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Connecting your AMS with APIs

In today’s world of tech wonders, companies require robust and efficient systems to manage their workflows, and packaging design for pharmaceutical and food companies is no exception, specially considering the complexity in the process and the number of stakeholders involved. In order to streamline the process of exchanging information during the different steps of the workflow when more than one system is involved, companies can use REST APIs.

What is a REST API?

REST (Representational State Transfer) API is an interface that allow different software applications to communicate with each other over the internet. REST APIs use HTTP requests to send and receive data, making it easier for software applications to exchange information and interact with each other.

One-directional and Two-directional communication

REST APIs can facilitate one-directional or two-directional communication between different software applications. In one-directional communication, data flows only in one direction, for instance sending an approved artwork to an ERP system. In two-directional communication, data flows both ways, allowing for a more robust exchange of information between different software applications, for instance obtaining a Material Number and providing an approval over a packaging material.

Benefits of using REST APIs for packaging design

REST APIs provide several benefits when it comes to packaging design for pharmaceutical and food companies:

  1. Streamlined workflow: REST APIs can facilitate a streamlined workflow by enabling different software applications to share data with each other. This reduces the risk of data corruption by ensuring a single source of truth. It can also reduce the amount of time and effort required to manage the packaging design process.
  2. Increased efficiency: REST APIs can reduce manual data entry and other repetitive tasks. This can lead to faster turnaround times, improved accuracy, and reduced costs. A good example is a Pharma company working with a CMO. Each have their own AMS and both insist in using their own for quality and audit purposes. Without an API connection, data needs to be entered in both systems, usually triggered by email communication, while an API connection can automate the data sharing process reducing in less manual work.
  3. Improved collaboration: REST APIs can facilitate better collaboration between different teams involved in the packaging design process. For example, designers and printers can use different software applications to work on different aspects of the packaging design process, and REST APIs can be used to share data between these applications, making it easier for team members to work together.

Challenges of implementing REST APIs

While REST APIs can provide several benefits, implementing them can also be challenging:

  1. Compatibility issues: Different software applications may use different data formats, which can make it difficult to share data between them. When such compatibility issues arise, the time and effort required to implement a connection tends to grow.
  2. Security concerns: REST APIs can create security risks if not implemented properly. Companies must ensure that their APIs are secure and that data is encrypted to prevent unauthorized access. A good API connection implementation will always secure protocols to encrypt the data while in transit.
  3. Maintenance: REST APIs require regular maintenance to ensure that they continue to function properly as the different systems involved change over time. Companies may need to allocate resources to maintain their APIs and ensure that they remain up to date with the latest software updates.

REST APIs offer several benefits when it comes to optimising your packaging design workflow. By enabling different software applications to communicate with each other, REST APIs can streamline the process, improve efficiency, and facilitate better collaboration between different teams while reducing manual work and reducing risk.

If you want to know more, check out our public API documentation to see how it can help your process.

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The Golden DTPr for Pharma Packaging

With Midjourney

Desktop Publishing (DTP) specialists play a crucial role in the packaging design process for pharmaceutical products. Sometimes they are called Artworkers, Artwork Specialists or Packaging Specialists. They work with complex design guidelines, technical requirements, and regulatory specifications, and are responsible for creating packaging materials that are both visually appealing and compliant with industry standards. In many cases they also act as Artwork Coordinators to ensure everything goes as planned in the workflow. In order to thrive in this highly regulated and demanding industry, DTP specialists need to possess a specific set of skills and aptitudes.

1. Extreme Attention to Detail

One of the most important skills that a DTP specialist needs to have in the pharmaceutical industry is an extreme attention to detail. Packaging design for pharmaceutical products is a highly regulated field, and even the smallest mistake can have serious consequences. Nobody wants to deal with a product recall or worse, a patient related issue. DTP specialists need to be able to work with complex design guidelines (150 page design guidelines are not uncommon) and technical specifications (working with many different manufacturers across the world), ensuring that their work meets all of the relevant standards and requirements. They also need to be able to spot errors and inconsistencies in their own work, as well as the work of others, and correct them before they become major issues.

