PHARMACEUTICAL

How Pharmaceutical Companies Get New Products to Market during Covid-19

How Pharmaceutical Companies Get New Products to Market during Covid-19

How Pharmaceutical Companies Get New Products to Market during Covid-19 1202 452 Xcelpros Team

Introduction

As the world continues to deal with one of the deadliest pandemics in modern history, governments are working overtime to protect their citizens from the deadly disease known as Covid-19.

With the potential impact of Covid-19 on pharmaceutical sales estimated to be huge, two types of drugs are being sought after:

  • Vaccines to keep humans from catching the disease
  • Therapies to treat people with the disease and help them recover

At the end of 2020, the U.S. Food and Drug Administration (FDA) modified its approval process for vaccines, issuing an emergency use authorization (EUA) to Pfizer-BioNTech for a vaccine to prevent coronavirus disease 2019 (COVID-19). The initial EUA applied to vaccines for people 16 and older. It was further modified on May 10, 2021 to include adolescents ages 12-15. The EUA lets the vaccine be distributed in the US. Similar documents were issued to Moderna, Inc. and Johnson & Johnson / Janssen. On July 9, 2021, Pfizer said it would seek approval for a booster shot to target the newer variants of the disease. The FDA and other regulators have, at this time, disagreed with the need for it. This could result in Pfizer share price climbing by as much as 66% in 2021, as suggested by analysts from investors.com

Companies might want to rethink their pharmaceutical product launch strategies. This change in the FDA approval process may require changes in pharmaceutical new product launch plans, prioritizing Covid-19 treatments over other medicines. These plans affect not only products sold in the U.S. but also in the Indian pharma market with its 1.4 billion residents (four times that of the U.S.).

Using enterprise resource planning (ERP) software can help pharmaceutical companies gain regulatory approval of their drugs and treatment plans.

By the Numbers

Expected 2021 sales from Covid-19 vaccine makers:

  • $15 billion-$30 billion: Pfizer/BioNTech (share price +1.8% for Pfizer, +156% for BioNTech)
  • $18 billion – $20 billion: Moderna (share price +372%)
  • $10 billion: Johnson & Johnson (share price +7.7%)

Five other companies are also making Covid-19 vaccines but none have been approved by the FDA yet. (Source: The Guardian)

Normal Drug Development Process

The normal pharma go to market strategy requires a clear long-term view since most medications take 10-12 years to go from the laboratory to the medicine cabinet. Full FDA approval requires six months of data plus another six months for review before official approval is given. These additional steps then come at the end of the drug creation journey:

  1. 1.Research and laboratory work begins.
  2. 2.Preclinical research and animal testing looks into the drug’s safety for human beings.
  3. 3.Clinical research begins on humans, typically comparing test results from patients getting the therapy to those receiving a placebo.
  4. 4.The FDA reviews the data and then decides to approve or disallow the medicine.
  5. 5.The FDA monitors the drug for safety once it becomes publicly available.

The Covid-19 vaccines are examples of drugs required to combat a crisis, one that has already killed more than 606,000 U.S. citizens and 4 million people worldwide. They present different pharmaceutical marketing challenges than existing medications.

“An EUA can be given if there are no adequate or approved alternatives,” WKYC of Cleveland, Ohio states. Pharmaceutical manufacturing companies still need to prove the drug is safe by thoroughly testing against thousands of study participants.

“The only difference really between the emergency use and the licensure is that volunteers are observed for a longer period of time to see the duration of protection and if there might be rare adverse events that occurred down the road,” WKYC quotes Dr. William Schaffner of Vanderbilt University as saying.

Figure:

 Normal Drug Development Process

Difference Between EUA and Standard Approval

Drugs with full FDA approval have several major advantages over those with just an EUA, including:

  • The medications stay on the market after the pandemic is no longer an emergency
  • EUA-approved therapies must be pulled from the market
  • Medicines still in the development pipeline may be tested against newer, more drug-resistant, variants
  • The pharmaceutical manufacturer can market directly to consumers
  • After full approval, businesses can require all employees to be vaccinated, WKYC states

The FDA Requires Records

According to the FDA’s Code of Federal Regulations (CFR), Section 312.57

“Recordkeeping and Retention,” a drug sponsor (i.e., manufacturer), “shall maintain adequate records showing the receipt, shipment or other disposition of the investigational drug. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped and the date, quantity and batch or code mark of each shipment.”

Records must be kept for two years after the marketing application is approved or for two years after shipment and delivery of the drug for investigational use is discontinued and the FDA notified.

Traditional Recordkeeping is Cumbersome

Many pharmaceutical companies still use spreadsheets to keep track of records. However, they often get data from a single source or department. Multiple sources may mean mixed-up or missing records, slowing the approval process.

Typically, companies using older software tend to silo their data. Inventory has its records. Finance has its own. Sales and marketing have theirs.

The problem in terms of regulatory compliance is that none of this information is shared across departments.

Enterprise resource planning software (ERP) such as Microsoft Dynamics 365 Finance and Operations lets pharmaceutical manufacturers gather information from all of these different sources. The data is combined into one unified whole.

Dynamics 365 can then automatically generate labels. It allows companies to track everything from large batches to individual doses, making FDA compliance simple and easy.

Data comes into the ERP network from sources scattered literally all over the globe. Real-time information is available with the click of a mouse or typing a few keystrokes.

Dynamics 365 data is securely stored on Microsoft Cloud servers. It’s available any time, anywhere. Executives can obtain any record in the system quickly and easily, ensuring compliance with FDA regulations. This lets executives provide accurate data to regulators quickly and easily.

Summary

Covid-19’s death toll led the FDA to accelerate its approval process from 10-12 years to a mere matter of months. Moving forward, agile pharma go to market strategies that can adapt to these changing requirements will undoubtedly be more profitable. An effective ERP software solution such as Dynamics 365 helps pharma companies adapt, and be able to quickly provide any required regulatory documents in order to remain compliant.

Get a free consultation on pharmaceutical go to market strategy during challenging times.

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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.

