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PHARMACEUTICAL

Batch Processing In Manufacturing Of Pharma Industry
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Unifying Pharma With Batch Manufacturing Process for Simplified Formula Management
Unifying Pharma With Batch Manufacturing Process for Simplified Formula Management 700 500 Xcelpros Team

At a Glance

  • Batch manufacturing or batch processing in manufacturing are conventional methods used by chemical, pharmaceutical and related sectors. These methods pose various challenges when it comes process management, formula simplification, quality checks and more.
  • Formula management is the core of process manufacturing to manage ingredients and related raw material, making it audit prone and a validated process.
  • Manufacturers are looking for solutions and software to allow the R&D and production team to work together on formulations. Manufacturers need to simplify Formula management and track changes to maintain an audit trail.

The pharmaceutical industry faces many challenges related to formula management in manufacturing. Maintaining formula, formula lines, cross-checking the data, managing raw material supply etc. can be a daunting task for the people on shop floor. Any change in formula needs to be communicated and cascaded down to production line operators to make necessary changes while running the manufacturing process smoothly.

We currently live in a modernized, connected world and it is thus essential to bring these modern hi-tech solutions to pharmaceutical formula management. After all, advanced technologies will dominate pharmaceutical manufacturing patterns, trends and changes in the coming future.

According to a survey by The Deloitte Center for Health Solutions, 68% of biopharmaceutical companies think that advances in technology will significantly impact their organizations.

Before we understand how manufacturing software can help in formula management, let us first consider the challenges in this area.

Challenges in Batch Manufacturing and the Need to Simplify Formula Management:

1.Formula Consistency:As stated earlier, pharmaceutical manufacturers need the formulations to be maintained. This would affect the quality and result of the drug (or other pharmaceutical product) being manufactured. In batch manufacturing, formula consistency plays an essential role in getting consistent results. The challenge lies in maintaining this consistency across multiple locations for different batches.

2.Communicating and Implementing Formula/Line Changes:A formula or formula line is subject to change based on batch history, planned vs. actuals, potency values or other unpredictable factors. When changes are not communicated and implemented correctly, pharmaceutical production can be challenging, especially while producing multiple lots. The cost and labor lost in such scenarios is tremendous. Communicating formula changes to all the stakeholders in the process is equally crucial to avoid quality discrepancies.

3.Maintaining and Managing Data:A pharmaceutical manufacturing facility deals with numerous formulations. Bill of Materials (BOM), ingredients, coproducts, byproducts, different formula lines, 3rd party manufacturing within a formula line, vendor management list, supply chain tracking etc. are all interrelated to formula management. This indicates extensive data generated daily, which needs to be collated, documented, and even analyzed, making it a daunting task prone to errors.

Leveraging Technological Innovations to Address Formula Management Challenges:

Today, digitization and automation have paved newer paths for conventional methods. Tools and systems developed for productiveness and superior performance can address the challenges faced by manufacturers. Speaking particularly of formula management challenges in pharma batch manufacturing, organizations can adapt batch manufacturing ERP software to facilitate:

  • Centralized record maintenance of formula, items, formula lines etc.
  • Formula management
  • Automated change communication
  • Data collation, systematic classification, report generation in the system and more
  • Track and tracing of the lot/ batch
  • Effective supply chain management
  • Production line management
  • Cost sheet maintenance and cost management

These and many more such benefits have turned pharma manufacturers’ attention towards integrating ERP in their batch manufacturing process to simplify formula management.

Figure 1:How ERP Software Can Simplify Formula Management in Batch Manufacturing

How ERP Software Can Simplify Formula Management in Batch Manufacturing

How Does Batch Manufacturing Software (ERP) Simplify Formula Management?

With the benefits mentioned above, subject matter experts and CXO’s in pharma companies know how to achieve formula simplification through an ERP software for batch manufacturing. The answer lies in the design and programming of the software which is built to

  • Manage item variants
  • Maintain purchase order sheets for scheduling, re-ordering, etc.
  • Inventory management, forecasting and order management
  • Formula recording, process control, change management and more

The payoffs of investing in batch manufacturing ERP software are numerous. With the increase in globalization, it is all the more important for pharma companies to reduce the time to market while ensuring that the product quality is not compromised. Managing the formula and how it scales for different sizes is probably the first step towards meeting those needs. With the help of high-end software, batch processing in manufacturing can be carried out effectively while simplifying formula management.

Key Takeaways

  • Pharma companies need to go digital to manage formulas for their product lines.
  • Batch manufacturing is a complex process with many factors such as scalability of batch sizes, scrap percentages, potency calculations, by product yields, etc. By simplifying formula management, pharmaceutical manufacturing companies can effectively track their batch production process.
  • There are currently many software tools/ solutions available for pharma companies to integrate into their manufacturing processes. By recognizing their requirements for formula management and batch manufacturing, they should invest in the ones that offer maximum ROI.

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5 strategies to save big on pharmaceutical r and d costs by going digital banner
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5 Digital Strategies to Save Big on Pharmaceutical R&D Costs
5 Digital Strategies to Save Big on Pharmaceutical R&D Costs 700 500 Xcelpros Team

At a Glance

  • Pharmaceutical research and development is steadily going on the path of digitization and the companies that can leverage this digital transformation will be ahead in the curve.
  • R&D digital transformation is not a goal; instead, it is a journey wherein companies would need to strategize their moves for an effective result in terms of cost reduction and manage quality criteria of the medicine.
  • R&D constitutes a significant portion of pharmaceutical expenses and by automating, optimizing, and expediting processes through digital technology, pharma companies can turn the corner and get better outcomes of the research.

The pharmaceutical industry relies on R&D and clinical research for drug development and efficacy testing. The core of pharma operations lies in the research that goes behind formulating, testing, developing and researching a drug. That’s the reason that the R&D costs in the pharmaceutical industry are in the higher stratum. Companies, both large and small, are searching for one answer- how to reduce cost in the pharma industry? Many experts believe that they need to start with R&D digital transformation in pharma companies. This will not only effectively cut down the excess costs but will also save time and labor.

