What Is Pharma 4.0, and How Can You Implement It?

  • Published:
    Sep 30, 2022
  • Category:
    White Paper
  • Topic:
    Pharma 4.0

How can you get drugs to market faster without sacrificing quality, all while saving time and money? This is the multi-billion dollar question pharma companies around are struggling to answer. 

Luckily, there’s a solution on the horizon: Pharma 4.0.

In this article, we’ll delve into this industry buzzword and explore its role in the future of pharma manufacturing. We’ll then outline clear steps you can take to realize its potential in your organization.

Jump to:

Overview: The Rise of Pharma 4.0

What is Pharma 4.0?

Pharma 4.0 refers to the convergence of people, systems, and data within one singular network. This term was originally coined by the International Society for Pharmaceutical Engineers (ISPE), and it represents a new era of digital transformation powered by innovative, advanced technologies such as artificial intelligence (AI) and machine learning.

These cutting-edge technologies instantly bridge knowledge and information gaps, providing life science professionals with relevant insights, available on demand. As a result, Pharma 4.0 connected systems can make better predictions, trigger automatic processes, and optimize the entire drug development and manufacturing workflow.

“In a nutshell, Pharma 4.0 is sustainable value creation across the global pharmaceutical manufacturing ecosystem by increasing connectivity and visibility; ensuring data integrity and right first-time manufacturing; and allowing real-time quality review and access to predictive/analytical data insights for faster decision making.” 

— Dominique Telfort, Manager, MES, Apprentice

Examples of Pharma 4.0 in action include advanced automation solutions, modern cloud-based manufacturing execution systems, and augmented reality (AR). These technologies are making it easier to scale drug production by integrating systems and highlighting patterns in the data that’s collected.

What is Industry 4.0, and how has it led to Pharma 4.0?

Industry 4.0 started a decade ago, and specifically refers to the digital transformation happening in various industries like banking, healthcare, education, and manufacturing.

More than just a buzzword, Industry 4.0 represents the fourth — and most advanced — industrial revolution.

Industrial revolution timeline: as technology advances, the time between revolutions shortens.

The technologies Industry 4.0 encompasses include cloud computing, augmented reality, real-time analytics, artificial intelligence, digital twins, autonomous robots, additive manufacturing, and more.

In the manufacturing sector, this revolution is known as “smart manufacturing” whereby technologies and data converge in real time. As a result, all components in the production line can talk to each other, which enables manufacturing companies to automate formerly manual tasks. In turn, this accelerates the manufacturing process, without sacrificing quality.

“Digital is the main reason just over half of the companies on the Fortune 500 have disappeared since the year 2000.” 

— Pierre Nanterme, Former CEO of Accenture

Pharma 4.0 was introduced in 2017 by ISPE, and adapted from this fourth industrial revolution, as a holistic approach to manufacturing. It specifically describes the Industry 4.0 operating model as it relates to medicinal products.

ISPE's Pharma 4.0 Operating Model.

This pharmaceutical model encompasses four areas, including:

  1. Resources
  2. Information systems
  3. Organization and processes
  4. Culture

Pharma 4.0: Passing Trend or Here to Stay?

Change isn’t just the “spice of life,” it’s also the only guarantee.

As the COVID pandemic illustrated, real-time agility and responsiveness are crucial for short- and long-term success in drug development and manufacturing. The right technology, at the right time, safeguards drug manufacturing organizations from downtime and allows them to maintain operations regardless of external events.

So, this brings us back to our initial question — is Pharma 4.0 a passing trend?

Absolutely not! It’s the future of pharmaceutical manufacturing. That's why savvy organizations are already making use of its capabilities and reaping massive cost and time-saving benefits, such as:

  • Improved compliance
  • Better planning capabilities
  • Enhanced connectivity 
  • Seamless audit trails 
  • Smarter, faster manufacturing

Through this convergence of people, systems, and data into a singular network, drug development is streamlined, and production takes less time. As a result, critical medicine can reach the people who need it most, sooner.

“Pharma 4.0 is a critical evolution in pharmaceutical manufacturing because it provides management a holistic overall view of their manufacturing ecosystem and ease of technical transfer across manufacturing sites. And best of all, it allows enterprises to manufacture drugs faster without affecting their quality to save and improve patient life.”

— Dominique Telfort, Manager, MES, Apprentice

How to Realize Pharma 4.0

It’s no secret the pharma industry has been slow to adopt new technologies.

Many organizations still rely on paper-based systems to track, record, and monitor processes. This resistance is understandable, especially because paper is tried and tested, but new technologies built to accelerate drug production are beginning to replace these older systems.

While change is never easy, sometimes it’s worthwhile. This is one of those times — the benefits pharmaceutical organizations stand to gain from Pharma 4.0 are undeniable.

In this section, we’ll walk you through three best practices that will help you realize Pharma 4.0. Let’s dive in!

#1: Assess Digital Maturity

Digital transformation doesn’t happen overnight. True change takes time, and an awareness of where you’re starting from.

Before your organization can reap the benefits Pharma 4.0 offers, you need to assess your current digital maturity level.

This will offer you a starting point and help to keep your goals tied to real-world actualities.

To do this, start by analyzing which of the following six areas are present in your organization, and to what degree.

These six areas are:

  1. Computerization: What aspects of production are computerized?
  2. Connectivity: How does data flow during production and between teams and sites?
  3. Visibility: How is data currently retrieved, and how much real time visibility do you have?
  4. Transparency: When it comes to data integrity, how complete, accurate, and transparent are your records?
  5. Productivity: What therapies are currently in development and to what extent? 
  6. Adaptability: How agile in your organization and adaptable to changing market demands and conditions?