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How ERP solutions benefit Pharmaceutical manufacturers

How ERP Solutions Benefit Pharmaceutical Manufacturers

How ERP Solutions Benefit Pharmaceutical Manufacturers 1200 450 Xcelpros Team

Introduction

Speed and accuracy are fundamental for any business, including the pharmaceutical industry. Microsoft Dynamics 365 for Finance and Operations (F&O) offers an intelligent cloud-based solution tailored to meet the pharmaceutical industry’s needs.

With the help of Dynamics F&O, pharma companies can reduce regulatory burdens, introduce automation, boost productivity and build a secure environment focused on achieving high-value work.

Pharmaceutical companies often prepare medicines with diverse formulas. Much of the focus is placed on raw material quantities, yields with constant and variable scrap percentages, and operations within production. Pharmaceutical companies need an enterprise resource planning (ERP) system that monitors functions such as procurement, production and supply chain operations.

Microsoft Dynamics F&O Features for Pharma

Feature Function
Product quality and safety Manage:

  • Multi-stage tests of raw materials
  • Lot expiration, stock aging and re-testing requirements
  • Supplier information such as vendor batch details/ expiration dates on raw material batches
  • Integration of quality management to inspect incoming raw materials
Sales and promotion management Manage:

  • Leads, prospects and customers
  • Delivery orders, sales contracts and export invoices
  • Discounts and price lists, including competitor analysis
Processing and packaging
  • Trace inventory including lots, batches and serial numbers
  • Generate bar code labels for packaging and shipping
  • Integrate with real-time data collection systems like PLC and SCADA
Financial control
  • Provide insights on intercompany purchases and sales
  • Track batch costing for planned vs. actual

1.CRF 21 PART 11 Compliance

Pharmaceutical companies are constantly searching for ERP systems that offer 21 CFR part 11 compliance. This FDA rule requires companies treat electronic records and signatures like paper records and handwritten signatures. Companies keeping any electronic records are required to comply with the regulation.

Pharmaceutical manufacturers require software that’s able to meet changing regulations. Integrated Pharma ERP systems track document revisions. They provide an audit trail of comments stating how members or groups interact with the documents. Effective software also boosts data security and includes intelligent document control.

Pharma manufacturers are using digital documents instead of paper for daily operations. CFR 21 Part 11 requires a legally bound signature to ensure its integrity. Microsoft Dynamics F&O includes this function. ERP software lets company owners relax in terms of digital document authenticity and validity. When an ERP system checks for electronic signatures, it looks for notarization, non-repudiation and integrity.

2.Inventory Management

Pharma companies constantly face inventory management challenges, including temperature control, inaccurate counts, poor warehouse management, imbalances in inventory supply, and even failure to shed excess inventory. A powerful ERP program helps eliminate these common problems.

Tracking expiration dates is another part of inventory management. When done incorrectly this can quickly add up to big costs for pharma companies.

An effective ERP inventory program such as Microsoft Dynamics 365 Supply Chain Management not only tracks inventory shelf-life, it can also track and trace lots, batches and individual products. This solution from Microsoft is also able to verify batch potency, generating notifications to the business owner about their products’ quality.

Dynamics Supply Chain Management also goes well beyond visual inventory counts. Using barcodes or QR codes, employees with handheld scanners or cell phones can use its mobile supply chain management features. These include recording real-time inventory counts during operations. Chief executive officers can verify inventory at any time, including pick and put away or when raw materials are consumed.

Figure: 1ERP for Pharma

ERP for Pharma

Another part of keeping accurate inventories is generating reports, like those dealing with aging. Reports provide a breakdown of inventory quantities and values by various dimensions such as batch, serial number, site, warehouse, location and license plate number. Dynamics Supply Chain Management includes many reporting features.

3.Transparency and Traceability

In the pharmaceutical industry, transparency and traceability is a complex issue. Companies need to keep track of product families, dosages, lot numbers, schedules, strengths, global trade item numbers (GTIN) and National Drug Code numbers. The Supply Chain Management module tracks product code, NDC number, brand strength and dosage.

Pharma firms also need end-to-end lot traceability. This comes in handy for recalls. Dynamics Supply Chain Management can notify all customers who receive the recalled batches without forcing employees to struggle through mountains of paperwork.

4.Quality Control

Quality control in an integrated ERP manages testing on raw materials, intermediates and finished products. Using an ERP to compare data ensures that raw materials meet agreed-upon standards.

For example, an ERP can quickly identify and provide the list of affected or remaining lots, and can even provide supplier details. Every pharma manufacturer wants to know their products are in compliance with FDA requirements to avoid penalties and fines.

5.Shipping

Dynamics 365 Supply Chain Management includes powerful lot and batch tracking functionality. It lets department leads monitor batches from the start to in-process quality control (IPQC). Executives have a program that reports delivery status as soon as items are scanned into the system.

Final Thoughts

Moving forward, the Pharmaceutical industry will continue to face increasingly stringent regulations. Companies seeking to keep up with ever-growing innovations in market trends, changes in the health care sector and rising global competition will need all the help they can get. An enterprise resource planning solution like Microsoft Dynamics 365 helps companies overcome these challenges everyday, while simultaneously reducing costs, streamlining operations and most importantly, helping businesses remain compliant.

Book a free assessment to get started with tailored ERP solutions for pharmaceutical manufacturing.

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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

Managing Pharmaceutical Discounts, Rebates Chargebacks

Managing Pharmaceutical Discounts, Rebates and Chargebacks

Managing Pharmaceutical Discounts, Rebates and Chargebacks 1200 450 Xcelpros Team

Introduction

The way pharmaceutical firms price their drugs and administer rebates and discounts, has put the industry in a potential governmental spotlight.

Key topics likely to be investigated include:

  • How discounts are set
  • How drug makers establish and monitor rebates
  • How pharma firms report their pricing details

Background

Around the world, pharmaceutical manufacturers are under increased pressure from governments and the public to reduce consumer drug prices. In some cases, the amount consumers pay for medicines has skyrocketed. One example cited by Endocrine.org is the cost of an insulin dose rising from $170 in 1987 to more than $1,400.