In addition to technical accuracy, DTP specialists also need to have a keen eye for design. They need to be able to create packaging materials that are visually appealing and easy to understand for a wide range of audiences, from doctors and pharmacists to patients and their families. This requires a deep understanding of typography, color theory, and layout, as well as an ability to balance form and function in their work.

2. Ability to Work in Unstructured Environments

Another key skill for a DTP specialist in the pharmaceutical industry is the ability to work in unstructured environments. Unlike other industries where workflows are well-defined and standardized, the pharmaceutical industry is highly complex and dynamic and the structure is not always there (unfortunately many organizations still use Excel to manage projects). Workflows are often influenced by many stakeholders, including regulatory bodies, marketing teams, product development teams, and more. Furthermore, many of these stakeholders are external to the team: printers, customers, CMOs, etc. DTP specialists need to be able to navigate these complex workflows, adapting to changes and unexpected challenges as they arise.

This requires a high degree of flexibility and adaptability, as well as an ability to work well under pressure. DTP specialists need to be able to prioritize tasks, manage their time effectively, and communicate clearly with all of the stakeholders involved in the process.

3. Ability to Communicate with a Wide Range of Stakeholders

Finally, a DTP specialist in the pharmaceutical industry needs to be able to communicate effectively with a wide range of stakeholders. This can include everyone from regulatory bodies and marketing teams to product development teams and vendors. In many cases, these stakeholders may not have a deep understanding of the complexities of packaging design for pharmaceutical products or they will have a deep understanding of their specific needs but not of the entire process, which can make communication challenging. Have you ever tried to explain a printing technical requirement to a regulatory affairs professional?

DTP specialists need to be able to translate technical jargon and complex concepts into language that is easy to understand for non-experts. They also need to be able to build relationships with stakeholders, establishing trust and rapport that can help them navigate the complex workflows and regulatory requirements of the industry.

The Golden DTP specialist in the pharmaceutical industry need to possess a specific set of skills and aptitudes in order to thrive in this demanding and complex field. If you are looking to insource your design process or hire a freelancer, make sure they have at least these 3 top skills.

If you cannot find the right candidate, check out our Studio and we can lend a hand.

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Improving your Artworks Workflow

With Midjourney

As an artwork coordinator working for a pharmaceutical company, I oversee the packaging design process from start to finish. It’s a complex process that involves multiple stakeholders and departments: regulatory, supply chain, printing houses, customers (we also do Contract Manufacturing), Quality Assurance, etc. It requires careful coordination to ensure that everything runs smoothly. Over the years, we’ve refined our process to the best of our abilities, but as with any complex system, there’s always room for improvement. We make our process work, but it requires constant emails, reminders and nudges to certain stakeholders to keep everything in check.

When we decided to purchase an Artwork Management System, we agreed to bring in an external workflow and process consultant to help us optimize our packaging design workflow as we intended to digitise our process. At first, I was a bit skeptical. After all, I knew our process inside and out, and I wasn’t sure how an external consultant could provide any value. Our initial plan was to simply move from a manual email based workflow to a digital one. However, after a couple of phone calls regarding the process, we realized that an external set of eyes can sometimes identify issues in your process that you simply cannot see because you’re too close and too busy.

The Consultant

The consultant that came in had extensive experience working with other pharmaceutical companies, not only within brands, but also in CMOs, design agencies, etc. He got us started by going thought our current process, which was drawn on a white board and asking a lot of questions as we went through every stage: who is involved, what information is provided, when, what are the challenges, what happens in this and that scenario, etc. Very quickly he was able to spot a few areas where we could make improvements. There were a couple of key aspects that were particularly interesting where he suggested some changes in the process by analysing and justifying those suggestions. The following was one of the most relevant ones:

Our Process

In the beginning of our process, the Regulatory Department provides the key information related to the change that has to be implemented in the packaging material: a new text, a set of annotated changes due to a change in regulations and anything in between. When this information is received, the Artworks Team checks it and forwards the request to the agency to execute the changes. Later in the process, once the design has been implemented, the Regulatory colleagues check the artwork to make sure it complied with their request for change. The consultant asked: how often does an artwork need to be redone because Regulatory spotted a mistake in the content (not a mistake introduced by the design agency). The answer across my team was consistent…..very frequently. The consultant then made an estimate of the amount of hours involved across all teams between the moment the request is sent by RA and the moment the design is sent back to them for changes. We calculated around 40 to 50 hours of work.

