lowest cost is to start with quality planning. The American Society for Quality defines quality plans as “a document or set of documents that describe the standards, quality practices, resources and processes pertinent to a specific product, service or project.”

A quality plan for manufacturing ensures:

  • Conformance to your customer’s requirements, which may include meeting government standards.
  • Verification of your own standards while confirming your internal procedures work as expected.
  • Tracking the motions of every product, from the moment raw materials or sub-assemblies enter your premises, to their delivery at your customer’s door.
  • Consistent results via ensuring the quality methods in production work as designed and as expected.
  • Deficiencies in worker training are identified, allowing them to be corrected.
  • Insights into ways to further enhance your quality control standard operating procedures (SOPs).

The major components of a quality plan which must be stated and defined:

  • Responsibility for distribution, in terms of which manager or department confirms each step in the process so the end result aligns with the company’s goals.
  • Process steps and individual procedures for each step in the overall production process.
  • Testing requirements and the amount of government oversight vary by industry. For example, medicines or chemicals have significantly more regulations to comply with than furniture, for example.
  • Methods for tracking changes and modifications, regardless of the cause.
  • Quality process measurement in terms of value provided by the quality plan.

The final and most essential components of a quality plan are standards: What practices and procedures must be followed in your quality plan so that manufacturing meets requirements, customer’s needs, and government compliance requirements?

The Value of Standard Operating Procedures (SOPs)

A key part of quality control in manufacturing is having standard operating procedures (SOPs) that are easily replicated. Each step in each procedure making up the entire production process is checked, re-checked, and confirmed by those designated to follow that specific SOP. The final test is completed by having a new hire follow said procedure and reviewing their results. When the results from a new hire are able to meet set production quality control standards, the SOP can be considered a success. When the results do not meet set production quality control standards, the fault lies with the SOP document, not the worker.

According to the U.S. National Library of Medicine at the National Institute of Health, Standard Operating Procedures (SOPs) create a structured approach to work and guarantee consistent execution of tasks by all individuals involved. Well-crafted SOPs play a critical role in maintaining Good Clinical Practice (GCP), preventing errors, reducing waste, and avoiding unnecessary rework. On the other hand, poorly articulated SOPs can lead to misinformation and confusion.

These documents must be user-friendly and written in a way that is easy to follow and leaves little room for errors. Preventing errors via SOPs improves quality, reduces waste, and when written with input from people involved in the actual manufacturing process, boosts efficiency.

The Role of Quality Assurance

In manufacturing, quality assurance (QA) encompasses the practices that manufacturers employ within a quality management system to uphold expected levels of consistent quality for the items they create.

When paired with quality control, quality assurance works to ensure customers receive products that meet specific standards, in terms of defects and tolerances. QA is a proactive method that works via employee training, defining processes in written SOPs, and selecting the right tools for each job. QC looks at the results from QA and determines if a product passes or fails.

Effective quality control and quality assurance plans, combined with quality auditors ensuring standards are met, results in cost savings, boosted efficiency, and boosted customer satisfaction.

Figure 1: The Role of Quality Assurance

The Role of Quality Assurance is to boost customer satisfaction and efficiency and provide cost savings.

The Role of Quality Assurance

  • Cost savings in terms reduced waste
  • Using equipment more effectively boosts efficiency

Quality management standards vary by the industry, though one of the most common is ISO 9000. A set of international quality standards, ISO 9000 covers many different industries and approaches.

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Quality Management Systems

A Quality Management System (QMS) is a structured framework that captures the essence of how things get done right. It’s all about documenting processes, procedures, and responsibilities, with the ultimate goal of achieving quality policies and objectives. By coordinating and directing an organization’s activities, the QMS plays a vital role in meeting customer needs, fulfilling regulatory requirements, and always striving to be better, faster, and more efficient.

An effective QMS helps manufacturing companies:

  • Define production processes
  • Reduce waste
  • Prevent mistakes
  • Lower costs
  • Engage staff
  • Set an organization-wide direction
  • Communicate a readiness to customers that it wants to produce consistent results

In today’s digital world, QMS doesn’t stand alone in a silo: it’s part of a company’s overarching software linking QA and QC to inventory, sales and other departments. One example of a versatile QMS is called Integrated Chemical Management (iCM), which integrates fully with Microsoft’s flagship enterprise resource planning (ERP) solutions Microsoft Dynamics 365 Finance, Supply Chain Management, and Business Central. When integrated with Dynamics 365, iCM  provides a scalable, easy to use overarching quality management tool that helps with on time delivery (OTD) for products, under budget.

