Regulatory Challenges in Pharmaceutical Packaging and How to Address Them

By Laura Foti

Regulatory Challenges in Pharmaceutical Packaging and How to Address Them

  • December 29, 2020

Regulatory Challenges in Pharmaceutical Packaging and How to Address Them

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Laura Foti PhotoThe pharmaceutical industry doesn’t allow room for error. 

This is the case not just for product quality, but also how products are packaged and labeled. Packaging is highly regulated around the world to ensure products are safe from contamination and tampering, as well as to ensure critical information related to dosage, usage, manufacturing, expirations, and more are correctly displayed.

Creating solutions that address all of the above is nothing short of complex. 

There are means to simplify parts of the process, however. Specifically, a few of the challenges with package design and implementation can be addressed with specification management software. 

Here’s what you need to know.

1. Anti-Tampering Requirements

The infamous Tylenol tragedy led to a complete overhaul in pharmaceutical packaging. Now, all manufacturers are required to create tamper-proof packaging, usually with a minimum of two layers of protection. These may include features like blister packaging, shrink wrap, HIS liners, or tape seals, to name a few. 

These requirements aren’t new, but they remain just as much of a priority today as they did when they were introduced. With rising shipping and production costs, many manufacturers are re-evaluating how they can create more efficient, less wasteful packaging that meets anti-tampering standards.

Specification management software puts packaging challenges into perspective for pharmaceutical companies. Tracking costs at the spec level, as well as understanding the packaging’s impact on sustainability, can help companies make impactful decisions that also comply with anti-tampering requirements.  

2. Multi-Layered Labeling Regulations

Labels for pharmaceutical products require a multitude of important information, including:

  • Product name
  • Ingredients
  • Intended use 
  • Storage instructions
  • Expiration date
  • Drugs facts table
  • Dosage instructions
  • Warnings or side effects
  • Allergy information

The information on each label will vary by the product, but it’s easy to see just how detailed and specific a single pharmaceutical product can be. What’s more, different products have different requirements when it comes to formatting. 

There’s also the matter of choosing label materials that meet regulations. Many manufacturers choose a multi-layer label printed on plain white paper because it allows them to print large amounts of information. You must also take care to choose labels or “low migration” inks or adhesives that will not come into contact with the product.

Managing all of these details is easier with specification management software. Companies can track unique data for every product and material to ensure proper labeling and potentially avoid costly recalls due to missing or incorrect label information.

3. Pharmacopeia Standards for a Global Market

The World Health Organization has established pharmacopeia standards for the global pharmaceutical market. 

In addition to these standards, manufacturers must also consider that individual countries and regions are allowed to modify these standards to satisfy unique needs (the European Pharmacopeia is an example of this). 

This creates a unique set of challenges for manufacturers who serve customers across borders as one pharmaceutical product may require multiple labels or types of packaging, depending on its destination country. 

Specification management software unites these various fragments into a centralized knowledge base. Knowing each country’s unique requirements with confidence makes it easy to do business across borders. Manufacturers can also use their spec management platform to improve supplier connectivity and collaboration and strengthen the pharmaceutical supply chain as a whole.

How to Address Regulatory Challenges with Packaging Specification Management Software

The myriad of moving parts to pharmaceutical regulations for packaging requires organization and attention to detail, both of which are supported with packaging specification management software. 

By managing package design requirements at the spec level, manufacturers can acknowledge the unique requirements for every product. What’s more, as industry regulations evolve, specs can be updated in real-time so designers can trust that they’re always designing for the most recent update and remain compliant. 

Watch our webinar to learn more about how Specright brings clarity to packaging regulations for high risk goods with specification management software.