Strengthen processes and increase safety measures to avoid costly delays and reduce recall risk.
When it comes to pharmaceuticals, it’s important to use the same degree of caution in packaging as you do in manufacturing the drug itself. Market research estimates that more than 50% of pharmaceutical product recalls are related to labeling or packaging errors.
Anytime pharmaceutical products are recalled or reach customers without full regard to safety, the cost goes beyond that of the product itself and can impact consumer confidence (and well-being). This can be even more costly — and potentially devastating — in the long run, so it’s vital that pharmaceutical companies take every precaution possible.
Here are 4 best practices to help ensure that your pharmaceutical products will reach the shelf intact and safe for consumption.
1. Prioritize compliance with pharmaceutical product regulations.
Due to the nature of the pharmaceutical industry, staying current with Good Manufacturing Practices (GMPs) and Food and Drug Administration (FDA) regulations is a must. The FDA has put pharmaceutical safety regulations in place both to protect the consumer and to standardize formatting across brands and product types.
Because pharmaceutical product regulations can be complex and require interpretation depending on the scope and region of distribution, it’s important to have someone on staff who is knowledgeable and dedicated to ensuring that you’re meeting regulatory compliance goals.
2. Design business processes to support packaging quality and labeling accuracy.
Evaluate your processes and communication between departments to make sure that any gaps or inconsistencies do not lead to labeling errors on the package of your pharmaceutical product. Pharmaceutical companies may develop label artwork for tens of thousands of products, with processes that involve thousands of people — often across different organizations and even countries. This kind of volume and scope increases the potential for error.
No matter the size of your operation or the complexity of your processes, human error can occur — with lives (and your company’s reputation) at stake, it’s important to have a system in place that allows for plenty of double-checks for accuracy.
A Regulatory Education for Industry (REdI) report indicated that some of the top reasons for pharmaceutical product recall due to packaging and labeling errors include:
- Defective containers
- Incorrect or missing package insert
- Incorrect or missing lot number
- Error on declared strength
- Label mix-ups
- Presence of undeclared color additive(s)
Being aware of the likelihood of these errors can help you identify solutions to mitigate your risk of recall.
3. Improve packaging and labeling efficiency through automation.
Since pharmaceutical products may have limited patent protection time and expiration dates to be concerned with, the cost of delays in getting the product to market can be significant. This may create the temptation to throw processes. However, there are better solutions available. A delay may be costly, but a recall even more so.
Instead of speeding through areas that need careful attention, it’s wiser to gain time by embracing automation technology. This can help reduce the risk of human error while increasing the overall packaging speed for your pharmaceutical products.
A high-quality pharmaceutical packaging and labeling system offers:
- Filling and capping capabilities. This includes options such as above liquid surface filling, underneath liquid filling, and bottleneck filling (and capping) of different types of viscous and semi-viscous products.
- Consistent label placement with speed and accuracy. This helps you avoid costly reprinting and relabeling while multiplying your output overnight.
- Pressure-sensitive labeling with flexibility. This provides tear-resistant, legible labeling with strong adhesion while allowing you to move between a variety of bottle shapes.
- Modular add-on options. This meets your unique needs with specialized pharmaceutical equipment such as automatic label printers that clearly label batch numbers and expiration dates.
4. Optimize the safety and quality of your pharmaceutical packaging.
As we’ve seen, there are potential quality control issues throughout the entire pharmaceutical packaging and labeling process. It’s a good practice to test your package design for sturdiness to ensure protection of both the pharmaceutical product itself and the end-user.
One of the most important safety measures you can take is to include a tamper-evident shrink band tunnel in order to prevent pharmaceutical products from being altered, diluted, or replaced with fake products. Additional pharmaceutical labeling requirements for tamper-evident packaging may include:
- Identifying tamper-evident features
- Placing label prominently on package
- Placing label to be unaffected if tamper-evident feature is breached or missing
- Providing one or more indicators or barriers to package tampering
- Ensuring that your package is distinctive by design and cannot be easily duplicated
- Ensuring that packaging remains intact throughout shipping, handling, and retail display
You’ll also want to be sure that the packaging meets accessibility requirements (such as Braille), includes anti-counterfeiting measures such as traceability, and offers child-resistance features as necessary.
Choose a trustworthy and knowledgeable labeling partner.
If you want to optimize your pharmaceutical packaging and labeling setup for efficiency, quality, and safety, Pack Leader USA can help. Our labeling machine experts are here for you every step of the way, from free consultations to training to service.
When it comes to the critical best practice of safety, our tamper-evident shrink band tunnel can help you solve this problem effectively and affordably. We’re here to partner with you in meeting compliance goals and keeping your pharmaceutical products clearly labeled and securely protected so you can deliver the utmost in quality and peace of mind to your customers.