The Suggestions

His suggestion was simple: add a four eye principle on the information provided by Regulatory BEFORE the artwork request is sent to the agency. The objective was to validate the information before those 40 to 50 hours of work were spent on the artwork so that the number of iterations would be reduced. We quickly involved the QA team, who happily agreed to review the data before it was sent to the agency. It was brilliant. A simple suggestion, a nudge to the colleagues in QA and the potential time savings were incredible.

At first, I was a bit intimidated by the prospect of implementing all suggested changes. After all, change can be difficult, especially when you’re dealing with a process that has been in place for years and many stakeholders involved. However, with an open discussions and proper justification of each suggested change, I realized that these changes were all aimed at making our jobs easier and more efficient. By embracing these changes, we could reduce the amount of time and resources we spent on each project and ensure the best possible outcome. Having an external set of eyes also helped align all relevant parties (external people are not afraid of starting difficult conversations).

Over the next few months, we worked closely with the consultant to implement the changes he had suggested. It wasn’t always easy, and there were a few bumps in the road, but overall, the process went smoothly. We saw an consistent improvement in in our process. and our workflow became much more streamlined. We were able to complete projects more quickly and with fewer errors, which made everyone involved in the process much happier.

Looking back, I’m so glad we decided to bring in an external set of eyes to help us optimize our packaging design workflow. I’m excited to see what other improvements we can make in the future, and I’m grateful for the opportunity to work with such a talented consultant.

If you want an external set of eyes on your process, setup a call with us and let’s work together to make your workflow flawless.

Contact us

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Your Quality Assurance in Check

Our Studio works under a four-eyes principle when it comes to artwork production. In any workflow, either our own or one that the customer decides upon, we always introduce an internal QA step. None of our Artworks are sent to the clients before they go through the review of a different person within the department who was not involved in the initial design.

Why is that?

Instructional brochure image – generated with Midjourney

Very simple. When you have been working on a leaflet or an instructions brochure for an hour (sometimes even more!), you are no longer able to distinguish a small mistake. A separate person who was not involved in the original design is the perfect person to take a fresh look at the artwork and detect any potential issues.

It is also essential that this person knows what they need to review, aside of the obvious mistakes that one could have introduced.

  • The internal QA check needs to start from a clear check of the briefing /work order request that has been received. This is because sometimes there are requirements in these that deviate a bit from the customer guidelines.
  • These guidelines are the next step. Clients often have very clear instructions on there about their fonts, colors, and graphics. It is crutial to have them accesible but also include your own annotations on how the guideline is generally interpreted, as you will find that sometimes they can be a bit ambiguous.
  • Regulatory information must be kept updated. Because of regulations being constantly evolving, it is helpful to make sure that you keep any documents related to rules that apply to your packaging designs up to date for anyone doing a QA review, so they can fall back on to it when checking the artworks.
  • Check for consistency – does this package/label/blister have major differences with others produced earlier on? If so, what are the reasons for that? (new regulations, change in guidelines, specific customer request…).

One thing that our team uses frequently when undergoing the internal QA process is to refer to a checklist that they have developed. This checklist starts as a template (which you can download for your own use), with generic areas to review, although they often create one specific for each customer, to make sure that the client’s peculiarities are included and always visible to the review team.

Using such a checklist has many advantages for our Studio:

  • Error reduction – with a four eye principle in combination with a proper checklist, we are able to reduce the amount of oversights and not pass imperfect artworks to our clients – incorrect information, missing or incorrect formats, or design inconsistencies. We may have an extra internal version on occasion, but we make sure that the changes the client sends back are reduced to a minimum. This is one of the reasons why our average number of versions on artworks is so low.
  • Compliance – we obviously follow the guidelines and industry regulations when we create artworks but by using a checklist, we are able to reduce risk of not being compliant with these as the specific requirements are included in the checklist making them hard to miss.
  • Time and Cost Savings – by potentially catching errors or issues before they reach the client, we are able to save both time and money. Imagine that these errors lead to a recall packaging redesign, the effect that this would have on both our team and our clients’ would be massive.
  • Collaboration – for us, checklists are also a way for our team to remain a good working team. By sharing the checklists not only with designs but also other involved departments, we are able to give visibility to all the team members and make them part of the same shared objective. So it may be a soft advantage, but in the long run, a close team who works together would be a much stronger one.
  • Competitive advantage – not all studios provide these type of quality services. A lot of times there is a GiGo mentality, and imperfection is rewarded (e.g. when each single subversion of an artwork is charged for). For us, it is really mandatory that the product we deliver is as good as it can get. Therefore, this quality control step is a key one.

