Quality Control

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

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Lasting Effects

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

  • Kay Schmidt of Catalent said finding vaccines and target therapies for Covid-19 has boosted demand for their services. The increased demand, “has led to greater collaboration and innovation between partners, regulators and throughout supply chains to meet key milestones”. This boost to business requires additional planning and communication to ensure resource allocation for multiple programs.
  • James Rogers of Sterling said, “The impact of the global pandemic has exposed the fragility of the pharmaceutical supply chain.” He predicts that supply chain resilience and reliability will be given the same importance as price when developing future supply strategies.
  • Danita Broyles of U.S. Pharmacopeia is quoted by Contract Pharma as saying, “the decrease in on-site inspections has the potential to increase quality risks to the global supply chain,” adding pressure to manufacturers and suppliers to ensure the quality of their products.
  • Ben Wylie of ChargePoint Technology said that, “many governments are now pushing the industry to rethink its model to safeguard drug production.” He cited a program in India to reduce reliance on China for critical drugs and APIs.

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

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

Among the changes forced on drug manufacturers includes a more decentralized approach to collecting patient information and rapid access to regulators, Dr. Brown said. This includes pre-investigational new drug meetings with the FDA now granted in less than 30 days. The FDA has also taken steps to accelerate the review and start of new studies.

Flagging potential obstacles and safety concerns during these early meetings lets pharmaceutical companies move faster into human trials, he explained.

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

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

How choosing the right ERP system can boost your company's growth

How choosing the right ERP system can boost your company’s growth

How choosing the right ERP system can boost your company’s growth 1202 452 Xcelpros Team

Introduction

According to the latest Mckinsey research, agile organizations are healthier and more likely to meet long-term performance KPIs than their counterparts. Moreover, such organizations are more likely to achieve:

  • greater customer centricity,
  • faster time to market,
  • higher revenue growth,
  • lower costs, and
  • a more engaged workforce.

One way to improve the agility of your organization is to employ an ERP solution. Here we explore the advantages of utilizing an ERP system and outline five ways the right ERP system can improve agility and help you grow your business.

40%

of all companies won’t survive in the next ten years if they fail to figure out how to change and transform their business to accommodate the latest technologies.

Source: East Innovations

Benefits of Implementing an ERP Software Solution: Key Areas

Enterprise resource planning (ERP) as a business process management tool can enable organizations to manage day-to-day business activities like:

  • accounting,
  • procurement,
  • marketing,
  • human resources,
  • project management,
  • risk management,
  • compliance, and
  • supply chain operations.

The right Enterprise resource planning software application allows these different departments to communicate and share information with the rest of the company.

Figure: 1Different departments integrating through an ERP

Different departments integrating through an ERP

In other words, ERP software helps your business by making it easier for different departments to cooperate with just one interface.

Book a free assessment to learn about the right ERP system for your company.

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5 Ways a Modern ERP Can Help You Grow Your Business

Large ERP solutions often slip to the bottom of IT management’s agenda, but the growth benefits of ERP solutions—seamless, end-to-end integration across functions and business units—make them a fundamental asset for most large companies.

Moreover, the next generation of modern ERP solutions offers even more promising capabilities, both functionally and technologically. Below we explore just a few of the ways a modern ERP can help you grow your business.

Enhanced Insight and Visibility

ERP software provides complete access to important business processes by making data from different departments easily accessible to senior management. It provides a birds-eye-view of daily business operations like:

  • Financial Accounting
  • Management Accounting
  • Human Resources
  • Manufacturing
  • Order Processing
  • Supply Chain Management
  • Project Management
  • Customer Relationship Management (CRM), and
  • Data Services.

The boost in visibility enables decision-makers with the information they need to not only control daily operations but also improve inefficient processes and reveal opportunities for growth.

Better Reporting and Analytics

Accurate and complete reporting helps businesses plan, budget, forecast, and communicate the state of operations to the organization and other interested parties, such as investors and shareholders.

ERPs make big data and big business a good match because they enable your team with a single, unified reporting and analytics system for every process. You also enable your team to analyze and compare functions across departments, without the hassle of multiple spreadsheets and emails.

