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How digital transformation is revolutionazing pharma packaging

image of what looks like pharmaceutical bottles, showing some overlay of digital information. the bottles include some Qr and RFDI codes on them

Globally, the pharmaceutical industry is experiencing considerable growth, driven by an ageing population and continuous advances in available treatments. This significant expansion has had a profound impact on the pharmaceutical packaging market, which is projected to grow to $284 billion in 2032.

Digital transformation has become a powerful engine for faster innovation, smarter drug development, and more resilient global supply chains, pushing pharmaceutical companies to modernize every layer of their operations.

Due to this digital shift, the role and capabilities of pharmaceutical packaging is transforming from a static container into a dynamic, intelligent, and interactive component of modern healthcare delivery. This digital shift does not come without challenges. The sector, for instance, has to deal with stringent compliance requirements to prevent counterfeiting.

Digitalization reinforces Good Manufacturing Practice (GMP), but it does not come without challenges

Digitalization directly supports Good Manufacturing Practice (GMP), which governs the manufacturing, processing, and packaging of medicines to ensure they are safe and effective. GMP aims to mitigate risks such as incorrect containers or labels and ensures quality is embedded at every stage of production. Digital systems can provide precise, step-by-step instructions for tasks like visual inspection of filled units before further packaging, significantly helping to prevent errors and ensure consistency.

All five principles of GMP – People, Process, Procedures, Premises and Equipment, and Products – must be in focus during the implementation of digitalisation processes. For example , the “Products” principle of GMP explicitly calls for repeatable methods in packaging and meticulous record-keeping, areas where digital tools offer immense advantages. The “Process” principle also stresses the need for precisely defined, consistent, and documented manufacturing processes to ensure quality and prevent deviations.

The benefits of digitalization for packaging companies are clear: increased productivity, enhanced product quality, tighter control over the packaging phase, and greater efficiency and flexibility in manufacturing. It helps to reduce waste and losses by detecting errors early in the process and streamlining processes like packaging labelling and equipment cleaning.

However, the journey isn’t without its challenges. Pharmaceutical companies face the complexities of digitalising diverse processes for a wide array of clients while simultaneously maintaining flexibility. Standardization across processes, especially when accommodating differing client specifications and equipment, is a significant hurdle. Another critical challenge is the substantial capital investment required for adopting cutting-edge packaging solutions, which can be daunting. Furthermore, getting staff on board with new digital tools and discerning which technologies truly add value are critical aspects that require careful management.

To overcome these, companies are actively harmonising and standardising cross-divisional processes, mapping out project dependencies and synergies. Flexibility must be a primary consideration when designing digital systems, for instance, by using predefined text modules for client specifications. Forming a well-trained digital task force can help manage stakeholder expectations and ensure a smooth cultural transition. Most importantly, the focus should always be on projects that genuinely improve quality and efficiency, starting with “low-hanging fruit” that yield immediate results.

Digital transformation is not merely an optional upgrade; it is an essential evolution for the pharmaceutical packaging industry. By embracing it, pharma companies can build more agile, efficient, and systems for their packaging processes. This strategic embrace not only provides a competitive edge and improves operational efficiency but, most importantly, enhances patient safety and satisfaction in an ever-evolving global healthcare landscape. The future of pharma packaging is smart, connected, and continually optimizing.

Photo by Jeff Trierweiler on Unsplash

PS: If you are wondering where you could start your digital transformation, these below are some of the ways digitalization is currently been used by pharma companies.

1. Enhanced Traceability and Serialization: A Shield Against Counterfeits

One of the most significant impacts of digital transformation on pharma packaging companies is the enhanced traceability and serialization of products. Drug counterfeiting presents a substantial risk to patient safety, with an estimated 13.6% of medicines in low- and middle-income countries being substandard or falsified. To combat this, governments have mandated serialization on all drug units.

Through digital technologies such as RFID tags, barcodes, and QR codes, companies can now track medicines with unprecedented precision throughout the entire supply chain. Legal frameworks, such as the EU Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA), establish stringent requirements for authenticity and traceability. This involves assigning a unique serial number to each dose and pack, allowing them to be tracked as they move through the supply chain.

For medicines within the EU market, these serial numbers can be inputted into the European Medicines Verification Organisation (EMVO) database, enabling pharmacies to verify packs at the point of dispensing. This robust system not only helps in detecting and preventing counterfeit products but also allows for rapid and precise traceability in the event of a recall or investigation.

