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Understanding the Basics of Quality Management Systems
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Understanding the Basics of Quality Management Systems (QMS)
Understanding the Basics of Quality Management Systems (QMS) 750 501 Xcelpros Team

Introduction to QMS

In our last post, we talked about the main principles of TQM, or Total Quality Management, which serve as the groundwork for modern Quality Management Systems (QMS). Today, Quality Management Systems have become the norm, often completely replacing the traditional Total Quality Management approach. The TQM process shares some common goals with QMS, but there are some distinct underlying principles.

Modern organizations have evolving needs, and a modern QMS prioritizes newer principles, such as organizational agility and transparency. QMS content and design also vary based on specific business requirements. While the components of a QMS may vary widely from organization to organization, there are some key elements which remain essential to any effective system.

Simply put, a QMS is a set of policies, procedures, and processes required to plan and execute an area of business. These systems influence an organization’s ability to meet customer needs and regulatory requirements. Therefore, an effective QMS focuses on streamlining processes, reducing errors, and increasing customer satisfaction.

Structures of Quality Management Systems

While the exact structure of a QMS can differ between organizations, certain standards must be met for it to be considered a true QMS. ISO 9001:2015 is the international standard for quality management systems (QMS), and it outlines requirements for organizations to establish, implement, maintain, and continually improve a Quality Management System.

The key requirements for a QMS, according to ISO 9001:2015, include:

  1. 1. Scope
    1. a. Define the scope of the QMS, including the products, services, and processes it covers.
  2. 2. Normative References
    1. a. Identify relevant standards and documents used as references for implementing the QMS.
  3. 3. Terms and Definitions
    1. a. Provide clear definitions of terms used within the QMS.
  4. 4. Context of the Organization
    1. a. Understand the internal and external factors that can impact the organization’s ability to achieve its objectives.
    2. b. Identify interested parties and their requirements.
  5. 5. Leadership
    1. a. Top management’s commitment to the QMS.
    2. b. Establish a quality policy and communicate it.
    3. c. Assign roles and responsibilities within the organization.
  6. 6. Planning
    1. a. Set quality objectives in line with the organization’s goals.
    2. b. Develop plans to achieve those objectives.
  7. 7. Support
    1. a. Provide necessary resources for the QMS.
    2. b. Ensure competent personnel.
    3. c. Establish communication processes.
    4. d. Manage documented information (policies, procedures, records).
  8. 8. Operation
    1. a. Plan and control operational processes.
    2. b. Establish controls for product/service requirements.
    3. c. Determine criteria for monitoring and measurement.
    4. d. Implement processes to address risks and opportunities.
  9. 9. Performance Evaluation
    1. a. Monitor, measure, analyze, and evaluate the QMS.
    2. b. Assess customer satisfaction.
    3. c. Conduct internal audits and management reviews.
  10. 10. Improvement
    1. a. Continually improve the effectiveness of the QMS.
    2. b. Correct nonconformities and take corrective/preventive actions.
    3. c. Enhance processes based on evaluation and analysis.

Figure 1:Key Features of a Quality Management System based on ISO:9001

Key Features of a Quality Management System based on ISO:9001

Revolutionizing Quality Management

Nowadays, advanced software and modern tools continue to saturate every facet of the business world. It should come as no surprise then, that more quality management / quality assurance professionals are pushing for the newest wave of QMS software solutions. Taking this approach enables them to optimize their business processes, elevating their performance to new heights. According to Harvard Business Review, companies with highly developed Quality Management Systems spend, on average, $350m less annually fixing internal mistakes than companies with poorly developed Quality Management Systems.

Implementing a Quality Management System (QMS) requires a strategic approach and commitment from all levels of an organization. An article from McKinsey states, “Quality is a value-added partner and coach that helps integrate compliance into regular operations while enabling speed and effectiveness.” With the right implementation partner, a QMS can significantly contribute to a company’s success- they are essential tools for enhancing customer satisfaction, increasing operational efficiency, and ensuring compliance with regulations.

However, these systems are not a one-size-fits-all solution; ideally, a QMS is tailored to the specific needs and circumstances of the organization it is designed for. By incorporating essential components and features for the specific business, developing an effective solution becomes a more straightforward operation.