While going digital is inevitable, many pharmaceutical companies are not yet fully equipped to undergo this change. Even today’s clinical trials have changed, and the pharmaceutical industry needs to cater to this rather personalized, targeted healthcare system. By adopting digital tools and artificial intelligence for faster and more accurate R&D, Pharmaceutical companies can achieve much-needed improvement in tracking test results and performing trending and analysis. Digitized systems also help save pharmaceutical research and development costs by reducing the human effort and error rate in extrapolating the data to adjust ingredients better while producing samples.

According to Investopedia, pharmaceutical companies spend, on average, 17% of revenues on research and development (R&D), making it one of the biggest spenders in this area.

So it is essential to look at some of the ways pharmaceutical and life sciences companies can leverage the latest digital tools and technologies to minimize expenses and maximize R&D efficiency.

5 Digital Strategies for Pharmaceutical Research and Development

1.Leveraging Artificial Intelligence for Identifying Drug Molecule:Identifying a drug molecule for a particular ailment and synthesizing it can take years of research and trials in the lab. However, scientists can run data through systems and identify the potential molecule/s and their plausible effective dosage within a short time with artificial intelligence. AI tools can also help devise the chemical formula and method of synthesis for these molecules to be synthesized entirely from scratch in a laboratory under controlled settings.

2.Using Predictive Analytics for Drug Discovery and Development:Like AI tools, predictive analytics software can be a boon for scientists looking to cut down pharmaceutical expenses and improve their outcomes. With predictive analysis, scientists get to know how a particular molecule or combination of different ones behave in the drug, how long they will take to be effective, and what percentage of ingredients will impact the drug’s potency and life. This will help in deciding drug dosage, its schedule and efficacy.

3.Streamlining Drug’s Regulatory Timeline:Pharmaceutical R&D works in close collaboration with the regulatory bodies to get the drug formulations approved. This involves much paperwork, which calls for time and effort. Digitization can easily create efficient methods of running operations without compromising regulatory requirements. Automated workflows will avoid slowing down your progress and expedite your ability to go to market.

Figure 1:Pharma R&D: Digital Transformation Elements

Pharma R&D: Digital Transformation Elements

4.More Efficient Selection of Volunteers/ Patients for Clinical Trials:The current Covid-19 pandemic has seen clinical trials at a break-neck speed and a large scale across various countries globally. Such speed and scale would not have been possible without leveraging digital technologies to select the most appropriate candidates for the trials. Digital databases can also analyze and prepare best-matched trial samples of the patients to represent diverse age-groups, ethnicities and even people from various socio-economic backgrounds. Such a varied and well-matched selection can yield better and more all-encompassing results.

5.Bridging the gap between pharmaceutical R&D and academia:R&D and academia go hand-in-hand. However, the lack of correct avenues has created a gap between these two research bodies. This data (non-confidential) can easily be made available to academic institutes and even research organizations for further insights and value generation with digitization.

Apart from these strategies, pharmaceutical companies can also leverage digital technologies to streamline their supply chain and optimize operations to effectively support their R&D. The R&D digital transformation journey is not an easy one as it has many challenges and setbacks. However, pharma companies must keep in mind that the long-term benefits of digitization strategies are plenty. With the right roadmap, pharmaceutical R&D can become less resource/ revenue-intensive yet more effective in terms of outcomes.

Key Takeaways

  • While pharmaceutical companies are keen on applying digital technologies, there needs to be a strategy in place for effective implementation as per the companies’ customized requirements.
  • Pharma executives and decision-makers will need to look at digitization as an ongoing journey and prepare themselves for internal resistance, technical challenges and more.
  • Going digital is indeed the need of the hour, and pharma companies need to strategize their R&D infrastructure accordingly.
Compliance readiness in pharmaceutical companies FDA audit regulations banner
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Compliance Readiness in Pharmaceutical Companies: FDA Audit & Regulations
Compliance Readiness in Pharmaceutical Companies: FDA Audit & Regulations 700 500 Xcelpros Team

Introduction

The pharmaceutical market has faced various challenges during COVID-19, including adhering to additional regulatory standards. Due to stringent FDA pharmaceutical regulations, pharma companies always need to stay upto date on their compliance tools. Many pharma manufacturers feel that following best practices and maintaining higher quality standards would turn into a hindrance to business productivity. However, with the right technology strategy , Pharma companies can employ the same standards to increase their overall productivity.

On an average, about 4,500 drugs and devices are pulled from U.S. shelves each year.Source: US FDA

Planned and unplanned FDA audits are common in the industry. Companies that don’t meticulously maintain accurate records tend to struggle when an unplanned inspection occurs. FDA inspections are needed to ensure that companies adhere to all compliance requirements. No organization should struggle to find the necessary details to justify deviations, out of spec procedures, batch approvals, and so forth. Read on more to know why Pharmaceutical companies fail FDA audits and how they can be more prepared when a random audit occurs.

Figure 1:The six systems that are CFR 21 Part 11 compliant

The six systems that are CFR 21 Part 11 compliant

Why Pharmaceutical Companies Fail FDA Audits?

An FDA audit gives Pharma companies a perspective on how well prepared they are. A forthcoming GMP audit can even serve as a driving force for long-awaited business initiatives. Hence, pre-audit preparations are all about focusing on quality issue identification and its resolution. However, FDA audits can be stressful for the Product Quality Management Officers, Quality Risk Managers, and other personnel responsible for ensuring GMP throughout the process control. As shown in Figure 1, the six systems that are CFR 21 part 11 compliant have to installed with the right processes  to record data accurately.

There are a series of factors that contribute to audit failures in pharmaceutical companies. Given below is a brief comparison of the major ones.

Figure 2:Factors Incurring Audit Failure

Factors Incurring Audit Failure

Coping up with Various Types of FDA Audits

Every Pharmaceutical company is bound by FDA regulations and can expect an audit sooner or later. These audits ensure process compliance relevant to Standard Operating Procedures (SOPs), good manufacturing practices (GMPs), and other regulatory criteria. FDA may conduct four different types of inspections depending on purpose and timing.

1.FDA Pre-Approval Inspections (FDA pai):A pre-approval inspection may occur after the company submits a new product to FDA. This audit intends to verify the data you have included in your application and ensure that your equipment plus facilities are appropriate for manufacturing the finished product. FDA determines the pre-approval inspection with a risk-based approach, product type, and process risk. Process risk factors in development data and whether the process is appreciably new to any you have done before.