A 2019 Time magazine article attributes rising consumer drug costs to a complex drug supply chain. Pricing is set by a combination of pharmaceutical manufacturers, pharmacy benefit managers (PBMs) who serve as middlemen, and insurers.

Typically pharmaceutical companies set a non-discounted “list” or base price for each product. Many pharmaceutical companies offer discount coupons and rebates. Depending on a consumer’s health insurance coverage though, some patients may be forced to pay the undiscounted list price for specific medications.

According to Time, manufacturers provide discounts based on the drug and the buyer. Typically these discounts are in the form of rebates negotiated with individual PBMs. The PBM gets paid for its efforts to reduce the amount the manufacturer charges. The final price—which may or may not include any rebates or discounts—is then passed to the insurance companies, who in turn pass the pricing on to consumers.

In addition to negotiating pharma rebates, PBMs also wield power by determining where a particular drug appears on an insurance company’s hierarchy, Time states. These middlemen can make a given drug the most discounted, and therefore most prescribed, medication. They can also exclude it, forcing patients who want or need it to pay more.

Prescription drug price negotiations often happen behind closed doors, leaving patients and physicians out of the discussion despite the impact drug pricing has on the health and treatment of patients,” The American Medical Association (AMA) stated in a 2019 online article on how prescription drug prices are determined.

Raising the price of prescription drugs forces patients with limited funds to skip doses, split pills or abandon treatment, the AMA states. All of these actions, plus growing demands for prescription drug price reforms, are causing the U.S. government to further examine medicine prices.

Figure: 1Percentage of Revenue Spent on R &D

Importance of change management in erp implementation

Governmental Scrutiny

Federal government agencies such as the Department of Health and Human Services (DHHS) are paying extremely close attention to how much consumers actually pay. Agencies want to know if the actual prices reflect the research and development (R&D) and other costs of creating and manufacturing new products. Or are consumer prices a way for an unscrupulous company to use its hot new medication as a way to boost profits and stock prices?

The Biden Administration froze drug price reforms started by the previous administration pending further review. One reason for reviewing these proposals is the fear of higher insurance premiums, an online article by Joshua Cohen in Forbes states.

Cohen suggests that the Biden Administration may require health insurers “disclose current list prices and historical net prices for prescription drugs and provide patients with personalized estimates of cost sharing.

Figure: 2Amount of Revenue Spent on R &D

Amount of Revenue Spent on R &D

Setting Discounts

One way pharma companies can protect their integrity is by using Enterprise Resource Planning (ERP) software such as Microsoft’s Dynamics 365. ERP software allows pharmaceutical manufacturers to set various discounts and rules for each price break. For example, one rule in Dynamics 365 Commerce asks, “is a coupon required to obtain a discount?” A slider lets authorized users select Yes or No. When this feature is active, the discount only appears when a coupon or bar code is provided. This section also has “All discounts” and “Pricing and discounts management” workspaces, letting companies create customized discounts.

ERP software works by creating a series of properties for simple pharmaceutical discounts and quantity price breaks. For example quantity tiers must be reached independently for each line or product.

Microsoft Dynamics 365 Commerce lets companies select between four types of discounts: “Discount,” “Quantity,” “Mix and match” and “Threshold.”

Users also have the option to determine which discounts compete on a transaction. Values are “Exclusive,” “Best price” and “Compound” with “Exclusive” always being calculated first.

Individual products or product variants can be selected along with categories, units of measure and many other variables. Other options include setting up sales lines and invoice discounts.

When there are issues with drug quality, the “Quality management” section establishes rules for pharmaceutical chargebacks.

Managing Rebates

Microsoft’s Dynamics 365 Supply Chain includes a “Rebate management module” with an important feature for pharmaceutical companies. “The setup on this page is shared across all legal entities and can be modified by users who have the appropriate security permissions,” Microsoft states.

This module makes it easy to create contracts, deals and agreements with customers and vendors. It lets firms calculate and keep track of rebates, deductions and royalties. The information is stored in a central location for easy review.

Rebates can be created for customers or vendors. The function also allows inputting notes about a specific deal. For example, a pharmaceutical rebate may be given to one company instead of another. A note can explain the reason like a long-standing business relationship.

Since pharmaceutical rebates appear to be a likely focus of government action, documenting a firm’s rebates makes it easier to show what is taking place.

Reporting

With transparency being a likely focus of governmental action on drug pricing, investigators may ask to see pricing reports. ERP programs like Dynamics 365 have a number of powerful reporting features. A Report Wizard lets users select from a series of previously created reports and update them. Tables and charts can be included.

A big part of Dynamics 365 Supply Chain is tracking the status of each rebate for reporting and inquiry purposes. Reports can be linked to web pages, static files and dynamic Office-based files that read data from a Dynamics 365 database. Reports are filtered using SQL or FetchXML queries depending on the software in use.

Summary

Consumer drug pricing is becoming a hot topic in Washington, D.C. Pharma manufacturers are likely to face increased scrutiny on how they set pricing. ERP programs like Microsoft’s Dynamics 365 let firms set and track rules for discounts and rebates, as well as generate all necessary reports.

Get a free consultation on how to manage pharmaceutical discounts in dynamics 365 supply chain management.

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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

Strategies to Implement Digital Processes in the Pharmaceutical industry

Strategies to Implement Digital Processes in the Pharmaceutical industry

Strategies to Implement Digital Processes in the Pharmaceutical industry 2400 900 Xcelpros Team

ERP software provides a cradle to the grave system of tracing an entire supply chain.

Digitizing the pharmaceutical industry supply chain pays benefits to the companies, executives and employees. How? By allowing companies to be more efficient, resilient and responsive to rapidly changing customer requests and regulatory demands. This digitization allows for:

  • Near real-time tracking of raw materials.
  • Accurate raw materials inventory tracking.
  • Updated details quality control.
  • Batch tracking from production to final delivery.

Companies benefit from greater efficiency and better resource allocation. Better resource allocations means employees can be performing more meaningful work.

Key Advantages

Accountability is one of the key advantages of using enterprise resource planning (ERP) software. When a company inputs data for supply chain topics such as inventories of raw materials, quality control test results, warehouse storage temperatures and government recall notices, it has the company’s core data at its fingertips. Chief financial officers (CFOs) and chief technical officers (CTOs) can track any product from its raw materials source through development, testing, production and distribution.