When merged with internet of things (IoT) sensors on production machines, Integrated Chemical Management (iCM) and Dynamics 365 manage and massage data. Among the results are ways to make incremental quality improvements that boost long-term overall quality scores, resulting in more sales and customer satisfaction.

Summary – Quality Management

For any company, producing higher-quality products takes forethought, patience, and serious effort. This means having a documented quality management plans that include step-by-step directions for every procedure and every part of the production process.

When it comes to manufacturing, an effective quality management plan looks at quality assurance and quality control, examining and testing various stages of the production process to ensure everything meets your demanding standards, boost efficiency, and reduce wasteful practices.

Helping measure these results is a modern quality management system like Integrated Quality Management (iQM) from XcelPros, which integrates fully with Microsoft Dynamics 365 Finance and Supply Chain Management. When used as part of an overall ERP software plan, iQM helps companies find ways to improve quality while reducing costs. This leads to an overall effect is a boost in profitability, helping power additional growth and granting ROI.

Taking the time to plan how to function in these uncertain times is essential. Using software tools such as Microsoft Dynamics 365 Finance, Supply Chain Management, or Business Central will help companies continue to operate successfully in rapidly changing conditions.

Get started on total quality management with XcelPros at your side.

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Also read: The Key Principles of Total Quality Management (TQM)

using AI ml-in the pharmaceutical industry key considerations banner
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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.

Time to Explore Pharmerging markets
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It’s Time to Explore Pharmerging Markets
It’s Time to Explore Pharmerging Markets 700 500 Xcelpros Team

Introduction

A relatively new term making waves in business is “pharmerging markets.” What does the term mean and why should pharmaceutical manufacturers care? The short version is these markets are expected to grow at a faster rate than the rest of the world.

Add in potentially catastrophic supply chain issues and it’s now a great time to invest in markets closer to where active pharmaceutical ingredients are produced. This includes China, India and those in Southeast Asia.

One definition is, “a group of countries having a low position on the pharmaceutical market, but having a fast pace of growth. Those are China and India and to a lesser extent, Brazil, South Africa and other countries,” IGI Global states.

Imarc adds Russia, Mexico, Indonesia, Turkey and others, placing them into three tiers. China is the lone Tier 1 entry.

Tier II contains:

  • India
  • Brazil
  • Russia
  • South Africa

Tier III pharmerging countries include:

  • Argentina
  • Mexico
  • Poland
  • Ukraine
  • Turkey
  • Saudi Arabia
  • Egypt
  • Algeria
  • Nigeria
  • Thailand
  • Indonesia
  • Pakistan

All of these countries share two important characteristics:

  • They have a per capita gross domestic product (GDP) threshold of $25,000.
  • They saw a spending increase of at least $1 billion from 2012 – 2016, though only part of that was in medicines.

Growth Rates

Figure: 1 Expected Growth Rate of Pharmerging Markets by 2025

Integrating the Purchase Order Process

Key Changes in the Outlook

  1. 1.2020: -1.8% (-$23Billion)
  2. 2.2021: +0.6% above pre-COVID-19 growth; +2.3% above 2020 growth
  3. 3.Current outlook including vaccines +4% over outlook that excludes vaccines due to ~$50-55billion vaccine spending in both 2021 and 2022, later reduced as volume shifts to biennial boosters and price drops over time
  4. 4.Expected budget pressures will emerge from longer-term pressures of sustained pandemic
  5. 5.Vaccine spending declines as biennial boosters and costs decline in endemic phase, followed by overall growth returning to expected levels

The 6-year cumulative delta on 2020-2025 spending excluding Covid-19 vaccines is -$4 billion globally.

Sources: IQVIA Market Prognosis, Sep 2020; IQVIA Institute, Mar 2021

Pharmerging markets are expected to have a combined annual growth rate (CAGR) from 6% -9% through 2025, reaching $1.4 billion by 2024. By comparison:

  • Developed nations will grow at no more than 3%
  • The rest of the world will grow 2% to 5%
  • The overall global growth rate is anticipated to be 3% – 6%
  • The U.S. market will grow no more than 3%, possibly less

Pushing the need for prescription drugs and targeted medical therapies in these countries are aging populations, more public hospitals and a heavier burden caused by chronic disease, Pharmaceutical Processing World states. The result is increased pharmaceutical spending since 2016.

A key note, industry research firm IQVIA states, is this growth excludes spending on Covid-19 vaccines. The cumulative spending on Covid-related vaccines, treatments and related products should hit $154 billion.

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Fueling Pharmerging Growth

Access to healthcare has historically been a driving force in the use of medicines within the Tier II and Tier III countries. However, IQVIA sees a slowing trend with volume decline across many markets.

