How to ensure artwork quality and avoid recall risks

Labeling and packaging development is a combination of regulatory, linguistic, commercial, and design expertise. A whole range of differing factors impact the quality of the final product.

And all are necessary for compliance.

If even one element is out of place, it can lead to quality defects and even product recall. To ensure you have every area covered, we’ve prepared a deep dive into all the moving parts of artwork development.

The challenge of local regulations

We all know artwork must be up to local regulatory standards and compliant with the current GMP.

When you look to broaden the market, you face an ever increasing number of local regulations. It becomes impossible to make a one-size-fits-all solution.

This is especially evident in Europe, as even neighboring countries with similar regulations can have nuances that can impact the compliance of artwork. Solid communication with trusted local experts plays a key role in artwork quality, so we nurture an efficient network of partners across the continent.

The right quality of translation

Closely linked to regulations, there is also the issue of translation. Each word and expression have their prescribed order, and even certified and expert translators are not guaranteed to make a compliant translation without close knowledge of local regulations.

It’s necessary to keep translation close to regulatory and medical writing experts. After each translation, we make sure the text goes through a quality check process that ensures it is completely in line with all relevant regulations.

Management of communication and approvals

Approvals from a plethora of experts and the clients themselves – it all has to be orchestrated to avoid delays. A setback in one approval threatens to push the deadline or create an unwanted rush down the production line.

That’s why project management and timely communication is crucial for keeping the schedule and smoothing unexpected setbacks.

We know how much impact and strain this element has in the project as a whole, and we never underestimate its value.

In order to keep every project on schedule and prepare for possible divergences from the timeline, we base our time estimates on clearly stated expectations and deliverables.

What should you know when starting new artwork development?

The first step of each artwork project is determining the materials we expect to receive, and the materials we will deliver at the end.

We take further steps only once both sides are completely clear about what the client sends in, and what we give out.

To make sure you have everything you need, here is a list of the materials and information we require to develop a good time estimate.

1. The format of the approved text content

The format in which we receive the text plays a significant role in its further treatment.

We insist all text for the artwork should be delivered in a DOC or DOCX file. Although PDFs are widespread and in common use, extracting text from this format isn’t reliable and should be avoided at all costs.

It’s also important that we receive the text as it should appear in the final artwork: bolded, italicized, numbered, or bulleted. We have to know the style requirements before we start layout design.

Even small adjustments to the text after first delivery can cause a headache-inducing layout reorganization and deviate the development timeline.

2. Packaging information

Don’t leave anything to chance. At the very start of the project, we have to determine the exact dimensions and descriptions of each element. This includes the leaflet, box, foil, and any other piece that makes up the artwork.

The most efficient materials you can send are preprint files with defined die cut. These are the most instructive, and leave no room for miscommunication.

3. Brand and packaging identity standards

Even though your product is new, it draws roots from your brand.

As new artwork we presume a project with defined brand and packaging design standards. More often than not, artwork already has a defined aesthetic it should follow. The more we know about your brand standards, the easier it becomes to bring your new product to the market in a distinct and familiar form.

By consulting your identity standards, we develop products that fit in with all existing lines of your company’s products.

What should your brand and packaging identity standards include?

  1. Pantone colors, fonts, logos, symbols, or shapes that are used in the existing line of products and will need to be added to the new artwork.
  2. Open files for elements you wish to use, as reconstruction from scratch impacts the timeline gravely.
  3. All fonts used for the new artwork. Expanding on a new market comes with the danger that your usual fonts don’t extend to all glyphs needed for the new translation (in Croatian, č ć ž š đ often become pain points). Make sure your choice of fonts does not evolve into a production setback down the line.

4. Regulatory considerations

Readability is essential for patient safety and therapy adherence. Almost all local regulations ensure that all written text is accessible to the wider public. Some include rules for Braille as well.

To ensure readability, the form and size of the letters is strictly prescribed. This minimal height of letters and size of font should be defined upfront.

Aside from compliance, defining the height and size of the font at the start of the project also makes the design process far more efficient and reliable. A change in font size can impact the entire layout design.

What else should you know before we start?

In artwork development, the saying “never judge a book by its cover” doesn’t apply. The compliance and quality of the artwork is seen as a reflection of the whole product.

That’s why it’s important to ensure everything is in its right place and form, from visuals and design to translation quality and regulatory requirements. At Marti Farm, we have a closely-knit network of both internal professionals and trusted partners that ensure the expertise of each step of artwork development.

Need more advice on starting a new line of artwork, or adjustments to already existing ones? Get in touch with our regulatory experts at bd@martifarm.com.

Ružica Štimac, Mpharm / Registration Associate

Contact us

Headquarters

Lašćinska cesta 40
HR-10000 Zagreb
Croatia

Office

Planinska ulica 13/2
HR-10000 Zagreb
Croatia

Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
info@martifarm.com

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farmakovigilancija@martifarm.com
Tel: +385 1 5588 297

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Legal info

Full company name
Short company name
Headquarters
Office
Legal form
Court register
Registration number

Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
080751121

 

OIB
Share capital
Authorized representative

29969122438
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)

 

Bank account

HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)

 

Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121

OIB: 29969122438
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)

Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)

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