When a company implements a fully digital solution, it has the ability to track any single item anywhere under company control. This permits more efficient use of raw materials—they go where they are needed now—and accurate planning for the future.

Raw Materials Purchase Order Workflows

Digitization dramatically speeds the ordering and delivery of purchase orders. With the click of a mouse, a company in the U.S. can send a PO to a supplier in India. The supplier can review the request and compare the materials and quantities requested to what is on hand. If the supplier lacks any of the requested items, it can either order it from a different firm or notify the requesting pharmaceutical plant. Either way, the production facility quickly knows what is coming and when.

Enterprise resource software such as Microsoft Dynamics 365 for Finance gathers information from multiple sources. It combines individual data points—a customer’s request for a new shipment, a salesperson’s request to have the order fulfilled, a stock check to determine if sufficient raw materials are on hand, an order to one or more suppliers for the active pharmaceutical ingredients (APIs)—in one place.

The end result is that instead of making numerous phone calls trying to locate everything, a chief financial officer can ask the question, “Can we fill this customer’s order now? If not, when?”.

Figure: 1Raw material purchase order process

Raw material purchase order process

Digitizing Quality Control Testing

Tracking products is important. So is tracking product quality. When the quality control testing process is digitized, CFOs:

  • Have access to standardized recording and reporting processes
  • Can act proactively instead of reactively
  • Have open lines of communication with different departments
  • See when a process is working and can discontinues those that are not

Digitizing these processes lets companies recognize and resolve quality control issues early in the process. They save money by not producing large quantities of inferior products.

It allows firms to recognize problems on the factory floor, saving the time and expense of shipping defective or poor quality materials—such as medicine stored at the wrong temperature—only to then pay for shipping it back.

Through digitization, quality control inspectors increase the speed of their inspections when they upload information into a centralized database.

Digitization also makes it easier for companies to comply with regulatory requirements. Required records and standards are a few keystrokes or mouse clicks away.

Data collected anywhere from cell phones, tablets and hand-held scanners allows workers to input inventory information. This can include creation dates, batch numbers, temperatures and anything required by company standards or to meet regulatory requirements.

Having digital records makes it easy for company quality assurance teams to create certificates of analysis (COAs). “A COA typically contains the actual results obtained from testing performed as part of quality control of an individual batch,” a report by InSource Solutions states.

When connected to an ERP system such as Microsoft Dynamics 365 Supply Chain Management, companies can:

  • Create quality orders based on trigger points
  • Document test results and then determine if they meet established criteria
  • Maintain nonconforming products to track down the original cause
  • Schedule error correction processes
  • Print a COA showing the test results

Figure: 2Quality control analysis from System Dynamics Supply Chain

Quality control analysis from System Dynamics Supply Chain

Batch and Lot Tracking

ERP programs such as Microsoft System Dynamics 365 Supply Chain Management allows companies to create and track specific production quantities.

For example, if an individual batch is created, the ERP program creates a label with a barcode or QR code on it. The label allows scanners to immediately access information such as the creation location, date and other relevant data. After the production batch is created, individual lot numbers are assigned. Serial numbers are then assigned to individual items.

Workers scan each batch and add its warehouse and location details, such as section, row and bin number. When batches are broken into lots, each scan updates the tracking information providing a clear path from the current location to its creation.

Using these codes, warehouse workers can locate any given batch, lot or individual item from the time of creation through storage and transportation until final delivery.

Lot Traceability

The ability to trace production lots is important not just to ensure that every item goes to the correct destination but to ensure when problems occur, they can be addressed quickly.

For example, a batch of Covid-19 vaccines is given an expiration date. New data arrives indicating that the original expiration is incorrect, prompting a safety recall.

Having digital barcodes on each lot and individual product allows pharmaceutical companies to track the batch and every lot from it. Requests to pull specific lot numbers are sent directly to affected customers only. Those receiving unaffected batches are not notified. Impacted customers can then be given instructions on what to do if they encounter a bad batch.

Digital Signatures

The days of requiring a person to manually sign a form acknowledging receipt of a delivery are long gone. The U.S. Electronic Signatures in Global and National Commerce Act (ESIGN) of 2000 ensures that electronic signatures are legal wherever federal laws apply. When federal law is not applicable, most U.S. states follow the Uniform Electronic Transactions Act (UEFA).

Now considered valid in terms of regulatory compliance are electronic signatures, such as using a stylus and tablet when making or receiving a delivery, and digital signatures. Digital signatures do not require a handwritten acknowledgement but are still considered legal, according to Adobe.

One of the benefits of using electronic signatures in the pharmaceutical industry more than paper versions is providing the proof of delivery. This authorization is readily available to authorized executives anywhere in the world within seconds. When questioned about a delivery, the electronic signatures provide proof of receipt.

Summary

Going digital saves companies time, money and unneeded expenses. Information can be organized more efficiently and is available on demand. ERP programs allow for accurate product tracking of raw materials and finished products, along with the added benefit of things like digital signatures and barcode scanning.

For more information on implementing digital processes in your pharmaceutical company, book a free consultation with our team of experts.

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

Digital transformation in Biotech and Pharma R&D

Embracing Digital Technologies to Transform Life Sciences R&D

Embracing Digital Technologies to Transform Life Sciences R&D 2400 900 Xcelpros Team

At a Glance

  • Biotech companies are now more dependent on the latest technologies for innovation and pace. Mid-size and larger life sciences companies are looking to invest in tools that offer precision and efficiency in R&D.
  • 2020 brought a spotlight to pharmaceutical and biotechnology R&D as the world sought ways to curb the Covid-19 pandemic. Pharma companies adapted and implemented high-end technologies for faster results.
  • Cost-efficiency is also a major concern for pharma companies’ R&D. Newer tools enhance efficiency while reducing costs.

The year 2020 was unprecedented in many ways. It engulfed the world in an unheard of disease, locking everyone inside and putting a serious strain on the global healthcare system.