Once you conduct a full analysis of your current stage of digital maturity, you'll be more prepared to create an informed roadmap for digital transformation.

#2: Audit Current Technology Needs

How are you currently using technology? What are your existing needs, and which processes are you aiming to improve?

For example, if your organization maintains paper-based records and mostly manual processes, it’s operating in what’s known as a “pre-digital plant.”

In this scenario, you may be looking to leverage technology for data capture and transcription, or to optimize the entire drug production lifecycle.

For a successful audit, start by identifying the gaps in your drug production lifecycle. Next, evaluate pharma-specific solutions that utilize cutting-edge technologies to accelerate time to market, maintain quality assurance, and reduce resource waste.

#3: Create a Digital Transformation Roadmap

Once you determine where you fall on the digital maturity spectrum, you'll better understand what your most pressing technology needs are.

Your next step: creating a roadmap for digital transformation.

To do this right, make sure you're asking the right questions. Once you shine some light on where you’re at and where you’ll need to be, you can begin mapping out your digital transformation plan to bridge the gap between them.

As you create your plan of action, consider the following questions:

  • Do you have the right workforce in place to implement new technologies? If not, think about the talent you’ll need to have in place before you get started. 
  • What’s your project timeline and budget? Consider the initial investment, as well as recurring costs. 
  • What are your anticipated goals and ideal outcomes? A roadmap isn’t a roadmap without clear-cut goals.

It’s easy to get swept away by goal planning, which means you might need to weed out goals that aren’t feasible or quantifiable.

Just like your manufacturing operations should be smart, your goals should be SMART as well — that is to say, Specific, Measurable, Achievable, Relevant, and Timely.

Our Take on Pharma 4.0

In pharma and medical manufacturing, an estimated 50% of existing work activities could be automated with next-generation digital technologies, which may reduce costs by 20% or more. What’s more, 93% of manufacturing and supply chain professionals plan to focus on the resilience of their supply chain, with 90% planning to invest in talent for digital transformation.

Our point? Transitioning to digital isn’t just a “nice to have” anymore; it’s essential.

Paper-based processes as legacy systems are no longer sufficient in a post-pandemic world because they create bottlenecks in the drug manufacturing process, and lead to data integrity issues. Plus, pharma companies lack real-time visibility into what’s happening during production, and lack the agility to quickly shift batch production size or focus based on changing market conditions.

Here at Apprentice, we create digital solutions that deliver on the promises of Pharma 4.0

By linking machines and systems together, we create intelligent networks that control each other, make better predictions and trigger automatic processes as needed. As a result, organizations can connect the dots between what they have, how or where they use it, and what they will need soon.

This deep insight is invaluable to life science teams, across all areas of pharmaceutical manufacturing. Greater speed to market means more critical products get to the people who need them the most.

Closing Thoughts: Future-Proof Operations with Pharma 4.0

Pharma 4.0 is here to stay, and it’s ushering in a new era of pharmaceutical manufacturing.

By converging people, technology, and data into one network, pharma companies can go digital, reduce time to market, and remain compliant every step of the way.

Change is never easy, but it's possible when there's a lear path forward. Luckily, there's a number of steps you can take to ensure a successful digital transformation, including:

  • Educating your team about digitalization
  • Creating your digital use case and get your team involved
  • Settling on a clear digital transformation vision
  • Prioritizing your digital transformation journey
  • Committing your team to the digital transformation project
  • Building a digital culture and start implementation
  • Refining your digital solution based on customer/user feedback

Looking for customized guidance on how your company can make the most of Pharma 4.0? Get in touch with our team and we’ll show you how.

The train is leaving the station; make sure you don’t miss it! Future-proof your business by stepping into this brave, new Pharma 4.0 world.

Our Featured Thought Leader

Dominique’s Background

Dominique Telfort is a Manager, MES Product Specialist at Apprentice based in New Jersey. He has previously worked for the two most popular MES legacy software companies until he found Apprentice, a next-gen MES software solution. 

With over 16 years of process manufacturing experience in the food and life sciences industry, Dominique brings a strong operations and implementation process on the table. He focuses on Biologic, Formulation, CAR-T, and Solid Manufacturing Process. 

Dominique wears a number of hats here at Apprentice, navigating between the worlds of Data and Process Mining, Software Development Process, Requirements Engineering, Object Oriented Software Engineering, Modeling, and Database application development.

Pharma 4.0: Dominique’s Point of View

I believe that data is the genesis of the most successful/disruptive technology companies today. That’s why I joined Apprentice — our out-of-the-box Tempo Cloud Software Solution is well designed to accommodate any enterprise digital transformation journey.

Apprentice MES digitalization offers a number of unique benefits, including:

  • Modern MES Platform
  • Amazing User Experience
  • Agile MES Solution Development and Smart Manufacturing
  • Connected Data across People, Sites, Applications and Equipment for Superior Insights
  • Additive Manufacturing (Cloud, Technique Media, Virtual Reality, Artificial Intelligence)
  • Operation Cost Reduction


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  2. Dukart, H., Patel, P., Telpis, V., & Yngve, J. (2021, September 15). Pharma operations: Creating the workforce of the future. McKinsey & Company. mckinsey.com
  3. Homepage | ISPE | International Society for Pharmaceutical Engineering. (2022, July 14). International Society for Pharmaceutical Engineers. ispe.org
  4. Pharma 4.0TM: Hype or Reality? (2022, September 2). ISPE | International Society for Pharmaceutical Engineering. ispe.org
  5. What is smart manufacturing, and how is it changing the industry? (2022). Texas A&M University Engineering. engineering.tamu.edu