ManageArtworks

Product labelling - Get It Right 

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Can’t someone else from Jack’s team review the artwork?

Artwork Management Challenges – Part 2

How many times has someone gone out-of-office and forgotten to tell you? More often than I care to admit. Artwork reviews are starting to pile up in Jack’s inbox and no one is aware he is out-of-office. Jack hasn’t checked his email and when the project manager calls him after a couple of days, everyone is upset.

ManageArtworks has a couple of things that will save Jack from this embarrassment. First is the Designate feature which allows him to assign all artwork review tasks to someone else in his absence. So while Jack is out on vacation, his review tasks automatically get forwarded to his co-worker. When he is back in office, he can instruct the system to stop forwarding his review tasks. Even if Jack forgets to designate someone before he went on vacation, he can call the project manager (who has admin privileges) to set the Designate option on his behalf.

Sometimes you are in-office but too busy to work on artwork review. The ManageArtworks system includes a Forward option which allows you to forward your tasks to a co-worker. Your co-worker will receive an email notification informing about the forwarded tasks.

So getting work done whether you are busy in office or out on vacation is simple using ManageArtworks.

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I can’t find the latest version of this artwork file

Imagine a scenario where the holiday season is coming up and your manager has asked you to modify the artwork with some holiday theme. You connect through the network drive to a server where all artwork files are kept neatly saved in product folders. You open the file to have a look and immediately realize something is wrong. The last time this artwork was changed was in early spring and you know for sure there was a change to the claims statement. So this is not the latest file. Where is the latest version?

You dig through your emails and open one attachment after another looking for the right file. You email your colleagues, you email the design agency and you even email your printer. All of them forward you more versions of the file, but none of them are the one you are looking for.

Has this happened to you before?

In these circumstances you do what you have done many times before, pick up the actual product and look at the artwork that is printed on it. You compare it with the file you have and mark out changes that were previously made. Now you have to get these changes done before you can make your holiday theme changes.

What a waste of time, waste of money (your agency is going to charge you for the re-work) and frustration that it keeps happening again and again.

There is a way to put an end to this wastefulness. Get your artworks organized into a central asset library which has automatic version control and great search capabilities which guarantees that you will find the latest version of your artwork file every time, any time.

Check out ManageArtworks if you would like to know more about how a central asset library can work for you.

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Does your product talk to customers?

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Future of Private Labels

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Are Packaging Labels Senior Citizen friendly?

Senior Citizens form 14% of the population in the US which is approximately 40 million consumers and is projected to increase to 72 million by 2030 and will be 20% of the population by 2040. The growing elderly population has attracted many consumer product companies to create senior citizen friendly packaging and labeling.

This consumer group struggles with the packaging, finding it hard to open, use and close product packaging used every day. With many health restrictions on their diet, senior citizens are very discerning and would like to know what’s in the package, know the ingredients, know how it needs to be consumed, etc. However, readability is a key issue when it comes to senior citizens packaging and labeling. Older people need information in larger font and easy to understand language so that they can use the product independently.

In an online poll in September 2015, Packaging Digest asked packaging professionals “In general, do you consider the needs of seniors when designing your packages?” While the overall numbers seemed to be in line with what you might expect—39% of respondents Always or Usually consider seniors’ needs, 24% Sometimes do, 28% Seldom or Never do and 9% said they Don’t Know. You can read more about it here (http://www.packagingdigest.com/packaging-design/are-seniors-top-of-mind-when-you-design-your-packages1510)

The regulatory trend in the Pharma industry is to share more information with the healthcare provider and the patient. This increases the amount of text that needs to be placed on the label or insert and with space at a premium, the font sizes are at the bare minimum required. This is true in Food and Cosmetic labelling too where limited space means smaller fonts and less readability for the elderly. With consumer companies favouring millennials, design trends that attract their attention are in vogue which are not exactly senior citizen friendly. Smaller single use packaging have very little real estate on the label and hence large font is not an option. Placing QR codes on packaging so that mobile apps can lead consumers to more information online is a trend that senior citizens haven’t caught on to as smart phones are cumbersome for them to use.

With the demand growing, it’s only a matter of time before consumer product companies start to release senior citizen friendly packaging and labeling.

