Process Optimization

Making Pharmaceutical Supply Chains More Resilient

Making Pharmaceutical Supply Chains More Resilient

Making Pharmaceutical Supply Chains More Resilient 700 500 Xcelpros Team

At a Glance

Building a resilient supply chain framework for pharmaceutical companies requires:

  • Understanding where the company is now.
  • Creating new business relationships with alternate raw materials suppliers, transportation providers, and other essential third-party businesses.
  • Weighing the benefits of a robust and versatile pharmaceutical value chain versus the impact on working capital.

Introduction

Pandemics, natural disasters, cyber-attacks, political turmoil, and other actions are beyond a company’s control. Any one or combination of them can thoroughly disrupt a smoothly running supply chain.

Critical supply chain areas getting battered by these disruptions include reduced or non-existent access to:

  • Essential precursor chemicals and components
  • Production facilities
  • Vital workers and managers
  • Transportation resources to bring in raw materials and ship out finished products

The unquestionable first requirement to improving supply chain resiliency is having access to accurate data and knowing what to do with the data-driven insights. Data sources such as the Industrial Internet of Things (IIoT) provide real-time information, and applications such as Microsoft Dynamics Supply Chain Management helps users evaluate existing information.

Precursor Chemical Supplies

A 2020 report from Avalere states that U.S. biotech firms making medicines here get their active pharmaceutical ingredients (APIs) from U.S. suppliers – import them or import finished products. These precursor chemicals accounted for $86.5 billion in the U.S. alone during 2019.

One issue U.S. companies are facing is the location of active pharmaceutical ingredient (API) manufacturers. According to the U.S. Food and Drug Administration (FDA), the top four places are:

  1. 1.U.S. – 28% (510 facilities for FDA regulated drugs)
  2. 2.European Union – 26%
  3. 3.India – 18%
  4. 4.China – 13% (230 facilities for FDA regulated drugs)

Figure: Percentage of API Sources in U.S. Dollars

Percentage of API Sources in U.S. Dollars

Figure: API manufacturing facility locations

API manufacturing facility locations

Canada and the rest of the world produce the remaining 20 percent of APIs used in medicines. Also, the FDA report states India, the EU, and the rest of the world have 1048 facilities making FDA-regulated drugs.

Adding to the importance of having resilience in the pharmaceutical supply chain are potential supply chain disruptions caused by using overseas suppliers. These include recalls, such as two from China cited by the FDA within the last six years.

One way to counter a dependency on foreign API supplies is by using advanced technology to produce chemicals and medicines at lower costs, the FDA suggests. Using the continuous manufacturing (CM) process to make finished products instead of producing batches with gaps between steps can be more effective.

Another method of reducing reliance on foreign API suppliers is using advanced technology. Newer methods producing APIs and finished dosage forms (FDF) helps in supply chain management in the pharmaceutical industry. The ability to rapidly respond to changes in demand, using smaller physical footprints that require smaller facilities, helps reduce pharmaceutical manufacturing costs potentially, offsetting overseas production advantages. High tech production methods, such as those in smart factories, also tend to have lower environmental impacts.

Pharmaceutical companies considering boosting their pharmaceutical value chain using this method can get help from the FDA. The FDA has an Emerging Technology Program (ETP) described in “Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry.”

The FDA is also working on a framework to develop miniature mobile manufacturing “Pharmacy on Demand” platforms to produce essential drugs at or near the point of care. This method, while requiring capital costs, provides the means of eliminating delivery costs.

Risk Sources

Before making changes to the current supply chain, CFOs should look at four primary sources of risk:

  • Sourcing of APIs and other raw materials risks. Counter risks by locating secondary suppliers and establishing working relationships with them.
  • Staffing and transportation risks. Consider having access to remote workers plus multiple methods of delivering finished products to customers.
  • Inventory risks. Contrast cash flow needs with inventories to be able to withstand short-term disruptions while also accounting for perishability.
  • Distribution risks. Be able to use multiple methods to deliver finished products to customers. Consider outsourcing part of the distribution to withstand problems in that area.

Strategic Questions

Before investing in building a resilient supply chain, CFOs would want to know:

  • How can we obtain the most accurate data on what we currently have? Is investment in IIoT sensors and other technology warranted?
  • What are our priorities based on what we have learned from the current pandemic? Is digitizing our data stream the top priority, or is securing a second or third API source more critical?
  • How do we balance internal conflicts? What will we do if a secondary API source that can deliver in the event of a natural disaster is more expensive than our primary source that cannot provide when we need the raw materials?
  • How do our risks integrate with risks from our third-party partners? How will a disaster impact their ability to supply critical products or services we need?
  • What do we consider a resilient supply chain? How much impact on near-term profitability is acceptable if we ensure that we can continue operations in the event of a significant supply chain disruption?

By the Numbers

$16 trillion (i.e., $16,000,000,000,000): Estimated total cost of the Covid-19 pandemic in the U.S. alone.

$85 billion (i.e., $85,000,000,000) lost by the Nasdaq Biotech Index in the week ending March 6, 2021, its third weekly loss in a row.

$242 million (i.e., $242,000,000) lost by the Health Care Select Sector SPDR Fund (XLV) in the week ending March 6, 2021, bringing the total loss to date to $1.68 billion

Source: U.S. National Library of Medicine and National Institute of Health

Strategies for Greater Supply Chain Resilience

Figure: 1A roadmap to digital transformation to a resilient supply chain

A roadmap to digital transformation to a resilient supply chain

According to a recent Deloitte article, CFOs can reduce their chain disruptions and improve their supply chain resilience by using these strategies:

  1. 1. Identifying and mitigating their most significant supply chain weaknesses. Questions to consider include: Where are your API manufacturers located? Are there alternative sources able to deliver the required quantities when needed? Are the raw material sources within an acceptable range of the production plants? Identifying these alternative suppliers helps ensure a more continuous input of raw materials.
  2. 2. Prioritizing investments in the supply chain infrastructure to ensure significant delays do not occur when disaster strikes. Technological improvements supporting product storage and movement (e.g., Microsoft Dynamics Supply Chain Management) can make processes more transparent and improve efficiency in financial transactions and information exchanges.
  3. 3. Balancing the supply chain investments with competing company requirements, such as costs and services. Deloitte cites, “managing working capital while restarting operations and rebuilding inventory as one major challenge of a supply chain disruption.”
  4. 4. Creating a playbook to handle the causes of supply chain disruptions.
  5. 5. Implementing the updates from the standpoint of cost, speed, and efficient operation. The Deloitte report states that supply chain leaders should work with CFOs to determine the effects of supply chain changes on their working capital.

Before Making Any Decisions

Before making changes to their current supply chain, CFOs, chief technology officers, and other executives should consider:

  • Evaluating where the current pharmaceutical supply chain stands.
  • Creating a plan or series of methods for sourcing alternate raw materials, workers, and production facilities should any natural or human-made disasters strike.
  • Analyzing the cost versus benefits of making the current pharmaceutical value chain more robust and resilient.

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Three actions CEOs can take to get value from cloud computing

Three actions to take to see cloud computing benefits

Three actions to take to see cloud computing benefits 700 500 Xcelpros Team

Cloud computing benefits: At a glance

  • The decisive role of C-suite executives in a company’s digital transformation is crucial in driving business towards success.
  • When it comes to the goals and benefits of cloud computing, CEO’s need to take charge and be involved in strategy to make sure that the blueprint matches the company’s requirements.
  • CEOs need to align with the CTOs and CIOs to get maximum advantages of cloud computing and be sure that their digital transformation journey is a smooth one.
  • Partnering with a business advisor can make or break a digital transformation.

Introduction to the benefits of cloud computing

The last decade has seen accelerated growth and transformation in various industries as they embrace the digital thread. There has been a pressing need for companies to streamline processes and optimize operations to go agile. Then, the Covid-19 pandemic left a mark on every industry, making agility (and flexibility) an inevitable aspect of business growth. Remote work is the new normal, so the advantages of cloud hosting are even more apparent.

