Diseño de packaging en medicamentos genéricos

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El packaging es un aspecto crucial en el diseño de productos, ya que es la primera impresión que un cliente tiene de un producto. Por esta razón, es fundamental tener un enfoque estratégico y un proceso bien estructurado para el diseño de packaging, que permita lograr un resultado profesional y atractivo para los consumidores.

En el caso de la industria farmacéutica y en particular en los productos genéricos el marketing es muy sutil porque esta regulado por la Agencia del Medicamento y el diseño se limita a ciertos colores corporativos así como logos y la fuente, nada más.

En cualquier caso hay detalles como el reconocimiento de marca que pueden generar una fidelización del consumidor final. En el mercado de los fármacos genéricos, dado que el resultado médico es el mismo, la diferencia esta en la distribución y la experiencia del usuario que puede variar cuando estudiamos el packaging y el contenido del mismo:

  • Un color terapéutico reconocible
    • La posibilidad de dividir la dosis en dos o más partes
    • El color del comprimido
    • Nombre y contenido claro en todas las caras
    • Legibilidad e instrucciones respecto a su conservación

    Puntos clave para homogeneizar tus materiales

    1.- Un procedimiento bien estructurado donde enumeramos los diferentes pasos a seguir. El procedimiento debe estar dividido en secciones que se centren en las diferentes partes que conforme el diseño, por ejemplo secciones de cada una de las caras o secciones de un prospecto.

    El uso de procedimientos es esencial en el diseño de packaging, ya que permite a los diseñadores tener una guía clara y estructurada para lograr un resultado óptimo, ayudan a identificar y solucionar problemas antes de que se produzcan, lo que reduce el tiempo y los costes de producción.

    2.- El uso de “templates” o plantillas siempre de uso común para todos los diseñadores. Los templates son una serie de directrices y estándares que se aplican a todos los diseños. Las plantillas incluyen aspectos como la ubicación de los elementos, el uso de colores, iconos, locos y tipografías, entre otros.

    Ni que decir tiene que debemos tener una template para cada categoría de producto, por ejemplo, envases, aluminios, etiquetas, etc. Son recursos necesarios para la gran mayoría de productos englobados en un grupo, las excepciones no deben incluirse en dicho documento.

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    Hay varias razones por las que tener templates es importante para el diseño de packaging:

    1. Garantiza la homogeneidad de los diseños: Las plantillas aseguran que todos los diseños sean coherentes y mantengan un estilo uniforme, lo que es esencial para crear una identidad de marca fuerte y reconocida.
    2. Evita errores: Ayudan a prevenir errores comunes en el diseño, como la elección de un tipo de letra demasiado pequeño o la ubicación incorrecta de los elementos en la etiqueta.
    3. Aumenta la eficiencia: Al tener disponibles elementos que siempre implementamos en cada uno de los diseños.

    En resumen, es posible hacer un diseño sin los recursos expuestos en éste artículo, pero si tu organización tiene un amplio portafolio con grandes volúmenes y se busca la homogeneización de los productos, un procedimiento bien estructurado y el uso de templates, no solo acelerará el proceso exponencialmente sino que además reduciremos, sin eliminar completamente por desgracia, la posibilidad de desviaciones que supongan una retirada del mercado dañando nuestra imagen de marca y resultados.

    ¿Puedes asumir el riesgo de tener una desviación o no cumplir tu calendario de lanzamientos?

    The nightmare of technical specs

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    Working in the pharmaceutical industry, the creation of packaging designs can be a challenging and complex process, especially when dealing with multiple Contract Manufacturing Organizations (CMOs) and Printing companies. There are many factors that can impact the design, including regulatory requirements, branding, marketing, and of course, technical considerations. One of the biggest challenges that packaging designers face when working with multiple printing stakeholders (weather it is a CMO or a printer directly) is the varying technical requirements. Different companies have different machinery and different Standard Operating Procedures (SOPs) (sometimes they don’t even have SOPs).

    Oh man…this is hard.