Integrated QMS Solutions for Dynamics 365

As a Microsoft Cloud Solution Provider (CSP), XcelPros provides implementations, services, and licensing for Microsoft products. To ensure we continue providing the best possible services for our customers, we regularly review our implementations of Dynamics 365 Finance and Supply Chain Management. Over time, we recognized a trend in the growing need for QMS features which integrate directly with Dynamics, as we found most of our customers were stuck using third-party QMS solutions. This was especially true of clients in highly regulated industries, including pharmaceuticals, chemicals, medical devices, and manufacturing (CMO, CRO).

In response to these findings, we developed our own line of QMS solutions that integrate fully with Microsoft Dynamics 365, eliminating the need for third-party solutions (not only pricey, but also not very user-friendly). First, Integrated Quality Management, or iQM, makes it easy to manage complaints, CAPA, and deviations centrally within Dynamics. Integrated SOP Management (iSM) offers comprehensive functionality for authoring, maintaining, and distributing Standard Operating Procedures (SOPs). Finally, with chemical and pharmaceutical companies in mind, we created Integrated Chemical Management. iCM offers complete functionality for SDS management, label management, and DEA customer management.

For companies without a system in place for managing complaints, deviations, and/or corrective actions and preventative actions (CAPA), iQM may be the perfect solution for you. Companies who are managing labels or safety data sheets (SDS) manually or need a better system for DEA customer management will find that iCM is just the solution you have been looking for. If you don’t yet have a way to manage internal SOPs digitally, Integrated SOP Management (iSM) offers everything you need. These products work great individually, or you can choose to bundle them all into a convenient package for maximum benefit.

Final Thoughts on Quality Management Systems

Your business may already have a solution in place for managing SOPs, labels and SDS, complaints, deviations, or any of the other features mentioned above. If that’s the case, is your QMS setup for managing those issues digitally and integrated with your organizational software?

Until now, even if you were using Microsoft Dynamics 365 as your ERP, it’s unlikely that your QMS was seamlessly integrated. Chances are, your QMS is a separate system, held together by an aging string of code that’s almost as old as your organization. Or, perhaps you are still using manual processes (which is more common than you may think). Whatever the circumstances may be, XcelPros can help make your processes more efficient. Modernizing products and processes is the best way to stay in compliance with any regulatory standards your business may be held to, and to keep customers coming back for reliable, consistent, and high-quality products.

Stay tuned for our next post, which will provide more detail about XcelPros’ QMS applications and how they can help your company.

If you are ready to put a new QMS into place now, there’s no reason to delay – Schedule Demo

Effectively-Tracking-and-Controlling-Inventory
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Effectively Tracking and Controlling Inventory
Effectively Tracking and Controlling Inventory 700 500 Xcelpros Team

Introduction to effective inventory management

Especially today, manufacturers, wholesalers and retail businesses from several different industries share several standard business practices, with inventory management at the top of the list.

An efficient, capable inventory management system can distinguish between struggle and success. Any boost to the efficiency of managing your inventory can result in a significant return on investment. To drive the effectiveness of your inventory management, especially when if you’re just getting started, it helps to pay attention to 10 popular techniques:

1.Fine-tune your forecasting Accurate forecasting is a must unless you want to either tie up precious capital in product stuck on warehouse shelves or be unable to meet your customers’ orders.

2.Identify low-turn stock Have a flexible ordering approach that, combined with accurate forecasting, lets to adjust inventory based on customer priorities.

3.Regularly audit your inventory Knowing—not guessing—what you have at any given moment lets you adjust ordering to ensure a balanced inventory.

4.Track stock levels You want to track all inventory from the moment you purchase raw materials or components to when you deliver finished goods to your customer’s door.

5.Keep track of your equipment Especially in a production plant – Knowing what you have, how quickly it wears and when to schedule repairs for optimal life ensures uninterrupted production runs.

6.Verify Quality Ensure all items in your inventory meet your quality control standards, ideally from the moment they arrive.

7.Categorize inventory based on customers needs Ensure you have the most sought-after products in stock at all times, working your way down the line to the least popular products.

8.Consider drop shipping This is much quicker especially for any items you don’t make yourself, especially when it becomes part of your product. An example is a Siemens ® controller for industrial machinery.

9.Rotate your stockTurn your stock so the oldest items are sold first This is especially true for pharmaceutical products with comparatively short shelf lives.

10. Use good inventory management software A viable program that meshes with your financial and sales software helps keep everyone informed, making for happier customers.