Getting a pre-approval inspection indicates that your company meets QMS requirements and can continue with the protocol. The required rule for pre-marketing audits originate from FDA, so it is possible to prepare ahead. A pre-approval inspection’s potential outcome is that the inspectors will either recommend for or against FDA approval.

2.Routine Inspections:Companies manufacturing class II and class III products will experience a routine inspection once in a couple of years. The purpose is to ensure that everything is still running according to the prescribed protocols. These audits follow the dual-level of the Quality System Inspection Technique (QSIT).

  • Level 2 Baseline QSIT: This is very inclusive and covers almost all the quality systems, corrective and preventive actions (CAPA), design controls, management controls, and process controls. Pharma companies plan FDA inspections and prepare ahead based on previous events.
  • Level 1 Abbreviated QSIT: This is a brief inspection conducted when the company has undergone a Level 2 Baseline. A CAPA system integrated with a Quality Control and batch manufacturing system help with more meticulous preparation. Information well streamlined and available at your fingertips makes you safeguarded when a sudden inspection occurs.

The type and frequency of audits largely depend on what the auditors find. If there is any public health risk unveiled during a routine check, they would possibly conduct a follow-up or for-cause inspection.

3.Compliance Inspections:These inspections review actions undertaken by a manufacturer in response to a previous audit that resulted in a noteworthy 483 observations. FDA office issues Form 483 observations when an inspection indicates violations in good manufacturing practices (cGMP). FDA will schedule a compliance follow-up audit to check if the company has responded sufficiently and has corrected its previous violations. The FDA may record current violations and opt for future regulatory action if you fail to meet requirements. A company will be well aware of this audit if it already has 483 observations or any warning letter. It should most probably, identify the issues that the FDA had found and address them quickly. It all comes down to well-managed compliance/follow-up audits, by fixing violations and be prepared with additional information concerning inventory, batches, and quality control.

4.For-Cause Inspections:These audits are in-depth and don’t happen as often as the other three. For cause audits to investigate a particular problem reported to the FDA, such as from manufacturers (recall of products, MIDR), consumers (complaints and feedback), and even employees. Companies should expect an audit in case of any health hazard or a severe product recall. There are no set guidelines here, and the type of inspection appears to be spontaneous. Irrespective of the QSIT, the auditors have a free hand to probe into other areas and aspects of the company besides the impending issue. The best way to manage this audit is to prepare for a regular FDA inspection considering you may not receive any advance notice. A real-time QMS, up-to-date management reviews, and internal investigations can adequately serve the purpose.

The Digital Connect

Almost every pharmaceutical company should comply with the FDA’s Title 21 CFR Part 11 Guidelines, commonly known as the ‘Part 11’ regulation. All records fall under this regulation when digitally stored, signed and processed as part of its business. Information security, hence, becomes significant for Part 11. All authorized users in the company require appropriate security permissions. So, managing a company’s protocols related to quality compliance can be very well achieved by digitization.

Unique usernames and passwords can provide access to user records. Moreover, this can also help monitor batch traceability with the right approvals in the warehouse. FDA audit will become straightforward when there is a record of every event in inventory with accurate time, date, and username. Electronic data further includes e-signatures, digital stamps, scans, etc. Under Part 11 compliance, these signatures must satisfy the primary & authentic cryptographic criteria abiding by a specific set of rules. The e-signatures and scans must retain an individual’s identity and the integrity of the corresponding data.

Compliance, being a perpetual process, needs continual vigilance of electronic records and signatures. Accordingly, the right digital solution for Pharma can streamline quality workflows and minimize non-compliance.

Key Takeaways

  • Pharmaceutical industries are more vulnerable to production & quality failures if a company is not proactive to handle FDA audits.
  • An effective training program ensures that SOPs and regulations are transparent to employees. The intent is to get them to prepare for an FDA audit by keeping product and quality documentation up to date.
  • Digital transformation for Pharmaceutical will hugely assist in meeting compliance criteria. It can keep pace with the increasing surge of data, make you prepared for FDA audits, and prevent the undesired consequences.

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Ways to enhance customer experience in pharmaceutical industry banner
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Ways to Enhance Customer Experience in the Pharmaceutical Industry
Ways to Enhance Customer Experience in the Pharmaceutical Industry 700 500 Xcelpros Team

At a Glance

  • The face of the pharmaceutical industry is rapidly changing from R&D to directly interacting with their customers.
  • With changing demand and expectations, technology will be more important than ever to establishing a fortified system that brings together businesses and their customers.
  • The conventional chain of interaction between the pharmaceutical sector and its customers involving healthcare professionals is set to undergo a change to help the pharmaceutical industry better understand and manage customer expectations.

For years the pharmaceutical sector has operated in silos, in terms of understanding and managing their customer base. While there has been considerable change in the technology used for research and development, when it comes to customer experience and engagement in the pharmaceutical industry, there is still a long way to go. There is a growing need for the merging of customer management, meeting demands for particular drugs etc. using complete solutions like Microsoft’s Dynamics 365 line of products.

It’s become obvious that technology will play a critical role at the forefront of customer engagement, sales and marketing departments. In this article, we explore how adopting cutting-edge tools and software pertaining to customer relationship management (CRM) can benefit organizations.

1.Going OnlineDue to the outbreak of coronavirus, there was a sudden and steep decline in financial outcome across multiple industries in the first quarter of 2020. The market slowdown led to slower investments, reduced credit timescales by banks (leading to delay in funding), lack of sufficient security packages, covenant limits, etc. The financial impact has caused significant distress for the chemical industry, and top-level executives had to rethink their business procedures to ride through these distressing times.

2.Leverage Technology for Stakeholder ManagementIn a connected world, it is essential for pharmaceutical companies to understand and cater to the needs of different stakeholders in order to ramp up sales and reach their target customers more effectively, including generic drug manufacturers, biotech firms, physicians, chemists and more. Technology plays a crucial role in this scenario by providing tools like the aforementioned Microsoft Dynamics 365 products that enable sales teams to connect with different users through a centralized system.