Smart labels with radio-frequency identification (RFID) or near-field communication (NFC) technology are increasingly being considered to support serialization requirements for both pre-filled syringes (PFS) and oral solid doses (OSD). Compared to traditional labels, these smart labels provide more robust information, including unique identifiers and serialization data, crucial for regulatory compliance and seamless scanning, which can help harmonise data systems and align serialisation compliance with operational efficiency.

2. Automation and robotics: precision on the production Line

The integration of automation and robotics is revolutionising packaging operations. Robotic arms, automated labelling systems, and advanced vision inspection systems are now common, streamlining tasks that were once repetitive and prone to human error. This automation significantly increases productivity, boosts speed and accuracy, and reduces errors, ensuring consistent quality and precision in packaging.

Historically, packaging and human-monitoring irregularities have led to costly product recalls. Digitalisation and automation are now crucial for reducing such mistakes, mitigating financial and reputational damage, and maintaining cleanroom procedures while managing electronic batch records effectively.

3. Smart packaging and IoT integration: packaging that communicates

Digital transformation enables the development of smart packaging solutions leveraging the Internet of Things (IoT) technology. This involves equipping packaging with sensors, RFID tags, and other IoT devices to monitor critical aspects like temperature, humidity, and potential tampering during storage and transportation.

This is particularly vital for temperature-sensitive drug products, such as biologics, many of which must be stored and transported at frozen or ultra-frozen temperatures. These smart packages provide real-time data on the product’s condition, ensuring its integrity and safety.

Smart labels with processor cores can enable real-time temperature monitoring during transport. The data collected allows for the identification and disposal of units with temperature excursions and aids in future root-cause analysis. By integrating IoT into packaging, companies can optimise inventory management, prevent product spoilage, and enhance overall supply chain efficiency.

4. Data analytics and predictive maintenance

Leveraging data analytics and predictive maintenance is another powerful impact of digital transformation. By collecting and analysing data from sensors, machines, and production lines, packaging companies gain valuable insights into their processes. This enables them to detect potential issues in real-time and make informed, data-driven decisions to improve efficiency and performance. Predictive maintenance, powered by machine learning and artificial intelligence, allows for proactive scheduling of maintenance tasks, reducing unexpected downtime and prolonging the lifespan of equipment, thereby ensuring uninterrupted packaging operations. The data gathered from smart packaging can feed directly into these analytics for detailed root-cause analysis.

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This is the reason why your design team hates artwork changes (and how to solve it)

Generated with ChatGPT

Anyone who has worked in pharmaceutical packaging knows the drill: you think you are done with a design, it’s ready to go, and then… a new change request comes in. And not just any change; a change that involves multiple departments, extensive back-and-forth communication, and, inevitably, hours of work.

This creates a lot of frustration in the design teams. However, it’s not about the design itself. It’s the chaos and frustration that surrounds it. Here is what typically happens when your design team faces an artwork update:

Endless Feedback Loops

Artwork changes are often passed around between multiple departments: Quality, Regulatory, Register, and Commercial/Marketing. Each department reviews, revises, and then sends it back, separately, to the design team with their feedback.

Confusing Version Control

How many times have you heard the phrase, “Which version is this?” With so many hands in the process

and multiple versions of the same artwork flying around, it’s easy to lose track of what’s been approved, what’s in progress, and what’s been rejected. This confusion leads to miscommunication, delays, and errors that ultimately cost time and money.

Last-Minute Legal/Regulatory Changes

Every time there’s a minor legal update or regulatory change (and this happens a lot in pharma), it requires last-minute revisions to packaging. These changes are often urgent, and because they’re so critical to compliance, there’s little room for error. Your designers are expected to respond quickly and get it right the first time, which can be a huge source of stress.

The Fear of Missing Small Details

In pharma packaging, every detail matters. The tiniest mistake in the artwork, whether it’s a text error or a missed symbol, can lead to serious consequences, such as product recalls, regulatory fines, or worse.

Design teams know this, and that’s why the pressure of making those changes without missing anything is enough to make them dread the entire process.

So, what is the solution?

The good news is that there’s a way to make artwork management easier, faster, and less stressful for everyone involved.

The key is to centralize and streamline the process using an Artwork Management platform designed specifically for the pharma industry. Here’s how it works:

Centralized Feedback and Approvals

Instead of bouncing emails back and forth and risking confusion, an artwork management platform allows you to centralize all feedback and approval processes in one place. This ensures that all stakeholders – regulatory teams, quality, medical affairs, or marketing – can review and approve changes in real-time, without missing anything.

Full Version Control and Traceability

With a centralized platform, version control becomes simple. Every change is tracked, and all stakeholders can see the latest updates clearly, and in one single place. You’ll no longer need to ask, “Which version is this?” or risk working with outdated designs.