There are quite a few benefits and moves a company can make around their move to cloud computing. These strategic moves must start at the top and cascade down for maximum efficiency. This is where CEOs come into the picture as the catalysts of accelerated growth. You can take your company down the path of agility and explore the benefits of cloud computing. When these actions are taken while closely with other C-level executives, such as your CTO and/or CIO, the more likely you are to be successful in your transformation.

 

32%

of IT budgets will be dedicated to the cloud within the next 12 months.

Source: Bloomberg

Any number larger than 30% of a budget is a significant amount. When a company makes such a big investment, there is a lot riding on the shoulders of the person in charge. Any CEO guiding their company through digital transformation can harness economic advantages of the cloud. Taking decisive actions while collaborating with other C-level execs can aid in the process. Read on to learn more.

Three game-changing actions CEO’s can take when it comes to cloud adoption

It is important to understand why the role of a CEO in cloud strategy is so important. To make cloud adoption a success for your company, a CEO needs to strategize transitional moves and make sure that all cogs in the machine are functioning properly for a smooth journey.

According to David Cearley, Vice President and Gartner Fellow, “Organizations that do not have a high-level cloud strategy driven by their business strategy will significantly increase their risk of failure and wasted investment” (from “Cloud Strategy Leadership” by Gartner).

Following these steps can help to ensure employees understand the importance of cloud computing and are comfortable with the change so that the company can see all the benefits from your digital transformation.

1. Communicate change within the organization, to the organization.

First of all, as a company executive, this might be one of the most important actions you can take to ensure a successful cloud implementation. As you know, any disruptive change within an organization creates certain resistance amongst employees. While some might be worried about their skills becoming obsolete, others may feel apprehensive about the security of cloud-based systems.

Basically, with direct communication, employees stay in the know-how and won’t be taken back by any steps in the process which may change their daily routine. This can occur through in-house campaigns, alignment with department heads, announcing new HR policies, and many other means of organizational communication- all helping to ensure a smooth cloud implementation.

2. Keep the financial flow stable.

Second, meeting the goals and benefits of cloud computing can only happen through proper funding. As a CEO, creating a financial funnel that supports every step in the company’s cloud transition journey is vital. Seeing  the advantages of cloud computing may take some time for your business. Because of this, being sure that the financial backing is stable and consistent is very important.

Figure 1: Benefits of Cloud Computing

Cloud Adoption Strategy Drivers

 

3. Create a cloud business strategy blueprint.

Third, transforming a businesses processes is only as efficient as the planning that goes into the transformation. Creating a strategy and supporting technology operating model to get optimal value from the move to cloud computing is crucial. Such a model harmonizes interactions between IT and business processes.

4. Partner with a business consultant to aid in strategy and execution.

Finally, there are companies whose sole mission is to aid other businesses in moving to cloud computing. Because this is the sole focus of these businesses, their expertise can be the one thing to make an implementation successful. Consider partnering with a business advisor or consultant to assist with planning, strategy, and change management during your move to cloud computing.

In summation, reaping the advantages of cloud computing can happen via high-level strategy. Seamless harmonizing amongst CEOs, CIOs, and CTOs can turn a digital transformation journey into a profitable benefit for the business.

Cloud computing benefits: Key takeaways

  • CEOs should be looking at cloud computing strategies from a long-term point of view and ensure that the company is allocated with the budget and resources for cloud implementation.
  • Proper communication is the key in migrating to the cloud: employees should receive communication from C-suite executives or department heads to develop trust.
  • Partner with a business consultant who has done this before and can provide expertise in planning and moving to the cloud.
  • Simply moving to the cloud won’t generate value for a business. Higher C-level executives should take lead in their company’s digital transformation to make sure the investment makes its return.

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Challenges of pharmaceutical supply chain banner

Top 8 Challenges of Pharmaceutical Supply Chain

Top 8 Challenges of Pharmaceutical Supply Chain 700 500 Xcelpros Team

At a Glance

  • The Covid-19 pandemic not only came as a health threat, but it also disrupted the world’s socio-economic thread. Industries like pharmaceutical and biotechnology were at the forefront attempting to find solutions.
  • Pharmaceutical industry supply chain challenges that concerned top executives include shortage of raw materials, unprecedented changes in demand pattern, inability to plan lead-times and shortage of labor.
  • The pharmaceutical industry’s supply chain efficiency still has room for improvement and may need some transformative changes to thrive in the new normal.

Pharmaceutical supply chain challenges have been a major cause of concern for the industry throughout 2020. The challenges are still very much prevalent, even as the world moves ahead in the era of the new normal. This pandemic caused a major global socio-economic impact and led to disruption in almost all facets of the industry. Modern companies equipped with the right tools and technologies have been quick to adjust to the changes. Organizations that still functioned on archaic systems were struggling to adapt to the business processes changes brought about by the pandemic. Slow to adapt companies had to put in more effort to understand the needed changes and adapting to the changes without the right technologies in place was daunting.

Figure: 1Major Pharmaceutical Supply Chain Disruptors

Cotributors of  Pharmaceutical Supply Chain Challenges

Added to that was the inability of companies to quickly onboard onto newer applications and get into the rhythm of modern cloud-based solutions. Some of the major issues that surfaced during the pandemic are:

  1. a.The demand for therapeutics and/ or vaccines led to an overdrive of pressure on the industry.
  2. b.The lack of resources and slow global travel have increased pharmaceutical supply chain disruptions.
  3. c.Changes in quality standards have added new tasks to the workforce that were not part of their day-in-the-life and had to adapt to rapidly.
  4. d.Changes in quality testing created adjustments in the test specification and additional steps in testing.
  5. e.Disintegrated systems made it harder for the workforce to stay agile and adjust to the changes that came their way.
  6. f.Inability to manage supply-demand cycles.

70%

of the leaders said that the pharmaceutical supply chain was vulnerable to ongoing problems caused by the continuation of the pandemic and that on-time, in-full delivery of medicines had deteriorated by almost 50 percent within the first few months of the pandemic.

Source: IDC Whitepaper Report

While modern manufacturing companies did rise to the challenges and leveraged solutions such as cloud applications, automation, Artificial Intelligence (AI), Machine Learning, and Big Data to their advantages, many risk-averse pharmaceutical companies are still prone to supply chain challenges due to the lack of right tools in place to make them nimble. Let us look at the top 8 concerns of the pharmaceutical industry supply chain that still are pressing concerns:

1.Unprepared for further disruptions: Different countries worldwide are struggling with second or third waves of the pandemic (and many have reported new mutant strains of the virus). These continuous disruptions have led to major disturbance in the pharmaceutical distribution system.

2.Technological bottlenecks are prevalent: The pharmaceutical industry has been highly apprehensive and traditional in adopting newer technologies. While the last decade has seen major leaps, there are still many bottlenecks in leveraging technologies to their full potential.

3.Shortage of raw material: The inability to plan effectively during the pandemic can cause many hurdles if procuring raw materials. Knowing lead times and accurate inventory quantities without a planning tool can slow you down significantly as you try to extrapolate data and understand your supply schedule.

4.Standard operating procedures and processes: As workforce within the pharmaceutical industry needs to be onsite, proper SOPs need to be set. This would add new processes that warehouse personnel need to be trained on. A lack of the right kind of training tools can add to the burden.

5.Managing cold storage facilities is resource-intensive: Some of the products have to be stored at very low temperatures to ensure that the potency and formulation remain intact. This would need pharmaceutical supply chains equipped with refillable dry ice containers or specialized freezers, both of which are not budget-friendly options.

6.Pharmaceutical safety guidelines and regulations differ across Borders: The pharmaceutical industry has to be very tenacious and alert when adhering to the safety guidelines and regulations. However, pharmaceutical supply chain challenges get magnified as the raw materials and drugs cross borders and these regulations keep on changing.