However, China’s use of non-Covid pharmaceuticals is expected to accelerate, especially once the pandemic dies down. Changes in the use of medicines, with demands for new vaccines plus shifts in demand for existing therapies and patient behaviors, will also have an impact on the global pharmaceutical market.

These same countries with lower incomes also have dramatically lower access to medicines. The result is an increased demand, especially in those countries where access to quality healthcare is improving.

Highlights of IQVIA’s report include:

  • The largest aggregate contributors to growth in the next five years are immunology, oncology and neurology.
  • Oncology and immunology are forecast to grow at 9-12% CAGR through 2025.
  • Oncology is expected to add 100 new therapies for migraines and possibly Alzheimer’s and Parkinson’s along with other, rare neurological diseases.

Selling in pharmerging markets may sound like a “no brainer” to some corporations but it comes with a critical catch right now: Covid-related issues have the world’s supply chains on the brink of collapse.

Supply Chain Failure?

In areas that pre-Covid rarely saw more than one or two ships waiting to dock, the Ports of Los Angeles and Long Beach had 72 ships at sea on Oct. 4, 2021, an Oct. 6, 2021 story on CNN.com states.

Before Covid, most ships went straight to a berth. Now? There’s an average 10-day wait to get in, unload and reload.

“It’s like taking 10 lanes of freeway traffic and moving them into five when the cargo gets here to the port,” Gene Seroka, executive director of the Port of Los Angeles, told CNN International on Oct. 5. “We’re having difficulty absorbing all of that cargo into the American supply chain,” CNN states.

Adding to port woes are a lack of truck drivers to move containers along the supply chain into warehouses. Delays in unloading also cause problems with getting empty containers where they are needed. Manufacturer’s can’t send large volumes of goods overseas when they don’t have containers to ship them. It’s either not enough empties or having empties in one port when they are desperately needed in another.

The effects of these supply chain issues are quickly reverberating back to consumers.

“Say hello to your pandemic price increase,” the headline of an Aug. 12, 201 column in SupplyChainDive states.

Gaps in the supply chain cause buyers to look at smaller suppliers to meet raw and unfinished materials demands. The result is procurement professionals are finding new suppliers, sometimes at a better price than their old standbys, the article states.

Now comes the question many pharmaceutical companies need to ask: Can they keep production on schedule even with a uncertain supply chain?

Technology is Part of the Solution

Enterprise Resource Planning products like Microsoft Dynamics 365 and its Supply Chain Management module can help. It makes tracking essential precursor materials pharmaceutical companies much easier. It can track APIs from the time they leave a factory in India to the moment they land in a production warehouse. From there, accurate labeling using barcodes and QR codes lets these companies know where every item, batch, lot and pallet goes.

Other software equipped with artificial intelligence can quickly produce usable supply chain information. When did we order this? Was it delivered in time to meet our needs? Is there someone else closer, either to our production facilities or our customers, that can ensure we meet our contractual obligations?

ERP software can also help forecast not only supply but demand and where that demand might be the greatest. If demand is in a pharmerging market close to where a company gets its raw materials, there might be a justification to build a new facility. Not having to cross oceans will reduce shipping costs and extensive delays.

Final Thoughts

Businesses don’t run in a vacuum. Supply chains that affect cars and consumer goods also impact pharmaceutical companies. Keeping very close track of where raw materials are produced, how long it takes for them to arrive are just as important as the time spent producing finished goods and then shipping them to the customers.

Implementing a solution like Microsoft Dynamics 365 Supply Chain Management goes a long way to removing the guesswork.

Process and systems to support the bio-economy banner
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Process and systems to support the Bioeconomy
Process and systems to support the Bioeconomy 700 500 Xcelpros Team

The public benefit gained through biological research can be seen through the eyes of a patient who receives a critical medication that did not exist a decade ago, a farmer whose higher-yield crops are turned into fuels, food, and intermediate chemicals, and a small-business owner whose innovative biobased products are breaking new ground in manufacturing. Increased societal needs for food and energy, combined with new knowledge/discoveries in biology and new methods for harnessing biological processes, have dramatically increased the economic potential of the bioeconomy.The National Bioeconomy Blueprint

Introduction

Though written in 2012, The National Bioeconomy Blueprint contains some information valuable to any company wanting to explore the bioeconomy. Critical elements are investments in research and technology.

“… If we want the next big breakthrough, the next big industry to be an American breakthrough, an American industry, then we can’t sacrifice these investments in research and technology,” then-President Barack Obama says in the report. The White House authored the report.

