Packaging in pharma fulfils three major functions – safety, logistics, and marketing. However, when it comes to errors in the packaging, they often become life-threatening. The prevention of errors at this stage is as critical as preventing errors in the drug development process.
Labelling errors should also be avoided. These can occur at any time in any industry in the form of misspelt texts, wrong product names, incorrect translations or incorrect fonts. The omission of country-specific information like the required warning is another common labelling error. However, at times it is not the pharmaceutical company that is responsible for the artwork errors. Instead, carton printing and suppliers become a part of the launch process.
When it comes to packaging and labelling, the question is – how can these common hurdles be avoided with the help of artwork approval software?
Pharmaceutical companies today are under higher regulatory scrutiny than ever before. Therefore, the biggest concern for pharma companies in compliance. All the labelling and packaging needs to be in compliance with the local regulatory requirements and current GMP (Good Manufacturing Practices) guidelines to avoid any safety issues.
What’s more, is that local regulations are also becoming highly complex. Even though pharma companies are working towards harmonized regulations, the nature of the supply chain results in the involvement of a wide range of local regulations. Therefore, for pharma companies to stay in compliance, they need to be adept at interpreting new requirements.
Another critical source of errors is the outdated manual processes. When there are many assets stored in many different places, it becomes difficult for companies to cope. If multiple people work on multiple documents, companies are at risk of incorrect or outdated information. This can further lead to process gaps and inconsistencies and systematic errors when the designs are incomplete, conflicting, leading to errors in the artwork content.
With such weak processes and regulations, pharma companies will face higher complexities with the increase in the number of stock keeping units. Many companies are trying to make the most of their current design assets by launching many product variants in the market.
Many previous studies have shown that more than 50% of product recalls are due to the packaging or labelling artwork, while 60% of the recalls are due to human errors. Such product recalls can also seem potentially harmful to patient safety and regulatory body compliance issues that can lead to reputational damage and maybe even job losses.
At times errors happen with labelling because of the vast amount of product-related data that companies set as the foundation for their labelling. This data is also often stored in formats that are not user friendly and across multiple formats. This is why companies have to manually process the labelling data, which is highly error-prone.
Quality control of the packaging design is an important aspect of the entire packaging and labelling process. The package design needs to be fit for purpose and appropriately tested as well as validated. It must need all the requirements like child resistance and braille. It should also provide anti-counterfeiting measures and be ready for forthcoming serialization legislation.
The other aspect is that of the quality of processes and management control. Even if the errors do not result in a recall, they still represent a quality defect which should still be viewed as a serious incident.
All of the above hurdles result in delays in getting the products into the market and to the patient who needs them. Once the label and text have been agreed with the regulator, then it is always a rush to have the other packaging components ready, the product packed and sent out to the marketplace. Finding an error at that point is the worst that can happen to a company as they will have to go through the process again.
The consequences of such delays can be quite dire as the impact on the costs can be substantial. There are immediate costs of repacking, re-supply to the market, loss of sales, market share, etc.
To address these challenges, pharmaceutical companies need to aim at building quality into their processes and maintain absolute control of the entire labelling process, including all assets, communication and interaction with stakeholders.
One simple and easy way to do this is through digital packaging management systems. Such a system can bring control, quality, compliance and visibility to pharmaceutical company’s packaging and labelling processes, thereby driving quality, GMP compliance and security.