Figure 1:Customer Engagement in the Pharma Sector Through Technology

Customer Engagement in the Pharma Sector Through Technology

3.Redefine Customer Engagement Strategy with a Sales-driven ApproachFor years, the pharmaceutical sector has by and large been driven through its approach towards research. While the competition for customer aquisition in the pharmaceutical industry, retention and expansion has always existed, not all pharma companies are known for aggressive sales-driven strategies. With the gap between the customer and pharma sector decreasing over time, the sales executives need to overhaul their strategies to directly engage with their customers and turn things around. Companies will be able to mitigate the costs involved in a conventional hierarchical setup for many of their products, and customers will have direct and easy access to drugs or other healthcare products that don’t require a physician’s supervision. An intelligent digital sales-driven approach can also boost revenue of pharmaceutical companies and keep them in sync with demands and expectations of their customer-base.

Key Takeaways

All said and done companies need to make better use of technology available to their sales and marketing departments in order to create an enhanced pharmaceutical customer experience in the pharmaceutical industry. Today, pharma companies that show agility and precision in adapting newer technologies, tools and software will lead the way in pharma customer engagement and retention. Below are some key takeaways –

  • Pharmaceutical companies need to embrace technology for a better understanding of customer expectations.
  • There is immense competition across the pharmaceutical market for customer acquisition and retention, that is achievable only by adopting a modern, sales-driven digital technology.
  • Use of transformative tools and processes are some of the best ways to manage all customers effectively.

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References: The Importance Of A Great Customer Experience For Pharmaceutical Companies

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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Pharmaceutical operations management
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Digital Evolution of Pharmaceutical Operations Management
Digital Evolution of Pharmaceutical Operations Management 700 500 Xcelpros Team

At a Glance

  • The healthcare and pharmaceutical sector is changing rapidly with the integration of latest technologies.
  • Digitization is on the agenda of major (and even most of the small-scale) pharma companies to enhance end-to-end operations management.
  • Pharma companies face challenges pertaining to manufacturing, quality control, serialization, supply chain management, process automation and more. Businesses can address these challenges with the help of cutting-edge tools and technologies.

The year 2020 has been particularly demanding for the healthcare and pharmaceutical industry. The increased need for newer or existing therapeutics and demand for a vaccine to curb the ongoing Covid-19 pandemic has put pharmaceutical manufacturers at the frontline. The challenges and pain areas that the pharma sector was dealing with became all the more prominent in 2020.

Pharmaceutical operations management has seen many changes in the past decade and these changes have accelerated because of rapid digitization. Top executives and decision-makers are looking for transformation technologies that can streamline operations, fortify quality control and optimize supply chain management. The manufacturers are looking at ways to transition from batch to continuous manufacturing. To say that the pharmaceutical and biotechnology sector is navigating through times of transformation would not be an exaggeration.

According to Mckinsey and Company, more than 65 percent reduction in deviations and over 90 percent faster closure times have been recorded in first real-life use cases of pharma manufacturing labs (that adapted emerging technologies such as automation and advanced analytics amongst others).

This period of transformation and disruptions is particularly testing for operations management in the pharmaceutical manufacturing sector. Here is a look at some of the challenges in pharmaceutical industry in this area:

1.The Shortcomings of Batch Manufacturing:This rather conventional method of manufacturing comes with its set of problems such as increased efforts and costs. Production in batches also entails batch-wise quality control increasing employees’ downtime. Batch manufacturing is also cumbersome to manage as it requires multiple storage facilities, multiple process reports, various checkpoints and overall increased chances for errors. Pharmaceutical Operations require agility and customized production and the batch manufacturing process falls short by being a rather ‘set’ process.

2.Quality Control and Quality Assurance Challenges:Quality is very obviously a non-negotiable aspect in the pharma industry. In Pharmaceutical operational management, regular quality checks and observing all deviations are a must. However, maintaining quality comes with its set of challenges. Many manufacturers often struggle with clearing quality control checks for raw materials as well as manufactured batches. There is a need to test every batch for generic and customer-specific potency requirements thoroughly, ensure proper storage conditions at every facility, report and record observations, perform in-process quality testing, etc.

Figure 1:Major Challenge Areas: Pharma End-to-end Operations Management

Major Challenge Areas: Pharma End-to-end Operations Management

3.Inventory Management Issues:If the current pandemic has disrupted a branch of pharmaceuticals completely, it would be supply chain and inventory management. Unpredictable demand patterns, over or under stocking, false forecasting have been some major challenges of pharmaceutical manufacturers and vendors. Major and small-scale pharmaceutical companies face issues with quantification and replenishment decisions.

4.Challenges with Digital Transformation in the Pharmaceutical Industry:Pharmaceutical, life sciences and biotech companies are going the digital way to expedite processes, integrate automation and streamline their operations. This journey of digitization in the pharmaceutical industry can be a daunting one for companies as they struggle with moving to newer systems. Top executives need to factor in the cost of digital transformation, expenditure to upgrade their IT infrastructure and budget to upskill their workforce.

To overcome these challenges, pharmaceutical companies need to rethink their operational management strategies. With the help of advanced systems such as the Microsoft Dynamics 365 Finance and Operations, biopharmaceutical manufacturers can make strides in their digitization journey while systematically managing their end-to-end operations. The strength is in the Microsoft cloud-based ecosystem that integrates the enterprise ERP with process automation, analytics, AI, etc.

Figure 2:All Microsoft apps under one umbrella

All Microsoft apps under one umbrella

Figure 3:Microsoft Dynamics 365 Finance and Operations quick glimpse

Microsoft Dynamics 365 Finance and Operations quick glimpse

Here are some of the prominent ways that Dynamics 365 is helping pharmaceutical companies build efficiency in operations management:

  • Automation of processes leading to reduced manual efforts, better time management, decreased operational costs and an overall reduction in time-to-market.
  • In-system generation of reports, invoices, and labels for quality checks, drug batches and related processes.
  • Efficient quality control and assurance with the help of customized processes.
  • Efficient monitoring of inventories to avoid wastage or stock-outs.
  • Real-time tracking of supply chain and centralized connectivity between various stockholder, creating a harmonized system that can run smoothly.
  • Effective raw material planning and in-system purchase order generation with timely reminders and customization options.

These and many such features make a high-end ERP system the must-have addition to pharmaceutical companies’ operational management strategy. Pharma companies need to chalk down their unique challenges and requirements and then invest in a comprehensive ERP tool to fulfill those needs.

In a complex and dynamic digital canvas, pharmaceutical companies are navigating their way towards efficient end-to-end operations management with the latest tools and technologies.