The entire world is now hoping for an effective vaccine to slow the spread of the Covid-19 virus. A vaccine or an effective treatment is at the top of every nation’s agenda. This focus puts tremendous pressure on pharmaceutical and biotech companies to fortify and speed their R&D. The ability to produce these products has direct impacts on our lives and businesses.

Even before the coronavirus pandemic, pharma companies were struggling to keep up with the demands for newer drugs, expiring patents, developing innovative formulations, etc. Compared to many other industries, the biotech and pharma sector was slow in terms of updating technology in business operations and labs. Times are changing and bringing R&D along.

The Tufts Center for the Study of Drug Development states the average cost to produce a new medicine is $868 million. -PwC

Updating R&D

Pharma and biotech companies want to make more efficient R&D choices. One goal is to ensure that more molecules from the initial phases become the part of the final product. New tools and tech are helping achieve these goals by:

1.Leveraging Data Analytics for Effective Insight Generation in the Lab: Scientists deal with numerous molecules, formulations and data-points while developing a drug. Manually keeping tab of all these data-points is cumbersome and time-consuming. It can lead to missing crucial data and other human errors, unintentional or not. Using “Big Data” and the latest data analytics tools, pharma companies are enabling their scientists to automatically collect, collate and manage large volumes of data.

2.Digitizing Labs with IoT: Labs become faster and more efficient by connecting every machine, enabling real-time information flow. This method generates quicker insights and results in faster decisions. Using internet of things (IoT) connected devices, the lab lets machines communicate with each other. The system becomes agile and proactive as compared to traditional responsive operations of the past. Digitizing labs helps predict and then eliminate bottlenecks. It removes ineffective molecules and formulations, strengthening the entire R&D workflow.

3.Digital Pathology with Virtual Staining: Virtual staining lets scientists highlight and study non-labeled sections of a single tissue for enhanced microscopic clarity. With the help of artificial intelligence-based tools, scientists can effectively digitize the entire process. These tools help automatically analyze radio images, pathological images and related medical data. Not only does this speed the entire process, it saves time and increases overall accuracy.

4.Creating a Shared Ecosystem between R&D Functions: R&D in pharma includes labs plus pre-clinical and clinical trials. Each function generates data points and massive amounts of information. With the help of digitally-enabled platforms, pharma companies can create a shared ecosystem that collects, classifies and provides centralized access to this data.

Example: Pfizer’s Precision Medicine Analytics Ecosystem provides shared access to information about genomics, formulations, clinical trials and other recorded data. Pfizer’s system allows scientists and researchers to simultaneously study possible outcomes and narrow down the best possible treatments.

Figure: 1Biotechnology R&D: Conventional vs. Digitally-enabled Processes

Biotech R&D: Conventional vs. Digitally-enabled Processes

The Covid-19 pandemic taught the world that leveraging technology for biotech and pharma R&D is not a choice but a necessity. Using the latest digital advancements, pharma companies are making a seemingly impossible feat possible by getting several vaccines approved for emergency use. Developing a vaccine for a novel pathogen in a year is truly a victory for science and technology. It also shows that the biotech and pharma sectors can create many new products by embracing the latest tools and technologies.

Key Takeaways:

  • Pharma/ biotech labs can be simplified and streamlined using newer tools powered by the latest technologies.
  • Pharma companies need to look into technologies to enhance efficiency and manage the financial aspects of R&D.
  • Adapting and implementing the latest technologies requires major changes and investments. In the long term, these investments will pay for themselves.
  • Digital trends are making R&D faster and more efficient, helping scientists narrow treatments and speeding clinical trials.

For more information on implementing digital technologies in your life sciences R&D, book a free consultation with our expert.

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.

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Trends Influencing the Future Pharmaceutical Supply Chain Management

Trends Influencing the Future of Pharmaceutical Supply Chain Management

Trends Influencing the Future of Pharmaceutical Supply Chain Management 2400 900 Xcelpros Team

Introduction

Pharmaceutical supply chains continue to evolve even as the worldwide Covid-19 pandemic shows signs of improvement in some countries (the U.S.) and worsening in others (India). Key trends include:

  • Geographically diverse suppliers
  • Sustainable sources of raw and packaging materials
  • Increasing use of computer technology to help manage companies

How chief financial officers (CFOs) and chief operating officers (COOs) of pharmaceutical companies respond to growing demands while facing labor shortages in areas hard hit by the pandemic largely depends on their ability to obtain raw materials and then manufacture and ship finished products.

Reports in SupplyChain Brain, EazyStock and Manufacturing.Net state that supply chain management trends likely to influence the pharmaceutical supply chains near term include increased use of:

  • Diverse (i.e., multiple) suppliers for improved resilience
  • Sustainable supply chain sources
  • Enterprise Resource Planning (ERP) and pharmaceutical warehouse management software (WMS) to improve management of the overall business, including the supply chain
  • Artificial intelligence (AI) to boost productivity and decrease errors
  • Cloud-based technology to permit scaling small and medium businesses as they grow using mutable
  • Industrial Internet of Things (IIoT) to track products ranging from individual batches to complete orders
  • Robots and other forms of automation to perform labor-intensive tasks
  • Flexible supply and delivery sources permitting personalized shipments
  • Layering technologies to eliminate data silos and create actionable data across technology platforms
  • Blockchain to improve transparency in data sharing using immutable databases Smart contracts that automatically execute when a set of conditions is met

Geographically Diverse Suppliers and the PSC

Having a geographically diverse source of raw materials such as active pharmaceutical ingredients (APIs) becomes important in a world proven so susceptible to pandemics. Companies whose primary suppliers are in India (currently suffering an uptick in coronavirus cases), for example, may find their suppliers are short-handed and unable to fulfill orders. CRB Group states supply chain challenges from rare events also include:

  • Transportation issues and disruptions
  • Adding counterfeit material into the supply chain
  • Site closures
  • Lack of coordination and traceability causing inventory build-ups or shortages

According to GoMarketWise, having a diverse supply chain also provides:

  • Access to innovation outside your organization
  • Flexibility to respond when market conditions change
  • Competitive pricing at local levels
  • Specialization many small to medium businesses (SMBs)

Sustainability in the Pharma Supply Chain

Many organizations across all business sectors are looking at climate-smart supply chain planning because of the effect of climate change on the availability of resources and materials, a report in All Things Supply Chain cites a Harvard Business Review study claiming companies advocating for sustainability grow 5.6 times faster than brands that don’t.