7.Rapid drug delivery: The historical task of bringing medicines to market is a race against time. Pharmaceutical operations and supply chain management handling need to be as efficient as they come to ensure lesser bottlenecks and plausible errors in these testing times.

8.Lack of integration across processes: When your inventory, manufacturing, labeling operations don’t talk to each other and are manually managed, the error rate will go up and business productivity will go down.

The year 2021 will probably push the pharmaceutical supply chain to its maximum limit yet. However, with the right strategy, technologies, and solutions, the pharmaceutical sector can rise up in these challenging times.

Key Takeaways

  • Pharmaceutical manufacturing and distribution companies are facing a once-in-a-lifetime level of challenge and they need to streamline their operations to ensure the efficiency of supply chains.
  • The pharmaceutical supply chain challenges have been a part of this sector for a long time and companies that are not properly equipped will tend to struggle more than others. This is the right time to transform to be equipped with the right technologies for a better tomorrow.

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Enhancing Chemical Plant Operations to Make it Smart Factory Ready

Enhancing Chemical Plant Operations to Make it Smart Factory Ready

Enhancing Chemical Plant Operations to Make it Smart Factory Ready 700 500 Xcelpros Team

Introduction

Creating an Industry 4.0 smart factory requires time, planning, money and employee buy-in. Companies are advised to develop a roadmap showing what they want to do before they start. Improving communication through a digital platform ensures alignment between people, processes, and technology.

Smart factories are facilities using computer technology to transmit real-time status of every machine to a central hub. The data is used to make decisions on the spot, avoid production delays, and provide opportunities to improve efficiency.

In these factories, a combination of electronic sensors connected to a computer network provides a constant flow of information. When combined with artificial intelligence software, the computers make autonomous decisions, improving chemical plant production.

In the United States alone, 86 percent of manufacturers believe that smart factories will be the main driver of competition by 2025.Source: Deloitte

How it Works

Enhanced communication between machines means: Receiving tells Procurement what raw materials arrived and when. Procurement knows what supplies are on-hand and what must be ordered. Machine A has the materials it needs to create products. Machine B is working on a different product instead of being idle while waiting on Machine A. Machines A through Z are programmed to perform their jobs and let human workers know when potential problems may occur. Sales knows what finished products are available for shipping and what is in the pipeline. Customers know when they can expect deliveries in the time and quantities they require. Best of all, this information is available in real-time, so everyone knows potential problems and how they can work around them.

Acquiring data from the industrial internet of things (IIoT)-enabled devices and rapidly analyzing it turns standard factories into smart chemical plants.

These plants can rapidly view their entire supply chain from inventory to production to sales. Having the ability to keep track of production flow and ensure the supply chain flows smoothly is the function of specialized software such as Microsoft Dynamics Supply Chain Management.

Converting an existing plant using older manual devices, though, takes time, effort and money. Thought and a lot of planning are required to bring an analog factory up to this level gradually.

Critical smart technologies include hardware components such as sensors, industrial internet of things (IIoT) connections, factory floor networking connections and cabling plus data storage for millions—possibly billions—of datasets. Company computers—either on-premises or connected via the cloud—require software able to organize and manage the data using artificial intelligence. One such product is Microsoft Dynamics Supply Chain Management.

Figure: 1 Working of a Connected Factory

Connected Chemical Factory

Industry 4.0

As part of the Fourth Industrial Revolution, commonly known as Industry 4.0, smart factories build on computerization added to manufacturing processes in the mid 20th Century’s Third Industrial Revolution.

Above and beyond automating individual machines, Industry 4.0 smart chemical plants have:

  • Dramatically increased data collection, allowing more accurate decision-making.
  • Increased automation to encompass entire production runs. This produces goods more efficiently, including during times when humans are not present.
  • Improved flexibility allowing factories to mass-produce lots in any size from one unit on up.

5% Percentage of factories are fully “smart”.

30% Percentage of factories are being updated to smart status.

65% Percentage of factories are not making progress toward smart status.

Source: Deloitte Insights

Smart Factory Challenges

Factory owners face several potential barriers to converting an existing facility into a smart factory running more efficiently with minimal downtime and defects. These barriers may include:

  • Employees accepting ongoing training and developing needed skills. Deloitte estimates a 2 million worker shortage in the US alone over the next decade.
  • The cost of updating factory floor machines to include sensors and information sharing capabilities. Some existing machines can be modified, while others may require replacement.
  • Networking all data collection points to ensure a smooth, continuous information flow. The information can flow to a central server on the premises or remotely.
  • Accepting the concept that smart factories cover the entire company, not just the production floor.
  • Ensuring all updated devices are compatible and can be integrated into a complete network.

Leading the Conversion Change

Some companies appoint “change champions” to lead their company into the smart factory 4.0 era. These people are often tasked with making the technology updates relevant to workers.

Change champions, which Deloitte’s research suggests, should be from the top-down (e.g., upper managers) and bottom-up (e.g., factory workers), help gain employee buy-in.

Their chief focus is answering the question, “What’s in it for me?” from individual workers’ perspectives. For example, change champions explain how mastering automation gives workers the ability to head off potential problems before they occur. Fewer problems in the production process mean greater output—and likely more sales—which benefits the entire company.

Change champions also explain to staff how they will benefit by gaining the new skills smart factories require. Additional training equals more skills and that translates to more opportunities for improved pay and job security.

Chemical Plant Automation Devices

One step existing factories must take to become smart chemical plants is updating equipment. For example, valves that factory workers open and close manually should be replaced by semi-conductor enhanced valves that do it automatically.

Among the many chemical treating instruments required to provide a smart factory technology with the information it needs are:

  • Smart pressure transmitters equipped with microprocessors and semiconductor pressure sensors that can directly measure pressure in pipes.
  • Microprocessor-equipped differential pressure transmitters to measure flow rates, pressure and liquid levels of gases, fluids and steam.
  • Flowmeters for measuring gas, steam and liquid, including vortex models that permit correcting temperature and pressure.
  • Level transmitters equipped with microprocessor sensors for measuring levels in liquids.
  • Control valves such as eccentric three-way rotary valves for mixing or dividing fluids.
  • Temperature controllers to ensure temperatures are within a device’s operating range and notify personnel of potential equipment problems before they occur.

The combination of electromechanical devices such as these with monitoring software lets workers watch conditions on the smart factory floor from literally anywhere: an office in the plant or a laptop on the beach.

Computerized positioners lets trained workers know the deviation between a set valve opening and the actual valve opening. This knowledge helps workers detect signs of impending valve failure before it occurs.

Creating A Roadmap to Success

Companies wanting to update their factory to a smart chemical plant may want to follow a path similar to this one:

  1. 1.Map a smart manufacturing strategy based on each firm’s specific industry dynamics. Be agile and able to change direction when real values begin emerging.
  2. 2.Create a smart pilot project with proofs of concept that demonstrate the project’s value to the company. Embrace failure and learn from mistakes.
  3. 3.Define the required capabilities using a scalable data model. Ensure the technology used in one area communicates with that used elsewhere.
  4. 4.Identify smart manufacturing insights appropriate to the company, such as cross-functional data analytic teams. Share information between teams to avoid duplicating efforts while gaining additional insights.
  5. 5.Institutionalize new approaches to prevent older, less efficient methods from creeping back into the updated operations. Show the staff concrete examples of how the technology upgrades are making a proven difference in the chemical plant operations.

Figure: 2 Creating a Roadmap to Success

Roadmap to Success

Key Takeaways

  • Converting an existing factory to a smart chemical plant requires time, effort, money and patience. Factory owners and managers must overcome barriers on the way to achieving their goals.
  • One of the most important tasks is appointing Change Champions at the top (executive) and bottom (factory worker) levels who work together to get the entire workforce on board.
  • Advancing into the Industry 4.0 era means updating devices to provide a constant flow of data. Companies should create a roadmap showing how they will move from their current position to be a smart factory.

