Your first step to SPL/QRD compliance – Automate Proofreading
The ability to manage product information is a daunting task. Many departments across the enterprise use the approved product information for a variety of purposes, including packaging, labeling, promotional materials, and product websites. It is a common practice for each department to take a copy of the approved content and recreate it for its own use, leading to significant inefficiencies and potential for inconsistent product information.
- Improved consumer safety through timely access to accurate and consistent product information.
- Ease of information exchange, allowing content to be created once and made readily available to all necessary consumers and computer systems.
- Promoting the use of standard terminology and coding across labeling content, such as ingredient names, package types, dosage forms, and routes of administration.
- Reducing the manual effort involved with the review and approval of labeling content.
- Reducing the amount of redundant product information provided to regulatory, for eg: unnecessary duplication of information submitted to regulatory authorities
- Reusing it to generate other product information outputs—such as Package Inserts, Brief Summaries and other promotional materials, product websites, and package components—which reduces the risk of non-compliance by reducing the incidence of inconsistent product information.
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 regulated markets, the SPL content (or extracts from it) is 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.
If your company has not begun to think about SPL, now is the time to start. To ensure compliance, you will be required to:
- Convert new and existing labeling content to XML format
- Submit to the FDA both the narrative labeling content and drug listing information
- Maintain consistent product information across all package, label, and promotional outputs
This new information now, as shown above, will have life sciences companies submit their labeling content to the FDA where it will be stored in the Electronic Labeling Information Processing System (ELIPS). Following the review and approval of labeling content, the FDA will automatically provide the National Library of Medicine (NLM) with labeling updates to populate their DailyMed repository. The NLM will then be responsible for publishing this labeling content in various formats.
Possible outputs include a browser-based view of product information for access by health care practitioners and the general public, as well as formats that will enable computer systems, such as hospital information management systems and electronic prescription systems, to process the labeling content for analysis, aggregation, data mining or other purposes.
And what if you’re doing business in or with the EU?
It is evident that the labeling requirements in the European Union (EU) are quite dissimilar given various region-specific regulations across 27 member states. Due to Brexit, the Regulatory landscape has even become uncertain.
The QRD template, which is based on Article 65 of Directive 2001/83/EC covers general requirements for the summary of product characteristics, labeling, and the package leaflet of medicines.
The QRD template itself is a text framework that provides headings for paragraphs and subparagraphs and includes standard statements applicable for the broad range of all distributed medicines. Medicine-specific information is inserted into this text frame by the pharmaceutical companies. The template is available in the 23 official EU languages with the addition of Icelandic and Norwegian and aims to support the pharmaceutical industry in providing user-friendly product information.
A case for adopting Text Comparison Tool
1. Manual proofreading is counter-productive
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 that certain text content is the same across both the components. The Proof-reader has to not only check the accuracy in one component artwork, but also make sure that the same content is available across multiple components of the same SKU.
2. Eye-balling word/pdf leaflet against another pdf is a time-guzzling task
From the previous point, it comes to show that a member in your regulatory team takes anywhere between 2 to 4 hours on an average to finish proofreading the leaflets. Multiply that with leaflets across each product-line and we’ve got an entire team of highly-paid qualified people using their time to perform a task that can be performed by a sophisticated AI-system in minutes. If you’ve contracted your proofreaders, here’s an option you could consider to increase your bottom-line.
3. Proofreading is frequent because USFDA update requirements are frequent
Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. The FDA receives 500,000 such reports every year. As a result, 400 to 500 label changes occur every year. Companies manufacturing APIs and molecules allot a lot of labour and time to attend to these changes.
4. And it’s not just USFDA we’re talking about
Changing regulations around the world require companies to manage packaging and labeling compliance across multiple jurisdictions. Even companies making a handful of products on a few lines can find it difficult to change over packaging and labeling in order to stay compliant with the geographic markets they may serve.
Using artwork templates, XML labeling content can be automatically integrated into package and labeling designs for box cartons, blister packs and other package components. This provides a streamlined process for package component creation which improves time to market, reduces the risk of errors, and reduces review cycles since the same content that has been reviewed and approved for regulatory purposes is inserted directly into the artwork.
To be continued…In our next blog, we will discuss about text comparison in CPG Industry
ManageArtworks is a Packaging Artwork Management Software that helps regulated industries like Pharmaceuticals and CPG to ensure regulatory compliance of their pack labels. It connects all stakeholders into an automated workflow, empowers users with sophisticated proofing tools including Text Comparison tools that reduce errors and speed up the process and gives complete transparency to the entire process with approval request tracking, audit trails and dashboards.
ManageArtworks is available as a ready to use cloud product or as a configurable on premise solution.
Click here to know more.