Greater Efficiency and Performance

By linking far-flung departments, ERP systems make it easier for your team to interoperate. The easier it is for your team to interoperate, the easier it will be for them to produce high quality work, and perform at their best.

“Higher the efficiency, the higher the profitability!”

Properly implemented, an ERP software suite can greatly reduce or eliminate repetitive manual processes, which frees up your team to focus on revenue-generating tasks. ERP systems can also aid in the adoption of industry best-practice, and alignment across the organization.

Stronger Data Security

ERP software improves data security by limiting input to a single system, thus eliminating the avenues by which a hacker could infiltrate the system and/or steal information. Both on-premise and cloud-based ERP systems provide a higher degree of security than the alternative, i.e., merging information from multiple systems.

Additionally, most ERP software runs on a single database system, which enables centralized backups of your critical and sensitive data.

Improved Supply Chain Management

The feature-rich working environment of an ERP suite provides a range of important supply chain advantages and play a key role in several aspects of the creation and maintenance of a superior supply chain management process, including:

  • Supply Chain Planning – ERP systems offer an easier and more flexible way to establish and alter the supply chain parameters.
  • Purchasing, Procurement and Execution – ERP software applications provide a more effective way to manage the procurement and supply of goods, services and other resources that are needed to operate a successful supply chain.
  • Monitoring and Maintenance – The ability to monitor, review and alter supply chain efforts and activities in real-time is essential for ensuring your business can maintain the flexibility needed to stay competitive and ensure cost-effective operations.
  • Measurement and Assessment – ERP systems offer superior information aggregation and organization, which makes it easier to identify and address undesirable variances throughout the supply chain.

How to Choose the Right ERP System

There is no one-size-fits-all ERP system for every business, but there are features that distinguish it from other types of business software, including:

  • Common database – Most ERP advantages stem from a common database that enables organizations to centralize information from numerous departments, and eliminate the need to manually merge separate databases.
  • Single user interface – ERP systems provide the same user interface (UI) and have a similar user experience (UX) across all departments and roles. In other words, everyone uses the same interface and sees the same thing when they interact with the software.
  • Process Integration – The right ERP system will enable your team to unify a diverse set of processes, and connect workflows that play crucial roles in the company’s success.
  • Automation – A basic feature of most ERP systems is the ability to automate repetitive tasks like manual data entry, which saves time, improves efficacy and minimizes human error.
  • Data Analytics – the most valuable aspect of an ERP is how it breaks down information silos, enabling your team to mix and match data from any part of your business into insightful reports.

Conclusion

The prospect of streamlined business functions and major boosts to productivity make ERP systems a good investment for any business owner. But which ERP system is right for your business? The answer to that question depends on your business.

Ultimately, the ERP system you choose for your business should not only make work easier, but also enable your team with the tools, time and information they need to improve business processes and set your company on a trajectory for growth.

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

Modern Methods to Best Manage Pharmaceutical Quality Control

Modern Methods to Best Manage Pharmaceutical Quality Control 1920 1080 Xcelpros Team

At a Glance

  • Quality control processes in the pharmaceutical industry are known for their rigorous and meticulous nature. It is of utmost importance to maintain the highest safety standards during drug manufacturing and managing pharmaceutical products.
  • With Industry 4.0, automation, Big Data, Machine Learning, Artificial Intelligence and systematic operations management, different Enterprise Resource Management (ERP) tools have become integral in the pharmaceutical quality control processes.
  • Advanced technology is undoubtedly becoming the backbone of futuristic quality assurance in the pharma and biotech industry.

The pharmaceutical industry stands at a pivotal conjunction point of technology and subject matter expertise. With times changing fast, the pharma sector’s processes and operations evolve to enhance accuracy and reduce efforts and time consumption. However, quality control is a highly complex field where the slightest of errors can lead to severe health consequences. At pharmaceutical companies, scientists and top executives look at the latest technologies like complete digitization of operations, automation at manufacturing units, and Big Data and Machine Learning to maintain records.