This feature also gives you a clear audit trail, ensuring that you can quickly trace any movements made to the artwork, which is especially critical in a heavily regulated industry like pharma.

Speeding Up Time-to-Market

When artwork approvals happen faster, your products get to market quicker. An effective artwork management solution can cut down approval times by up to 60%*, which means your design team can focus on important work without being bogged down by endless approval processes.

Ensuring Regulatory Compliance

Pharma packaging needs to comply with a lot of regulatory standards. With the right system in place, your design team doesn’t have to worry about missing critical updates. Everything is built to ensure compliance, making the process smoother and reducing the chances of mistakes that could lead to recalls or legal issues.

How can an artwork management system benefit your design team?

When your design team is freed from the constant back-and-forth, version confusion, and last-minute changes, they can focus on what they do best : creating designs that stand out on the shelf.

By simplifying the artwork management process, you’re not only reducing the stress on your design team but also improving overall efficiency and product quality.

* https://www.linkedin.com/pulse/how-does-artwork-management-software-affect-bottom-line-mansi-s-/

Ready for the next step?

If you want to see how pharma companies are improving their artwork management processes, and making life easier for their design teams, let’s talk. https://www.twonas.com/contact/

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2024 … 2025

As this year comes to an end, we want to take a moment to reflect on the months past and thank our clients for their continuous support and confidence in Twona.

The last months we have released a lot of new functionality improvements (you can check some of them here: https://www.twonas.com/updates/), many of them as a result of customer feedback. For us this is a fantastic result, to be able to collaborate with clients to make our tool even more robust and better fitting the industry needs. This also shows that our customers do not see the limitations but mostly the possibilities that the tool offers to their daily work, which makes us extremely happy.
Some of the work that was performed by the team was also not visible, but changes in infrastructure have made Twona even more robust and faster to the end user.

We also completed several new implementations, a few of which are considered some of the most complex we have worked on so far – and in record time, too! Those included not only configuration of several work processes, as well as complex permissions and automations, but also data migration and validation services. If you did not know we offer a validation service, download our white paper : Fast track validation, or contact us.

Our sales team was present at several events and exhibitions, where they were able to meet new prospective customers (some of which are now clients ❤️ ) as well as existing users of the platform. We are currently finalizing the list of events we will be attending in 2025. If you are attending any events next year, share those with us, we would love to meet you there face to face!

All the team has been working on multiple tasks, diversifying in some cases from their regular daily jobs, and with a lot of involvement in daily operations, to understand better what the clients need and what situations they encounter, so we can serve current and future customers better.

We are extremely proud of our client reviews, not only on our testimonials, but also on their NPS scores which keep improving over time (NPS of 68 for 2024); we do take feedback seriously, so we can make an even better Twona for our users.

We are looking forward to 2025, and to continue building a better Twona and growing our customer and partner base. We hope you will be around to see it all happening!

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Mastering Packaging Version Control through Artwork Management

version control
Version management in Twona AMS

Precision and consistency are essential for a good packaging design, which makes version control keystone in the creative process. Any misstep in managing design versions can lead to costly errors, delays, and even brand integrity issues. Artwork Management plays a critical role in mastering packaging version control, even if most of the times, this role is seen as a silent hero as it is rather transparents for users of these systems.

The Challenge of Packaging Version Control

Design projects, especially in industries like pharmaceuticals, retail, and food production, often involve numerous stakeholders contributing feedback, revisions, and updates. The result? A myriad of design versions that need to be tracked, compared, and managed efficiently. Failure in version control can result in:

  • Inconsistencies: Different versions may introduce inconsistencies in branding, messaging, or design elements.
  • Delays and Revisions: Unclear version control often leads to delays as teams struggle to identify the latest approved version.
  • Quality Issues: Printing or production errors may occur if the wrong version makes it to the final stages.

Artwork Management’s Crucial Role

Artwork Management systems provide a structured and organized approach to the complex process of design iteration. Here’s how:

1. Centralized Repository:

Artwork Management systems serve as a centralized hub for all design versions. Every iteration, feedback, or change is documented and stored in an organized manner, eliminating the chaos of scattered files.

2. Version Tracking:

The ability to track changes across design versions is fundamental. Artwork Management systems meticulously record modifications, allowing teams to trace the evolution of a design from inception to approval.

3. Collaboration without Confusion:

In collaborative design processes, multiple individuals may be working on different aspects simultaneously. Artwork Management systems facilitate collaboration without the risk of conflicting versions, ensuring that everyone is on the same page.

4. Seamless Approval Processes:

Efficient version control streamlines the approval process. Stakeholders can review and approve the latest version without ambiguity, reducing bottlenecks and speeding up the journey from design to production.