    The first challenge related to working with multiple printers is the differences in print and packing capabilities. Each printer may have different printing processes and equipment that they use. For example, one printer may use a rotogravure printing process while another may use flexographic printing. This can result in differences in color accuracy, registration, and overall quality of the final print. Additionally, some printers may not be able to accommodate certain design elements, such as holographic foils or raised printing, which can impact the design and the overall look of the packaging. Additionally, and more specifically for the packaging industry, the printed materials are going to be the input of a packing machine which is going to fold, fill, glue and whatnot in an automated machine. This process is critical since failure can have a high cost impact. Most “reasonable” printing companies and CMOs provide technical specifications to their design agencies (or their clients) so the design materials can be created to specs.

    The second challenge is the complex technical documentation that designers must understand in order to create compliant designs. Technical documentation often includes specifications on dielines, varnish free areas, margins, folding lines, visual marks used for automated packing and many more. Understanding these guidelines and ensuring that the design meets them can be a time-consuming and confusing process, particularly for designers who are not familiar with the specific requirements of each printer and considering some of these technical specification documents can be 40 page long. If you are dealing with 10 suppliers, times 40 is a 400 page documentation. That is not easy to manage. This can result in mistakes and miscommunications between the design team and the printer, which can ultimately impact the time to market.

    What can we do to fix this?

    There are ways to improve the process when technical specification documentation is complex and there are many different suppliers:

    1. Write and maintain proper design manuals specifically for each printer/CMO. This will help ensure that the design team has all of the information they need to create designs that are compatible with each printer’s technical requirements. This can also help avoid misunderstandings and miscommunications between the design team and the printer. Additionally, it will be required should you have to face a customer audit.
    2. Perform training of the design team on all technical requirements. This will help ensure that the design team is aware of the specific requirements of each printer and can create designs that are compatible with those requirements. Furthermore, it will help designers find and interpret information faster and accurately.
    3. Allow a direct line of communication with the printer instead of via the client. A direct line of communication can help avoid misunderstandings and miscommunications that may occur when the design team is communicating through the client. Let the technical people speak to technical people directly, otherwise you will face the broken phone syndrome.

    The creation of packaging designs can be challenging, especially when working with multiple CMOs and printers. The varying technical requirements of each printer and the long and complex technical documentation can be a pain in the arse to deal with and a high risk factor. But don’t despair, by following these three tips – writing and maintaining proper design manuals, performing training on technical requirements, and allowing a direct line of communication with the printer – designers can improve the process and ensure that the final product meets all of the necessary requirements.

    Mistakes on medical leaflets

    The packaging of pharmaceutical products is a crucial aspect of the industry. It serves not only as a protective barrier for the product, but also as a means of communication between the releaser and the consumer. The releaser, a pharmaceutical laboratory, must ensure the existence of an appropriate pharmacovigilance system that allows him to assume his responsibilities and obligations in relation to the pharmaceutical specialties he markets and ensure the adoption of appropriate measures when necessary.

    Risks and consequences

    One of the most important components of pharmaceutical packaging is the leaflet, also known as the patient information leaflet (PIL), which provides information about the product, including its intended use, side effects, and usage instructions.

    To check the content of a leaflet thoroughly is critical, as even a small typo, missing text, or added text can have significant consequences for the patient and the releaser.

    Why?

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    It is important to avoid errors in the leaflet because they can result in medication errors. For example, if a typo results in the incorrect dosage instructions being printed on the leaflet, the patient may take too much or too little of the medication, which can have serious consequences for their health. Similarly, if important information about side effects is missing or incorrect, the patient may not be fully aware of the risks associated with taking the medication. Believe me, there are side effects which patient and relatives should be fully aware from small possible irritations to a tendency to gambling, side effect that is only revealed after clinical trials for obvious reasons.

    Deviation in the leaflet can also result in recalls and legal issues for the releaser. A recall is a costly and time-consuming process, as it requires to retrieve all the affected products from the market and replace them with new, corrected versions. In some cases, the recall may result in significant financial losses, as well as a damaged reputation and loss of trust from consumers.