The (pharmaceutical) industry increasingly wants more out of their data, and the focus in manufacturing data analysis is about quality, not quantity.– Joe Haugh in an article for the European Pharmaceutical Review

The ongoing Covid-19 pandemic and the ensuing search for a vaccine has shown the world that with the help of technology, it is possible to witness a never-seen-before feat of producing a potential vaccine candidate in mere months for a novel virus. Even the numerous clinical trials and related reporting are performed unprecedentedly with the latest tools. Manufacturing and supply of potential drugs to even the remotest parts of various countries are plausible with robust ERP models and streamlined supply chains.

Figure: 1Pain Points: Quality Control in the Pharmaceutical Industry

Let us take a deep dive into understanding the different ways technology helps reshape methods of quality control in the pharma sector.

01.The Automation Effect: Mitigating Errors, Reducing Process Time and Saving Efforts

Businesses have discussed automation in pharmaceutical manufacturing for a long time, but this technological advancement is a boon in quality control. Pharmaceutical companies can leverage automation within quality assessment by reducing manual documentation efforts to cut margin errors and automatically carry out a quality check for batches or samples.

02.A Robust ERP System: The Way Ahead for Comprehensive Quality Control Process Optimization

Quality control happens at various stages throughout a drug’s lifecycle. This involves different stakeholders spread across multiple departments and most probably other locations. Conventional methods or legacy systems involved manual record maintenance, report generation and communication, leaving scope for errors. The traditional approach also was highly time-consuming. Companies can effectively address the issues with a robust ERP system. A system that provides a centralized database visible to all stakeholders in real-time helps drive better business decisions. The system should leave no scope for communication gaps and help align business objectives with workforce activities. Through report generation and data analysis within the ERP system, companies can make adjustments to operations and subsequently improve productivity.

03.Internet of Things (IoT): Creating a Centralized Database for Enhanced Visibility in QC Labs

Most traditional quality control departments in pharmaceutical companies involve manual work where Quality Control and Quality Assurance work in tandem. However, the cumbersome nature of the job at hand- manual documentation, record maintenance for individual drug components, random testing records, call-back records, etc. creates caveats and increases error margin. IoT helps create a blueprint for various processes through device integration to feed in respective data and insights. This helps in maintaining transparency across all levels of quality control and pharmaceutical quality assurance processes.

04.Digitized Change Control Management: Fast-tracking Quality Assessments in Case of Any Changes

Drug manufacturing is subject to changes throughout its lifecycle. In a conventional QC lab, these changes are recorded and communicated manually to various stakeholders, who then carry out respective tests and derive insights. These insights also drive changes required on a work in process batch. With the help of a digitized ERP system, changes can be communicated in a central system and all the stakeholders can evaluate real-time quality data. This expedites the quality assessment process and helps record maintenance quickly refer to relevant documents during quality inspections.

05.Automated Data Analytics: Applying Machine Learning to Derive Insights

Quality control techniques in pharmaceuticals involve working with precise data. With machine learning and automated analytics, pharma companies can leverage the same amount of data to generate maximum insights.

What does Quality Control in Pharmaceutical Look like in Microsoft Dynamics 365 ERP?

The evolution of Dynamics 365 to a customized, purpose-based system makes it a comprehensive solution for a quality control pharmaceutical lab. It creates a central database, alerts all stakeholders of defects, helps in record maintenance and instant report generation. With Microsoft Dynamics 365 Finance and Operations, life sciences companies can manage in-coming/ in-process inspections for batch and continuous manufacturing. Track and trace functions enable pharma companies a base for better inventory management and can be especially helpful during drug call-backs, in case such a situation arises. On top of the Integrated quality management that includes SOP, CAPA, Deviation functions will help Pharmaceutical companies manage Quality compliance.

Key Takeaways

  • The pharmaceutical industry is cautiously yet steadily adapting to technological advancements. With advanced quality control, pharma companies can make great strides in assurance, uniformity and transparency.
  • Advanced technological applications are must-haves to address the pain points in pharmaceutical quality control.
  • The fast-paced, demanding world of drug manufacturing requires a fast-track yet highly stringent quality control mechanism, which is made possible through cutting-edge technologies and tools.