Key Takeaways

  • The challenges in end-to-end operations management are not new to the pharma sector, however, the recent Covid-19 pandemic has made these matters even more pressing.
  • Integration of tools and technologies that can optimize and aid in enhancing process efficiencies are must-haves for the pharma manufacturers.
  • A comprehensive and systematic ERP tool can prove to be the game-changer in pharma and life sciences operations management.

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New technology in pharmaceutical industry
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Maximize Profit with New Technology in the Pharmaceutical Industry
Maximize Profit with New Technology in the Pharmaceutical Industry 700 500 Xcelpros Team

At a Glance

  • Pharma industry is moving from conventional methods of research, manufacturing and distribution towards more technologically adept ways for better output.
  • The globalized nature of the pharma supply chain calls for technological transformation at macro and micro levels of every player in the industry.
  • The need for newer technologies, the cost of their adaption and the overall ROI are factors that pharmaceutical companies should consider to bring about a technology-driven reformation of their processes.

For years now, the pharmaceutical sector has been slow to adopt technologies, especially when it comes to their business models. While the past decade has seen positive changes in the way technological advancements have made their presence felt in this industry, there is still a lot to be desired. Technology can be leveraged by pharmaceutical companies (start-ups and the giants) to transform their operations, the pace of research, and manufacturing processes. Even the pharmaceutical supply chain is on the verge of going through a digital overhaul, changing how medicine/ raw material distribution will be handled locally and globally.

Pharmaceutical Facets Being Transformed by Cutting-Edge Technologies

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Application of Newer Technologies

01

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Expedited Process, Optimized Operation, Reduced Manual Labour and Error Mitigation

02

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Better Understanding of the Market and End-User Dynamics

03

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Formation of a data-driven and Technologically-Enabled Business Strategy for Enhanced ROI and Profitability

04

The impact of adopting newer technologies on the business front is going to be positive. However, the pharma companies’ key decision-makers would need to align their business models with the current market needs and then choose the right mix of technologies to drive growth and maximize pharmaceutical profits.

Let us look at how technology in the pharmaceutical industry can prove to be integral in accelerating business growth for pharma companies.

01.Going Big with Big Data – Anchoring Business Decisions Based on Data Generated Insights

Big Data has made its way in almost all the major industries and healthcare-pharmaceutical integration can benefit from this technology to store, organize and leverage the humongous amount of data generated. The pharmaceutical industry can gain insights from the patient data stored on various applications. It can also leverage the data generated at hospitals to gain foresight into the current medicine demands and the c-suite level executives can drive their decisions based on these insights. The global pharmaceutical supply chain can benefit from historical and real-time data sources available on Big Data platforms. This will help mitigate supply errors, prevent bottlenecks, and ensure smooth distribution of medicines and raw material. To make best use of Big-Data learn more about pharmaceutical data analytics and business intelligence here.

02.Artificial Intelligence (AI) is the Way Forward- Expediting Processes and Enhancing Profitability

The past few months are abuzz with the news of AI being used to fasten vaccine development using computerized programs. AI is imperative to complete genome sequencing of the Covid-19 virus, running humongous data through machine learning tools to shortlist plausible drugs and vaccine candidates and systematically design massive-scale clinical trials. The pharmaceutical industry has been using AI and related technologies to fine-tune operations, fasten the drug discovery processes, and minimize human efforts. Speaking of its impact on business, the pharma executives see the positive transformation of accelerated processes. The increase in profit margins caused by AI tools and techniques has encouraged pharmaceutical companies to expand AI use.

According to Gartner’s 2020 CIO Survey, AI is the healthcare industry’s top game-changing technology. These analysts predicted 75 percent of healthcare delivery organizations will invest in an AI capability to explicitly improve either operational performance or clinical outcomes by 2021.

03.Going Virtual – Catering to the Need of the Hour to Make Better Business Choices

The past few years have seen a shift in the way the healthcare sector has been operating. Patients are moving towards online consulting and self-medication via various forums and apps. The partial shift of the healthcare sector to virtual platforms has created a ripple effect on its related sectors. The pharmaceutical companies can use this transformation to their benefit and enhance customer engagement by going digital. Digital customer engagement and experience will help them in understanding the demands and expectations of their end-users. Pharma companies can align Business strategies for manufacturing and distributing generic and over the counter (OTC) drugs with insights generated from capturing the consumer behavior on these virtual platforms. A well-researched business strategy can become the blueprint that the pharmaceutical companies can replicate in other geographies to grow their business.

How Technology is Crucial in Enhancing the Pharma Business

01

Research and Development – Cloud Computing, Big Data, AI, and Machine Learning are Expediting R&D in the Pharma Sector

02

Drug Manufacturing – Automation is Proving to be a Game Changer in Continuous Manufacturing

03

Pharmaceutical Supply Chain – The Pharmaceutical Supply Chain is Getting Digitized and Optimized with Latest Technologies

04.Opting Automation – Moving from Batch to Continuous Manufacturing to Meet the Demands

There is an ever-growing demand for medicines and vaccines worldwide, and pharmaceutical companies are on the lookout to enhance their manufacturing capacity without inflating costs to the extent that it will disrupt their business models. Technology experts are touting automation in the pharmaceutical industry as the next big thing for them. Automating the manufacturing processes and facilities will enable pharma companies to move from batch production to continuous manufacturing. Business process automation will help meet customer demands and enhance their operational efficiency.

To summarize, adapting new technologies in the pharmaceutical industry during these rapidly changing times will favor these companies. The key decision-makers who are ready to think out of the box and take bolder steps by trusting the endless possibilities of technology will be remembered as pioneers in transforming the pharmaceutical sector.

Key Takeaways:

  • Adapting new technologies and up-scaling entire infrastructure as needed might be a cost-intensive process, but in the long run, it will help pharma companies cater to the needs of changing times.
  • Business executives in pharmaceutical companies have started looking at newer technologies as imperative factors in not just R&D optimization but as catalysts in the overall transformation of the sector.