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Reducing the Risk of Pharmaceutical Non-Compliance with Technology

How Technology Can Reduce the Risk of Pharmaceutical Non-compliance

How Technology Can Reduce the Risk of Pharmaceutical Non-compliance 700 500 Xcelpros Team

At a Glance

  • Pharmaceutical manufacturing companies are investing more money and resources to assure adherence to regulatory compliance.
  • Non-compliances need to be managed and tracked through their lifecycle, and using a digital platform eases the end-to-end process and follows it to completion.
  • The first step towards regulatory adherence is to thoroughly understand the compliance requirements and form a dedicated process to comply.

Many pharmaceutical companies have restructured their financial and resource allocation models to invest more in adhering to compliance. Compliance requirements around the globe have grown in past decades. Each country has differences in safety standards, and global companies have to ensure they meet local requirements. Companies need better management and tracking of non-compliance. This article discusses the ways to reduce risks of non-compliance in the pharmaceutical industry. Manufacturers and distributors have dealt with compliance issues in the pharmaceutical industry. Companies have to conform to multiple complex and varying regulatory norms and safety standards. All the stages involve detailed compliance requirements, from procuring raw material to producing finished goods and quality testing of the final product. These complexities have further multiplied in recent years because of:

  • Addition of several more regulations globally in the pharmaceutical and life sciences sector.
  • Differences in the rules and regulations related to pharmaceutical compliance across different geographical regions.
  • Absence of a viable infrastructure to manage and track non-compliance.
  • Unclear SOPs and redundant record maintenance practices often lead to pharmaceutical manufacturing non-compliance.

Apart from these, non-compliance can result from other various smaller factors like faulty equipment, maintenance issues, faulty formula controls/ lab controls, etc. All contribute to quality compliance in the pharmaceutical industry. This is the reason that pharmaceutical and life sciences companies spend a fortune to avoid non-compliance. The costs of non-conformity are very high and thus, companies want to make sure that they adhere to the rules and regulations.

40%

of the pharmaceutical IT budget is spent on regulatory compliance.

Source: Gartner

Figure: 1 Major Factors Affecting Compliance in Pharma

 Major Factors Affecting Compliance in Pharma

So how can pharma companies leverage technology to mitigate the consequences of non-compliance? Here are some ways that experts believe newer tools and innovations can help in better pharmaceutical compliance management:

1.Making use of the right tools: Documentation and record maintenance are a big part of the pharmaceutical industry’s compliance processes. Conventionally these documents have been manually maintained, which can lead to both errors and oversights. However, newer pharmaceutical software platforms come with the ability to gather and store data efficiently. It is essential to track user behavior and user audits to ensure compliance. A compliance management system with audit tracking and reporting tools can avoid non-compliance and improve overall product quality.

2.Leveraging integrated labeling: Pharmaceutical companies struggle to manage compliance as they enter newer territories and markets. There are different labeling practices and regulations which are challenging to manage. The labeling practices keep going through changes and updates even in familiar territories, making it essential for pharmaceutical companies to stay on top of these changes. To tackle labeling issues, companies can leverage the automated labeling platforms wherein the data can be auto defaulted from the different processes such as receiving, production and shipments. Inbuilt label printing within business process workflows avoids user errors and enforces process compliance. With integrated labeling within the ERP, users are equipped to manage changes and make the labeling process run smoothly.

3.Standardizing processes across the organization with a common technology platform: Major pharmaceutical manufacturers and distributors are tying up with technologists to deploy a common technology platform and implement it across their locations. Companies that invest in business process uniformity will witness business improvement and growth. Quality issues often arise due to non-compliance of processes, undefined procedures, changing equipment and labels, etc. Many companies find that quality is impaired when processes vary from location to location. With the latest technology platforms, organizations can centrally assure that standardized practices are being followed across all locations.

4.Effective strategies to managing data: Non-compliance in the pharmaceutical industry is often a result of a poorly managed information loop. Systems supporting pharmaceutical manufacturing and distribution generate enormous data. When data is managed systematically, the right information is made available to appropriate users. The right system can notify regulatory changes, changes in formulations, or process variations. Every data point serves as a crucial piece of information that can guide users to be more proactive in conforming to business processes. Data management and analytics platforms are equipped to enable pharmaceutical companies to report anomalies as they occur. Dynamic reporting cumulatively helps in better quality compliance.

The Covid-19 pandemic has added impetus on pharmaceutical companies to adhere to regulations while working on therapeutics and vaccines at an unprecedented speed. Companies that leveraged the latest machine learning, analytics, and other IoT tools/ platforms, perform better.

Pharmaceutical companies are always looking for newer methods to balance quality compliance and productivity.

Johnson & Johnson, for instance, has a comprehensive quality management framework in place for continued focus on compliance and quality, amongst other essential parameters. The latest technologies and innovations back this framework.

All in all, reducing the risks pertaining to compliance issues in the pharmaceutical industry requires a well-planned and executed technological strategy. With the latest innovative platforms, companies can ensure adherence to quality compliance regulations in the industry.

Key Takeaways

  • ERP, automation, data analytics, and machine learning are imperative in enabling pharma companies to mitigate the risks of non-compliance.
  • To reduce the consequences of non-compliance, pharmaceutical companies need to strategize their technological moves.

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References: Reducing the Risk of Noncompliance

How do smart factories help boost your supply chain

How do smart factories help boost your supply chain?

How do smart factories help boost your supply chain? 700 500 Xcelpros Team

At a Glance

  • Smart factories can use technology to boost productivity and increase quality. Merging data and insights from the shop floor with the supply chain and the entire organization can uncover ways to improve operational efficiency and boost business relationships.
  • By connecting devices and sharing information, smart connected factories permit automatic optimization. The machines can adapt to changing conditions in real-time and run the entire production process without human intervention, a white paper from Deloitte states.
  • A smart factory is one where information is continuously shared between devices and resources. Sharing this information reduces waste, thereby increasing efficiency and productivity.
  • It impacts the supply chain by anticipating needs and automatically ordering materials. That in turn keeps the factory running at maximum efficiency.

The smart factory represents a leap forward from more traditional automation to a fully connected and flexible system.Source: Deloitte

Traditional factories tend to have discrete machines and production lines. Information gathered from one device stays with that device until manually uploaded into a computer network.

Smart factories eliminate the barriers between machines, using computer sensors to monitor every stage and every process, producing huge volumes of data. The information is shared vertically on the factory floor and horizontally with other departments. This method lets the company rapidly adapt to marketplace changes, expanding its offerings and encouraging innovation based on customer needs. Smart connected factories are much more than just machines knowing when to open and close valves. They integrate the entire operation—including supply chain, manufacturing, information technology (IT) and operations technology (OT)—into one unified, agile organization.

Characteristics of a smart factory

Smart factories share five characteristics. They are:

  • Connected across machines and departments
  • Optimized for reliability and predictability
  • Transparent for quick decision making and order tracking
  • Proactive for identifying potential problems before they occur and restocking materials before running out
  • Agile for quick changeovers and product modifications

Benefits of a smart factory

Important benefits of a smart factory include:

  • Using data to create pattern identification and mapping the production process. This method gains production insights and allocates resources more efficiently.
  • Identifying and logging all process problems from machine and worker input.
  • Identifying waste creation points and processes.
  • Sharing data not only with the factory floor but with sales, marketing, finance and other departments to improve overall results.
  • Mastering the smart supply chain, permitting advance ordering of critical components before running out of them and delaying production.
  • Customizing small orders, permitting small batch creation when machines are not in use on large projects.
  • Diagram an ideal state.
  • Develop a plan to make the ideal state a reality.
  • Monitor and continually adjust new processes—including educating and training employees—ensuring maximum efficiency.