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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

Pharmacovigilance Importance

The Importance of Pharmacovigilance During a Pandemic

The Importance of Pharmacovigilance During a Pandemic 1440 810 Xcelpros Team

At a Glance

  • The World Health Organization (WHO) has always emphasized providing the most effective drug that does not cause severe adverse effects.
  • An understanding of adverse effects and how to prevent them by assessing the right chemicals, quantities, and processes in drug/ vaccine manufacturing is a must.
  • There are several digital solutions and services available today designed to help the top scientists and decision-makers in the pharma companies in their pharmacovigilance journey.
  • Both now and after the Covid-19 pandemic, organizations worldwide will need to place significantly more focus on drug quality checks to avoid any mistakes caused by rushing the process as we return to ‘normal’.

Today, terms like ‘clinical trials,’ ‘safety assessment tests for vaccines,’ and ‘FDA approvals’ are trending due to COVID 19. While these terms have always been a part of any pharma and biotech manufacturing companies’ pharmacovigilance protocol, the pandemic at hand has brought them light. Most of us are curious about why it takes so long for a drug or vaccine to get approved for mass use, and rightfully so. The answer lies in the principles of pharmacovigilance.

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.

The Primary Goals of Pharmacovigilance Guidelines

  • Assessing short term and long term adverse effects of a drug
  • Continuously collate and monitor the safety-related data of a particular drug
  • Perform risk v/s benefit assessment of the drug to make a guided decision on the administration of the drug
  • Two-way communication of the data about any Adverse Drug Reaction (ARD) between health professionals and clinical researchers to maintain transparency at all levels
  • Intervention by medical bodies/ pharma companies whenever required to prevent an unsafe drug’s distribution and administration

Pharmaceutical companies require a team of professionals to carry on this constant quality check journey for their drugs. This team can consist of scientists, clinicians, biochemists, physicians, and medical writers. Their job is to collect, collate, analyze, and assess every drug’s safety profile data. However, for a task that requires constant alertness and an unprecedented level of agility for accurate and quick response, manual applications are no longer enough. Pharmacovigilance plays an important role for pharma and biotech companies to use it as a solution. This solution should be smart enough to aid in centralized data collection, analysis, and run AI-based programs for drug composition analysis, safety profile mapping, and other crucial steps required for quality checks.

Pharmaceutical companies need to follow a wide range of processes to ensure their pharmacovigilance is up to standards. Any negligence or oversight can lead to severe fines, injuries, or even death.

According to a paper by Elizabeth Ndichu, MD, and Kevin Schulman, MD, The scope of the problem of poor-quality drugs transcends national borders because the manufacturing and supply chain of medical products thrives in an international market.

To comply with the quality standards and still meet the demands of fast-track drug development and clinical trials (especially in the times of a global pandemic), pharmaceutical and biotechnology firms need to strictly adhere to the process for end-to-end pharmacovigilance, which can include, but not limited to:

  • Carrying out detailed patient surveys for different age groups, geographies and of varying health conditions
  • Appointing pharmacovigilance consultants and experts (either in-house or third-party) to manage the intricacies of this journey competently
  • Making use of extensive databases to support technological platform such as Microsoft Dynamics 365 for the pharmaceutical industry to ensure error-free data maintenance and analysis along with report generation
  • Keeping all the stakeholders in loop at all times to avoid any oversight
  • Maintaining records of different pharmacovigilance solutions, especially products other than medicines such as cosmetic goods, nutritional supplements, and dietary products
  • Formulating a plan for intervention, mitigation, assessment, and resolution in the event of drug quality issues

Figure 1:Digital Ecosystem: Pharmacovigilance

Pharmaceutical companies will also need to be nimble in their approach towards pharmacovigilance. Leveraging technology for streamlining safety procedures and quality checks is not a matter of convenience, but an absolute necessity.

Solutions like Microsoft Dynamics 365 Finance and Supply chain provide Quality Control functionality and a way to enter, track, and report quality test results. This makes it easy to leverage technology to streamline quality check operations.

Using these solutions can pave the way towards regulatory compliance, stringent component mapping, and monitoring of a drug’s safety profile and reduce manual intervention for pharma personnel, allowing individual case safety reports (ICSRs) to be performed with ease. Microsoft Dynamics 365 is a comprehensive solution that forms an ecosystem for all stakeholders involved by mapping a drug’s safety profile with intervening bodies.