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Pharmaceutical industry challenges
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Top 5 Challenges in the Pharmaceutical Industry: The COVID-19 Effect
Top 5 Challenges in the Pharmaceutical Industry: The COVID-19 Effect 700 500 Xcelpros Team

At a Glance

  • The economic upheaval caused by the shutdowns to prevent the spread of coronavirus is raging globally, and many industries, including the pharmaceutical sector is facing uncertainties.
  • The pharma companies, however, have another significant role in the pandemic, and that around managing Pharma operations during the pandemic.
  • The unprecedented demand and expectation from the pharma sector in terms of R&D, production, supply chain management, and cost optimization is presenting many issues across the industry.
  • Top executives and decision-makers will need to maneuver their pharma companies in a calculated manner to rise to humanity’s occasion and make their businesses steady again.

The rapid spread of the coronavirus across the globe halted air travel, crumbling healthcare systems, countries going under lockdowns, thousands losing their jobs, and a looming prospect of the economic crisis are all the events that we as a world have seen in 2020. Industries across the board face the brunt of disrupted supply chains, skeletal workforce, and dwindling investments. However, one industry to which everybody is looking with bated breaths is the pharmaceutical industry- for it can provide an answer to this pandemic in the form of a drug or a vaccine.

Figure 1:Adverse Effects of the Covid-19 Pandemic Globally

Adverse Effects of the Covid-19 Pandemic Globally

To say that major and minor pharma companies have sprung into action would be an understatement! The leaders and decision-makers from different pharma companies have responded reasonably quickly and are guiding the world towards a better tomorrow. However, the ‘new normal’ that we live in currently presents many pharmaceutical industry challenges (from financial to operational).

According to a report by Global Data, 23 percent from the pharmaceutical sector are concerned about supply and demand gaps tied to the COVID-19 outbreak.

Let us take a look at some of the top concerns that the pharmaceutical sector will be facing in the current times and the post-covid-19 world:

1.Disrupted Supply ChainOver the globe, supply chains have been broken, disrupted, and some have even come to a grinding halt because of the nation-wide lockdowns, closed borders, and halted air travel. The coronavirus pandemic has created a disorder of the kind that we have never witnessed before. The pharma sector drives its operations through the smooth running of the supply chain to deliver drugs and vaccines across the globe by:

  • rapid procurement of raw material and chemicals for drug manufacturing
  • managing equipment for research & production
  • optimized warehouse management
  • inventory management through track and trace
  • on time in full shipments to customers

The industry executives will need to reduce their pharmaceutical supply chain challenges by changing strategies and using available resources to their fullest. A robust supply chain management (SCM) tool with interconnectivity and interoperability can work wonders to realign the supply chain and provide extensive visibility to stakeholders that sequentially bring processes back on track for pharma companies.

2.Need for Highly Skilled Workforce Almost all the developed and many developing companies are involved in research, development, and clinical trials for the potential coronavirus vaccine. This research requires scientists with immense knowledge, experience, and skills. The pharma sector will need to boost its investment in the high-skill workforce to continue making progress in the current and future times.

3.Humongous Data Collation and AnalysisThe research and clinical trials for potential drug treatments and vaccines for coronavirus worldwide generate unprecedented amounts of data and information. Paramedical experts and scientists in the pharma industry look at agile tools to collate and manage data while generating insights. After all, the clinical trial data insights will help pharma companies guide the world towards a better tomorrow.

4.Need for Agility and TransparencyWith the Covid-19 pandemic, there has been immense interest in the pharma sector’s workings by almost all social hierarchies. There is an increased need for faster, accurate, and transparent operations across the board.

5.Workforce optimization and ControlsDuring COVID-19, Pharma manufacturing companies made many adjustments to modus operandi. That includes accommodating remote workforce, social distancing when in person, wearing masks and gloves, and avoiding any possibility of spreading the coronavirus. Mainly while dealing with organic material within the raw material ingredients, additional testing is needed before the drug passes Quality and is deemed ‘in spec’. The extra impetus has led to newer Standard Operating Procedures in operations and quality when it involves batch production through batch records.

While these changes and concerns are bound to affect the pharmaceutical industry’s workings, proper management, technology, and software to navigate these challenging times will enable the pharmaceutical sector to rise to the occasion.

The Covid-19 pandemic has brought forward existing and new challenges for the pharma sector. However, it has given a chance to create opportunities and get transformations that can have a positive impact on the pharmaceutical industry.

Key Takeaways

  • Pharmaceutical companies need to change their business strategies to suit the current environment and to navigate smoothly through the times of the Covid-19 pandemic.
  • There is a need for pharma companies to invest in robust software and tools that can optimize supply chains, facilitate automation, reduce manual labor, and systematically manage the enterprise to maximize their output.

For more information on our Microsoft offerings for the Pharmaceutical industry, Contact us today!

pharmaceutical supply chain best practices
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How technology helps in optimizing the Pharmaceutical supply chain
How technology helps in optimizing the Pharmaceutical supply chain 700 500 Xcelpros Team

At a Glance

  • The Pharmaceutical industry has witnessed exponential growth during the past decade, and pharma revenues worldwide totaled 1.25 trillion U.S. dollars in 2019 – Per Statista.
  • This growth rate automatically created a need to boost supply chain visibility and inventory traceability.
  • Regulatory measures put forth by the government or agencies such as the FDA can create unforeseen challenges for Pharma companies.
  • Leveraging technology’s power and identifying solutions for Pharma to streamline operations can effectively boost your bottom-line and help in better quality control while meeting both regulations and market demands together.

Understanding the Pain Points

The inability to adapt to technological advancements and rapidly changing regulatory landscape makes managing pharmaceutical supply chains quite a tough pill to swallow. Successful pharmaceutical companies leverage the power of IT to streamline their supply chain operations.

Figure 1: Pain Points in Pharmaceutical Industry

Pain Points in Pharmaceutical Industry

The pharma industry has established itself as one of the fastest-growing industries in the past few decades, with a significant share of its investments in research, marketing, manufacturing, and development of its products.

In the present scenario, the table seems to be turning. The industry is struggling to keep pace with rapidly changing regulations and dealing with challenges such as:

  • Keeping up with the growing competition due to faster technological advances
  • The rapid development of new products to handle growing health concerns.
  • Healthcare providers and government reforms putting downward pressure on product prices of the industry.
  • Full traceability of the product pipeline to be on par with requirements like quality compliance, serialization mandate, and the rise of counterfeited drugs.
  • Issues related to delivering products to the market.

The above challenges highlight the importance of comprehensive solutions that help Pharma companies progress and overcome various hurdles in shipping products to customers.