Government agencies at the time were supporting the bioeconomy by:

  • Identifying research and development (R&D) methods
  • Developing foundational transformative technologies
  • Integrating approaches from engineering, physical sciences and computers
  • Improving predictions of vaccine and drug toxicity and efficacy
  • Identifying and characterizing any microbial organism, including purely synthetic versions
  • Creating “science enclaves” that allow analysis of large, complex datasets while maintaining proprietary information.

The report also wanted American industry to increase investment in and production of biofuels, replacing fossil fuels with biomass systems.

Other tasks cited in the report included converting carbon dioxide into liquid fuels, improving biofuel and energy crops, developing new agricultural research programs that drive job creation and transforming manufacturing through bioinnovation.

Some of these tasks have already shown results.

Recent Biotechnical Innovations

A 2020 post on the Klabtree Blog lists 10 biotech innovations.

One of them is CRISPR-based platforms. An acronym for clustered regularly interspaced short palindromic repeats, CRISPR technology was used to create the Pfizer-BioNtech and Moderna Covid-19 vaccines. Other medicines are also using the same technology.

The CRISPR tool, “is based on a system that bacteria use to fight viruses. Bacteria develop clustered repeated sequences in their DNA, known as CRISPRs, that can remember dangerous viruses and then deploy RNA-guided scissors to destroy them,” an article in Time magazine states.

Unlike a DNA-based product that targets a cell’s nucleus, messenger RNA (mRNA)-based vaccines just need to get into the more accessible outer regions of cells where proteins are built.

Using CRISPR technology to accomplish this task, both companies were able to produce Covid-19 vaccines that meet FDA emergency standards. The Pfizer-BioNTech vaccine, now known as Comirnaty, uses its regular, non-emergency procedures. The “regular” and “emergency” variations share the same formula, the FDA states.

Another technological innovation cited by KolabTree that is still being developed involves using DNA as a computer hard drive. The concept would turn cells into data storage chambers with the not-yet-realized ability to store information similar to current data storage.

A third innovation is using base pairings of DNA and RNA nucleotides in what is known as “DNA origami” after the Japanese paper folding art form. Nanovery is using this technology to create diagnostic nanorobots. The robots are inserted into a blood sample. When cancerous DNA is found, the robots light up.

Bioeconomy Business Strategies

Having the technology to turn biological products such as corn husks into fuel does not generate money. Having people who can see profits in the bioeconomy does.

“Entrepreneurs can contribute to the (bioeconomy transformation) by commercializing innovative technologies through startups and new business models,” Andreas Kuckertz writes in a white paper published through MDPI.com.

Figue: 1Bioeconomy Business Strategies

Bioeconomy Business Strategies

Using his research, key strategies for the United States mentioned by the author include:

  • Regulatory framework: Creation of tax breaks, reducing regulatory barriers and helping entrepreneurs obtain and defend patents
  • Market Conditions: Use the public procurement process to speed market adoption
  • Access to Finance: Support the bioeconomy by using venture capital for startups
  • Knowledge Creation and Diffusion: Educate entrepreneurs, connect them to mentors and educate government agencies about entrepreneurship
  • Entrepreneurial Capabilities: Enhance university entrepreneurship
  • Culture: Create an overview of available prizes and awards (mentioned in the National Bioeconomy Blueprint)

Kuckertz suggests modifying these strategies to include those that are:

  • Holistic and based on a clear, causal rationale
  • Include policies with measures tied to clear key performance indicators (KPIs) that can measure progress
  • Have, “dedicated innovation programs accounting for the specifics of bioeconomic innovation will be required to recognize the potential of many promising and possibly game-changing entrepreneurial initiatives.”

While Kuckertz’s comments are oriented at new business development, these same strategies can be used by existing companies. One way is by taking advantage of current cutting-edge business technology: Enterprise Resource Planning (ERP) software.

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Common Themes in Bioeconomy Products

Each of the previous technological innovations has at least three common themes:

  1. 1.Collecting massive quantities of data, also known as “big data.”
  2. 2.Analyzing it and making sense of what is found. Researchers can pour over spreadsheets and try to understand the data or they can use software. Machine learning (ML) and artificial intelligence software helps find the nuggets. These are the test samples that show a formula’s promise while also listing all of the others that don’t.
  3. 3.Safely storing this information away from prying eyes and competitors.

The good news for many companies is the technology to accomplish these three tasks exists today.

The industrial internet of things (IIoT) lets companies gather big data. ERP software is adept at many tasks, one of which is using artificial intelligence (AI) to provide business insights.

Cloud data storage is generally considered to be more secure than that on many small and medium business (SMB) internal networks, using the Microsoft Azure platform to run Windows-based products, adding extra layers of security and reliability.