Realizing the Benefits: From Efficiency to Compliance

1. Enhanced Efficiency:

Efficient version control translates to faster approval cycles, reduced back-and-forth, and a more streamlined design process. This efficiency is invaluable in industries where time-to-market is a critical factor.

2. Error Reduction:

By providing a clear history of design changes, Artwork Management systems significantly reduce the likelihood of errors making it into the final production stage. This ensures a higher level of quality and consistency in the end product.

3. Compliance Assurance:

Certain industries, such as pharmaceuticals, require stringent compliance with regulations. Artwork Management systems provide the necessary documentation and audit trails, ensuring that the design process aligns with regulatory standards.

Integration with Workflow: A Synergistic Approach

Artwork Management’s role in version control becomes even more potent when seamlessly integrated with a workflow management tool. This synergy ensures that version control is not a standalone process but an integral part of the broader design and approval workflow.

If you also want to embrace the advantages of Artwork Management in your packaging design process, and witness how mastering version control becomes the cornerstone of a successful and precise creative journey, do not hesitate to check Twona AMS, which integrates artwork management, workflow management, version control and approvals under one single roof.

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Empowering Mid-Size Companies: Harnessing the Power of Artwork Management Solutions

Photo by Magic Mind on Unsplash

One size does not always fit all. While large corporations often have the means to invest in high-end Artwork Management Solutions (AMS), mid-size companies face a unique challenge. They need to find a middle ground between limited budgets and the demand for efficient, compliant processes.

Thankfully, this is not a problem without a solution as there is not only large scale AMS solutions in the market today but also those that cater to the needs of mid-size enterprises.

Navigating Mid-Size Challenges

Mid-size companies encounter a distinct dilemma: how to achieve streamlined packaging design processes without exceeding their financial capacities, and still complying with regulations for quality, control, and even validation. Unlike industry giants, these businesses require a solution that is both powerful and cost-effective, yet equally adept at ensuring quality and compliance.

Harnessing Innovative Solutions

What are the main benefits that solutions such as Twona for mid-size companies offer?

1. Affordability: Mid-size solutions are designed to be budget-friendly without compromising on performance. This enables mid-size companies to optimize operations without straining their financial resources.

2. Scalability: As mid-size companies evolve, their solutions must evolve too. AMS solutions can adapt to new challenges as businesses expand and diversify.

3. Flexibility: Unlike one-size-fits-all solutions, you will find that it is possible to match the unique workflow of your business, ideal for mid-size companies with distinct processes.

4. Compliance Alignment: Even though you’re not a corporate giant, regulations are still pertinent. You should still be able to meet industry standards and compliance requirements, safeguarding your business against costly setbacks.

Realizing Efficiency: The Power in Practice

The benefits of adopting an AMS solution for mid-range companies extend well beyond the fiscal aspect:

1. Time Efficiency: With AMS solutions fine-tuned to your workflow, tasks become streamlined and automated, drastically reducing the time needed for design approvals and collaboration.

2. Error Reduction: Automated workflows and version control mechanisms significantly diminish the risk of errors, ensuring accurate designs are approved for production without unnecessary delays.

3. Collaborative Seamlessness: encompass collaboration features that enable teams to work harmoniously, regardless of geographical separation.

4. Competitive Advantage: In a competitive arena that values efficiency and adaptability, mid-size companies equipped with an AMS can stand tall alongside industry giants.

Embrace the Opportunity: Unleash the Power of an AMS Solution

If you’re a mid-size company aiming to gain a competitive edge in the packaging sphere, don’t underestimate the use of a powerful AMS. Embrace a solution designed to match your ambitions, enhance your efficiency, and usher in a new era of accomplishment, all while keeping your financial landscape in focus. In a world of dynamic solutions, your business deserves nothing less.

Check out our AMS solution www.twonas.com/ams/ and how it can fit your company.

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Forget Email Attachments: Modernizing Packaging Approval with Digital Solutions

Photo by Brian J. Tromp on Unsplash

Picture this scenario: endless email threads, multiple attachments in several emails as the size limit is reached, wrong attachments sent, lots of back-and-forth to explain that the attachment was wrong and here is the correct one, version confusion… If this is your day-to-day, you can see how it is a recipe for delays, miscommunication, and even the occasional oversight that can have far-reaching consequences.

Thankfully, you can stop that chain of inefficiency and elevate packaging approval processes to new heights of effectiveness—using digital solutions that go beyond the limitations of email attachments.