Collaboration Within the Pharma Value Chain

To keep up with the growing list of challenges, Pharma companies are increasingly relying on third parties like CROs, CMOs, 3PLs to manage the following:

  • outsource research & development.
  • manufacturing of intermediates.
  • 3rd party logistics for warehouse and inventory management.
  • quality control testing.
  • shipping and distribution of products.

While this is beneficial for Pharmaceutical companies, it comes with its complexities, including the remote location of different departments, inventory, and testers. How do you run a pharmaceutical supply chain effectively when all the departments are functioning from other locations? How would you effectively manage workflows that involve the exchange of information with outsourced parties on multiple tiers of your supply?

A report by FDA showed that over 60% of the shortages in 2019 were attributed to supply disruptions due to manufacturing or quality issues.

Following are a few benefits for Pharma companies to be technology-centric:

  • Real-time & end-to-end supply chain visibility.
  • Collaboration with the Pharma value chain.
  • Optimized inventories with least stock out situations.
  • Higher margins through smarter channel allocations for an increasing share in the market.
  • Improved customer experience.
  • Visual analytics and reporting.

Digitize the Pharma Supply Chain

Companies require well-streamlined processes and collaboration using agile software solutions for Pharma that provide significant cost savings and flexibility. Technology for Pharmaceutical industry can be a helping hand to optimize the supply chains. Advanced Solutions for Pharma increase inventory visibility and lot traceability across your supply chain, ultimately improving the overall product quality. Post COVID-19, embracing technology as a growth enabler has become the need of the hour for the pharma industry.

Following the path of other industries like hi-tech and consumer goods, the Pharma companies also need to focus on these five initiatives:

01.Connecting and collaborating using a working business network

A digital business network sets the foundation of a multi-enterprise supply chain, where all departments are interconnected on the cloud, ensuring seamless information flow and collaboration. Unlike the outdated model based on point-to-point connections, this multi-tier network is much advanced and helps end-users stay in sync with counterparts and move quickly through the process. The ability to collaborate enables end-to-end visibility and collaboration – the two critical factors that support smooth business interactions among different business partners involved in the value chain. Seamless integration helps you get real-time visibility and coordination in your entire extended supply chain, including multiple partners.

Figure 2: Process of Temperature Control

Process of Temperature Control

For example, there can be immense damage caused to vaccines due to the drop in temperature in the storage areas while being transported from one place to another. Real-time data tracking can help with adequate temperature controls by notifying when the temperatures are above or below the desired levels.

02.Estimating true demand

Demand predictions are just well-painted guesses of how much percentage of the population would require a particular product in the future. Most innovative pharmaceutical companies are now following demand forecasting as per consumer product companies for their OTC products. They do this by capturing massive volumes of demand related data and feeding it into sophisticated demand planning software, which helps them predict demand effectively. The data or demand forecasts captured are shared with all supply chain partners, ensuring the pharma companies, suppliers, and CMOs align with the arrangement. Estimating actual demand helps them to bring significantly higher on-shelf availability and lowers the inventory.

03.Control quality for CMOs

Pharmaceutical companies need to ensure end-to-end traceability. How do they keep track of their pharmaceutical manufacturing supply chain when a CMO is involved? Having visibility into partner’s manufacturing operations and tracking product quality across the multi-tier system is essential for pharma companies. The real-time visibility can be done by connecting CMOs to your Manufacturing Execution Systems. A manufacturing execution system helps capture relevant data at all production stages, providing granular visibility into plant operations. Pharma companies will effectively track material flows, lot genealogy, processing steps, and associated parameters, such as yields or test results – critical information to ensure traceability. Quality control is of optimal importance for any serialization initiative within Pharmaceutical companies.

04.Faster planning across the network

Another essential requirement for companies is to detect and respond to changes in supply and demand faster. With largely connected systems and expanding business networks, companies have a clear, end-to-end visibility of the supply chain in the Pharma company and not just in-house operations; this includes expected lead times on inventory from a contract manufacturer or raw material supplier. However, traditional planning systems can impact your decision-making capabilities required to manage inventory shortages and suggest alternative purchase/ manufacturing scenarios. Advanced planning tools allow rapid evaluation of new buy-sell signals and easily recommend purchases from secondary vendors or alternate manufacturing routes. This new plan can then be shared with all the supply chain partners within the value chain through collaboration portals, tools, so forth.

05.Manage distribution

Pharma companies are increasingly relying on third parties for transportation, warehousing, and other value-added services. Ensuring product availability implies proper management of distribution partners. For downstream visibility, inventory management coupled with sophisticated stock strategies are needed. Proactive pharma supply chain management helps all products be delivered to the right customers to increase your sell-metric, which is critical when competing in the market.

Pharma companies will customize supply chains to suit the product types being transported – data will play a key role in enabling this vision.-PWC Pharma 2020: Supplying the future

Key Takeaways

  • The expectation of better customer experience is the same across all industries and progressive Lifesciences companies understand the need to embrace digital for Pharma.
  • More Pharma companies are continually evaluating ways to address supply chain challenges to meet customer’s needs ultimately.
  • A cloud-based agile technology network to increase visibility in the supply chain and keep all functions connected for better collaboration can boost your profits and increase growth potential.

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Predictive analytics in the pharmaceutical industry key use cases banner
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Predictive Analytics in the Pharmaceutical Industry: Key Use Cases
Predictive Analytics in the Pharmaceutical Industry: Key Use Cases 700 500 Xcelpros Team

At a Glance

  • The digital era has given companies various tools and techniques to help pharmaceutical manufacturers optimize and streamline their operations, and predictive analysis is one such highly advanced method.
  • There are different ways with which predictive analytics can integrate with existing software setup and forecast plausible technical glitches and predict future trends, thus helping in enhancing operational efficiency.
  • Predictive analysis can help planning to execution, aftermarket services level to develop better products/ services, improve their response time, and stay ahead of the curve for delivering better customer experience.

The Role of Robust Infrastructure

Database management has become one of the topmost priorities for companies across the globe. This database is used to fabricate trends and patterns for a particular time-frame or a process or a product. Data historians have been around for quite some time now, but manufacturers have recently started to look at them as more than software that stores and retrieves data. Application of predictive analytics is turning out to be a game-changer in terms of predicting the future with maximum accuracy and helping manufacturers make the right calls across various functions- purchase, operations, consumer demands, marketing, and more.