How it Works

The information process begins by using machine sensors and operators to capture data points during the 7 Flows starting with the supply chain in the form of raw materials. Each of these flows is part of the Lean Manufacturing Process.

Seven Flows

The seven flows involve:

  1. 1.Raw materials
  2. 2.Work in progress
  3. 3.Finished goods
  4. 4.Operators
  5. 5.Machines
  6. 6.Information
  7. 7.Engineering

All of the flows working together tend to efficiently produce products with few defects, Kettering’s article states.

Software such as Microsoft Dynamics 365 Supply Chain Management is designed with these concepts in mind.

For example, Microsoft Dynamics 365 Supply Chain Management allows factories to integrate industrial internet of things (IIoT) and artificial intelligence in the process flows.

Technical Advances Enabling Smart Connected Factories

Recent technical advances permitting the creation of smart factories include the development of:

  • Sensors collecting information, providing access to various activities and processes.
  • Using connected IIoT (Industrial Internet of Things) devices transmitting the sensor data to a database that in turn, massages the data to identify and correct inefficiencies.
  • Analyzing data as it is being collected. This permits rapid responses to changing situations, such as correcting a manufacturing defect as it occurs.
  • Employing AI (artificial intelligence) coupled with machine learning permits self-correcting when detecting errors such as closing an open door that might affect a temperature-sensitive section.
  • Relocating some IT resources to “the cloud.” Cloud Computing reduces data costs by transmitting it to a remote location where an interconnected network of computer servers processes, shares and stores data in a secure location away from the factory.
  • Running a digital version of a process in advance. By identifying and correcting potential errors and sticking points in advance, actual production is not affected.
  • Keeping data secure from outside cyber threats and attacks such as ransomware or hacks that steal data or damage or destroy critical components.

When many people think of the Internet of Things (IoT), they visualize home products such as lights that turn on and off when people enter rooms, saving electricity. Maybe they consider newer smart refrigerators that let homeowners use an app on the attached touchscreen monitor to order food items when they are running low.

The IIoT expands this connectivity from computers and the home to computers and industrial machinery. For example, it allows remote workers to monitor temperatures and automated chemical blending, ensuring the correct mixtures.

Figure: 1Functions coming together within smart factory

Functions coming together within smart factory

Why Update Now to a Smart Factory Solution?

The rapid pace of technological innovations means that the cost of making some of these updates—computing speeds and data storage, for example—has dropped. Technology is more sophisticated allowing systems not only to gather information but interpret it and automatically make adjustments.

A more complex supply chain means manufacturers must be more nimble than ever before while also adapting to constantly shifting priorities.

Merging parts of IT with parts of OT, in combination with device hardware and software such as Microsoft Dynamics 365 Supply Chain Management lets factories analyze their data now in real time for smart supply chain management.

Smart Factory Categories

Smart factories come in four categories, all based on data.

  1. 1.Available—but not accessible—data that must be organized before being transmitted.
  2. 2.Accessible data, which is organized and stored in ways that permit analysis.
  3. 3.Active data, which can be analyzed by computer software such as Microsoft Supply Chain Dynamics 365.
  4. 4.Machine-controlled modifications using solutions identified earlier, all with limited human input.

Making Factories Smart

Owners and managers may want to start with a single device, get it working the way they wish and then gradually expanding to a full production line. Companies considering updating an existing factory will need to have methods of obtaining data from the factory floor, which might require updating or replacing some machines. The cloud can help with processing and storing the information but data collection takes place locally.

Investments in other technologies—including AI, augmented reality and optical sensors—may be required to understand the data and digitize the production process.

Another important change is staffing. Even though much of the work will be automated, skilled workers are still required. This could involve realigning departments and eliminating or drastically changing individual roles.

Key Takeaways

  • Technological changes are turning the dream of smart factories into reality.
  • Smart Factories have the ability to highly automate many repetitive steps using a combination of device sensors and computer software.
  • Factory data can be used to create artificial production lines. Running them virtually lets managers spot potential problems before affecting actual production.

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Clearing the Air About Cloud- 7 Cloud Myths Debunked

Clearing the Air About Cloud: 7 Cloud Myths Debunked

Clearing the Air About Cloud: 7 Cloud Myths Debunked 700 500 Xcelpros Team

At a Glance

  • Cloud migration is one of the most prominent IT overhaul strategies that many companies need go through to become more agile.
  • As often witnessed with any new technology (and its offerings), there are certain misconceptions about cloud computing, migration to the cloud and data security.
  • To harness the most out of your company’s investment in the cloud, you need to understand the misconceptions and be able to see past them.
  • Upper management needs to realise the significant business gains when moving to the cloud.

Agility and flexibility are perhaps two of the biggest drivers for companies looking to overhaul their IT infrastructure. For many companies, cloud adoption is an important step in that direction.

74%

of participant companies have moved a cloud-based app back on their premises after failing to see an anticipated return.

Source: HIS Markit

The upper management and IT departments of most companies often start with a vision of unlimited possibilities when they begin exploring the idea of integrating their IT strategy into the cloud, and often get discouraged because they buy into certain cloud myths and misconceptions. These myths can often poison an otherwise perfect vision, making it difficult to see the real benefit that migrating to the cloud can offer any business. From an early stage, it’s imperative to understand that simply transitioning to cloud computing is not a one-step-solution for better performance. You will need to make it work for you – and that’s the beauty of computing in the cloud, you can customize your experience to suit your unique business needs.

The first step is to dispel misinformation in some of the most commonly heard cloud computing myths.

7 Common Myths about Cloud

1.Cloud is All About Cost-efficiency: Many CIO’s we come in contact with have a notion about the cloud – that it is (or should always be) the cheaper option. Truely, when you compare CAPEX vs. OPEX, the cloud is most certainly a cost-effective option. Unfortunately, this is a somewhat layered and nuanced determination. It should be understood that the initial migration of workload to the cloud can be a very disruptive and resource-intensive process. There can be latency issues and if the entire strategy is not in place before the migration begins, these issues can multiply rapidly.

2.Everything in Cloud is Automated: The cost of skilled resources often gets forgotten when a company believes that the cloud can operate without interaction. While it is true that the cloud offers high levels of automation and many self-reliant features, there will still be a need for skilled professionals to manage the infrastructure. Additionally, simply managing and maintaining the cloud will continue to require human intervention.

3.Security on the cloud is not on par with in-house data centers: This is by far one of the most prevalent cloud myths that becomes a major sticking point and concern for CIOs. While data security is not something to be taken lightly, the fact is that cloud computing security issues only occur because of failure to adhere to regulations and governance guidelines. In fact, in recent years, cloud service providers (CSPs) have invested millions in strengthening their security capabilities.

Figure: 1Know Your Cloud Concerns: Myth or Fact?

Cloud Concerns Myth or Fact?

4.Application-wise transition to cloud is the best way to go:A lot of planning goes into cloud adoption and migration strategies. However, a common misconception is that the transition needs to take place for each individual application. Doing it this way results in significantly higher costs for the company as they end up paying more for the in-house data centers and the CSPs to host the apps. The right way is to move entire business domains to the cloud at once.

5.The downtime in cloud migration will have a huge impact on business:While it’s true that any big transition can be intimidating, companies are most often apprehensive about migrating to the cloud because of the misinformation regarding downtime and other difficulties involved. This is one of the older myths, no longer applicable as the larger number of experienced service providers available to help companies smooth the transition all but eliminates this risk.

6.Cloud is yet to approach maturity:We may have all heard this by now, and we’ve been hearing it a long time – the benefits sound enticing, but the cloud is still at a nascent stage and the many disadvantages of cloud computing present red flags, but this is no longer entirely true. In fact, the rapid pace of new innovations when it comes to the cloud is because the cloud in fact has reached maturity, and will only get better from here.