If you also find quality an essential step in your artwork process, and need some help getting started, you can download our checklist template from this link. Remember that adding your own items to the list is very important!!

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Asking vs SOPing.

In today’s fast-paced business world, every second counts, and no one wants to waste time on repetitive tasks. One area where this is especially true is in the supply chain of packaging design processes where not only time matters but reducing risk is a key factor of the process. Frequently, supply chain teams are asked to supply information that is mostly static and unchanging, yet the requests for this information continue to pour in. For every artwork material surely comes an email requesting the same information. In these cases, identifying repetitive tasks and documenting the necessary information can help save time across the supply chain while reducing unnecessary risks related to information processing.

Let’s consider the following example: An artwork coordinator requests information from the supply chain team regarding the technical specifications of serialisation printing. The details provided by the supply chain always relate to the market where the product is going to be released (different market, different rules) and change only every one or two years when the regulatory bodies change the laws. The request for information is done for every product, and therefore the response from the supply chain is almost always the same. Furthermore, supply chain is the only team up to date on when the regulations change.

In this situation, creating a set of technical specifications in the form of a Standard Operating Procedure (SOP) can help streamline the process. The SOP would describe the serialization requirements per market (what information can be printed where and under which technical specifications), and the supply chain team would become the owners of these documents. By creating and documenting these technical specifications, the supply chain team can prevent the information from being requested for every product, thereby saving a tremendous amount of time while reducing the risk of misinformation.

The benefits of creating SOPs and technical documents go beyond time-saving. By documenting and standardizing information, it becomes easier to communicate and collaborate with team members and stakeholders. This standardization can also reduce errors and improve the quality of the work.

Furthermore, the benefits of documenting information go beyond the immediate supply chain team. If the information is needed by other teams, such as quality assurange or regulatory affairs, having a documented SOP can ensure that everyone is on the same page and using the correct information. This can help prevent delays and ensure that all aspects of the product development process are aligned.

In conclusion, identifying repetitive tasks and documenting necessary information can help save time across the entire supply chain of packaging design. The example of creating an SOP for serialization requirements illustrates how this process can be applied in practice on any company that markets products across different countries. By creating and maintaining such documents, teams can save time, reduce the risk of misinformation, and improve the overall quality of their work.

Do you email or do you SOP?

Interested in hearing more?

Click the button below to receive a call, or send us information on what you are looking for to improve Artwork Management. We will be happy to help you!

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The Jack / Jacqueline of all trades

Labeling and Artwork management is a critical aspect of product development and packaging. It involves the creation, organization, and distribution of all labeling and artwork used on a product, including packaging, promotional materials, and instruction manuals.

To guarantee that the packaging meets your brand’s requirements and is produced to a high standard of quality, companies hire Artwork Coordinators. This role, which is often undervalued, is critical to the success of product launch. Why is that?

Artwork coordination is a multi-faceted role. It involves a lot of juggling between activities that are interconnected, and working as liaison with diferent departments or stakeholders even external to your own team. It also involves some technical knowledge and a good eye for detail. All this makes an Artwork Coordinator a complex role with a lot of hidden skills needed to be successful.

Brief Creation

The artwork coordinator creates a brief/work order/request for the designer or agency responsible for producing the packaging artwork. The brief outlines the packaging requirements, including the brand guidelines, technical specifications, and any other relevant information. Being able to collate information from multiple sources, make it understandable and actionable, and distinguish between relevant and accesory information is a key still to have for this role.