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Figure 1:Common inventory management challenges

Common inventory management challenges

Common Inventory Management Challenges

Among the most common inventory management challenges that can affect a number of different businesses are the following:

  • Inconsistent tracking Working with older software that relies on manual data entry opens a company to data entry errors. Mistakes are bound to happen when different departments use different spreadsheets to input the same information.
  • Inaccurate data Companies need to know how much of everything they have on hand and in the pipeline. Without accurate information, you won’t be able to track your production. This can be a massive problem if you’re still manually entering data.
  • Order management Manufacturers often live on the edge of logistics, struggling to make sure deliveries are going out just in time – right before their customers need them.
  • Juggling a complex supply chain Manufacturers need alternate ways of obtaining raw materials and shipping finished products. For example, your primary port is running behind because dock workers are sick. How do you get what you need when you need it?
  • Communications and planning Intercompany communication is critical, especially in a world where companies often have business units in different countries, keeping everyone focused on the same task can be difficult.
  • Robust competition In every industry, competition is ready and willing to grab your customers when you make a mistake or find yourself unable to deliver on time and within budget.

These are a few examples of the challenges faced by modern manufacturers. Thankfully, the good news is that modern ERP solutions can be a huge help when it comes to addressing these issues.

Inventory Management Software As a Solution

Several inventory managements programs available on the market today that focus not only on addressing these challenges, but also by identifying potential issues before they can impact your operations. Some of the best solutions available, like Microsoft Dynamics 365 Supply Chain Management, can seamlessly integrate with your existing software, reducing data silos, allowing different departments to share more information. Instead of requiring three departments to input the same information into a database, each group is able to provide material unique to their specialty.

Effective inventory management programs like Microsoft can print barcodes and QR labels. When these codes are scanned with a hand-held reader or cellphone, users can be rewarded with a wealth of information. The most critical data to track are precisely how much of any product you have, where it’s being stored, and what it will be used for.

For example, you need to produce 20,000 doses of a Covid-19 treatment. Your customer needs them yesterday but will settle for next week. Do you have enough raw materials on hand to meet your customer’s deadline? If not, what can you do to obtain what you need?

Using this information wisely lets management develop complex plans, like the ability to track everything from small lots to pallet loads. A company can learn by checking an item’s progress at different points—its arrival at the warehouse, use in production, loading onto a truck or ship, and delivery to the customer. By examining reports, you can identify potential delays or roadblocks and find ways to speed up delivery.

Supply chain management software on a secure cloud computing platform like Microsoft’s Azure let’s you communicate securely and safely with other researchers, salespeople and vendors. With Azure, you’ll know that your intellectual property and contracts are safe from competitors.

Boost Decision Accuracy with Power BI

With today’s supply chains – seemingly constantly in a state of upheaval – effective inventory management that goes beyond tracking stock on hand is critical to operations. Effectively managing your inventory and raw materials ensures you’ll have the materials you need when you need them. It means having more than one source of supplies and materials. It also means constantly checking with vendors to ensure you have the goods to meet your own delivery deadlines. This is where an integrated business intelligence solution comes into play.

Microsoft Power BI let’s you connect to hundreds of data sources, preparing reports you can easily share. You can confidently deliver interactive messages to customers using information from inside and outside your company. Inventory planners can be warned of potential shortages in time to find alternate supplies. Salespeople can be told of possible delivery delays caused by outside forces, giving them time to ask the customer if they want to use a different shipping method.

Accurate business intelligence at your fingertips puts you ahead of competitors stuck using their “tried and true” methods that are becoming increasingly worthless every day.

Final Thoughts

Effective inventory management comes down to data: knowing what you have and where it is.

A modern inventory control system that supports labels and barcodes lets you track raw materials, work-in-progress and finished goods simultaneously, with high accuracy.

An inventory system with business intelligence helps you find faster and alternate ways of obtaining raw materials and pre-made products, mainly when shipping delays occur. That information can help you get your products to your customers when needed, balancing everyone’s inventory.