7.Moving to the cloud can cost jobs:Cloud adoption often meets with resistance as there’s a big misconception that it will lead to resources becoming obsolete. Fortunately for us, this couldn’t be farther from the truth as the constant innovations in the cloud are actually paving the way for more opportunities for skilled professionals. In the future, we should see educational branches dedicated to training young coders and developers in shared, public and dedicated cloud environments.

Misconceptions can lead a company in the wrong direction. Knowledge about the cloud and understanding the benefits helps you discern the myths to unlock your business’s true potential. Modern cloud computing capabilities far outweigh the difficulties in cloud adoption and should support your vision every step of the way.

Key Takeaways

  • Companies need to look at the cloud as a comprehensive step towards agility and flexibility and not simply as a cost-effective investment.
  • Getting skilled professionals onboard is imperative to dispel cloud myths and get the maximum ROI.

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References: Debunking seven common myths about cloud

ERP in developing the operational efficiencies in Pharma

Impact of ERP Software in Boosting Operational Efficiencies for Pharma

Impact of ERP Software in Boosting Operational Efficiencies for Pharma 700 500 Xcelpros Team

Introduction

Increased efficiency is an ongoing goal for any organization looking to stay ahead in today’s market, especially those in the Pharmaceutical industry. There’s often a lot of focus placed on things like increasing productivity, lowering operating costs, enhancing operational efficiency and improving product-based profitability, to name a few.

On top of that, pharmaceutical organizations need to devote a considerable amount of time towards operational planning, drug commercialization, go-to-market strategy and more.

While today’s best-in-class companies conduct these operations using automated tools, smaller pharma and biotech companies end up handling these operations with manual processes. Especially for these companies, a modern Enterprise Resource Planning(ERP) system that can handle end-to-end business processes and be used to collect, track, manage, and distribute critical information across all departments is invaluable.

A few high-level benefits of a modern ERP System include the ability to

  • Standardize business processes and enable automation across different departments.
  • Monitor business processes across departments to accelerate operations.
  • Allow visibility and transparency by data sharing.
  • Establish strong collaboration across multiple departments.
  • Provide a multitude of flexibility and customization options to meet specific business requirements.

Modern ERP systems

Today’s ERP systems have evolved into powerful, agile platforms designed to integrate core and incremental business functions into one unified system. These modern ERP applications automate the flow of real-time information across departments, allowing easier collaboration and actionable insights to help drive important business decisions.

Based on experience, here are some of the differences seen in higher-end ERPs.

ERP SYSTEM ORACLE SAP MICROSOFT
ATTRIBUTE      
COLLABORATION MEDIUM MEDIUM HIGH
LOW CODE INTEGRATION MEDIUM MEDIUM HIGH
USER ADOPTION MEDIUM LOW HIGH
UPGRADE COSTS HIGH HIGH LOW-MEDIUM
CHANGE MANAGEMENT MEDIUM MEDIUM MEDIUM
ENHANCEMENT COSTS MEDIUM HIGH MEDIUM
EASE OF INTEGRATION LOW LOW MEDIUM
SCALABILITY TO BUSINESS GROWTH HIGH HIGH HIGH

Different Types of ERP Deployment

01. Cloud

A cloud-based solution delivered over the internet using Software as a Service (SaaS).

Benefits

  • No upfront cost for hardware and software
  • Remote access to critical business applications
  • The cloud vendor manages costs related to updating and upgrading.
  • Datacenter takes care of IT support services.
  • The company server is secured against the threat as the data is stored in the cloud.
  • Cloud services are scalable and can be consumed as per the requirement of the business.

02. On-Premise

The ERP system is installed locally in the client environment, and data is stored on internal servers.

Benefits

  • More customization options are available and with greater ability.
  • The organization holds control over the implementation process.
  • Data security control remains in the hands of the organization.

03. Hybrid

Splitting ERP functions between on-premise systems and the cloud server to receive the best outputs.

Benefits

  • Increased flexibility allows loose coupling among modules.
  • An intermediate cost between cloud and on-premise solutions.
  • Lesser training expenditure involved compared to cloud ERP.

93%

percent of organizations apply cloud-based software or system architecture. Also, the application of hybrid cloud systems has escalated from 19% to 57% in 2017, a three times rise in a year.

Source: Mcafee

The role of ERP in the Pharmaceutical industry

At present, the pharmaceutical industry faces numerous business challenges including

  • Major healthcare reforms
  • Rigorous regulatory requirements
  • Incalculable market trends
  • A discerning and demanding customer base
  • Increasing global competition
  • Lower drug prices demanded by consumers

The growing consumer demand for superior-quality healthcare products at compelling costs and the competitive market makes it essential for pharmaceutical companies to streamline operations, reduce cost, and maximize efficiency.

From planning and purchasing to things like inventory, supply chain management, sales, marketing, and human resources, a modern ERP technology solution can enhance operational transparency with better collaboration across all departments.

Why do companies choose ERP?

When current systems become the reason for slowed business growth most companies start looking for other options. Some companies just want to positively change the way they function and switching to an agile ERP system can help trigger a major change.

Some additional reasons a company may choose to implement an ERP solution include

  • Improving business performance
  • Making employee jobs easier
  • Satisfying regulatory compliance
  • Improving system integration

Reasons for Budget Overrun

One of the big detractors of new ERP implementations is budget, as it can be easy to underestimate the complexity involved. There are numerous reasons for a budget overrun during an ERP implementation, including

23%of budget overruns take place due to unexpected technical issues.

22% for the additional technical necessity

20%for increased scope

17% for underrated project staffing

The benefit of ERP for Pharma companies

In an industry that is so highly regulated, implementing an ERP can help streamline your organization’s ability to operate efficiently. Below are a few major benefits that pharma companies can gain from a modern ERP

  • Streamline production floor processes leading to a higher production rate
  • Manage sales & purchases in a few simple steps
  • Closely monitor and control inventory, including raw materials
  • Minimize operational work by sending real-time data alerts across departments
  • Increase operational performance accuracy
  • Ability to perform WIP and yield quality testing for an item or group of items
  • Save time and operational expense
  • Limit material wastage with pre-expiry alerts
  • Help maintain and manage compliance
  • Track the distribution of manufactured goods
  • Enhanced customer support
  • Maintain records of all business transactions through extensive reporting
  • Allow remote access to data to help make better business decisions 24/7
  • Handle all payments including customers and vendors

Challenges implementing an ERP in the Pharmaceutical Industry

Despite widespread ERP usage, there are still companies that face difficulty moving to a modern solution. Can the same ERP implementation strategy and formula work for every business? Unfortunately not, as each organization follows a distinct process, and has unique needs and expectations.

Here are a few challenges that companies usually encounter:

  • Selecting the ERP software that best meets their companies requirements
  • Attempting to complete the implementation in one step leading to numerous unforeseen problems
  • Crossing the budget limit because of project schedule overruns due to poor planning
  • Encountering compatibility issues with different ERP modules

Don’t forget

Finally, here are some things to consider when you begin the task of finding the right solution

  1. 1.Conduct in-depth research before selecting any ERP software. It’s wise not to make a decision based on a high-level feature list alone. Rather, go by detailed research that includes an understanding of the entire project.
  2. 2.Analyze your specific business requirements. Before choosing any ERP application, define a clear vision of what you plan to achieve from the ERP Solution.
  3. 3.Work with a partner that provides a free assessment. This process gives you the ability to break down the project into easy to manage pieces.
  4. 4.Evaluate the Return on Investment (ROI). The initial investment cost in an ERP solution may seem high, but the long-term benefits more than outweigh the initial cost. Understand from what specific solutions you need, and you can more accurately determine cost.
  5. 5.Ensure appropriate personnel training. Your team needs to hold a clear overview of how to use the ERP application. Initiating a mandatory training program for all users should help solve any such issues that may arise.

Key Takeaways

The right ERP solution, along with proper planning can improve your business processes and catapult your business to the top of it’s game.