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Text Comparison on Regulated Industries, CPG and Artwork Management

Text Comparison in Regulated Industries,

Pharma Industry

In the Pharma industry there are two standards that are used as Briefs

Structured     Product Labelling (SPL) followed     by the FDA

Quality     Review of Documents (QRD) followed     by the European Medicines Agency

In the CPG industry there are no such standards.

In the regulated markets, the SPL content (or extracts from it) are available as a Word document and this is the brief document given to the designer. The Word Document is typically a single column file while the PDF version of it from the designer is a multi-column version. The text flow does not always start from the first column in the PDF. Depending on the folding pattern of the leaflet or PIL, the text could start at the beginning of the last column and flow all the way to the first column.

This constant jumping across columns and matching them with text in the PDF file, make manual proofing cumbersome, tedious and error prone.

The QRD content is typically used to share text placed in labels. The placement of text on the label could be in any direction. The same text in the brief could be placed multiple times in the label. If the text 5 mg is used thrice in the label, the proof reader has to make sure it’s correct in all instances. When multiple components (label and carton) are prepared for the same SKU, the designer has to make sure certain text content are the same across both the components. The Proof reader has to not only check the correctness in one component artwork, but also make sure the same content is available across multiple components of the same SKU.

Such requirements make the need for automated proofing a mandatory thing rather than a nice-to-have.

  Text Comparison in CPG Industry

With no standards available in the industry, each company has its own formats. However, there is a common pattern across most of these briefs. They are in one of these formats

In the form of     a 2 column table in a Word Document. The first column has the names of the     sections (e.g. Ingredients, Nutrition, Manufacturing address, etc.). The     second column has the text against these section titles which the designer     will use to cut-and-paste into the artwork.

In the form of     a 2 column Excel Document. Its very similar to the Word Document described     in 1, but managed in an Excel file

In the form of     a Word Document with H1, H2 or H3 headings for the section names. The text     within each heading is used by the designer for creating the label.

There are of     course variations of the above used by many companies

  Text Comparison in Artwork Management

All packaging artworks and labels contain text. This text starts its journey early in the product design lifecycle and continues to be changed until it’s printed. The text originates from different departments, claims text from marketing, nutrition and ingredients text from formulation and product development, etc. As the product gets closer to launch, the text is finally given to a design team to place on the artwork.

This handover of text happens in numerous ways, through emails, Word or Excel documents or structured content in the form of XML in the case of Pharma. The designer then cuts-and-pastes this content in the appropriate areas in the artwork and adjusts its font, size and other attributes based on regulatory and brand requirements. The artwork text along with its design elements are then sent (typically as a PDF file) to multiple departments for approval.

In a global company thousands of Artworks get approved every year in different languages and in different markets. Most of the text in these artworks are proof-read by eye-balling the artwork and the brief side-by-side. This is repeated over and over again every time the artwork is changed. Sometimes people don’t have the time nor the inclination to proof read the text multiple times. They just trust someone else has done the job right and just approve it without checking. Most others just check the portions of the artwork where changes were requested, without realizing that when a designer opens an artwork file to edit, he or she can introduce errors inadvertently in any part of the artwork.

Text proofing tools not only take the drudgery out of proofing the text but increases the accuracy and reduces the time taken to proof read the artwork.

Going through the artwork approval process, the PDF artwork is compared the first time with the Brief document. In subsequent iterations, the current version of the PDF artwork is compared with the previous version of the PDF artwork.

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Effectiveness of Warning statements on Labeling

Warning Statements are seen in Foods, Drugs, Medical Devices, Cosmetics, Food Supplements, Kids Toys and practically everywhere.

The purpose of a warning statement is to warn the consumer about the potential risk(s) of using the product and decide for themselves whether the benefits outweigh the risks of using the product. Warning statements also provide details of the precautions to be taken and so the consumer is expected to make an informed decision after reading it.

Effectiveness of a label warning can be measured using five factors:

Attention is the first dimension of effectiveness. It assesses whether consumers notice or see a warning label that appears on a product. Once the warning label has attracted consumers’ attention, the next question is whether or not they proceed to read/understand its information. Then, consumers must be able to remember/recall the information presented in the warning label. Next, warning labels need to influence consumer judgments concerning their perceptions of how hazardous and dangerous a product really is. Finally, a warning label is effective if it successfully influences consumer to engage in behaviors that comply with the safety precautions conveyed in the label.

So are warning statements effective? Have they helped consumers make an informed decision?