Microsoft Dynamics 365 AI is designed to help businesses gather insights into customer needs and experiences. It helps companies accelerate a single process and lets groups solve problems and make decisions based on the data.

Microsoft Azure’s cloud computing service provides a stronger, safer and much more resilient computing platform than the average SMB network. It also has the advantage of making data easily accessible from anywhere in the world, all without compromising data security.

The Bottom Line

The bioeconomy is slowly making inroads into various industries. The chemical and pharmaceutical fields are perfectly set-up to take advantage of reusable biological materials such as corn husks for fuel. Other materials can be used to produce less toxic plant-based solvents.

Making money from the bioeconomy requires not only forward-thinking investors who care about the environment, but also advanced technology like Microsoft Dynamics 365 to make sense of it all.

REFERENCE:

Top 10 Biotech Innovations you should know about

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.

Challenges in Pharmaceutical Supply Chain due to Covid-19
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Pharmaceutical Supply Chain Challenges due to Covid-19
Pharmaceutical Supply Chain Challenges due to Covid-19 700 500 Xcelpros Team

Introduction

Even while the United States and much of the world continues to vaccinate and protect its citizens from COVID-19, new variants of the disease continue to pop up around the world. Since its arrival, not only have millions of lives been lost and affected, problems caused by the disease continue to wreak havoc on the pharmaceutical supply chain.

As of May 2021, Google states nearly 3.4 million dead in 220 countries and territories worldwide, including over 587,000 in the US alone

Some of the more prominent short-term effects cited in a July, 2020 article on Springer include

  • 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, resulting in a 70 – 80 percent drop in visits to physician offices and clinics
  • Change in the focus of research and development programs to dealing with COVID-19

More Long-lasting effects include:

  • Delayed approvals for non COVID-related pharmaceutical products, partially 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 delays in manufacturing and disruption to shipping and logistics
  • Organization growth impacted by economic slow-downs around the globe
  • Ethical issues from poorly researched clinical therapies and products
  • Drastic change in consumer use of cleaning and health products

By the Numbers

  • 2x 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)
  • Upwards of 24 million excess prescriptions have been written in the U.S. alone, for things like hypertension, mental health issues, respiratory problems, diabetes, and anxiety.
  • 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 now being done online

Source: Springer.com

Supply Chain Effects

A recent report by Deloitte about the impact of COVID on the pharmaceutical industry includes a look at Supply Chain Management. The report cites a number of key risks to be aware of in different functional areas, including the following

Procurement

  • 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. Prevented 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. Solved only by identifying shutdowns from remote (i.e., Asian) sources and pressure testing supply chains for various scenarios.

Planning

  • Expiration of materials and monitoring for reassessments and quality certificates where the solution is submitting studies to the FDA with the longest agreeable expiration date.
  • Shutdowns from contract manufacturers, requiring sufficient communication regarding their ability to deliver products.
  • Additional quality control checks for contamination issues. This can be mitigated by having quality control personnel on-site and thorough sanitizing of all in-bound products, employees and equipment.
  • Contamination after final packaging. Requiring the disinfecting of shipments before delivery, possibly with photographic proof.

Transportation and logistics

  • Non-availability of local transportation to move raw materials and finished goods. Can be solved by locating alternate partners and getting approval to move essential drugs should a lockdown occur.
  • Contamination issues related to transportation or vehicles. Requires the disinfecting of all vehicles, plans for properly storing temperature-sensitive products in assigned warehouse space.

Export

  • Contractual compliance. This can be mitigated by ensuring the person collecting the order is aware of any regulatory restrictions.
  • Contractual terms with domestic and export customers. Preventing this requires seeking advice from insurance brokers and engaging early with clients to determine what could work if supply chain or personnel issues occur.

Figure: 1Pharmaceutical Supply Chain Areas Affected by Covid-19

Supply Chain Effects

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Lasting Effects

The effects from COVID have caused businesses to do whatever necessary to stay competitive, such as the repurposing of disposable components from single use systems to use in COVID-specific programs at the expense of other critical efforts. This is just one of the continuing effects on the supply chain cited by Contract Pharma in a recent COVID-19 Impact Report, as well as the following pointed out by other executives in the industry.

  • Kay Schmidt of Catalent said finding vaccines and target therapies for Covid-19 has boosted demand for their services. The increased demand, “has led to greater collaboration and innovation between partners, regulators and throughout supply chains to meet key milestones”. This boost to business requires additional 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.

Final Thoughts: The Impact of COVID-19 on Regulatory Practices

COVID-19 will continue to 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 manufacturers includes 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.

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.

Get a consultation to learn more about building resilient operations for your company.

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