Different departments can use these systems, clinical researchers, scientists, medical writers, physicians, medical representatives, state-owned drug governing bodies, and more, and are usually considered one of the best investments a company can make today.

Key Takeaways

  • Technologically-enhanced pharmacovigilance is the need of the hour for pharmaceutical companies.
  • Globally, the pharma sector is transforming, and this needs collation of medicinal data at a global level to map drug safety across geographies.
  • Forming a blueprint to follow the pharmacological journey is imperative for any pharma and biotech company.

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

Customer Journey VP of Quality Control

Customer Journey VP of Quality Control 1440 810 Xcelpros Team
PHARMACEUTICAL QUALITY CONTROL

Pharmaceutical Quality Control – Improving Methods & Systems

Pharmaceutical Quality Control – Improving Methods & Systems 1920 1080 Xcelpros Team

At a Glance

  • The definition of quality has evolved with changing business dynamics, particularly in regulated industries such as pharmaceutical, chemical, and food & beverage.
  • The Pharmaceutical & Drug industry witnessed a 168% increase in drug approval by the FDA in 2018 compared to 2016, testifying the growing quality adherence among manufacturers.
  • Compliance to quality guidelines is only getting more stringent with time. Pharmaceutical & Drug industry also saw high rejection (73) through 2018 including Recalls, Market Withdrawals, & Safety Alerts, highlighting the importance of quality standards set by the industry watchdog.
  • While quality is increasingly becoming an integral part of modern-manufacturing practices, our research revealed that some organizations continue to devalue the importance of quality to a mere afterthought.

Introduction

Quality plays a pivotal role in the success of a business and is no longer considered an impediment to a successful business. It’s often that the release of a product for shipment is delayed due to standards not being met, causing stress on the customer service reps working closely with Customers.

Saying yes to sub-standard ‘products to the market’, however, are catastrophic, with damages that could at times be irreparable. Companies that are embracing modern-day Quality Management are supporting technology initiatives. Successful businesses ensure that the right systems are in place to allow a product to pass all quality checks.

This article highlights a small section of Quality Management related to processes and systems. The intent is to help businesses understand how technology has evolved with the changing business landscape and how manufacturers (in any highly regulated industry) can leverage technology such as the One-Microsoft ecosystem to stay relevant, and ahead of competition. In this article we will discuss Quality Management holistically, and follow it up with the finer aspects of Quality Management in subsequent posts.

FIGURE 1 Classification of Quality Management

The Evolution of Quality Management

Quality management has evolved from being an afterthought to becoming a rigorous self-discipline that most modern-day manufacturing companies have taken onto themselves. What used to be quality control in the 1960s has evolved to become “total quality control” in its present form. The US FDA is tightening its norms to ensure higher quality standards, and companies are responding to such challenges by increasing their quality standards. The below timeline depicts how the definition of quality has evolved over time since the 70s.

FIGURE 2 The Evolving Definition of Quality Management

Process Improvements in Quality Control

Improvements always start by first understanding the issues that reside in a department. Following are some typical activities in the Quality control department of a Pharmaceutical company:

  • Manage Quality control tests
  • Manage Quality control specialists and their workload
  • Allocate and calibrate test instruments
  • Establish appropriate test methods
  • Document test specifications
  • Perform tests in the order of priority and
  • Accurately record test results.

Trending and analysis, as well as stability studies, would be a follow up of quality data that is captured for understanding the reliability of manufactured batches. This is just a quick and simplified view; in reality, all of the activities listed above have many details involved. Ensuring that all processes and procedures are handled with precision ultimately reflects on how well you are able to maintain the quality standards.

Processes in the Quality Department

A typical day in the life of a Quality control department could start with lab analysis and paper requests to perform quality tests on a sample batch size. At times it could be multiple batches for different products that are either produced in-house or received from 3rd party manufacturers. The Quality lab prepares test instruments for each test and accurately records the test results along with any digitally signs-off for each work order. If we were to take a quick view of what is involved in ‘getting it right’, our understanding of all essential requirements for an optimal quality process could change.