Richard Zeckhauser from Harvard University published a paper titled “Efficient Warnings, Not “Wolf or Puppy” Warnings” (https://research.hks.harvard.edu/publications/workingpapers/citation.aspx?PubId=11338&type=WPN ). Richard argues that the present system treats all the risks as equal, even though they are not. The current labeling regulations do not distinguish between the risk levels. For example, California’s Proposition 65 says that businesses selling products to people in California must provide “clear and reasonable warnings” before knowingly exposing people to any chemical on a published list, unless the expected level of exposure would pose no significant cancer risk. This warning is often in the form of a label on the product or its packaging. The Prop 65 labels only tell you that a product has something in it that might cause cancer or affect reproduction. They don’t say what the substance is, where it is in the product, how you might be exposed to it, what the level of risk is, or how to reduce your exposure. Not surprisingly, individuals homogenize abundant warnings, and often fail to respond to the small minority that impose grave risks.

The current regulations fail at distinguishing between large and small risks. When a risk is truly present, people all too often ignore the warning, having been conditioned to believing that such warnings rarely connote a serious threat for them. Moreover, the way an individual perceives the risk is different from others. This can vary depending on that person’s social status, age, frequency of product use, etc. However companies do not take into account different people profiles and issue blanket warnings for all consumers.

So do you take warning statements seriously?

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Best Practices in Artwork Management – Part 1

Regulatory Agencies are becoming stringent on Labeling. Coupled with today’s economic environment, enterprises are focusing on operational excellence, cost-cutting, and Return On Investment (ROI) to help maintain profitability.

Packaging Artwork Management is evolving from a departmental file management tool to an enterprise wide workflow and collaboration system.

Implementing and deploying enterprise solutions for internal and external users is a complex art and involves many strategic and technical decisions. Organizations make significant investments to ensure the solution they deploy meets the needs of their business community and stakeholders.

The following series of posts are a collection of our learnings from implementing Packaging Artwork Management Systems for various industries (Food, Cosmetics, OTC Pharma, Regulated Pharma, Industrial Chemicals, Gaming).

Analyze your Current State

Define an Efficient Workflow

Internal ONLY / Global

Organizing Files

Organizing Metadata

Organizing Projects

Data Entry Forms & Checklists

Integrations

Extensions

Proof-reading

Pre-Flight

Brief Vs Artwork Comparison

Tracking

Analyze your Current State

One of the biggest fears people face when looking at an Artwork Management solution is that they don’t know how to get started, or they’re afraid they’re going to “get it wrong”.

Successful implementations of Artwork Management Solutions start by understanding your current processes and needs

What are your current business processes?

What is your existing organizational structure     – how are assets routed? Who is involved? How are responsibilities divided     up?

Where are the current pain points and     bottlenecks?

Define an Efficient Workflow

Once you understand how your existing processes work, you can start thinking about your desired workflow and the specific tasks performed by various individuals. An efficient workflow is imperative to keeping track of your assets. The solution should be powerful and flexible enough

so that you aren’t pigeonholed into a limited workflow.

Typical questions that need to be answered are

  At a Component Level

  At a SKU Level

   Who checks the Text Matter and When ?

 Who checks the Color and When?

 Who checks the key-Lines and When?

 Who checks the Dimensions and When?

 Who checks the Barcodes and When?

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It’s not easy being an Artwork Coordinator

Here is what a job description for an Artwork Coordinator in a global company looks like

Ensuring delivery of     packaging artwork for all brand portfolios     across multiple markets.

Acting as interface between all relevant parties in the     artwork process, both internal (marketing, regulatory, logistics, finance)     and external (pack change analyst in regional service centre, site,     artwork house).

Coordinating artwork process     between all relevant parties in     the artwork supply chain, both internal (Marketing, Regulatory, Global     Category, Planning, Legal & trademark and Packaging support) and     external (Factories, Printers and artwork providers).

Helping shape local processes and procedures to     achieve quality and best practice artwork management that meets the     commercial needs of the business.

Ensuring all artwork is     progressed in compliance with local     procedures.

Holding ownership of artwork     workflows (Managing Pack Changes and Create New Packs (NPI)) and coordinating the resolution of all     technical queries from design, printers, marketing, medical, regulatory     team and supply chain.

Facilitating and     contributing in cross functional     artwork brief meetings.