Rephrase

The Drawbacks of Using Email for Approvals

While­ email has earned its place­ for business communication, it proves ine­fficient when managing esse­ntial tasks such as approving packaging designs due to seve­ral shortcomings:

1. Disconnected Communication: Kee­ping track of context and accurately recording change­s can be tough due to the scatte­red nature of email thre­ads.

2. Confusion with version management: The­ presence of multiple­ attachments with nearly identical name­s could breed misunderstanding, chie­fly when various editions are be­ing scrutinized at the same time­.

3. Sluggish replies: Overfille­d inboxes or a surge of incoming emails may re­sult in important messages being misse­d, leading to holdups in the approval process.

4. Ambiguous Re­sponsibility: Figuring out who has examined or gree­nlit a design at any moment proves difficult, re­ndering accountability a fizzy concept.

The Digital Leap: What Modern Approvals Demand

Fortunately, there are digital solutions that tackle the challenges of packaging approvals. These solutions offer a range of features that revolutionize the approval process:

1. Collaborative Workspace: Imagine a virtual space where stakeholders can congregate, review designs, provide feedback, and hold discussions—all within a single, organized platform.

2. Version Tracking: A digital system maintains a comprehensive history of design versions, enabling easy comparison and minimizing errors caused by outdated versions.

3. Transparent Approval Paths: Digital solutions allow you to define and visualize approval paths clearly, ensuring designs navigate through the correct channels without bottlenecks.

4. Automated Reminders: Say goodbye to chasing approvals. Automated notifications ensure that reviewers are prompted at the right time, reducing approval cycle times. You can also choose to send manual reminders.

5. Accountability and Audit Trails: Each action is recorded, creating an audit trail that clarifies who did what, when, and why—an essential feature for compliance-driven industries.

The Transformative Impact: Efficiency and Precision Redefined

Do you need to hear about the advantages of using such a digital solution ?

1. Streamlined Workflows: With collaborative workspaces, design reviews become intuitive and streamlined, eliminating the confusion associated with email chains.

2. Rapid Turnaround: Design approvals take less time, enhancing your ability to bring products to market swiftly and seize new opportunities.

3. Improved Accuracy: Version control hiccups and miscommunications become a thing of the past, reducing the chances of errors slipping through the cracks.

4. Compliance : Industries subject to regulations can breathe easier knowing that an accountable, traceable process is in place.

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So, are you ready to leave the era of email attachments behind and embark on a journey towards efficient, compliant, and precise packaging approvals?

If you are, please give a try to our approvals solution and then, contact us to help you implement it for your team.

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What is the process for a new Twona Release?

Some of you may have been wondering what happens before a new release of Twona AMS takes place. 

When developing any new functionality for our Twona system, we follow a clear structure, which is consistent with SaaS product development. It consists of a well-defined series of steps that allows us to design, develop, deploy, and maintain the system in the best way possible.

Here is a bit of what happens : 

Image source https://wallpapercave.com/bpm-wallpapers

Ideas and planning

Where do new functionality originate from? That depends. Sometimes new functionality is linked to user feedback which comes from tickets, or conversations with their customer success managers; other times, we follow the market to see what functionality is out there that could be interesting for our users and we evaluate it; a new feature could also be the result of an internal business objective that we aim at achieving. 

Whatever the source of this, we always assess what the impact of the functionality would be on other features already in the system, how it would affect user experience, whether this is something that all or most customers would benefit from and use, and how it would affect our existing infrastructure. 

During this phase, we also make sure that the user requirements (internal or external) are clearly defined, looking at all possible scenarios.

All this information is gathered in our Product Development board, in the form of cards, which will go through several process steps if they are validated by the product owners. If the card gets validated, the next phase will kick in, that would be the design phase.

Design 

When we talk about design, we are referring to the visual interpretation of the application screens that will contain the new functionality. These are often referred to as wireframes or mockups. When we create these, we also make sure that we cover the interactions and integration with existing features, and we involve the technical and customer team to generate a result that is consistent with the rest of the application and will be seamless for customer experience. 

Here we define a lot of possible scenarios of how the functionality would be used, where it would be accessed from, and how it will show to users with different access levels to the platform. 

Development 

Photo by Shahadat Rahman on Unsplash

Here is where our front and back-end developers get to work! They will be writing code (clean and modular ;)) to implement the wireframe design, integrate it with the existing software, and make sure that all is compatible and it will create no disruptions to user experience. 

The development takes place in servers separated from our own platform, to make sure that nothing is compromised.. When it is ready, it is moved to the testing environment. 

Testing

During the testing phase, several departments will be involved. 

Initially, the development team performs a test to confirm the functionality is working as expected, but more importantly, they perform some integration tests. These make sure that the new functionality is not going to break anything that was already in place. 