Organize your operations today, to lead your company to success tomorrow.

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Ensure Workplace Safety with The Proper Handling of Hazardous Chemicals

Handling Hazardous Chemicals at Workplace to Safeguard Health and Environment

Handling Hazardous Chemicals at Workplace to Safeguard Health and Environment 700 500 Xcelpros Team

Introduction

A worker dies of toxic exposure every 30 seconds worldwide, whereas a worker dies of workplace hazards every 15 seconds.-UN Report, Sep 2018

These numbers are alarming indeed. While chemical safety management has always been one of the top concerns of organizations to ensure employee safety and meet regulatory compliance, accidents with chemicals can occur at any time during production, storage, transportation, when in-use, or even disposal. Your organization and surrounding communities can be placed at great risk if chemicals are used unsafely or accidentally released in the environment.

Since the rapid outbreak of Covid 19, limitations and lack of visibility in the workplace have made managing chemical hazards significantly more difficult. While much of the world is still figuring out ways of dealing with the after-effects of the COVID-19 pandemic, organizations have already started to emphasize improvements in employee health, safety and well being. Their keen focus now is on integrating safety across all chemical processes. Companies are taking help from Environmental, Health & Safety(EHS) professionals to inspect and approve their facility standards and build awareness and caution among the workforce. In this capacity there will be a need for continuous communication, especially for add-on visibility of when the process is followed and not.

The recent Control & Prevention plan of the US Occupational Safety and Health Authority (OSHA) states:

Employers should adopt infection control strategies based on a thorough hazard assessment, using appropriate combinations of engineering and administrative controls, safe work practices, and personal protective equipment (PPE) to prevent worker exposures. Some OSHA standards that apply to preventing occupational exposure to SARS-CoV-2 also require employers to train workers on infection prevention elements, including the use of PPE.

To What Extent Are Chemicals Used in Workplace & Environment?

96%

or more of all manufacturing companies utilize chemical substances to develop their products.

Source: American Chemistry Council (ACC)

Whether it’s the construction industry, mobile device manufacturing, or even pharmaceuticals, there are very few industries and trades in the world that are absolved from chemical exposure. There have even been reports of chemical-related accidents in organizations where it was least expected.

In the US, 90% of all industrial materials and wastes generated from the following four industries:

  • Chemical Manufacturing
  • Primary Metal Production
  • Metal Fabrication
  • Petroleum Processing

Hazardous chemicals are found in most consumer products around us, ranging from household electronic appliances such as televisions, refrigerators, and personal computers to home goods such as furniture, carpets, cleaning supplies, and more. On the one hand, we use chemicals to purify our drinking water, increase crop production and simplify everyday household chores. In contrast to this, some chemicals pose severe hazards to human life and the environment if used or mishandled.

For example, the chemical Bisphenol A (BPA) is found in plastics that we use every day in our regular life and exposure, which is known to cause hormonal problems.

Figure: 1Your everyday things with hazardous chemicals

Hazardous Chemical & it's impact

Exposure and Handling of Hazardous Chemicals in the Workplace: Measuring the Impact

Prolonged exposure to chemicals and hazardous physical agents has been to cause multiple adverse health conditions. Cancer is one of the most commonly experienced results. Due to the inhalation of carcinogenic substances, lung cancer accounts for 86% of all premature deaths in the workplace. The yearly death toll of workers has crossed 2.8 million globally due to an unhealthy and unsafe work environment, according to the 2019 UN Report. A worker died of leukemia due to exposure to toxic substances daily. Another worker died of CO2 poisoning.

In 2019, OSHA cited a few events of chemical exposure as damaging to environmental health & safety

  • A pet food manufacturer in Florida exposed employees to corrosive chemicals for failing to provide PPE.
  • A Pennsylvania-based hair salon exposed its workers to formaldehyde due to inadequate precautionary measures. The resulting fine was upwards of $17,000 for not abiding by OSHA’s formaldehyde and hazard communication standards.
  • An Ohio-based musical instrument factory exposed its workers to toxic copper dust after attempting to use it on a greater scale than the recommended permissible level. Consequently, the company had to pay a hefty sum of $200,230 for severe safety and health violations.
  • A Texas indoor gun range exposed its workers to unsafe levels of lead at its facility. The employer was fined $214,387 for exceeding the permissible exposure limit, failure to decontaminate the surface and not replacing damaged PPE.

Chemical Safety Management in the Workplace Is a Responsibility, not a Choice

Dangers mentioned above and the growing list of regulations from agencies like OSHA and Reach are leading more and more companies to take preventive measures to identify and eliminate hazardous chemicals in the workplace, which pose a threat to your organization, employees, customers, and all other stakeholders involved.

Managing chemical footprint is not just an OSHA compliance but more a civic duty.

Why It’s Essential for Companies to Abide by Regulatory Compliance

Regulatory Compliance has become something that can’t be forgotten, with non-compliance attracting unwanted attention from regulatory agencies – often followed by large penalties as well as a threat to your business’s licenses.

Figure: 2 Regulatory compliance agencies

Regulatory Compliance Agencies Acts

We covered the penalties involved in a previous article, ‘How Managing Hazardous Chemical Information solves EHS Challenges’ ‘We have noticed that in 2017, the Occupational Safety and Health Administration (OSHA) increased the severity of penalties by 80% and imposed hefty fines ranging from $7,000 up to $12,000 for noncompliance to GHS through 2016-17. For serious violations, the penalties could be as high as $70,000 to $127,000.’

Figure: 3 OSHA penalties for non-compliance

OSHA Penalties

According to OSHA’s recent revision of chemical safety standards, each container of hazardous chemicals needs to be labeled with a set of standardized pictograms in alignment with the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The intention is to help workers identify the containers with hazardous chemicals rightly despite language barriers to avoid accidents.

Labels must also provide instructions on how to handle the chemical so that chemical users are informed about how to protect themselves. Specifically, labels must contain the following information: product identifier; signal word; hazard statement(s); precautionary statement(s); pictogram(s); and the name, address, and telephone number of the chemical manufacturer importer or other responsible parties.

Safety data sheets (SDS— formerly referred to as “material safety data sheets,” or MSDS) will require a new standardized look that will help workers anywhere quickly find and understand the information they need. The revised standard requires using a 16-section SDS format, which provides detailed information regarding the chemical. As with MSDS, OSHA requires that SDS be kept in work areas where chemicals are used and stored. Labels offer essential information for anyone who handles, uses, stores, and transports hazardous chemicals, but, of course, they are limited by design in the amount of information they can provide. SDS is a complete resource for details regarding hazardous chemicals.

Some of the things that organizations can do to avoid such fines and unwanted attention from regulatory agencies are relatively straightforward:

  • Chemical manufacturers need to ensure their products are correctly labeled according to GHS label requirements.
  • They should also strive to remain compliant with all other regulatory policies, industry standards, and government policies to ensure safety management.
  • Periodic testing should be performed to ensure that chemicals will not cause harm to public health, and if they do, they should be either re-formulated or correctly safety-labeled.

Figure: 4Reach compliance measures to control the environmental impact of chemical substances

Measures to Bring in Control the Environmental Impact of Chemical Substances

Registration, Evaluation, Authorization, and Chemicals (REACH) restriction came into effect on June 01, 2007, to regulate chemicals used in consumer products. REACH has the potential to regularize chemicals.

Under this new law, all chemical companies have to submit a Chemical Safety Report to REACH that includes information on their chemical substances and their effects on the environment, public health, and safety. Chemical companies must register all the new and existing chemicals marketed for commercial use and those exported or imported.

Figure: 5The significance of REACH in terms of numbers is highlighted as below:

REACH Highlights

The above image depicts the enormous benefits gained in return to REACH’s cost as per the BBC.

Streamlining Processes with Technology

In the current day, having the right technology in place can simplify everything we do. Thankfully, most of the issues we mentioned can be taken care of with integrated applications designed from the ground up to help chemical companies easily meet their regulatory obligations for compliance and safety.