Conducting supply chain impact assessment as     part of change request process, considering all factors that affect the     consumer, supply chain and overall business.

Accountable for the timely     progression of all artwork changes, from     briefing to file delivery at printers. Chasing approvers where     necessary, escalating any delays / issues to key stakeholders.

Liaising with other regions if using shared materials and/or suppliers.

The words in bold, highlight the level of coordination this person needs to do between different internal and external stakeholders, across multiple regions and time zones, with deep understanding of local / regional regulations to resolve issues and get faster to the market.

The job gets even more complicated with each subsequent Merger and Acquisition. Given the increasing length and complexity of global supply chains, managing vendors and agencies across the globe is not an easy job. Meanwhile an explosion in SKUs and shorter product development lifecycle combined with pan-regional or pan-global product rollouts requires an almost 24x7 coordinator.

The number of people contributing to an artwork has gone up. Today a supplier could provide the formulation details, one or more agencies do the design concept and packaging artwork, maybe a translation agency for multi-lingual text, 5-6 different internal stakeholders approve the artwork, double checked by regional or country specific marketing folks, a pre-press or print management vendor prepares the file for print and finally the artwork is printed by one or more printers. Throughout this process the Artwork Coordinator does numerous ‘follow-ups’, sets up meetings to get people on the same page while still keeping an eye on the launch date.

Artwork Management Systems have made the Artwork Coordinator’s job less stressful and given the stakeholders a ‘self-service’ platform to perform their tasks and get answers from. However, nothing beats an Artwork Coordinator’s experience in conflict resolution, generating consensus and pull-out-all-stops to hit the print deadlines.

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Copy Text in Labeling

Copy refers to written material, in contrast to photographs or other elements of layout, in a large number of contexts, including magazines, advertising, and books. In advertising, web marketing and similar fields, copy refers to the output of copywriters, who are employed to write material which encourages consumers to buy goods or services.

In Labeling, copy is the text that goes on the Artwork or Label and includes marketing claims, ingredients, address, phone number, etc. Every piece of text is part of the copy and is an essential input to the designer. Get the copy wrong and the Artwork is bound to be rejected at some point in the approval cycle.

Most often designers struggle with constantly changing copy text. Marketing is notorious in making last minute changes to the text and resetting the approval process. The copy is also part of a bigger Brief document which might include artwork and print specifications and instructions.

Even though there is no global standard for capturing copy-text content, some organizations have put together an Excel or Word based template that suits their requirement. The European Medicines Agency (EMA) has come up with a template for copy-text that goes on pack designs and labels called the Quality Review of Documents (QRD) which is used widely in EU. However, for the rest of the industry and markets there is no standard template. In the Food and Cosmetics industries there is even less standardization and each organization is free to make up their own template.

Most processes for creating Artwork for a new product or new SKU start with the collation of copy-text and its approval. Since the copy-text content that goes on the pack or label is contributed by multiple departments, its always a time consuming exercise. The copy-text must also go through an approval cycle to ensure no rework later on. Its very important that the copy-text is captured correctly since all future proof-reading and verifications will be done based on this. If the input itself is wrong, the outcome is most definitely going to lead to rework or delayed product launches.

Automation

Today, technology can help in capturing and collating the copy-text information and even automatically compare the copy-text (in Word or Excel template) with the PDF artwork to highlight differences. Capturing the copy-text into a database has many benefits. Among them are

1.       Instantly copy and modify copy-text for a new SKU or variant

2.       Independently make translations of the copy-text into all required languages in which the product is sold

3.       Check the consistency of the text across products, e.g. is the ingredient list the same across all my pack sizes, is the name translated in the same way for a language across products, etc.

4.       Check ‘where-used’ scenarios when a change is required. E.g. check which artworks still have the old phone number of the company

5.       Use the copy-text database as a content source for downstream design tools which can consume the text directly into the design tool. E.g. through an Adobe Illustrator plugin connected to the copy-text database, the copy-text can be directly used inside the artwork without having to cut-and-paste. Once the designer has laid out the text in the right location and with the right formatting attributes, any change to the copy-text will automatically refresh the text in the artwork. So language and text changes are no longer ‘cut-and-paste’ but ‘dragged-and-dropped; from within the design tool.