When this is confirmed, product owner and customer success get to test the functionality. Several eyes see more than two, so we always make sure that not only the originator of the request for new functionality gets to test it, but at least one other person does, although often testing is performed by at least 3 people, sometimes taking different roles and user permissions when performing the test.. 

If any issues are identified, it means we are back to the development team. A proper description of the issue is registered in our Product Board and the card about the functionality is sent back. The development team then works on the areas that are not working as expected, usually have questions for the requestors, and get back to coding. 

The full process above is repeated until the functionality passes all tests. 

When this happens, the functionality can be put into the production enviroment. 

Deployment

At Twona, we have a rule to not deploy (send to production) on a Friday afternoon. Although we very rarely experience any issues when doing a deployment, we want to make sure that if we do encounter an issue, this is sorted quicky, without robbing anyone of their weekend. 

So, we normally plan for deployments during the day. This is posible because there is little to no disruption to our client’s work when deployments take place, they are rather transparent to their operations. The reason for this is that we use a process where the old functionality/current version of our system does not get disconnected until the new one is in place, so the users will not notice anything until that happens and the new release is appearing in their screens.

The work starts by preparing the deployment environment : servers, databases, any infrastructure changes (if any , as we normally do these separately). When we start the deployment to the production environment, this is constantly monitored for any issues. When the release is completed, a notification is sent internally so that account managers can keep an eye on their clients for any potential ticket that may be related to the deployment. 

Documentation and Communication

This phase does not really start now, after the deployment, but from the moment the development starts on the new functionality. 

We make sure that new functionality is added to the online user guides, and start the preparation of newsletters with information on the changes. Very often, we distribute this information before the deployment is done so that our users get to know what is coming and how it will look when they log in to the system.  

We also organize online webinars regularly to communicate and explain about the new releases, especially when these cover several items, or when the functionality is very new or very different to what our users were experiencing before so we can make sure that they can continue to make the most out of our tool.  

Customer feedback, support, and continuous improvement

And mentioned before, we closely monitor our user experience after a release. This happens proactively through interactions with clients via their success managers and during trainings/online sessions about the new functionality, and more reactively through reaction to tickets that customers may have raised. 

We do receive a lot of positive feedback as a reaction to new features, but of course there are also improvement points that customers may notice. We definitely react immediately to any comment that would indicate a bug/malfunction of the functionality or any other area of the application as a result of the release, and those are given priority and sorted with urgency. 

However, we do take all feedback very seriously, and even though not all requests for improvement or changes are seeing the light immediately, they are always studied by the product team in combination with customer success to define whether these are individual/customized requests or they would benefit our customer base. 

Photo by Jon Tyson on Unsplash

As mentioned, many of our new features start off as a customer feedback request, which is why we appreciate any input we receive about the tool. We are always looking for opportunities to identify areas for further enhancement. 

Of course, we have our regular development and update cycles, but we aim to combine both our own views and expertise on the market with the needs of our customers to make the best artwork management system possible.

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Ensuring Regulatory Compliance in your Packaging Artworks

If you follow us in Social Media (if you do not, this is the time! Follow now) you would have seen a quick poll we had where we were asking what are the main challenges you face when launching a new product. Majority of the responses went about “meeting all the regulations”. Indeed, due to the highly regulated industry, pharmaceutical packaging is not a simple one to tackle, and it makes it essential for packaging artwork coordinators to have a good understanding of the complex regulatory requirements governing pharmaceutical packaging. So, what it is exactly you need to pay attention to?

Generated with Midjourney

Labeling Requirements

One very important aspect of pharmaceutical packaging compliance is adhering to labeling requirements, which are likely to differ from country to country or region to region. It is crucial to familiarize yourself with the specific regulations governing your target market. Some common labeling elements are:

  • Drug Name and Strength: to be clearly and prominently displayed on the primary packaging.
  • Indications and Usage: accurate information regarding the approved indications for use of the medication.
  • Dosage Instructions: recommended dosage, frequency, and administration route.
  • Storage Instructions: appropriate storage conditions to maintain the drug’s stability and efficacy.
  • Expiration Date: expiry date prominently displayed to ensure patients use the medication before it becomes ineffective.

Warning Statements

It is important to include warning statements where applicable, to communicate potential risks and ensure patient safety:

  • Contraindications: Clearly state any circumstances under which the medication should not be used.
  • Side Effects: comprehensive list of potential side effects and instructions for managing them.
  • Allergies: any known allergens or substances that may cause an allergic reaction should be highlighted.
  • Drug Interactions: if interactions with other medications, supplements, or substances are identified, these need to be mentioned.
  • Special Populations: these are specific instructions for groups such as pregnant or breastfeeding women, children, or elderly patients, amongst others.

