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.

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!!

Two Factor or not two factor … that is the question

Image created with Midjourney

Did you know that there are almost 1,000 attempts to hack account passwords every single second?

That is 1,000 now

… and 1,000 now,

… and 1,000 now.

In today’s world where cyber threats are on the rise, companies must prioritize the protection of their data and systems. Implementing a Two-Factor Authentication model is a sensible way to make sure that your tools, data and information are secure.

So, what is Two-Factor Authentication?

Two-Factor Authentication (2FA) is a security process that requires users to provide two forms of identification to access their accounts. You can see it as an extra layer of security that makes it harder for hackers to gain access to sensitive information such as username and passwords, as well as critical company data.

Why should you use a 2FA process?

Here are a few reasons why it may be important for your company to consider this option:

  1. Enhanced security

    2FA adds an extra level of security to the login process. With it, in order to access an account, a hacker would need to have both the password and the second factor (a one-time code sent by email, phone, or generated by an authentication app). This makes it much harder for a hacker to gain unauthorized access.
  2. Prevents account takeovers

    Account takeovers occur when a hacker gains access to a user’s account and can cause significant damage to the company’s systems, data, and/or its reputation and brand image. With 2FA, even if a hacker obtains a user’s password, they will not be able to access the account without the second factor.
  3. Meets industry standards/ requirements

    This may be one of the reasons why many companies are implementing a 2FA protocol. For industries with very strict requirements (or even regulations) regarding data security, companies may be required to use 2FA to be in compliance.

    By using 2FA, companies can demonstrate their commitment to data security and avoid potential fines and penalties for non-compliance.
  4. Easy to implement

    2FA can be easily implemented for most systems and tools, and many already have built-in 2FA options. In many cases, users simply need to enable 2FA in their account settings, and they’re good to go!
  5. Improves user trust

    By using 2FA, companies can show their customers, users, and partners that they are committed to protecting their sensitive information. This can build trust and improve customer satisfaction, as users will feel more confident that their information is secure.

Are you in charge of making these decisions, or at least, of bringing the discussion around it in your organization? A word of warning for you then: It is possible that some users would be a bit against the implementation of 2FA, as it requires an extra step. Imagine that because some users decide that taking 2 extra seconds to verify a code on their email is too long, and this protocol is not implemented, and this user’s computer gets hacked and access to your data is obtained. Was it worth it? I bet it would not be. As the saying goes… it is always better to be safe, than sorry.