In summary, taking the time to get the copy-text right early in the artwork cycle can save significant time and money. Technology goes a long way in helping achieve the collation and use of copy-text without the normal cut-and-paste methodology.

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Calculating the Principal Display Panel (PDP) area

PDP is defined as that part of a label (or package) that is most likely to be displayed, presented, shown or examined under normal and customary conditions of display for retail sale.

Many regulatory requirements are based on the area of the PDP. E.g. the print size of the net quantity statement.

The area of the principal display panel can be calculated as follows:

For rectangular containers, the height times the width (H x W) of the front of the package, where the front of the package is determined based on how the package is designed to be displayed;

For cylindrical or nearly cylindrical containers , 40 % of the height times the circumference [0.4 x (H x C)] of the container; E.g. to calculate, measure around the bottle (the circumference) and the height of the bottle, not including the slope at the top (called the “shoulder”).

For other shaped containers, 40 % of the total surface area of the container. If the container has an obvious principal display panel (for example, the face of a triangular or circular package of cheese, or the top of a can of shoe polish), the area shall be calculated from the shape of that surface.

For a small container that holds less that 1/4 ounce (by weight) or 1/8 oz (by volume), that is labeled with a tag or attached card, then the PDP can be calculated based on the size of the tag or card it is attached to.

In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars.

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All about Fonts, Text and Line Widths

Continuing from our previous blog article (http://manageartworks.com/blog/brand-owners-and-pre-flight), we will talk about Fonts, Text and Line Widths and how pre-flighting these cuts down on errors and time.

Fonts

It is up to the Brand Owner to decide whether the Artwork file to be shared to the printer will contain live text (open file) or not (curved / closed file).

Fonts are important from three aspects.

a) Technical:

Font related issues are the most common reasons for workflow interruption.

All fonts should be embedded in the Artwork PDF file. This is done to ensure that an incorrect font does not get used, which could lead to text becoming illegible or part of the text disappearing.

There are various fonts available (like True Type, Type 1, Type 3, etc.) and when a certain font is not available during the PDF creation step, it typically gets replaced by the Courier Font.

So the pre-flight system has to check and warn the designer if the artwork contains Courier Font and confirm if it was intentional or it was a replacement for a missing font. Designers who want to use Courier on purpose, can use variants like ‘Courier New’, which are not flagged during preflight.

b) Branding:

Special fonts used in Brand names and logos are typically not available in public domain. These are created specifically by the design team for the brand. So while new print vendors are added to the supply chain, not all of them will have access to this special font. Embedding the font in the PDF is a good practise to make sure all vendors have access to the right font. Pre-flight tools can examine the PDF file and detect which fonts are embedded and which are not.

c) Regulatory:

As per EU regulations, readability is determined by the combination of font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background. Here are a few examples of how the same text can be written in a legible or illegible way.

Text Size

Similar to the fonts, the text size is a factor in the regulatory guidelines also. Regulations mention the minimum font sizes required (as per Packaging size, packaging type, component type (like Medication Guides). Some regulatory agencies mention the requirement in mm, some in x-height. European Union’s FIC Regulation 1169/2011 requires that the minimum x-height of the font be 1,2 mm with the exception of containers where the largest surface area is less than 80 cm2, in which case the x-height of the font size shall be equal or greater than 0,9 mm.

There are also technical limitations on using smaller font sizes for some substrates and printing methods.

Depending on the component type, printing method & regulations, the pre-flight check should be able to suggest whether there is any text in the artwork below the recommended size.

Line Width

Artwork creation applications offer a line thickness of ‘hair-line’. But how thick is a hairline? A hairline is the width of one row of printer elements. So depending on the resolution of the printer, these lines are not the same thickness.

So instead of using the hairline option, its best practise to set the minimum line weight depending on the intended printing process. For newsprint and commercial offset printing, a minimum line thickness of 0.125 points is required. For screen printing 0.15 points is required.

Letting mistakes and bad files get through to print is obviously expensive and leads to issues of who pays – customer or (sadly often) the printer who doesn’t want to lose further business by kicking up a fuss. Printers know, at least in theory, that powerful preflight checking software will increase production efficiency in the workflow. With a pre-flight check done early in the design cycle, errors at a later stage can be avoided saving both time and money.

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Brand Owners and Pre-Flight

“A stitch in time saves nine.”