The coordinator needs to ensure that the brief is clear and concise, allowing the designer or agency to create the packaging artwork that meets the brand’s requirements. If you want to know more about how this brief should look like for success, take a look at our earlier post on this matter.

Juggling of Multiple Projects and Deadlines

The role of an artwork coordinator also requires them to manage multiple projects simultaneously. It is not rare that an artwork coordinator would be dealing with tens of projects at the same time. Some of them would be more urgent than others, and some would have extra complexity or require extra time to produce (e.g. think of a label versus a leaflet, or a new product versus a change).

This is why good time management and being able to see the big picture are relevant criteria, so that the workload is effectively managed, and they can ensure that all projects are delivered within the specified timeline. The coordinator needs to be able to prioritize projects based on their importance, deliver and receive input on time, and not loose control of which status each project is at.

Coordination (of course!)

Artwork coordination requires effective communication skills to gather requirements and input with different teams involved in the packaging production process. The artwork coordinator needs to understand the needs of the brand, the regulatory teams, the translation agencies, the quality team, the printer, the suppliers… to ensure that the packaging artwork meets everyone’s requirements. They need to be able to manage the project timeline and update all the parties involved with any changes or progress made. The coordinator also ensures that the artwork is produced on time and meeting the quality, regulatory, and industry requirements.

Chaser

An artwork coordinator is also responsible for obtaining approvals from various stakeholders involved in the packaging production process. They need to follow up on the approvals, ensuring that the artwork is approved on time, and any feedback is incorporated into the artwork. The coordinator needs to be persistent in chasing approvals while maintaining good communication with all stakeholders, which at times could be a hard thing to do.

Final Reviewer

An Artwork coordinator is responsible for bringing a packaging product from start to end succesfully. Therefore, after they have all feedback incorporated into the design, they will then proceed to ultimately review and confirm the artwork meets all required quality standards. They check for any errors or inconsistencies in the artwork and make sure that the files are print-ready.

The coordinator also ensures that the artwork files are compatible with the printer’s specifications, minimizing any issues during the printing process. All this requires a certain level of technical knowledge about how printing works, which can be aquired with time, but always comes as a nice to have /must have criteria in job offers. So learning about color separation, bleeds, kerning, pantones, varnish or proofing is not a bad idea if you are considering a job like this!

We have put together a simple PDF explaining the multiple “hats” of an artwork coordinator.
Download it if you are interested in being an artwork coordinator or want to explain to your parents what it is that you do for work 🙂

Download PDF

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Trabajando en remoto recordando el trabajo en la oficina

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El trabajo remoto o teletrabajo ha ganado mucha popularidad en los últimos años debido a las facilidades que brinda en términos de flexibilidad, reducción de costos y mejora en la calidad de vida. No vamos a mencionar la causa que, no hace mucho tiempo, nos obligó a trabajar de esta manera temporalmente. Sin embargo, como toda modalidad de trabajo, tiene sus puntos positivos y negativos que es importante tener en cuenta si puedes tomar la decisión de trabajar de forma remota.

En este articulo vamos a numerar algunos pros y contras de a ambos modelos donde aportaré mi experiencia personal al respecto.

Trabajando en remoto

Uno de los mayores beneficios del trabajo remoto es la eliminación del tiempo de desplazamiento. Al no tener que desplazarse hacia y desde la oficina, los trabajadores pueden ahorrar tiempo y dinero en transporte. Además, al evitar el tráfico y la aglomeración de personas en el transporte público, se reduce el estrés y se mejora la calidad de vida.

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En mi caso, tengo una dicotomía al valorar el tiempo de desplazamiento, por un lado no puedo decir que fuera estresante dado que trabajo en Málaga y mi desplazamiento al trabajo era en bici por un precioso paseo marítimo, no me odies, no es culpa mía..jajajaja; cero estrés a mencionar, en cualquier caso si he tenido algún día de mucho trabajo y estrés, ¿y quién no?, donde he echado de menos un tiempo de desconexión de la vida laboral a la vida familiar, a veces no es sencillo cambiar el chip en los dos minutos que tardas en cerrar la sesión de tu portátil y tener que lidiar con una pelea de hermanos, la razón es clara, no somos máquinas.