What are some key functions that help Chemical Companies with compliance?

Chemical companies’ ideal functioning method is when seamless integration of SDS Chemical Management, Label Management, and DEA controls align with your operational ERP system’s transactions. You simplify the software landscape without additional applications or tools to author Safety Data Sheets (SDS) and print labels anymore.

Regulatory Compliance

  • The integrated software should help comply with regulatory standards and government policies such as OSHA, REACH, FDA, HIPAA, LCSA, DEA to reduce risks and improve safety.

Key Product Functions

  • Extensive SDS Management functionality, Label Management (incl. Private Labels) & DEA Management in one unique integrated application will give the necessary leverage to chemical companies and help function more efficiently.

Label Printing

  • An included Label Management function enables chemical companies to automatically print labels according to Globally Harmonized System (GHS) labeling standards. These labels can be embedded within the workflow of key operational transactions such as Production Orders, eliminating the need for manual intervention.

SDS Chemical Management

  • A full-function SDS Chemical Management & Authoring system helps chemical companies handle the GHS, OSHA, REACH, and Chemical Environment Safety. Companies can now maintain Safety Data Sheets (SDS) within the ERP system without integrating a 3rd-party application.
  • Companies would still be required to identify and validate chemical information with the appropriate agencies and ensure accurate information management within the system.
  • An integrated software application provides the technology, workflows, infrastructure to maintain chemical data and print safety data sheets.
  • The system should provide versioning, country and language packs and maintain different SDS templates in the system.

Validation

  • An ideal system will also include DEA Management features designed to perform validations in real-time, ensuring that the contacts, customers, and buyers are DEA-certified.

Ongoing these systems and proper labeling ensure chemical safety for the consumers and the companies handling these chemicals. Utilizing the right technology helps reduce input needed when generating labels and streamline the processes and ensure your organization remains compliant year after year.

Key Takeaways

  • Chemical companies must label chemicals in adherence with the regulatory standards related to storage, transportation, handling and disposal of hazardous materials and waste.
  • Business in this industry should be taking advantage of modern, powerful ERP systems to help manage chemical inventories with increased safety and efficiency.
  • Failure to follow these guidelines can lead to large fines and penalties, damage to an organization’s reputation, and in worst cases – injury and loss of life.

To learn more about ICM (Integrated Chemical Management), contact Xcelpros today.

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Rethinking pharmaceutical strategies in the new normal banner

Rethinking Pharmaceutical Strategies in the New Normal

Rethinking Pharmaceutical Strategies in the New Normal 700 500 Xcelpros Team

At a Glance

  • The year 2020 showed the world that every sector has to be prepared for disruptions of unprecedented scales. This has been especially true for the pharma industry, which already had stagnant operational models and a lack of consumer connection.
  • Working on a new pharmaceutical strategy model is a necessity and top executives at pharma companies concur that there is a need for integration of the latest technologies in pharmaceutical and life sciences operations.
  • Industry leaders have demonstrated that during difficult times they are able to quickly respond to changes and are nimble in adopting newer ways of running operations. This quick-to-adopt way of leading will enable pharmaceutical companies to succeed in the new normal.
  • Agile technologies and tools that streamline processes will be indispensable in the latest roadmap of pharmaceutical strategy.

The pharmaceutical sector has been traditionally apprehensive towards adopting newer technologies and methodologies. Compared to other industries, operations management within the pharmaceutical industry has not been quickly modified or completely transformed. C-suite executives are now looking to overhaul their pharmaceutical strategies ensuring growth in the new normal.

During the pandemic pharma supply chains were adversely impacted and witnessed supply-demand discrepancies. Companies that could quickly adapt rose to the challenge. The spirits have changed since the onset of the pandemic and so has the market. Thanks to visionary leaders, pharmaceutical companies began work on something that the world had never witnessed before – to develop and test drugs/ vaccines for a novel pathogen in mere months’ time since the gene identification.

70%

of leading pharmaceutical executives (respondents of the survey) were optimistic that the industry will continue to grow over the next 12 months.

Source: GlobalData Survey

This optimism calls for a strategy that enables companies to –

  • get their supply chains back on track
  • optimize operations
  • effectively handle the shortage of workforce
  • leverage the latest technologies for accelerated production and overall better
  • create more personalized patient connections.

However, the path ahead is not without its set of challenges. After all, the pharmaceutical sector has been conventional in its outlook when it comes to newer technology adoption. There are also challenges related to budget, upskilling of employees, technological glitches and more. Companies need to gauge the path ahead and handle the challenges faced by pharmaceutical industry in 2020 and beyond.

Steps towards Transforming Pharmaceutical Strategies

1.Recognize Best Practices and Retain Them:The path to recovery is a tough one as it involves undergoing quite a metamorphosis. However, this does not entail letting go of all the practices. Pharma executives would need to analyze their operations and chalk down the practices, tools and technologies that have worked the best for them and also have the potential of harnessing benefits in the future. Continuing these practices will make restructuring in other facets of pharma operations a relatively smoother task.

2.Restructuring Assets for Process Streamlining: Be it the shop floor operations or inventory management or handling the entire supply chain– a new pharmaceutical strategy would be truly beneficial when pharma companies reassess and restructure their assets. This would fortify individual practices resulting in overall process optimization. It would also help to let go of stagnant and redundant technologies or practices to make way for more agile tools.

Figure: 1Pharmaceutical Strategies Breakdown: Towards the New Normal

Pharmaceutical Strategies Breakdown: Towards the New Normal

3.Adopting Digital Drivers of Change: The new normal is eventually going to be the only normal and thus pharmaceutical companies need to harness potential through digital tools and technologies. After retaining the best and letting go of the redundant, pharma operations would benefit greatly by using tools for Enterprise Resource Planning (ERP), Supply Chain Management (SCM), Customer Relationship Management (CRM), Artificial Intelligence (AI), Machine Learning, Big Data, Advanced Analytics etc. These tools and technologies would help in process automation, centralized data access, real-time supply chain monitoring and a lot more. Many pharma companies are looking at the digital revolution as their segue to pharma 2.0.

For instance, pharma giant Sanofi has already rebooted it’s digital strategy and is now ramping up operations in marketing, research and even e-commerce.

4.Moving from a Product-centric to a more Patient-centric Model:The healthcare sector is transforming and is becoming more personalized. With access to information and medical assistance becoming quite easy through smart devices, the consumers are highly aware of what they want. This is the pharmaceutical sector’s chance to connect with their end-users and know their requirements. The overall shift to become a patient-centric industry would take time and effort, but it is the right step. In fact, patient-centricity is already one of the key goals for many pharmaceutical companies, contract research organizations (CRO’s) and contract development and manufacturing organizations (CDMO’s). For example, the contract research organization, Parexel has hired its first-ever chief patient officer, with a focus on boosting clinical trial diversity for better results and ensuring that their drug is scalable to multiple demographics.

These points of considerations serve as the platform for companies to work on their renewed pharmaceutical strategies. Of course, every company has its unique set of operations, models and unique challenges. However, optimizing operations and leveraging digital technology to expedite growth are common must-haves for a pharmaceutical company’s renewed business approach. After all, the new normal will bring as many opportunities in the form of challenges and a well-equipped pharmaceutical company can harness the most out of its investments and talent-pool.

Key Takeaways

  • Even though the pharma sector has been slow to adapt to newer technologies, the dynamic changes in the past decade seemed to have enabled the industry to step up to the challenges posed by the Covid-19 pandemic.
  • A change in perspective is essential for success in the new normal and to rethink pharmaceutical strategies. Equally important is the communication of the perspective of this change from top management to employees.
  • Pharmaceutical companies would need to make use of the data being collected to generate insights and know exactly what their end-users need. Transforming to a more patient-centric business with the help of the right digital platform is the need of the hour.

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