Quality Management

Challenges in Pharmaceutical Supply Chain due to Covid-19

Pharmaceutical Supply Chain Challenges due to Covid-19

Pharmaceutical Supply Chain Challenges due to Covid-19 2035 764 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

Book a free consultation to learn more about building resilience in the pharmaceutical supply chain.

Book Now

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.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

mistakes that slow the growth of a chemical manufacturing company

Mistakes that slow the growth of a chemical company

Mistakes that slow the growth of a chemical company 1202 452 Xcelpros Team

7 Quotes

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

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

Introduction

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

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

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

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

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

Figure: 1Ansoff Matrix: Product-Market Expansion Grid

Ansoff Matrix: Product-Market Expansion Grid

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

Chemical Industry Mistakes

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

According to Global Safety Management, these unique challenges include:

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

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

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

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

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

Translation Errors Can Prove Fatal

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

  1. 12.Translation Mistakes.

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

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

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

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

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

Technology Helps Reduce Mistakes

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

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

Integrated Chemical Management with Microsoft Dynamics 365 Supply Chain Management

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

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

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

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

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

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

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

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

Figure: 3Translation Service Process in Dynamics 365

Translation Service Process in Dynamics 365

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

Summary

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

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

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

Book Now

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

ERP in the Oil and Gas Industry

ERP Solutions to Rev Up Oil and Gas Industry

ERP Solutions to Rev Up Oil and Gas Industry 2400 900 Xcelpros Team

At a Glance

The Oil and Gas Industry is highly dynamic and volatile. Wars, politics and environmental concerns are some of the stressors affecting a capital-intensive industry. Centralized software that manages the nuances and intricacies will boost each company’s financial performance.

Enterprise Resource Planning (ERP) systems, which are becoming more common in many other industries, help to integrate all related tasks. One of the best examples is inventory and finance, letting companies know what they have and how much it’s costing them. ERPs help create a performance standard, letting companies set goals and use real-time data to know if they’re achieving them. Effective ERP solutions easily integrate tasks, manage risks, localize financial accounting and ensure quality checks.

Introduction

A slang term for crude oil is “black gold” because of its value. Oil is a pillar of the world economy, with prices playing a major role in determining the cost of goods and services around the globe. The industry’s size, complexity and high operating costs all demand organized management. Executives need to know where each asset sits in the pipeline. They need accurate, detailed data for planning and budgeting plus inventory and distribution.

Integrating ERP in the Oil and Gas Industry

More and more oil companies and refineries are starting to embrace ERP software solutions. Why? Because it addresses real-time business operations. Areas that benefit the most include:

  • Obtaining raw materials
  • Monitoring production
  • Managing inventory including spills, waste and burn-off
  • Tracking handling equipment

One major challenge facing oil companies is their broad distribution. For example, they can have production facilities in the Middle East and refineries in the United States, Europe and China. This means they have to maintain distribution routes almost everywhere.

Oil companies have an intricate supply chain that never stops working. This can add undue stress to both employees and equipment.

ERP software lets companies monitor operations from anywhere. They can know now, not in a week, the status of an oil field in Saudi Arabia or a tanker going through the Panama Canal. Modern ERPs help identify different ways to improve efficiency while boosting flexibility.

5 Key Reasons to Add an ERP

ERP solutions are the most viable option for improving production and overall management. Traditional companies in the Oil and Gas industry stand to gain significant advantages when they implement a modern ERP solution, including:

Figure: 1Key Reasons to Add an ERP

Key Reasons to Add an ERP

  1. 1.Ease of Integration: ERP solutions are designed to be stable, easily scalable and flexible. They function on-site and with cloud systems. ERP systems especially shine in asset planning and budgeting lifecycles. ERP solutions such as Microsoft Dynamics 365 easily integrate with a suite of related third-party programs. Instead of having a plant’s production department using one system and inventory management using something else, the entire operation is integrated into a single system. By having departments talk to each other, business meets its productivity standards, regulatory requirements and other deadlines.
  2. 2.Effective Risk Management: Risk management is a vital component of everyday business activities in the oil and gas sector. Geopolitical pressures, environmental concerns, social activities, asset damage, cost overruns for high-value construction projects, fines for non-compliance, cyber threats and protecting personnel: they all impact daily operations. Integrated ERP solutions let management identify potential risks. You can detect risks before they become expensive problems. Companies can balance and manage multiple operations simultaneously, ensuring they all run smoothly. By seeing how the supply chain functions in real-time, companies can prepare emergency contingency plans.
  3. 3.Efficient Project Management: A key advantage to ERP software such as Microsoft Dynamics 365 Supply Chain Management is its ability to manage complex supply chains regardless of their locations. An effective ERP helps manage both offshore and onshore operations, streamlining procedures driving basic business goals, helping to move raw materials to new markets. As individual shipments move from wells to refineries, ERP software lets companies adhere to regulations in every country and state along the way.
  4. 4.Localizing Financial Accounting: Oil and gas companies are aware of the huge capital investments, long lead times and unfavorable environments needed to extract and process their raw materials. Exploration and production frequently involve joint ventures to share the costs. Once the product is pulled from the ground, these companies face multiple regulations, compliances, currency risks, commodity pricing and other challenges as they move it from the wells to refineries and then to consumers. Efficient ERP solutions keep track of the regulations, taxes and fees in each region. They provide detailed financial records at every step.
  5. 4.Quality Control: Robust ERP solutions also integrate state-of-the-art engineering utilities matched with high-end total quality management (TQM) functionality. The result is a 360 degree view of quality issues, helping to address problems more quickly.

5 Features to Look for in an ERP Solution

Now that you’re aware of some possible uses, it’s equally important to make sure these five features are in whatever ERP solution you choose. The Oil and Gas sector’s sensitivities create unique requirements from its ERP solutions. These following features continue to be increasingly related to real-time operations and complex business compliance issues.

  1. 1.Asset Control: Managing all assets—such as locating new resources, acquiring them, and then refining the products—is vital for efficient operations. When you’re trying to find the best ERP System for an Oil and Gas Company, you’ll want to make sure it defines and tracks your assets, monitors their usage and availability, manages all documents, integrates mobile apps and data, and submits reports.
  2. 2.Agile QA Processing: Quality assurance is the key to constant improvement, especially in the oil and gas sector. Finding more efficient ways to convert raw materials into finished products helps offset research and development costs.
  3. 3.System Integration: Integrating existing software is often a key decision point in getting an ERP up and running quickly. It’s critical to make sure that whatever ERP solution you choose meshes with the software your employees use daily, otherwise you may face delays while work-arounds are developed. The perfect ERP solution creates superior analytics using real-time data from different sources. This will include workflows and service calls.
  4. 4.Standardizing Data Processes: The Oil and Gas industry is heavily impacted by precise management of workflows and global market analysis. Effective ERP solutions use a standard data storage method. Using this method, companies can balance multiple projects no matter where they occur: upstream (exploration and drilling), midstream (transportation, storage and processing) or downstream (refining crude oil and purifying natural gas).
  5. 4.Compliance: Many ERP solutions fail to deliver when it comes to overseeing complex compliance issues. Not being accurate often causes problems over time. Effectively managing different government regulations—such as when a pipeline crosses national or state borders—is a key benefit of a robust ERP solution.

Final Thoughts

The best ERP solution for companies in the Oil and Gas sector is one that:

Companies that navigate smoote implementations often start training almost from Day One. Training employees early gets their buy-in and lets people learn how D365 can make their work lives easier.

  • Integrates with a company’s current third-party software
  • Tracks inventory, plans capital projects and creates emergency plans
  • Streamlines the data into a unified flow
  • Collects data from diverse systems scattered around the globe
  • Allows the data to be used by any division
  • Integrates information from devices equipped with industrial internet of things (IIoT) sensors
  • Aligns with your company’s requirements to ensure minimal waste and deliver the best results

Expect nothing less than perfection. Having the right ERP solution will help you achieve just that.

Book a free assessment to get started with tailored ERP Solution for your Oil and Gas Company.

Get Started

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com