Otro beneficio del trabajo remoto es la flexibilidad en cuanto a horarios y ubicación. Los trabajadores que producen en remoto pueden establecer su propio horario y trabajar desde cualquier lugar con acceso a internet, lo que les permite equilibrar su vida laboral y personal de manera más efectiva. Esto es especialmente útil para aquellos que tienen responsabilidades familiares o que necesitan trabajar en horarios no convencionales.

He trabajado con un compañero que por razones que no vienen al caso tuvo una experiencia en Australia durante 2 meses, es un front-end developper y adecuando los horarios pudo tener esa experiencia y hacer su trabajo sin ningún problema. Es cierto que puede ser un caso extremo ir a la otra parte del mundo, pero es una experiencia real y de éxito.

Además, el trabajo en remoto puede mejorar la productividad. Al trabajar desde casa, los empleados pueden evitar distracciones y ruido excesivo, lo que les permite concentrarse mejor en sus tareas. También pueden establecer un ambiente de trabajo personalizado y cómodo, lo que les permite ser más eficientes.

Respecto a distracciones y ruido en realidad es una cuestión de profesionalidad respecto a la implicación con tu trabajo, puedes tener la mala suerte de que todos tus vecinos decidan secuencialmente hacer obra en su baño pero eso no tiene nada que ver con tu lugar de trabajo, si no te sientes implicado e ilusionado con tu trabajo, cualquier mosca que pase, estes donde estes, será muy interesante.

Trabajando en la oficina VS trabajo en remoto

Por otro lado, hay ciertos aspectos negativos que también deben tenerse en cuenta. Uno de ellos es la falta de interacción cara a cara con colegas y compañeros de trabajo. Aunque la tecnología ha permitido una mayor comunicación en línea, todavía no se puede reemplazar la interacción personal y la camaradería que se desarrolla en un entorno de oficina. Esto puede afectar negativamente el sentido de pertenencia y la cultura de compañerismo de la empresa.

Otro desafío del trabajo remoto es la necesidad de establecer límites claros entre el trabajo y la vida personal. Al no tener un lugar de trabajo físico, es fácil caer en la tentación de trabajar todo el tiempo, lo que puede llevar a la sobrecarga de trabajo y el agotamiento. También puede ser difícil desconectar del trabajo cuando el ambiente de trabajo y el hogar son el mismo lugar.

Comparando el crecimiento del primer y segundo peque, la verdad es que me he sentido mucho más conectado con su evolución temprana trabajando desde casa y estoy eternamente agradecido por la coincidencia por haber tenido un bebe “pandemiar” ya que llegó en pleno encierro. Mentiría si diría que trabajar en remoto siempre es fantástico y solo cuento con mi experiencia y la de mis compañeros.

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Resumiendo, entiendo que hay miles de detalles atenuantes en lo que se refiere a optar por un trabajo en la oficina o desde casa, es importante tener en cuenta tanto los beneficios como los desafíos del trabajo remoto antes de tomar una decisión. Para muchas personas, el trabajo remoto puede ser una gran opción que les permite equilibrar su vida laboral y personal de manera efectiva. Sin embargo, para otros, la falta de interacción personal y la necesidad de establecer límites claros entre el trabajo y la vida personal pueden ser desafíos significativos.

Rafael Cruz Núñez
Artwork Manager
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Los medicamentos genéricos y el árido campo para sembrar la polémica

La industria de los medicamentos genéricos es una parte integral del sistema de salud de todo el mundo. Sin embargo, existe un debate en curso sobre la verdad en la industria de los medicamentos genéricos. En este artículo, se discutirán las leyes que regulan el mercado de los medicamentos genéricos, así como la realidad química de los efectos beneficiosos y secundarios de estos medicamentos.

Midjourney image

En primera instancia quien tiene cierta relación con la industria farmacéutica debería tenerlo claro pero lo cierto es que he oido a médicos cuestionarlo, si si, a médicos, en Europa en el siglo XXI. Bajo mi punto de vista este tipo de cosas, van de la mano con comentarios como que los aviones de una compañía de bajo coste son inseguros, el gran argumento es que supuestamente no pasan los mismos controles de seguridad en los aeropuertos. Ni voy a entrar en quien siembra este tipo de bulos por llamarlo de una manera menos hiriente, a los efectos da igual, es una cuestión de dejadez e ignorancia porque todos tenemos internet y con una búsqueda sobre la ley o entidad reguladora la duda queda resuelta.