    As a designer and knowing the sensitivity of this situation, the corresponding procedure, quality documents and relevant tools are essential. Just thinking about the lack of an appropriate software 15 years ago makes me dizzy.

    How to avoid mistakes

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    In order to avoid errors in the leaflet, it is important to have a robust quality control process in place. This may involve multiple rounds of review and testing by different employees within the company, we call it four eyes principle. The process should also include a thorough review of the final product before it is released to the market, in order to catch any last-minute changes or mistakes.

    In conclusion, checking the content of a leaflet in the packaging of pharmaceutical products is a crucial step in ensuring patient safety and avoiding costly recalls and damage to brand image. By having a robust quality control process in place, releasers can avoid errors and ensure that the information provided in the leaflet is accurate and up-to-date. Patients can also play a role reporting any discrepancies to their healthcare provider. By working together, the industry and consumers can ensure that the information provided in the leaflet is accurate and that patients receive the best possible care.

    Is Software Validation outdated?

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    Software validation is the process of ensuring that software systems meet the requirements set forth by regulatory bodies, such as the FDA in the United States. This is particularly important in highly regulated industries, such as the pharmaceutical industry, where software systems are used to manage and analyze critical data that is used to support the development and manufacture of drugs.

    The origin of software validation can be traced back to the early days of computer technology in the pharmaceutical industry. In the 1970s, the FDA began to recognize the importance of software validation as a means of ensuring the accuracy and reliability of data generated by computer systems. This led to the development of guidelines and regulations for software validation, specifically in the pharmaceutical industry, such as the FDA’s “Guideline on General Principles of Software Validation” in 2002.

    One key document that is created during the software validation process is the Master Validation Plan (MVP). The MVP is a comprehensive document that outlines the overall strategy and approach for validating the software. It includes details such as the scope of the validation, the validation team, and the schedule for validation activities. It is the first and foremost piece to documentation that needs to be created.

    Following the MVP, you need to build three key documents: OQ, IQ and PQ.

    Operational Qualification (OQ) and Installation Qualification (IQ) are used to ensure that the software system is installed and configured properly, and that it functions as intended in its intended environment.

    Performance Qualification (PQ) is a process of testing software systems in order to verify that it performs as intended, and that it meets the acceptance criteria defined in the Qualification Protocol (QP).

    As the technology and software development methodologies have evolved since the 70s, the need to adapt the validation model for modern SaaS cloud-based solutions has become increasingly important. With the advent of cloud computing, software systems are no longer installed and run on a single machine, but rather they are accessed through the internet from various devices and locations. This is the so called “single tenant system”, which is a radically different paradigm from the early on-site installations. This has led to the development of new guidelines and regulations for validating cloud-based software systems, such as the FDA’s “Guidance for Industry: Cloud Computing and Mobile Medical Applications” in 2013, although one might argue that those models are still outdated given the speed of the advancement of technology and cloud services.

    In conclusion, software validation is a critical process in ensuring the accuracy and reliability of data generated by computer systems in highly regulated environments. However, application of outdated validation methods will only led to frustration and failure.

    If you are about to embark on a validation process for a SaaS solution but your QA team has only experience on traditional on-site installations, do not rush. Take your time, read the available literature, get familiar with the tools and infrastructure used by your chosen vendor and if necessary, ask for additional budget to ensure the validation is not only successful, but more importantly, relevant.

    Leaflet digitalization in the European Union?

    Photo by Danielle Rice - map of europe
    Photo by Danielle Rice

    If you follow us, you would remember an earlier article about changes in the pharmaceutical industry in the last years, around tools and technology for document management.

    Was it an exponential change in the industry ?

    Some examples of these changes are:

    • A paper archive/database
    • Tracing in an spreadsheet
    • Control of changes on paper
    • Email or Fax as project manager
    • Visual Artwork review
    Photo by EMA

    These types of processes are now a thing of the past, and are being replaced by Artwork Management systems, and proofing tools that take change management to a totally new level.

