Philippe Adam is vice-president, Global Marketing, Esko.

Philippe Adam

	Pharmaceutical companies want an efficient, error-free packaging and labelling process that is fully compliant and counterfeit-proof. Packaging and labelling challenges, however, occur on a regular basis, and can result in a product recall in the worst-case scenario. This article looks at five of the most common hurdles in packaging and labelling artwork and how to avoid them.

	Being part of a highly regulated industry means that GMP compliance is often one of the top priorities for pharmaceutical companies. Because of the global nature of the pharmaceutical supply chain, companies have to deal with different regulations worldwide. Local regulations are becoming more complex despite efforts to harmonize the pharmaceutical regulatory framework. As a result, companies need to be adept in interpreting the different requirements of local regulations.

	Outdated manual processes can be a source of errors. Too many assets stored in too many different places being emailed to too many people can be difficult for companies to handle. With multiple people working with multiple documents, companies run the risk of working off of incorrect or outdated information.

	For a large global pharmaceutical company, developing artwork for thousands of products typically involves a number of organizations across several countries. To orchestrate all of this activity, the right combination of business processes, organization design, information technology, facilities, and suppliers has to be managed. Too often, there are process gaps, inconsistencies, and systematic errors that occur when the design of the business processes are incomplete or conflicting, hence, leading to errors in the content of the artwork. Pharmaceutical companies may want to make the most out of their current assets by launching as many product variants in as many markets as possible, and the complexity increases with the number of stock keeping units (SKUs) being developed by companies.

	For pharmaceutical companies, product recall is the worst scenario, particularly if patient safety is at risk. According to Esko’s market research, it is estimated that more than 50% of product recalls are related to the labelling or packaging artwork, and more than 60% of recalls are caused by human error.

	Errors sometimes occur with labelling due to the vast amount of product-related data companies have as the foundation for their labelling. The data is often in non-user friendly file formats, stored in multiple locations. Companies have to manually compile and cross-check labelling data, which then makes the labelling process prone to error.

	While recalls are the extreme end of the spectrum, there are potential quality control issues throughout the entire packaging and labelling process. For example, there is the quality of the packaging design itself, which needs to be fit for purpose and appropriately tested and validated. It needs to meet legislative requirements (e.g., Braille), provide the required anti-counterfeiting measures and child-resistance features, and be ready for the upcoming serialization legislation. The quality of the processes and quality management controls are also important, because even if errors do not necessitate a recall, they can still represent a quality defect that should not be taken lightly.

	The issues discussed (compliance concerns, process problems, recall risks, and quality quibbles) can cause delays in getting the products onto the market. Once the label text has been approved by the local regulator, for most markets, it is then a real rush to have the packaging components ready, have the product packed, and get it out to the marketplace. The last thing companies want is to find a mistake at that point, because then they will have to go back through the whole process again.

	The consequences of delays can be significant, especially for a pharmaceutical product with limited patent protection time. The cost impact can be substantial. There are the immediate tangible costs of repacking and market re-supply and the less tangible follow-on costs through loss of sales and market share and customer reimbursement. In the extreme, these consequences can affect the company’s share price.

	The key priorities for companies are to reduce the risk of errors at every single stage of production and to ensure they are fully GMP compliant. To address these challenges, pharmaceutical companies need to build quality into their processes and maintain absolute control of the entire packaging and labelling process, including all assets, communication, and interaction with stakeholders. One way to take control is through digital packaging management systems. These systems can bring control, quality, compliance, and visibility to pharmaceutical companies’ packaging and labelling processes, driving quality, GMP compliance, and security.

Three benefits of packaging management systems

	Packaging management systems can improve visibility of artwork changes. The teams involved can see upfront what work is heading towards them and can plan ahead better.

	Secondly, having a closed-loop artwork management system can ensure that everyone is looking at the right document and using the right version of artwork at the right time. The system can include an electronic signature that is validated and controlled, hence, driving a higher level of accountability. Online proofreading tools are also available, and these tools play an important role in detecting human error.

	Companies want to avoid packaging and labelling hurdles and manage artwork production in the most cost-effective way. Packaging management systems are becoming the standard way for brands to streamline their labelling and artwork production process.

 is vice-president, Global Marketing, Esko.

Articles

This article looks at five of the most common hurdles in packaging and labelling artwork and how to avoid them.