More Regulations Are Coming – How to Remain Compliant

Over the last several years, it has felt as though new regulations are being announced or coming into effect every few weeks. On top of the authorities’ need to protect patients, consumers expect more and more transparency.


With many proposed or updates to existing rules being announced in 2016, such as the Plain Language Labeling, the electronic submission of labeling for certain home-use medical devices and IDMP, as well as the uncertainty of Brexit and what this means for the relationship between the MHRA and the EMA, we can only assume that 2017 will be another year of change for the Pharma industry. 

Inevitably, the more rules there are, and the more frequently these change, the greater the risk of something going wrong. We’ve seen it all too often, errors can creep in so easily. According to a Pharmaceutical Recall study, 51% of product recalls in Q1 of 2016 were caused by mislabeling. 

People make mistakes, especially if they’re tired, busy or stressed. On a pharmaceutical product, while the difference between “do not divide, crush, chew or dissolve” and “do not not divide, crush, chew or dissolve” would be a big embarrassment, “store this product at 2-8°C” and “store this product at 28°C”  or “take 1-2 a day” and “take 12 a day” could be a matter of life or death.

Similarly the more products, variants and markets a company is dealing with, and the shorter the release cycles, the greater the controls needed across documentation, packaging and labeling to ensure nothing slips through the cracks. It’s no coincidence that a number of our existing customers came to us after a recall from a labeling mistake.

So how do you manage? 

1)      Make sure you know the regulations:

RAPS, Topra and DIA offer advance education and training courses. These associations are also great resources for staying on top of the newest regulations.

2)      Ensure process standardization across your supply chain:

The Ghent Workgroup, founded in 2002 is a group of international graphic arts experts which have developed useful tools for automating processes and establishing guidelines on PDFs creation for print publishing.

You can become a member, which grants you access to member meetings and seminars, but even non-members can access their wealth of publications.

3)      Implement tools that help you automate and maintain control:

The Text Verification Tool (TVT) is a text and graphic verification software. TVT allows users to compare the content of 2 files regardless of their file format or layout and highlights any differences between them. This ensures accurate document inspection at a fraction of the time it would take manually.

Document, Regulatory and/or Artwork Management Systems can assist with your product lifecycle management and approval processes. They also allow you to automate a traditionally cumbersome process of exchanging files and ensuring everybody is working on the latest version with the correct content. There are many suppliers on the market, too many for us to list them all. The good news: most of these can be integrated with TVT to make it an even more bullet-proof process.

Feel free to reach out if you have any questions about this blog, TVT or Document, Regulatory and/or Artwork Management Systems.


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RegulatoryKate Riven