Package Inserts

Package inserts or leaflets provide a wealth of information to patients and healthcare professionals. If you incorporate an insert or leaflet in your product packaging, consider the following:

  • Information should be organized in a clear and legible manner, using appropriate font sizes and layout.
  • Comprehensive Product Information: the information provided should not leave doubts to interpretation and should not leave the patient with questions about usage or contraindications.
  • Provide detailed instructions on dosage, administration, and any special considerations.
  • List potential side effects, their frequency, and steps to take if they occur.
  • Include contact details for reporting adverse events or seeking additional information.

Working with Regulatory Agencies

Finally, one way of making sure that you remain compliant with packaging regulations is having a good relationship with regulatory bodies and agencies that lead in your area of operation. You can achieve this by staying up to date with regulatory changes and engaging with the regulatory agencies early in the process to seek guidance and clarification, in a proactive manner. In order to do this, you will need to identify the right contacts in the regulatory agency, and maintain open communication lines so that when you have comments, queries or concerns, you do not loose valuable time trying to find the right person to answer. Also important is to be acquainted with their submission timelines, so when you need to submit artworks and documentation for approval, no deadlines are missed and approvals are provided in time. This is very relevant since failing to reach approval deadlines can mean that your product will no go to market when planned, with the implications of costs and process loss that this entails. When submitting these, not only timing is important, but you should also pay attention to the accuracy of all materials (artworks, texts,…) so that there is no way they are sent back/rejected. Finally, it is important that you realize that being in this industry means that you will be audited periodically; this means that maintaining comprehensive records, documentation, and an organized system for tracking changes on your artworks is of main importance!

Although the landscape of pharmaceutical packaging regulations is complex, using best practices and understanding these key areas would make your work much easier, ensuring that you safely and effectively delivery medications to patients worldwide.

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5 best practices for artwork coordinators to ensure packaging consistency

Image generated with MidJourney

Having a consistent brand experience is one important element for your product success in the market. Achieving this is not always easy, specially when companies have a multitude of products in different categories, or products that are targeted at different customer groups, when they use many different designers/agencies, and specially, when deadlines are tight. As an artwork coordinator, you have to bridge those gaps and make sure that your brand stands out, and is recognizable throughout all your different product lines, without incoherences and mistakes.

These 5 best practices can help you get there!

1. Define brand guidelines

We have talked about brand guidelines before. A complete brand book will contain the rules and directions on how to use design elements like typography, colors, imagery and logos, as well as define the brand tone of voice and messaging, so that the brand values and image are easily recognizable by the product users. Artwork coordinators need to have a deep knowledge of the guidelines, how to implement them, and when exceptions can be made. It is your job to make sure that the brand guidelines are complete, and cover all possible packaging scenarios, so that when new products are introduced, their packaging design is easily replicated with its specific differences and nuances.

2. Use consistent templates

Once you have your brand guidelines in place, you should make sure to develop templates that make your work easier when creating new artworks; that way, you can be sure that all your product line will have a similar look and feel. The templates can have locked out elements like the placement of logos, product name, or key visual elements, so that you can be sure that those align perfectly.

Not sure how you feel about it, but I hate when I purchase a bag of chick-pea crisps and a bag of lentil crisps from the same company, and the packaging is “slightly off”, with small detail things like: a logo is bigger in one bag than in the other, or moved to the side, or the key selling point of the product appears on a particular font or color, and these do not match. Clients notice these small things, and they are annoyed by them. At least, clients like me :D!

3. Work closely with designers

If you are not acting as a designer as well (which let’s be honest, happens quite often to artwork coordinators), you will certainly be working with them very closely, to create the packaging artworks.

It is of absolute importance that the guidelines are understood by the design team, so you should make it a priority to teach them about the guidelines, not just show them where the brandbook document is stored (*yes, I know you have done this before, it is ok, that is why I am here to let you know that you need to stop doing that and provide proper training on your brand guidelines).

Additionally, you also should make sure that they have all in their possession all key brand elements: logos in the right size and formats, fonts that they will need to use, color codes for RGB/CMYK, image bank/library access, design tool licenses… so that the quality of what they produce can be up to standards.

4. Conduct regular reviews

Once the packaging design is completed and in use, it is not crazy to plan periodical reviews. One clear scenario for this is when you are working with different designers/studios, or when you recently changed providers, so that you can compare their adherence to the guidelines and verify that brand consistency remains intact. It is also possible that over time, your guidelines evolve as your brand does, and this is also a moment when reviewing your packaging design would be needed, so that any changes implemented in the guidelines can also be put in place in your packaging moving forward.