Any business operates with the ultimate motive – to enhance productivity and profits. Optimizing operations thus becomes a must for manufacturers. Companies are riding the digital wave with cutting-edge technologies and tools such as Cloud, Internet of Things (IoT), Machine Learning, and Digital Analytics. By making the most of this digital disruption and using predictive analysis to their advantage, companies can achieve better operational efficiency and higher productivity.

Increased and better predictability for both structured and unstructured data helps companies in planning their operations accordingly for enhanced productivity and a faster pace of work.

Predictive Analytics in Pharmaceutical Operations

Predictive analytics is creating a buzz in the Pharma industry for quite some time now. Different pharmaceutical manufacturing companies are looking to model their business processes by gauging the future requirements. The predictive analysis makes use of data historians to accurately make predictions about future trends, possible glitches, and diversions along the road. While technology has come a long way when it comes to predictive analysis, at an enterprise level, there are many things you can do to make the most of this technique.

93%

of healthcare executives stated that predictive analytics is important to their business’ future.

Source: CIO.com

As major companies are competing to stay ahead, product sales and consumer acceptance of a specific drug are a few contributing factors that help decide on advancing to Predictive analytics.

Here are a few ways that predictive analytics helps Pharmaceutical operations become more streamlined and agile:

01.Predictive analytics assets help in understanding patient needs ahead of time

For years Pharma companies have invested heavily in market research and insight experts to understand various geographies and patient domains. This included research to understand and forecast patient needs and medicine usage compliance to help both R&D and manufacturing teams prepare them ahead, thus catering to the requirements of the patient base. Predictive analysis plays a vital role in this domain by taking historian data and mining it to populate trends and patterns that can be used by Pharma companies to decide upon the demand for their product. Advanced digital analytics is also capable of generating models based on consumption density for a particular geography, demographic, and health index of the patient base. A pharmaceutical company, thus, would automatically be empowered by knowing its end customer base better and learn the composition of drugs and approximate quantities to produce. You can, therefore, produce the medicines as per the forecast and restructure your supply chain as per the demand. All this will optimize your operations by streamlining both the production department and your supply chain. This will result in enhanced productivity and reduced risks of stock-outs or inventory influxes.

02.Digital analytics plays an imperative role in predicting plausible manufacturing equipment glitches

Anyone working on a production line can vouch for the fact that faulty equipment can cost fortunes by becoming the reason for slowed down or altogether stopped production for days. What predictive analysis does is that it uses the stored equipment data and runs the algorithms to understand the working patterns of any equipment. This, in turn, helps in generating reports for plausible scenarios of equipment malfunction. The production team can get forewarned and can work on the said equipment beforehand to prevent any glitches. Apart from helping in enhancing the operational efficacy, this can also help in preventing loss due to stalled production.

One can take the predictive analysis a step further and use the trends generated to get into a proactive maintenance mode, rather than a more cumbersome and costlier reactive maintenance option.

9%

uptime improvement can be achieved by ensuring predictive maintenance in factories.

Source: A Report by PWC

03.Predictive analytics enhances operational efficiency by enabling risk assessment

Predicting the actions and production outcome of a batch record has become integral to measuring the performance of a Pharma product line. Predictive analytics helps in this assessment with maximum accuracy. It also helps in proactively foretelling issues risks related to product line performance, which allows Production Managers to mitigate these risks to raise product quality standards, and hence become a key driver in increasing product performance in the market. This could apply to both software and hardware in a production line. The cumulative phenomenon results in better risk assessment. This helps the operations team to proactively plan the course of their actions for a better outcome. The advanced predictive analytics tools integrate with different software used by the manufacturers to recognize patterns, share information with other machines and apply the principles of machine learning to automatically gauge risks and alert the users on a timely basis. For optimized operations, risk aversion plays an important role.

Figure 1Use Cases of Predictive Analytics in Pharma

01

Deriving 360 degree patient journey insightsDeriving 360 degree patient journey insights

02

Influencing patient adherenceInfluencing patient adherence

03

Capturing genomics data to accelerate discovery of precision medicineCapturing genomics data to accelerate discovery of precision medicine

04

Speeding up drug discovery and developmentSpeeding up drug discovery and development

05

Improving the efficiency in clinical trialsImproving the efficiency in clinical trials

06

Identifying gaps in compliance to streamline regulationsIdentifying gaps in compliance to streamline regulations

07

Reducing cost and speeding up time-to-marketReducing cost and speeding up time-to-market

08

Improving safety and risk managementImproving safety and risk management

09

Managing operations and employee trainingManaging operations and employee training

10

Taking effective sales and marketing initiativesTaking effective sales and marketing initiatives

04.Advanced analytics is essential in accelerating operations

The ways mentioned above with which advanced predictive analysis helps in operational efficiency have all resulted in more agility in the overall operations. Rapidly delivering medicines to the end customer, is becoming a primary responsibility for Pharma companies within the Pharma Value Chain. Companies see a rapid generation of patterns, demands met with more ease, lower risks in manufacturing processes – advancing production lines, and related functions to be more agile.

Business Scenario

Meridian Medical Technologies, a Pfizer company, continues to experience manufacturing challenges in the production of EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths. These challenges are expected to result in tighter supplies and greater variability in pharmacy-level access at this time.

Added to the shortage of EpiPens due to tighter supplies, the U.S. Food and Drug Administration provided additional information on lots that are about to expire creating further risk in Epipen availability for the patient base.

A good model of predictive analytics in the Pharma supply chain that provides a gauge of stock requirements based on patient demand, in-store inventory, and expiration dates would have mitigated this risk of Epipen outage before it is too late. Time to market is an essential factor in deciding the success of a product. Accelerating pharma manufacturing processes will thus help companies stay ahead in the competition.

Key Takeaways

  • Predictive analytics is highly effective in risk assessment, equipment analysis, trend forecasting, and data mining.
  • Every industry has their specific criterion to make use of predictive analysis to boost sales and with better use of such tools, enterprises will be better prepared to serve their customer base.
  • Manufacturers can benefit highly from this advanced digital technology by optimizing their operations and enhancing the speed of production.
  • Speeding up the medicine to the market process by predicting demand based on patient demographic enables Pharma companies to be prepared for the increase in end-customer demand and manage stock outages without compromising patient needs.

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