The importance of pharmacovigilance during a pandemic banner
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The Importance of Pharmacovigilance During a Pandemic
The Importance of Pharmacovigilance During a Pandemic 700 500 Xcelpros Team

At a Glance

  • The World Health Organization (WHO) emphasizes providing the most effective drugs that do not cause severe adverse effects.
  • Understand adverse effects and how to prevent them by assessing the right chemicals, quantities and processes in medical vaccine manufacturing.
  • Digital solutions and services are designed to help scientists and pharmaceutical company decision-makers detect, assess, understand and prevent adverse effects from their medicines.
  • Starting now, pharmaceutical companies are placing a greater emphasis on drug quality checks to avoid mistakes caused by rushing the production process.

Introduction

Today, most people are familiar with terms like “clinical trials,” “safety assessment tests for vaccines” and “FDA approvals” because of COVID-19 media coverage over the last few years. While these terms have always been a part of any pharma and biotech manufacturing companies’ quality assurance program, the ongoing pandemic has made them part of everyday conversation.

People often wonder why it takes so long for a drug or vaccine to get approved for mass use, and rightfully so. The answer however, lies in the principles of pharmacovigilance, also known as drug quality control.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Source: The World Health Organization

The Primary Goals of Pharmacovigilance Guidelines

The goals of a typical pharmaceutical quality control program include:

  • Assessing a drug’s short-term and long-term adverse effects and any harm the drug might cause a patient.
  • Continuously collating and monitoring a particular drug’s safety data.
  • Assessing the risks and rewards of the drug to make a guided decision on the administration of the drug.
  • Communicating adverse drug reactions (ADRs) data between health professionals and clinical researchers while maintaining transparency at all levels.
  • Preventing the distribution and administration of unsafe drugs by medical bodies and drug companies.

All pharmaceutical companies require a team of professionals to carry on this constant quality check of their drugs. This team can include scientists, clinicians, biochemists, physicians and medical writers. The team’s job is to collect, collate, analyze and assess the safety profile of every drug.

This task requires constant alertness and unprecedented agility for an accurate and quick response. In today’s market, manual data reviews are no longer adequate. Combining finely tuned digital tools and well-trained employees is the best way to protect patients from severe injury or death.

A drug maker’s automated quality control program should be smart enough to help collect, analyze and check data. The software equipped with artificial intelligence can check a drug’s composition, verify safety profile mapping and perform other crucial steps required for necessary quality checks.

Pharmaceutical companies need to follow a wide range of procedures to ensure their pharmacovigilance is up to government and industry standards in order to remain compliant.

“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.” Elizabeth Ndichu, MD, and Kevin Schulman, MD

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To comply with new quality standards and still meet today’s demands for fast-track drug development and clinical trials, pharmaceutical and biotechnology firms need to strictly adhere to the process of end-to-end pharmacovigilance.

  • Carrying out detailed patient surveys for different age groups, countries and health conditions
  • Using consultants and experts to manage its quality control program
  • Using software such as Microsoft Dynamics 365 for the pharmaceutical industry to help ensure error-free data maintenance, analysis and report generation
  • Keeping all stakeholders in loop at all times to avoid any errors
  • Maintaining records of their quality control policies and procedures. These records are required for medicines plus other products such as cosmetics, 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

Digital Ecosystem: Pharmacovigilance

Pharmaceutical companies need to take an agile approach toward pharmacovigilance. Leveraging technology for streamlining safety procedures and quality checks is no longer a matter of convenience but a necessity.

Solutions like Microsoft Dynamics 365 Finance and Supply Chain Management provide Quality Control functionality. Each of these computer programs has methods to collect, track and report quality test results. This software is a comprehensive solution that makes it easy to leverage technology to streamline quality check operations.

These solutions can pave the way towards regulatory compliance, stringent component mapping and monitoring of a drug’s safety profile. It reduces manual intervention by employees, allowing individual case safety reports (ICSRs) to be performed easily.

Microsoft Dynamics modules can be used by different departments by the likes of clinical researchers, scientists, medical writers, physicians, medical representatives and government drug governing bodies. These solutions for monitoring drug safety are considered one of the best investments a company can make today.

Key Takeaways

  • Technologically-enhanced pharmacovigilance is the need of the hour for today’s pharmaceutical companies.
  • The pharmaceutical sector continues to evolve on a large scale. This change requires gathering medicinal data at a global level to map drug safety.
  • Forming a blueprint to follow the pharmacological journey is a critical step for any pharma and biotech company.