These changes can also be driven by new regulations that require new icons/information on your packaging, and without a proper review, some of your artworks could be deviating from the way you want them to be created, just due to lack of communication about the changes, country-specific regulations, or others. It is your job as an artwork coordinator to have this under control, and ensure that the packaging effectively communicates the product’s value proposition at any given time.

5. Ensure consistent production

In the end, what the client will see is what they can get their hands on, so the final product on the shelves. For multiple reasons, the production of different products of your portfolio may not take place in the same printer, or production facility , which means that the printing or quality standards may vary. Because products end up sitting next to each other on the shelves, it is possible that two variations of a product / different line of a product, end up showing small (hopefully) differences in the final sold product.
Consistency of the final product with the approved artwork is key to a positive brand image. This is why it is often important to be able to compare the final product (e.g from a photo of a box, wrapping, bottle, can…) with the final approved artwork. This is something that you can for instance do with Twona X-RAY, a complete Artwork and Graphic Design Comparison Platform that helps you effortlessly review your text, graphics, and final packaging.

Compare your final product with your artwork files

Packaging consistency is therefore a matter of aligning multiple stakeholders and making sure they all adhere to the brand standard, templates and guidelines defined by your company. It involves activities such as information sharing, training, and reviews (multiple rounds) that often fall on the task list of an artwork coordinator, while juggling other many tasks and deadlines. The job of the artwork coordinator is a complex one, as we explained before!

Following these 5 best practices, we are sure that you will achieve more consistency in your packaging design and new product launch. Do you have any other tips to share with fellow artwork coordinators?

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Striking the Right Balance: Key Aspects of Designing SOPs for Pharmaceutical Packaging

Midjourney

Designing packaging materials for pharmaceutical brands can be a meticulous and complex process. As a designer working for a studio that works exclusively with pharma, my work primarily involves implementing a strict set of rules on various packaging materials that will be commercialized across different markets. To keep everything in check, in my team we write SOPs tailored to each customer. In this article, I’ll discuss the key aspects we consider when writing those SOPs and comment on the balance between effectiveness and completeness.

Clarity and Simplicity

The first aspect to consider when writing a design SOP is clarity and simplicity. The document should be easy to understand and follow for all team members, regardless of their expertise or experience. If a Junior designer cannot follow the document, then it does not fulfils its purpose. This can be achieved by using clear language, avoiding jargon, and providing visual examples when necessary. An image might be worth a thousand words. An effective SOP should prioritize essential information and avoid excessive detail to ensure that it remains concise and focused. If complex details are needed, you can always reference a more complex or complete document such as complete brand design guideline.

Compliance with Brand Guidelines and Regulatory Requirements

Pharmaceutical packaging must adhere to both the company’s brand guidelines and the regulatory requirements of the target market. It also needs to comply with all technical specifications from the manufacturing entity. A design SOP should provide clear instructions on how to maintain consistency with the company’s visual identity and fulfill the necessary legal obligations. This includes guidelines on colors, fonts, logos, and layout, as well as any specific labeling requirements mandated by law. And these change per country! Templates are in this case VERY useful.

Adaptability for Different Formats and Materials

We deal with packaging in various formats and materials, such as boxes, bottles, and blister packs. An effective design SOP should account for these variations and provide guidance on how to adapt designs accordingly. If you ever faced implementing a tini tiny label, then you know what it’s like. This may involve including modular design elements that can be easily rearranged or resized to fit different formats. Again, templates are your friend.

Revision and Update Process

Finally, a design SOP should include a clear process for revising and updating the document. This is crucial to ensure that the SOP remains relevant and up-to-date with any changes in brand guidelines, regulatory requirements, or industry best practices. This is particularly critical if your studio is ISO compliant. It is as important to make the right changes as to track who made those changes and why.

Striking the Right Balance

An effective and useful design SOP should provide enough information and guidance to ensure that all team members can create consistent, compliant, and technically correct packaging materials. However, it’s essential to strike the right balance between providing necessary details and overwhelming the reader with excessive information. An over-complete SOP may lead to confusion, inconsistencies, and a slower design process. By focusing on the key aspects outlined above, you can create an SOP that is both comprehensive and efficient, ensuring that your pharmaceutical packaging designs meet the highest standards.

If you are unsure as to what is the right level of detail, use an Agile process. Write a draft, let your team use it, get feedback and refine the document iteratively.

Your Studio Partner

Do you feel stuck with your current design process? Reach out to our studio and let us give you a hand. We can help you implement artworks or improve your studio processes.

Your Studio Partner