Dicho esto y retomando el tema de los genéricos y centrándome en Europa, la ley cambió en 2004 donde desaparece la obligación de que el medicamento de referencia deba estar comercializado en el estado miembro en el que se pretende comercializar el medicamento genérico y se fija un único período de protección administrativa de los datos relativos al medicamento de referencia de 8 años aunque no podrán comercializarse hasta transcurridos los 10 años desde la fecha de autorización inicial del medicamento de referencia. Es decir, un laboratorio tiene 10 años para amortizar y rentabilizar un nuevo fármaco.

Leyes que regulan el mercado de los medicamentos genéricos

En Europa, la Agencia Europea de Medicamentos (EMA, por sus siglas en inglés) es la agencia responsable de la aprobación y regulación de los medicamentos, incluidos los medicamentos genéricos. La EMA requiere que los medicamentos genéricos sean bioequivalentes al medicamento de marca y cumplan con los mismos estándares de calidad, fuerza y pureza, es decir que contiene los mismos ingredientes activos y se absorbe de la misma manera en el cuerpo.

En los Estados Unidos, la FDA es la agencia federal responsable de la aprobación y regulación de los medicamentos con los mismos criterios de la EMA.

En ambos casos, la aprobación de un medicamento genérico requiere pruebas rigurosas y rigurosos estándares de seguridad y eficacia. Aunque algunos críticos argumentan que los medicamentos genéricos no son tan efectivos como los medicamentos de marca, los estudios han demostrado consistentemente que los medicamentos genéricos son igual de efectivos que los medicamentos de marca.

Realidad química de los efectos beneficiosos y secundarios de los medicamentos genéricos

La realidad química de los efectos beneficiosos de los medicamentos genéricos es la misma que la de los medicamentos de marca. Los medicamentos genéricos contienen los mismos ingredientes activos que los medicamentos de marca y, por lo tanto, tienen los mismos efectos beneficiosos. Sin embargo, los medicamentos genéricos pueden contener diferentes excipientes, que son los ingredientes inactivos que se utilizan para dar forma a la píldora, mejorar la absorción o el sabor, o para ayudar a preservar el medicamento. Estos excipientes pueden variar entre los medicamentos genéricos y de marca, pero no afectan la eficacia del medicamento. A veces esta parte es la que los escépticos toman como bandera para justificar lo incuestionable.

Por otro lado, los efectos secundarios de los medicamentos genéricos pueden ser diferentes de los efectos secundarios de los medicamentos de marca. Esto se debe a que algunos de los excipientes utilizados en los medicamentos genéricos pueden afectar la absorción y la metabolización del medicamento en el cuerpo, lo que puede afectar la probabilidad de experimentar efectos secundarios.

Photo by MichaÅ‚ Parzuchowski on Unsplash

Para cerrar con un ejemplo, el ácido acetilsalicílico o AAS, conocido popularmente como aspirina, nombre de una marca que pasó al uso común, fue creada por Bayer en 1897, el siglo pasado ni más ni menos, es decir, el ácido acetilsalicílico es exactamente igual en todos y cada uno de los laboratorios que se produce en todo el mundo, ¿queda alguna duda al respecto?.

Rafael Cruz Núñez
Artwork Manager
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The battle between designers and clients

Image created with Midjourney

Effective communication is crucial for the success of any well thought through design project, more so in packaging design for highly regulated ventures such as pharmaceuticals and food. One of the key aspects in the field related to the communication between designers and clients, which can be very challenging at times, particularly when it comes to the approval of designs. This challenge is particularly relevant when tracking multiple design versions. Read on as we explore the key challenges and discuss the benefits of implementing a digital design approval process.

The Challenges

The lack of clarity in the feedback provided by clients is one of the biggest challenges (and pains that designers have to suffer) in the approval process. Designers may create a design that meets the client’s requirements (in principle), only to receive feedback that is not clear, ambiguous and difficult to follow. This can lead to a frustrating back-and-forth process, usually by email, that wastes time and may not lead to a satisfactory outcome.