These six words capture the essence of pre-flight. As with any process, the more upstream a problem is detected, the easier and cheaper it is to fix them. This implies that designers should preflight the Artworks before sending them to their agency or printer.

So, how do you go about doing this?

Let me share some examples of how our clients (CPG Brand Owners) are leveraging the power of pre-flight.

a)      Colors: 

Knowing the number of colors used is important. Many a time the printer gets a job to print in process colors (CMYK) but finds that the artwork supplied has multiple spot colors in it. When spot colors are converted into process colors, the outcome is usually not the same. Also, each spot color you use will generate an additional spot color printing plate for a printing press, increasing your printing costs.  

               Spot colors are best used in the following circumstances

-          Consistent Branding / Logos

-          Colors outside the range of CMYK

-          Color consistency across pages

-          Smooth coverage of large areas

Depending on factors like printing method and substrate, the Brand can set the number of colors that can be used and what spot colors if any can be used. When the designer submits the artwork for approval, the system will then make this check and reject the artwork automatically if its not acceptable.

b)      Ink Coverage or Limit – Tic Tac Toe 

Printing is a physical thing. One ink color hits the paper and combines with another to create a mixture of the two colors. With four process inks, you can have up to 400% of the process colors on the paper. That’s too much ink for a printing press to handle. The ink starts to clump up on the paper. The printer rolls become smudged. And pages start to stick together because the ink doesn’t dry properly.

That’s why it is important to make sure that the ink doesn’t exceed a certain amount called the ink limit. The ink limit amount changes depending on the type of paper you’re printing on, as well as the kind of press you’re using. Your print shop will let you know the ink limit for your job (that’s why you need to involve them during the design stage).

TIC is the Total Ink Coverage, TAC is the Total Area Coverage and TOE – there is no Toe J

Whether the limits is 240% or 300%, its easy to check this and automatically reject the artwork if it exceeds the limits and return it to the designer. 

c)       WYSINWYG - “what you see is not what you get”! 

Varnishes, metallic and fluorescent inks, print on foils and embossing are examples of this – there’s no way you will get an accurate preview of these on a computer screen.  While all these special print effects result in different finishes, the process of identifying these areas in the artworks is the same. Best practise is to place the special finish as a separate layer in the artwork and create a special spot colour swatch for the special areas so that the printer can easily identify the areas. 

With this practise in place, when the designer uploads the Artwork, the system can show the different layers individually so that everyone is sure on what’s required and where. 

d)      Key-Line Diagram / Cutter Guides: 

The artwork dimensions are decided by the Cutter Guides. All variants with the same pack size could use the same Cutter Guide. Its good practise for designers to place the Cutter Guide as a separate layer in the artwork, so that they can check whether the artwork’s dimensions are correct. During print, this layer is switched off so that the dimensions don’t show up in print. Its required for verification, but not in the final print.

 When the designer uploads the Artwork into the system, the system can list the individual layers and show the cutter guide layer used in the artwork. 

e)      Knockout and Overprint: 

You may have overlapping colored objects in your PDF document, for example text or an image on a colored background. If so, you can specify what should happen with these colors when they are printed: 

Knockout, meaning that the colors of the object in the foreground cut out the area underneath. In other words, the background color is erased and the resulting color will be the foreground color. 

Overprint, meaning that the colors of the object are printed on top of the back­ground colors. The resulting color is a combination of the foreground and the background color. 

The designer needs to know what the default settings are in the design tool (InDesign or Illustrator) and make the appropriate changes for the artwork being prepared. To avoid the special finish elements knocking out the other print plates the elements must be set to Overprint. This is crucial for spot varnishes that are meant to highlight underlying areas of the design, otherwise the varnish would be applied directly onto the paper. 

It’s a good practise to create a separate layer in the artwork to identify these areas so that its clearly communicated to the printer. Artworks once prepared with this practise and uploaded into an Artwork System will list these special effect layers so that everyone can understand the design elements before approving the artwork.

In the next article, we will continue on pre-flight checks related to Fonts, Text and Line Width and how it cuts down errors and time.

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Structured Product Label (SPL)

Structured Product Label refers to the electronic document to be submitted by Manufacturers for Drug establishment registration and Drug listing information to US FDA. The electronic document is in XML format with a pre-defined structure detailing the different sections as indicated by FDA. The SPL is created with a list of acceptable terms or variables as recognised by FDA SPL has been mandated since 31-Oct-2005 for all labelling submissions to the FDA's Centre for Drug Evaluation and Research (CDER). This is a FDA initiative to improve patient safety through better access to product information.