One area impacted by sustainability is product packaging. A study by Pelican BioThermal quoted in The LoadStar states that 48% of respondents claim to be looking for packaging that is recyclable or can easily enter the waste stream. Larry St. Onge, president of DHL’s global sector, life sciences and healthcare is quoted as saying his customers’ packaging would become a strategic priority in the near future. “This is of utmost priority because 25% of the global 8.3 billion tons of plastic produced originates from packaging and more than 90 countries have imposed bans on single-use plastic.”

“A more sustainable pharmaceutical supply chain (PSC) should be implemented to match future operations and management of the pharmaceutical products across the entire life cycle,” a look at Pharma Industry 4.0 on ScienceDirect states.

Further restricting the adoption of sustainable processes in the PSC are high costs and time consumption, enforcement of regulations, a lack of business incentives, lack of objective benchmarks, poor end-customer awareness and other issues.

Increasing Use of ERP and WMS in Pharma

Pharmaceutical companies are increasing their use of enterprise resource planning (ERP) and warehouse management software (WMS) from companies like Microsoft to improve management of the overall business, including the supply chain. Software add-ons automate many previously manual tasks, such as inventory optimization and shipping solutions, EazyStock states.

A report by Grand View Research states the market size for WMS programs is expected to grow from $3 billion in 2021 to $8.1 billion with a compound annual growth rate (CAGR) of 15.3% from 2021-2028 with a CAGR of more than 17% in WMS software alone. The WMS market was $348.6 million in 2016.

Grand View Research cites healthcare as one of the biggest growth sectors as companies seek to increase product output and meet rising customer demand. “A WMS helps reduce lead time, increase product delivery speed and minimize distribution costs,” Grand View states.

Much of the increased demand for pharmaceutical WMS software is expected to come from small- and mid-sized businesses using it on a cloud-based computing system. WMS software, “is widely used as a tactical tool by businesses to meet the unique customer requirements of their supply chain and distribution channel,” the report indicates.

Figure: 1 Recent Trends in Pharmaceutical Supply Chain

Pharmaceutical Supply Chain Management Trends

Using Robots in Pharma Factories

Robots offer several advantages over human workers in select conditions, a report by TweakYourBiz states. including:

  • Increasing worker safety when assembling implants and drugs containing radioactive or biohazardous compounds
  • Reducing contamination by having robot-only areas
  • Performing repetitive tasks to perfect efficiency, increase productivity and eliminate human error
  • Retooling and refitting a robotic ensemble to perform different tasks
  • Automating high-throughput screening (HTS) for chemical or biological compounds
  • Scanning products to identify potential counterfeits

“Robots provide improved reliability and result in fewer rejects and material waste,” the TWB report concludes.

Smart Contracts and the PSC

Administrative expenses are a significant part of PSC expenses, which add 7% – 8% to the final cost of a pharmaceutical product, a report by Exyte claims. Administrative staff is required to handle invoices and send payments. These processes are automated when using smart contracts that automatically execute using a transactional computing protocol when stated conditions are met.

However, these contracts use blockchain technology to, “verify, validate, capture and enforce agreed-upon terms between multiple parties,” Finextra states.

Summary

As businesses strive to increase their efficiency and performance, increasing diversity in terms of raw materials sources, APIs, using software to help manage operations with robots and other forms of automation on both factory and warehouse floors continue to rank high among emerging pharmaceutical supply chain trends.

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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.

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Covid-19 Impacts on the Pharmaceutical Supply Chain

Covid-19 Impacts on the Pharmaceutical Supply Chain

Covid-19 Impacts on the Pharmaceutical Supply Chain 1821 674 Xcelpros Team

Introduction

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

Figure: 1Covid-19 Impacts on the companies

Covid-19 Impacts on the companies

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

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

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

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

By the Numbers

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

Supply Chain Effects

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

Key risks in procurement cited by Deloitte are:

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

Key risks for planning include:

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

Logistics and transportation risks cited by Deloitte include:

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

Export risks are:

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

Continuing Effects

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

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

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

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

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

Covid-19’s Impact on Regulatory Practices

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

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

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

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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.

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Streamlining Production Process in Pharmaceutical Manufacturing

Streamlining Production Process in Pharmaceutical Manufacturing

Streamlining Production Process in Pharmaceutical Manufacturing 2400 900 Xcelpros Team

At a Glance

  • There’s a consistent demand for scaled capacity when it comes to pharma manufacturing as healthcare demand continues to rise globally.
  • Cost-savings, shorter turnaround time, and enhanced productivity are some of the key criteria for top executives in pharma manufacturing companies.
  • Automation of production lines, minimizing raw material wastage, stakeholder synchronization, optimized resource allocation, etc. are some of the ways with which pharma manufacturing can be streamlined.

Around the world, we continue to see rising demand for access to quality healthcare. Side-effects of the recent pandemic significantly added to this demand. This has placed a lot of pressure on pharma and biotech manufacturing companies, who are finding it difficult to:

  • Streamline research and development (R&D) processes.
  • Reduce overall costs and improve time to market.
  • Ensure 100% safety and regulatory compliance.
  • Enhance production capacity.
  • Expand market reach.

Pharma manufacturers are having to constantly up their game when it comes to R&D, operations, production, and distribution with newer technologies and strategic business moves. With signs indicating the industry is poised for extraordinary growth, it’s becoming a given that manufacturers will need to invest in leaner, more agile production processes.

According to the 2020-2027 Pharmaceutical Market Size Report, by Grand View Research, the global pharmaceutical manufacturing market size was valued at USD 324.42 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 13.74% from 2020 to 2027.

These growth stats put focus on the need for ramping up production without compromising on safety, all while ensuring consistent profitability.

Key Factors and Processes in Pharma Manufacturing

Before we look into the ways with which manufacturing in pharma companies can be streamlined, it’s essential to consider some of the key processes involved.