In any design process, it is unlikely that the first version will be approved and multiple iteration are usually needed. The designer may create several different iterations to explore different ideas and make changes based on client feedback. It can be challenging to keep track of all these files, which can result in confusion and mistakes. The larger the number of version, the higher the risk of introducing a mistake that is eventually printed.

The benefits of a digital approval tool

Many designers have turned in the past few years to digital design approval processes. With a digital process, designers can present their designs to clients in a clear and organized way, making it easier for clients to provide feedback and streamlining the overall design workflow. The digitalisation of the approval process also allows for tracking multiple versions of a design, which helps eveyone stay on the same page.

Some of the benefits of a digital approval tool are:

  • It can save time. Instead of going back and forth through email or in-person meetings, the digital process allows for quick and easy communication between designer and client. This can help speed up the approval process, which is essential when working on tight deadlines. It also keeps all the information in one single place. This is called: Single Source of Truth.
  • It can help reduce errors and misunderstandings. By presenting designs in a clear and organized way, the designer can reduce the risk of miscommunication and ensure that the client understands the design and any changes that are made. Visibility is essential in an effective communication channel.

A digital process can definitely help improve the overall quality of the design while reducing miss-communication risks and providing a streamline workflow . By allowing for easy collaboration and feedback, all stakeholders can access true and accurate information regarding the designs.

Are you using a Digital Approval System? If not, what are you waiting for?

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Accountability and Authority, The Saga

Image with Midjourney

Once upon a time, in a packaging company not so far away, there was a team of designers tasked with the creation and management of product packaging for their Ancestors . The designers were excited to start working on the project and put their creative and technical skills to the test. They had been trained by the master Designers and could summon the Gods of Regulatory.

The Gods of Regulatory were responsible for ensuring that the package met all necessary regulations and guidelines, Lord praise the FDA, the EMA and the local regulatory bodies. They were accountable for the content that was placed on the packaging design. And they were good at it. They had to appease the recall demons, for one mistake could cost them dearly.

After many times together in the battle field however, the Designes and the Gods of Regulatory realized that while they were accountable for the packaging, and would suffer the consequences of an attack on their impeccable recall record, they lacked the authority to make any meaningful changes on their battle process. There were simply too many stakeholders, too many hidden decision makers and way too many KPIs to fulfil.

One day, the designers submitted a proposal for an improved workflow model that they were particularly proud of. They had worked hand in hand with the regulatory team tirelessly on it for weeks and were excited to finally present it to the higher court, the Decision Makers. However, they were swiftly denied their wishes. The Decision Makers had rejected the proposal outright, without providing any concrete reasons for their decision. They simply said: It shall not be done.

The designers were frustrated, the regulatory experts were angry. They all felt like they were being held accountable for something they had no control over. If something went wrong, their heads would roll, but without the means to change course, they felt abandoned and desperate. They began to lose their faith, their motivation and engagement in the project. To make matters worse, they soon discovered that the same thing was happening to other teams in the company.

The problem wasn’t just with their process; the company’s organizational structure and old fashioned culture made it difficult for anyone to have the necessary authority to make meaningful changes. Everything had to be escalated to the high court, where decisions were made without hands-on knowledge of the actual work that had to be done.

As a result, the frustrated designers and regulatory experts decided to take matters into their own hands. They started taking actions outside of their workflow to expedite the pressing deadlines and reach their tight objectives. They were operating under the blanket of cover and darkness, very much aware of the lack of compliance and added risks. But they had no choice, it was the only way to complete the assigned tasks.

The moral of the story is that accountability without authority can be a frustrating and demotivating experience. Furthermore, when the processes in place do not match the actual job requirements, the non-authoritative stakeholders are usually forced to take action, stepping outside of the agreed models to accomplish their tasks. When key stakeholders lack the necessary authority to make changes, it can lead to a lack of engagement and creativity, and in most cases non-compliance with SOPs. In the case of packaging companies, designers and regulatory experts must work together to ensure that the design process is collaborative and efficient, but they need to have authority to make changes to the process when it no longer works.

Do you feel accountable but lack authority?