    The change has been enormous and more changes could be needed due to agreements between the European Medicines Agency (EMA) , management at Medicine agencies (HMA) and the European commission projects from 2018, aiming at a digital transformation in sanitary support in the European Union (see the draft here: EMA)

    This transformation has implications that are beyond my knowledge, but some of the phases that it entails were:

    • March 2017 – report from the European Commission with an action plan for the EMA to identify areas susceptible of improvement to satisfy the needs of patients and professionals.
    • 2018 – collaboration between EMA-HMA-EC identifying the needs for a future digitalization.
    • March 2017 – report from the European Commission with an action plan for the EMA to identify areas susceptible of improvement to satisfy the needs of patients and professionals.
    • 28 november 2018 – EMA runs a workshop with patients/consumers, health professionals, interested parties in the industry, academics, NGOs and regulators. This returned the key principles of this process.
    • February to July 2019 – public consultation with over 500 comments.

    After reviewing these comments in relation to the key principles defined, a pilot program emerged in January 2022, aimed at evaluating the impact of the removal of the paper leaflets in a small portion of medicines for human use, within hospitals.

    These medicines should include in their primary packaging a non serialised Data Matrix code that, once captured, would allow direct access to the digital version of the leaflet from the information allocated in CIMA.

    Photo by Rodion Kutsaev

    The pilot duration will be at least 2 years, and it will be implemented progressively.

    Would there really be a digitalization in health assistance in the European Union? I believe that after all the effort, this will become a reality. The only question is to what extent is the EU capable of coordinating for the big change of digital times.

    And you, are you ready?

    Rafael Cruz Núñez
    Artwork Manager

    Standardizing products in the pharmaceutical industry

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    Homogeneize/Standardize is the process to harmonize or confer homogeneity or unity to the elements of a set or an area. When it comes to our packaging, it has many other implications:

    • Identification & communication of attributes and visibility.
    • Item Distribution Strategy.
    • Increase in perceived value of the product.
    • Brand recognition.
    • Loyalty.

    With the term defined and considering the high strategic importance of standardizing our packaging, we are going to focus on how to deal with the production of (standardize) materials.

    What is the best way to guarantee that our team of designers produce homogeneous materials?

    Without a doubt, it is the use of templates. These templates, which are expected to be a shared resource, must be unique and protected to avoid changes and therefore generate unwanted deviations.

    It is important to develop as many templates as types of products are in our portfolio. These types or groups of products have similar content, form and distribution:

    • Blister box
    • Vertical box
    • Label
    • Leaflet
    • Blister

    Using a Folding Box as an example, our template must contain: logos and corporate identity signs, road safety or photosensitivity icon, recycling symbol(s), dosage chart and a long etcetera depending on the complexity of our design.

    In order to complete our template, we are currently still missing a fundamental element. It is of vital importance to have a mockup in our template so that designers can use the elements that compose it when building new products.

    Back to our example of a Folding Box. In our mock-up there will be a set of elements in the front face such as the name of the product/component in the correct corporate font, size and formatting that would help the designer create the final material. Very important is to make sure that these elements are not to be specific and refer to a real product/component. These should contain a generic text, such to avoid human errors by not replacing the correct text from the Medicines Agency.

    For example: Molecule Brand 00 xx xxxxxxx xxxxxx EFG – all these in the correct font and sizes/styling.

    Austrian national library – unsplash

    Besides reducing risk of mistakes, another benefit of using templates is to exponentially speed up the design process. The template is expected to already solve many questions when starting producing a material: What font should I use? Where are the logos and icons? What were these products like that I haven’t worked on lately?…

    To finish with our recommendations to standardize your designs with the use of templates, it is important to highlight that a template is subject to real and common cases. What does this mean? The template should be simplified as much as possible so that its use is agile and efficient, therefore, they should not include exceptions or extreme cases when creating the template.

    Our template must encompass the common elements of at least 90% of our materials, as well as our guide or procedure for a material that you can see in a previous article: Facing a Rebranding without stress.

    Rafael Cruz Núñez
    Artwork Manager