1.Robust R&D: For pharma and biotech companies, continued investment in the laboratories is essential in ensuring long-term success. With Robust R&D comes increased chances for innovation, which can define a pharma company’s overall market position in terms of being the first to manufacture a ground-breaking formula. Strategic movement towards streamlined manufacturing begins with ensuring superior, quality research in the labs.

2.Raw Material Acquisition and Distribution: Whether it’s small-molecule or biological drugs, pharma companies are typically dependent on an intricate network of raw material manufacturers and their distributors to acquire safe and superior quality products. In addition, complex formulations require compounds manufactured across multiple facilities to be stored and transported in optimal conditions. Manufacturers could be dependent on multiple, different suppliers for raw materials globally.

3.Managed Production Lines: Today, pharma companies are more dependent than ever on fast-paced production lines backed with technology-enabled batch manufacturing, serialization, and traceability. Bridging the gap between hardware and software for streamlined drug production can make a huge difference in speed to market.

Pharma Manufacturing Process Issue/ Roadblocks How Technology Can Help
R&D Prone to human error, slower processes Automated data integration and analysis, AI for molecular identification
Supply Chain Highly complex, data discrepancies or duplication, missing information, stock-outs Centralized SCM for real-time visibility, centralized data access, real-time stakeholder communication, inventory management in ERP
Drug Manufacturing/ Production Shop floor to top floor communication glitches, communication time-gaps, human errors in reporting/ record maintenance Automated production lines, report generation in ERP, real-time communication between shop floor and top floor
Quality Control Counterfeits, fake drugs, human errors, formulation errors Computerized serialization, use of blockchain to ensure drug safety

4.Competent Supply Chains: Healthcare is a global business and now more than ever, pharma manufacturers are dealing with complex supply chains involving multiple stakeholders spread worldwide. Ensuring that these supply chains are competently managed is critical to ensuring overall streamlining of pharma manufacturing.

5.Quality Checks: When it comes to drug manufacturing, anything less than 100 percent is often unacceptable. Pharma companies are well aware of the perils of lawsuits, license cancellations, and other dire consequences when it comes to quality management. At every stage of pharma manufacturing, quality checks are paramount to ensuring drug safety and compliance with all required healthcare regulations.

How Can Pharma Manufacturers Streamline Their Production Processes?

Pharmaceutical companies are embracing newer and newer technologies for quicker results, better process management and enhanced productivity. Still, there’s a lot more that pharma manufacturers and their CDMOs can do in order to enhance the overall pharmaceutical production process, for significantly better results.

  • Integrating new technology in the lab is proven effective in accelerating research and innovation. Leveraging Big Data and Analytics for data collation, integration, and insights generation from clinical trials can not only expedite the process but also ensure accuracy and transparency. Similarly, computational permutations are effective in molecule identification for a particular drug. Gene sequencing, digital record maintenance, computerized medical equipment, etc. are becoming game changers in strengthening R&D, along with the production process typical in pharma manufacturing.
  • Pharmaceutical shop-floors can and should be well-integrated with the IT infrastructure on the top floor. By embracing software-managed production lines, manufacturers can leverage automation for faster and error-free processes. Similarly, production supervisors can benefit from the automated data flow from an Enterprise Resource Planning (ERP) system to and back from the production lines. Tasks like reporting and serialization can be managed by this software to save time and cost.
  • Newer technologies and software for SCM are becoming pivotal in helping pharma companies stay on top of complex supply chains and distribution networks. IoT solutions are being leveraged in pharma manufacturing and distribution for real-time monitoring and communication. Better shipping times and inventory management become possible through effective data analysis. Many companies are also making use of blockchain to ensure data security and encryption while managing the complex supply chain networks globally.
  • Use of blockchain and comprehensive ERP software (for serialization) are also helping manufacturers in ensuring drug safety. Since these tools and technologies provide the option of complete traceability (from production to patent), drug counterfeits become extremely difficult, if not impossible. Drug quality and safety is one of the major concerns for manufacturers and optimal use of technology can ensure quality checks thereby saving efforts, costs and time.

Pharmaceutical manufacturers are embracing newer technologies for better production and profitability. With these technological advancements, companies would be able to achieve their manufacturing goals without compromising quality and safety.

Key Takeaways

  • Newer technologies and software such as IoT, Artificial Intelligence, Data Analytics, SCM and ERP are playing important roles in streamlining manufacturing processes in pharma.
  • Pharma companies need to technologically reinvent themselves to keep up with the complex and ever-expanding canvas of global healthcare.

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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.

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Warehouse Management Challenges in the Pharmaceutical Industry

Warehouse Management Challenges in the Pharmaceutical Industry

Warehouse Management Challenges in the Pharmaceutical Industry 2400 900 Xcelpros Team

At a Glance

The pharmaceutical industry faces some unique warehouse management challenges. Many of these issues can have a dramatic impact on medications, even though they may not exist in industries such as general retail.

Key issues facing warehouse managers are:

  • Keeping portions of their facilities at the correct temperatures to prevent medications from spoiling.
  • Following federally-mandating good manufacturing process rules.
  • Security issues for products and intellectual property.
  • Inventory controls.

Warehouse issues specific to the pharmaceutical industry include:

  • Temperature control: Active pharmaceutical ingredients (APIs), precursor chemicals and manufactured drugs frequently require controlled temperatures. A general temperature range for a cool, dry place is between 59-77° F (15-25° C). Some products such as vaccines may require freezing. Exposing drugs to temperature outside their effective ranges can cause chemical changes and reduce a drug’s effectiveness. For example, Baystate Health states that medications containing hormones do not work as well when exposed to colder or hotter temperatures.
  • Humidity control: Moisture condensing inside packages can impact a medication’s effectiveness. Baystate Health states that blood glucose strips exposed to humidity will give inaccurate readings.
  • Light exposure: Exposure to ultraviolet light from the sun and other sources can change the chemical structure of some medications. The light exposure causes photodecomposition, reducing the medication’s potency. Light exposure can also cause side effects after administration such as phototoxicity and photoallergy, a 1997 post in PubMed states.
  • Adhering to the Food and Drug Administration (FDA) Current Good Manufacturing Process (CGMP) standards for warehouses, processes and drugs. This includes keeping careful track of item locations within the warehouse.