Use cases with digitization and automation have demonstrated a more than 65% reduction in deviations and over 90% faster closure times.” The Future of Quality Control, Pharma Manufacturing

It involves having all the SOPs opened up in front of you to perform a test with precision and not allowing any deviation in process unless the ‘method to deviate’ is clearly spelled out. It is challenging to hold the people in your department compliant to a process unless there is a stringent system in place. If the system is paper-based, you are adding laborious tasks with corrections and piled up paperwork. Every time an audit occurs, it would require digging through so many stacks of paper to bring out the right answers.

FIGURE 3: A Central Filing System to Manage Documents and Information

Quality Control Systems

Pharmaceutical companies that are implementing an electronic system need to decide how tightly the system has to be built. The process could add discomfort to users due to various systemic restrictions, or an uneasiness around user errors.

People could start feeling anxious about making mistakes, as every change would have a digital stamp tied back to the person modifying the data. It could also get a bit cumbersome to fix errors in retrospect while using a controlled and validated system that is 21 CFR part 11 compliant.

The idea is not to add discomfort but to build the right kind of habits in users. Ideally business users need to be given enough information about how the overall system works. A well-planned training plan can help the users move from discomfort to being champions – promoting the process in the organization.

Anyone with a basic understanding of compliance would prefer an electronic system instead of a paper-based process, for the strength and ability to capture data as is. It then requires a change in mindset of ‘ continuously fix errors’ to ‘proactively do it right in the first place’. At the end of the day you want to foster efficiency in your whole organization. This can be achieved by evaluating a reliable process that could be quickly adapted by your department.

Elimination of up to 80% of manual documentation work will improve productivity. The Future of Quality Control, Pharma Manufacturing

Quality Management Challenges – What Does a Plant Manager Look for?

A Plant Manager would have a specific view of the business as their purview is not restricted to one department but to the overall operations of the plant. Some key concerns that typically need to be addressed by a Plant Manager or a General Manager of Plant are:

  • Quality Management
  • Compliance with evolving regulatory standards
    • Take control of your Documentation such as COA
  • Safety
    • Corrective and Preventative Actions management (CAPA)
    • Location directives
    • Raise flags when two reactive chemicals are placed in proximity
  • User Adaptability and training to conform to the new Quality standards

These concerns are typically addressed by:

  • Efficient Document Management – allows you to centralize documents into a secure repository that is seamlessly accessible. This ensures quicker decision making and effective change management. It also helps in ensuring visibility of your documents, enhances traceability by tracking amendments, and document safety with revision control features.
  • Addressing Non conformance – can be done through a unified platform to log non conformance, quality of incoming raw materials, complaints, delay, etc. This helps in addressing compliance at an early stage, paving the way for course correction and registering the same in the system.
  • Corrective & Preventive Action – a method with advanced analytical features built in to help you learn and unlearn from records of the past. As discussed, registering a non-conformance incident into the system initiates a workflow for corrective measures. This system learns from past incidents and recommends preventive action to control similar incidents from recurrence.
  • Implementing the right kind of tools and technology can help with Process automation and reduce data entry errors along with tracking process efficiency.

Identifying the right system to help make the most impact will be the first essential step to move in the right direction. Once that hurdle is crossed, it is important to build a ‘to be’ mindset instead of worrying why the system doesn’t do what your workforce is used to doing. Evaluate how stringent you want your process to be, based on your company’s needs and accommodate a well-defined method that is native to the application.

Key Takeaways

  • Quality management is no longer an afterthought and has evolved to become a discipline in most prosperous manufacturing organizations. Quality management which was once considered as a business function that hindered speed to market and product launch, is now embracing modern technologies to fuel innovation, bring in efficiency, eliminate the scope of incidents within a plant, and offer better predictions for the future.
  • Pharmaceutical companies that have evolved to modern, automated quality control systems are able to empower their workforce to rapidly adopt process improvements and optimize all the functions in the department.
  • The adoption of better tools in one department typically sets the standard for the entire ecosystem, including functions such as regulatory compliance, procurement, demand management, research & development, inventory and warehouse management, etc.

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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