packaging recall – TwonaBlog

The packaging of pharmaceutical products is a crucial aspect of the industry. It serves not only as a protective barrier for the product, but also as a means of communication between the releaser and the consumer. The releaser, a pharmaceutical laboratory, must ensure the existence of an appropriate pharmacovigilance system that allows him to assume his responsibilities and obligations in relation to the pharmaceutical specialties he markets and ensure the adoption of appropriate measures when necessary.

Risks and consequences

One of the most important components of pharmaceutical packaging is the leaflet, also known as the patient information leaflet (PIL), which provides information about the product, including its intended use, side effects, and usage instructions.

To check the content of a leaflet thoroughly is critical, as even a small typo, missing text, or added text can have significant consequences for the patient and the releaser.

Why?

It is important to avoid errors in the leaflet because they can result in medication errors. For example, if a typo results in the incorrect dosage instructions being printed on the leaflet, the patient may take too much or too little of the medication, which can have serious consequences for their health. Similarly, if important information about side effects is missing or incorrect, the patient may not be fully aware of the risks associated with taking the medication. Believe me, there are side effects which patient and relatives should be fully aware from small possible irritations to a tendency to gambling, side effect that is only revealed after clinical trials for obvious reasons.

Deviation in the leaflet can also result in recalls and legal issues for the releaser. A recall is a costly and time-consuming process, as it requires to retrieve all the affected products from the market and replace them with new, corrected versions. In some cases, the recall may result in significant financial losses, as well as a damaged reputation and loss of trust from consumers.

As a designer and knowing the sensitivity of this situation, the corresponding procedure, quality documents and relevant tools are essential. Just thinking about the lack of an appropriate software 15 years ago makes me dizzy.

How to avoid mistakes

In order to avoid errors in the leaflet, it is important to have a robust quality control process in place. This may involve multiple rounds of review and testing by different employees within the company, we call it four eyes principle. The process should also include a thorough review of the final product before it is released to the market, in order to catch any last-minute changes or mistakes.

In conclusion, checking the content of a leaflet in the packaging of pharmaceutical products is a crucial step in ensuring patient safety and avoiding costly recalls and damage to brand image. By having a robust quality control process in place, releasers can avoid errors and ensure that the information provided in the leaflet is accurate and up-to-date. Patients can also play a role reporting any discrepancies to their healthcare provider. By working together, the industry and consumers can ensure that the information provided in the leaflet is accurate and that patients receive the best possible care.

The packaging world shakes hands with a plethora of different industries; Pharmaceutical, Fast Moving Consumer Goods, Food & Beverage, Cosmetics, etc. Each industry has its own unique working environment, including unique hazards that come with each. But any industry that deals with packaging shares some overlapping risks. Here are the top three compliance risks for packaging, and one potential solution that can take them all on.

The Three Monsters:

1. Recalls

Anyone involved in the packaging world knows the dreaded word “recall.” Some have had the misfortune of dealing with this problem head on, and others have only heard through the grapevine about the steep consequences that must be faced when dealing with a recall.

A recall is peculiar in that one seemingly microscopic misprint can make the difference between a successfully launched product and millions of dollars worth of logistics rollback and untold damage to quality and reputation. The consequences of recalls have short term immediate impact as well as long term ramifications, such as sanctions.

2. Process Risks

A process risk, while often less blunt than a recall, can have more subtle and extended impact, which makes them more dangerous in that they are easier to overlook. Process risks involve a failure to follow established processes. In the packaging world, an example of this could be as simple as skipping a step in the validation process for the design of a new pamphlet.

Photo by UX Indonesia

process with postits — Photo by **UX Indonesia**

When process risks become habitual the potential for heavier risks (such as recalls) increases, productivity can decline, and the quality of output can suffer, overtime causing damage to the bottom lineand more importantly to the vital structures that keep companies afloat.

3. Illegal Practices

The risk of illegal practices is in many ways self explanatory. Everyone would like to believe that their company is immune to such risk, but illegal practices are not exclusively intentional. More often than not illegal practices take place unknowingly and are a result of the mismanagement of processes or resources.

In terms of packaging, unintentional illegal practices can take the shape of mislabelling, mismanagement, and nonobservance of legal requirements.

What causes these risks?

While there are varying factors that enhance the probability of the risks above, it is clear that the three risks share some common threads. Miscommunication is a likely cause in many errors attributed to recalls, process risks, or illegal mishaps, and can be an ill-fated result of disorganization with an individual or team, lack of transparency for the proper parties, or workflow inconsistencies. Time Pressure is another phenomenon that those involved in packaging design are intimately familiar with. The rush to get to the shelf can often mean that safekeeping processes are overlooked and corners are cut to decrease the amount of time it takes to start seeing a return on investment.

Photo by Kenny Eliason

Photo of a sand clock — Photo by **Kenny Eliason**

Completely eliminating these risks may not be possible, but companies can create some mitigation strategies to lower the probability of these occurrences.

One Solution to Rule Them All – Online Artwork Management Tools

While the root causes of compliance risks may seem intimidating at a glance, the good news is that these issues can be prevented with proper support. In today’s technological age there is a wide range of Artwork Management Systems (AMS) that boost communication efficiency and workflow organization through a plethora of verification, workflow management, and proofing tools. By using an AMS, companies are able to support the artwork design process by eliminating old manual processes and lengthy back and forth email exchanges with different parties.

But what really makes an AMS so interesting for organizations? You can find some of the well-known benefits below.

Organize communication and create one source of truth

Create one centralized artwork repository containing all versions, which is accessible at any time.
Eliminate back and forth email exchanges and communicate about the project within the project itself.
Allow for internal and external feedback and approvals, tracking status, comments and confirmations to be accessed in one single place.
Record full audit trails of what happens with the project from briefing to print.

Increase workflow visibility

Identify & eliminate bottlenecks in your workflow process, see where improvements are needed most.
Track KPIs & gain actionable insights, visualize your workflow and prevent process errors.

Streamline approvals

Share files of any size, no more inbox limits.
Request feedback approvals from internal and external stakeholders on the right version.
Return annotated files and attach new ones for changing purposes.
Visualize all approvals from one single place.

Give you the power of proofing

Gain a clear view of changes in packaging done through different versions (text & graphic) and reduce the need to inspect manually.
Red line overlapping documents and also x-ray side by-side comparisons.
Download proofing reports.
Comment directly on documents, where multi-user notes combine together.

Automate and integrate to eliminate redundant tasks

Set automatic notifications.
Integrate with other tools to speed up processes.

Do the reasons above sound like something that would make your process easier, and give you the peace of mind that your company requires? If the answer is yes, you may be a good fit for an AMS.

Compliance Risks are Nothing to Fear

Compliance risks are an ever present obstacle that anyone in the packaging industry must stay vigilant against. But that doesn’t mean that they are insurmountable. With proper workflow transparency and consistency, compliance risks are easily mitigated. If you’re ever in fear, you can depend on AMS and other solutions to save the day.

Published by Twona: Twona is a multi-faceted packaging specialist company with 20 years of experience in software solutions and packaging design. Twona’s flagship product Twona AMS has helped companies worldwide organize and streamline their packaging design process. You can start a free trial of Twona AMS today by clicking the following link , or request a demo now.

Tag: packaging recall

Mistakes on medical leaflets