According to Kanban, the FDA’s CGMP warehouse standards include:

  • Contamination prevention: Storage must allow inspection and cleaning.
  • Identification: Each drug must have a unique, traceable code that identifies the lot’s status, such as approved, quarantined or rejected.
  • Distribution Procedures: Written procedures describing the distribution process for each drug including recalls.
  • Storage Procedures: Written procedures describing the storage conditions for each drug are required.

Some pharmaceuticals require only temperature controls for specific ranges. Other medications require climate controlled environments affecting temperature and humidity.

Figure: 1Pharmaceutical Warehouse Management Challenges

Pharmaceutical Warehouse Management Challenges

Following GMP Rules

GMPSOP states that following the Good Manufacturing Process (GMP) rules enables manufacturers to:

  • Protect medicines and raw materials for medicines during storage
  • Prevent finished product degradation
  • Avoid contamination from other materials
  • Prevent damaged or expired product from being shipped

Warehouse managers also face the challenge of keeping track of three types of items appearing on the packaging bill of materials governed by GMP procedures. Each of these item types requires unique lot numbers:

  • APIs, precursor chemicals and other starting materials
  • Packaging materials
  • Printed materials

All warehouse managers face inventory control requirements. Those in the pharmaceutical sector also deal with intense government scrutiny.

Receiving Shipments

Other GMPs in the pharmaceutical industry require materials arriving from suppliers to be reviewed based on their use. For example, check starting chemicals to confirm they are:

  • From a source approved by the company
  • Free of damage and defects
  • Labeled with all required information
  • Have a unique identifier
  • Registered in the company’s inventory database
  • Quarantined until quality control tests are performed
  • Stored appropriately and safely, such as in a temperature controlled section or “Dangerous Goods” area for flammable and toxic materials

Unlike retail goods warehouses, pharmaceutical warehouse managers should also set aside an area for raw materials that have been tested and confirmed to meet all required standards. A similar section should exist for any materials that fail these tests GMPSOP states.

Sampling and Testing

Sampling and testing should be done in a room having sections with positive air pressure (i.e., the air pressure is higher than that outside, preventing contaminants such as dust, microbes, pollen, cleaning agents and lubricants from entering) and negative air pressure (i.e., the pressure is lower than that outside to prevent materials from inside the room going outside). An airlock with positive pressure keeps out external contaminants. With the airlock sealed, the inner testing can have negative air pressure to keep chemicals from contaminating the larger warehouse.

Other sampling room requirements include clean instruments and appropriate personal protective equipment (PPE) as required by the federal Occupational Health and Safety Act (OSHA) and the FDA. OSHA has a downloadable brochure on warehouse safety.

Storage and Tracking Inside the Warehouse

“Lack of control over material movement in the warehouse can, and has, led to defective products,” GMPSOP states.

General warehouse practices (GWP) require that:

  • Received unused goods and finished products are quarantined until approved for release
  • Items have correct status labels (e.g., current, expired, etc.)
  • Unique identifiers are clearly visible
  • Products are stored by type when appropriate
  • Access to toxins and addictive drugs or chemicals is stored separately. Access is limited only to approved personnel
  • Materials are tracked as they move through the production facility from the Receiving area to Production and then to Shipping

When possible, warehouse managers should have separate sections to store damaged or returned goods, recalled items, “not for sale” samples and when identified, counterfeit materials.

Labeling

Another challenge for pharmaceutical warehouse managers is accurate labeling.

GMP rules require labels to include a standard name and Unique Identification Number that must be different from the supplier’s lot number. The UIN must be recorded in the lab, on the facility’s computer system and in production.

GMPSOP suggests not referring to the IUN as a batch number.

Other unique to pharma labeling requirements are:

  • Expiration dates
  • Barcodes for additional tracking options
  • Status indications, typically in the form of a color code
  • Quarantined products
  • Items being held for investigation
  • Rejection labels when an item fails to meet required standards
  • Approval and/or release labels indicating the item can proceed to the next step in the supply chain

Security Challenges

Medicines and other pharmaceutical products are in high demand, making them tempting targets.

Warehouses should have secure physical storage areas for raw materials and finished products.

In addition, Avcostar states that the formulary, drugs and drug components are expensive and prone to theft. It suggests performing a risk analysis audit that includes where known security breaches occurred. “The company can then focus on identifying and eliminating the most vulnerable posts and systems against malicious access, modification or deletion of data, enhance access control to systems and data and implement new cybersecurity best practices,” Arecont Vison Costar VP of Marketing Jeff Whitney states.

The code of federal regulars 21 CFR Chapter 1 requires control of all production stages, including system validation and audit trails. Refer to this article from Cornell Law School for detailed information.

Solving Challenges

Effective use of warehouse management computer systems such as the warehouse management module in Microsoft Dynamics 365’s Supply Chain Management can help keep accurate track of inventory management in pharmaceuticals and manage these challenges.

The module, “has a wide range of features to support the warehouse facility at an optimal level at any time,” Microsoft states.

Among the warehouse module’s function are:

  • Workflow support
  • Using mobile devices
  • Full batch and serial item support
  • Label printing and routing

Summary

Pharmaceutical warehouses management can have unique issues, issues not found in other businesses. One of them is following FDA regulations related to warehousing known as GMPs. Using effective warehouse management software will help chief financial officers and warehouse managers prevent and resolve these issues.

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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

Batch to Continuous Manufacturing in the Pharma industry

Moving from Batch to Continuous Manufacturing in the Pharmaceutical industry

Moving from Batch to Continuous Manufacturing in the Pharmaceutical industry 2400 900 Xcelpros Team

At a Glance

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

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

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

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

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

Continuous Manufacturing and Its Impact on the Pharma industry

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

Figure: 1Batch Manufacturing vs. Continuous Manufacturing

continuous manufacturing vs batch production

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

3 Hurdles Implementing Continuous Manufacturing

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

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

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

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

The Right Path for the Pharma Industry

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

Key Takeaways

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

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