References: Pharmacovigilance: Regulation and Prequalification

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

Introduction to Quality Management and Control

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

Three ways any industry can improve quality control include:

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

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

Quality Control Starts with Quality Planning

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

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

A quality plan for manufacturing ensures:

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

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

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

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

The Value of Standard Operating Procedures (SOPs)

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

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

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

The Role of Quality Assurance

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

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

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

Figure 1: The Role of Quality Assurance

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

The Role of Quality Assurance

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

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

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Quality Management Systems

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

An effective QMS helps manufacturing companies:

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

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

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

Summary – Quality Management

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

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

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

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

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

Pharmaceutical Quality Control : Improving Methods & Systems
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Pharmaceutical Quality Control – Improving Methods & Systems
Pharmaceutical Quality Control – Improving Methods & Systems 700 500 Xcelpros Team

By the Numbers

Ensuring pharmaceutical products meet regulatory quality standards is critical for business success, especially now. Companies that consider quality an afterthought do so at their peril. Companies meeting those standards are finding more of them approved at a faster rate than ever before.

  • 209 new drugs were approved by the FDA from 2000 – 2008
  • 302 new drugs were approved by the FDA from 2009 – 2017
  • 59 new drugs were approved in 2018, an all-time record
  • 53 new drugs were approved in 2020, #2 all-time
  • FDA review times decreased from more than three years in 1983 to less than one year in 2017
  • Between 2011 – 2015, the FDA approved 170 new drugs compared to 144 for the European Medicine Agency, while also doing it 60 days faster
  • The FDA approved 168% more drugs in 2018 than in 2016 because companies met quality standards

Figure: 1FDA Approvals for Pharmaceutical Products

FDA Approvals for pharmaceutical products

Introduction

Quality plays a pivotal role in the success of any business. Shipping delays now are often caused by products not meeting mandated quality standards. This adds stress to production environments and can potentially impact a company’s public perception. For example, 2018 saw 73 drugs subjected to FDA recalls, market withdrawals and safety alerts.

Companies saying yes to sub-standard products to the market are finding the results can be catastrophic. Some of the damage can be irreparable.

Those embracing modern-day Quality Management by supporting technology initiatives are finding success. These firms ensure that the right systems are in place to allow a product to pass all quality checks.

Continuing to embrace changing technology can help manufacturers in highly regulated industries leveraging it to stay ahead of their competition.

Figure: 2Classification of Quality Management

Classification of Quality Management

The Evolution of Quality Management

Today, quality management has evolved from being an afterthought to a rigorous self-discipline that most modern manufacturing companies embrace. Quality control in the 1960s has evolved to become today’s “total quality control.”

The US FDA is tightening its norms to ensure higher quality standards before approving medicines for sale. Pharmaceutical manufacturers are responding to such challenges by increasing their quality standards as shown in the graphic below.

Figure: 3 The Evolving Definition of Quality Management

The Evolving Definition of Quality Management

Process Improvements in Quality Control

Improvements always start by understanding departmental issues. Some typical activities in a pharmaceutical company’s Quality Control department are highlighted by:

  • Managing quality control tests
  • Managing quality control specialists and their workload
  • Allocating and calibrating test instruments
  • Establishing appropriate test methods
  • Documenting test specifications
  • Performing tests in priority order
  • Accurately recording test results

Following up on this involves analyzing trends and quality data plus running stability studies on 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 a company maintains its quality standards.qc pharma

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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. There could be multiple batches for different products produced in-house or received from third party manufacturers.

The quality lab prepares test instruments for each test. It accurately records the test results along with any digital signs-off recorded for each work order. Taking a quick view of what is involved in “getting it right,” an 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

Achieving optimal quality requires precisely following standard—and possibly regulated—operating procedures. Deviations are not allowed unless the “method to deviate” is clearly spelled out.

Getting staff to meet the optimal quality goal is challenging without a stringent system in place. For example, using a paper-based system requires adding laborious tasks with corrections and piled up paperwork. Every time an audit occurs using this system requires digging through stacks of paper to find the right answers.

Figure: 4: A Central Filing System to Manage Documents and Information

>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 to build their system. Some users may be uncomfortable with various systemic restrictions or uneasy when user errors are found.

People could start feeling anxious about making mistakes since every change has a digital stamp tying the person modifying the data. Fixing errors can become cumbersome especially when using a controlled and validated system that is 21 CFR part 11 compliant.

Effective QC systems replace discomfort by getting users to develop good habits. This starts by providing them with clear, accurate and thorough information about how the overall system works. A well-planned training plan can help users move from discomfort to being champions promoting the process in the organization.

