The volume of intellectual, scientific, logistical, entrepreneurial, administrative and practical skills needed to produce a medical device or drug is staggering. So, it’s easy to ask, “What’s the big deal about label validation?”
The R&D team working 16-hour days on perfecting the product might answer, “Nothing at the moment,” or “Labeling??” The packaging point-person may even say, “Right now, I’m a lot more concerned about my sterile barrier.”
It is worth noting that even the most savvy teams can miss the point. ISO 11607 does not specifically call out any standards regarding labeling, so why sweat it? A couple good reasons:
1) The upcoming EU MDR bar code and symbol rollout could be a catalyst for more reviews and new requirements.
2) Labeling issues were the second leading cause of 2018 medical device recalls.
No joke. FDA data shows that 382 device recalls due to labeling occurred in 2018. That is second only to software defect recalls (over 500). Is label validation worth acting on? Absolutely. But how?
Know Your Limits
For the many firms working without the benefit of an in-house engineer, that can be a challenge. Resources are at a premium, staff is stretched, but somehow it seems as if everything is getting done. Yet, especially if you don’t have an in-house packaging engineer, it can be impossible to know what you don’t know. What follows is my free advice as a packaging engineer on how to protect your presence in the market and the risks of maintaining the status quo when it comes to labeling validations.
A Gram of Prevention = A Kilogram of Cure
You already know that validations are a significant part of getting a device to market. If you include labeling validation in the plan from the start, just as you do with transit, sterile barrier and other high profile tests, everything will be accounted for. Leaving out label validation is like buying a gift (your device) and feeling good about it; until you get ready for the party and realize you didn’t take the time to buy a card, batteries or wrapping – yes, you have the gift, but it isn’t really ready to hand over to the recipient. Without validated labeling, your device isn’t ready for the end user.
What Can Go Wrong
Maddening, yes, but some of the most innocent details imaginable can derail your device. For example, let’s say a device has a two-year shelf life. Equations are entered, units produced, packaged and labeled, and off they go. Unfortunately, without label validation, it went unnoticed that the label states a three-year expiration date. That’s a true story.
Or, how about this expiration date disaster: when the labeling software didn’t compensate for leap years—and who thinks of the leap year? While it is “only” a day, it is one day that can bring into question the reliability of many factors about your validations.
Dates aren’t the only fly in the ointment. Consider a 2018 recall of a joint replacement device component. The label stated that the package contained size 1, when in actuality, the package contained size 2. Enough said. Validation, validation, validation.
I could share dozens of examples where professional guidance over labeling could have averted recalls. Or, you could browse all of the FDA recall database yourself and learn a lot. The greatest companies and teams in the world can be vulnerable to label issues, because there is no straight, foolproof path to success.
Label Validation is Insurance
Label validation verifies all content (i.e., a manufacturing date, expiration date, serial number, etc.). It is key to show that all intended items are being applied to the label and that the information is also correct. Validation also includes bar code grading tests, which are important for several reasons. Knowing the quality of your printing process gives you confidence that your labels will be readable when scanned in the distribution environment and in a hospital setting. If you are trying to meet GS1 requirements for UDI, there is actually a minimum grade specified within their guidance material. If you can’t show you’ve met the grading requirement, you haven’t met the requirements for GS1. If you don’t meet GS1 requirement then you also don’t meet the FDA requirements.
We can agree that inspection of 100 percent of labels during manufacture would ensure 100 percent accuracy and performance. Yet, no one would argue that this is also 100 percent unrealistic, and the root cause of many undetected fails. All the more reason to consult an ISO-certified laboratory to run validations. There are several proven methods, depending on the nature of your medical device and its packaging. Once our validation and inspection activities are performed and results are known, we prepare a formal report. Your files will have details about the label validation process and findings that support the quality, accuracy and performance of your labeling protocols. That is peace of mind that can carry your product forward.
Advantages to you of “not” going it alone? Label validation will:
- Protect your product and help keep it on the market.
- Save time and money by having an experienced expert who knows exactly what to do and how to do it
- Save more money by preventing labeling issues that can have costly, domino effects on your bottom line
- Provide you with a validation report to offer should an audit or inquiry occur
- Create a viable history by which to track future needs if manufacturing, materials or resources of any kind change down the road
Another practical benefit of bringing in a consultant is that we have seen it all. Because PCL services a full cross-section of industry organizations, from the small startup to billion-dollar industry icons, we have many benchmarks that inform, expand and confirm our approach, deep knowledge and awareness. In summary, never underestimate the value of a label validation. Scroll down for options.