Manufacturing companies (registrants) upon first engaging in the manufacture, preparation, propagation, compounding, or processing of drugs, (including human drugs, veterinary drugs, and biological drug products) to register their establishments and submit listing information for all drugs in commercial distribution.  Registrants are also required to submit registration information for their establishments on or before December 31 of each year.

Among the multiple formats of SPL submitted, the most common formats are:

·         NDC Label Request: This processes involves the registration of a label which requires a NDC Code. This provides you with the NDC Code for a product. This NDC code is linked to the Drug Applications.

·         Establishment Registration: This process involves detailing the Establishment information, like Company name, Address, Contact Details (email, phone number), Website URL etc.

·         Product Label : The product label includes all published material accompanying a product, such as the actual label on a prescribed dose as well as the package insert which contains a great deal of detailed information about the product. SPL documents contain both the content of labelling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type)

All FDA approved SPLs are publicly available from DailyMed (https://dailymed.nlm.nih.gov/dailymed/ ) website. This is a comprehensive and up to date source of information describing the composition, form, packaging, and other properties of the drug products in detail.

To create an SPL is a lengthy and time consuming process. So it’s important to try and get it right the first time. Else any errors like typo etc also will be carried forward to the Product label, Packaging inserts etc. This is where ManageArtworks can ensure that the SPL is reviewed and approved internally before submitting to the US FDA. Usually the steps to create an SPL are:

1.       Create an FDA ESG account.

2.       Acquire a DUNS number. Dun & Bradstreet (D&B) provides a D-U-N-S Number, a unique nine digit identification number, for each physical location of your business.

3.       Send details for Establishment Registration

4.       Request a NDC Label Code

5.       Submit the specific Product SPL

The essential components of a Product SPL are:

 Product Name

 Dosage Form

 Route of Administration

 Ingredient      (active/inactive/adjuvant)

 DEA Schedule

 Product characteristics      (color, shape, size, etc…)

 Packaging

 Marketing Information      (category, status, start and end dates)

US FDA provides the XML standard. SPL gives accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format. SPL acts as the source document for Pack Inserts and thus, the SPL is not only important for the Regulatory Teams, but also critical for the Labeling Team.

[manageartwork-blog]

Impact of Brexit on Labeling

The European Medicines Agency has announced on 6th July that the Agency will continue its operations as usual, in accordance with the timelines set by its rules and regulations.

It adds that the current situation is unprecedented and “The implications for the seat and operations of EMA depend on the future relationship between the UK and the EU. This is unknown at present and therefore we will not engage in any speculations”, which essentially translates into “currently status quo; but expect changes in the near term”.

The last thing the industry wants is another market implementing its own set of regulations.

At present, whether it’s Pharma or Food, most of the regulations on safety, quality standards, Labeling are harmonised across the 28 EU countries.

Indeed, even if the UK were free to set its own rules, the industry would probably lobby for it to copy EU ones.

As per analysts, it will likely take at least two years for the UK to negotiate an exit from the EU from the point when the UK notifies the EU of its intention to leave, which will not be until October 2016 at the earliest.

Companies need to look into details of their Labeling, their sourcing and map out the impact of potential changes.

a)      EU food law requires the food label to include details of the food business operator in the EU responsible for labelling. If this is a UK entity, then companies should make plans for listing a different Member State entity going forward. This is particularly important for foods with a long shelf-life (two to three years) since these products may still be on the market post-Brexit.

b)      The UK may implement specific legislation about traffic light labelling, something the EU has chosen recently not to do, which would increase the Labeling cost and affect the timelines of product launches.

c)       Most of the companies are ready for the EU Food Information Regulations (FIR) which become mandatory on 13th December, 2016. There is no way of knowing if and when UK-only regulations will be introduced, necessitating further changes to Labeling and effectively wasting the previous investment in FIR compliance.

d)      With a typical large retailer having over 10,000 SKUs, the costs of adapting products for any new regulation could once again run into the tens of millions.

e)      Artworks of Companies whose Marketing Authorisation Holder is based out of UK would be affected.

Link to the EMA Announcement:http://goo.gl/TMiIzT