People with a basic understanding of compliance prefer an electronic system for its strength and ability to capture real-time data. Instead of continuously fixing errors, workers proactively do it right from the start.

When the goal is to boost efficiency throughout an entire organization consider evaluating a reliable process that can be quickly adapted by the QC department.

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

What Plant Managers Look for in Quality Management Challenges

Plant Managers have specific views of the business since they oversee the overall plant operations. Key concerns plant managers or general manager address include:

  • Quality Management
  • Compliance with evolving regulatory standards
    • Taking control of documents such as Certificates of Analysis (COAs)
  • Safety
    • Corrective and Preventative Actions management (CAPA)
    • Location directives
    • Raising 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. It 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 document visibility, enhances product traceability by tracking amendments and documents safety with revision control features.
  • Addressing non-conformance. Meeting this requirement can be done through a unified platform to log non-conformance, noting the quality of incoming raw materials plus reviewing complaints, delays and other issues. This helps in addressing compliance at an early stage, paving the way for corrections and registering them in the system.
  • Corrective & Preventive Actions. Having software that documents these while adding built-in advanced analytical features built in helps companies learn from past actions. Registering a non-conformance incident into the system initiates a workflow for corrective measures. This system learns from past incidents and recommends preventive actions to prevent or reduce similar incidents from occurring again.
  • Implementing the right kind of tools and technology such as can help with process automation and reduce data entry errors while also tracking process efficiency.

Identifying the right system to help make the most impact is the first essential step to moving in the right direction. After crossing that hurdle, it’s important to build a “to be” mindset instead of worrying why the system doesn’t perform as it did in the past.

Evaluate how stringent you want your process to be based on your company’s needs and then accommodate a well-defined method that is native to the application.

Key Takeaways

Quality management is no longer an afterthought. It has evolved to become a discipline in most prosperous manufacturing organizations. Once considered a business function that hindered speed to market and product launch, quality management now embraces modern technologies – fueling innovation, adding efficiency, eliminating the scope of incidents within a plant, and offering better predictions for the future.

  • Pharmaceutical companies that evolve 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.
  • Adopting better tools in one department typically sets the standard for the entire ecosystem. It includes functions such as regulatory compliance, procurement, demand management, research & development plus inventory and warehouse management.
Challenges in Pharmaceutical Supply Chain due to Covid-19
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Pharmaceutical Supply Chain Challenges due to Covid-19
Pharmaceutical Supply Chain Challenges due to Covid-19 700 500 Xcelpros Team

Introduction

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

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

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

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

More Long-lasting effects include:

  • Delayed approvals for non COVID-related pharmaceutical products, partially caused by the closure or semi-closure of regulatory agencies
  • Self-sufficiency and lower demand for APIs and finished products made in China and India caused by delays in manufacturing and disruption to shipping and logistics
  • Organization growth impacted by economic slow-downs around the globe
  • Ethical issues from poorly researched clinical therapies and products
  • Drastic change in consumer use of cleaning and health products

By the Numbers

  • 2x increase in investigational treatments in the U.S.
  • 100% – 700% increase in the use of medicines to treat COVID-19 in U.S. hospitals (January-July 2020)
  • Upwards of 24 million excess prescriptions have been written in the U.S. alone, for things like hypertension, mental health issues, respiratory problems, diabetes, and anxiety.
  • 156 clinical trials for COVID-19 in the Middle East and 140 in the EU
  • 70%-80% reduction in patient visits to doctors’ offices in the EU
  • 23% of patient interactions in the EU are now being done online

Source: Springer.com

Supply Chain Effects

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

Procurement

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

Planning

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

Transportation and logistics

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

Export

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

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

Supply Chain Effects

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Lasting Effects

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

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

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

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

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

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

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

How choosing the right ERP system can boost your company's growth
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How choosing the right ERP system can boost your company’s growth
How choosing the right ERP system can boost your company’s growth 700 500 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 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.

Modern methods to best manage pharmaceutical quality control banner
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Modern Methods to Best Manage Pharmaceutical Quality Control
Modern Methods to Best Manage Pharmaceutical Quality Control 700 500 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

Pain 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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Customer Journey VP of Quality Control
Customer Journey VP of Quality Control 1440 810 Xcelpros Team

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