Key process elements to achieve successful artwork

Pharma and life sciences companies are governed by the global Health Authorities with stringent quality norms. With years spent on innovating new drugs the life sciences organisations, due to tight timelines, sufficient time may not be available for artwork design processes, which may result in an incompliant product presence. In such scenarios, a company’s well-defined artwork management system plays a key role in curtailing the possible compliance setbacks. With defined regulatory artwork processes, organisations can sustain such critical situations, especially in time-bound pressures.

Introduction

Being an intrinsic part of the pharma product supply, the Artwork process always goes through constant pressure to deliver accurate output in a compressed time frame. Even minuscule errors (such as misplacement of a decimal point) can be costly, damaging, and puts companies at risk owing to the threat of product recalls, health authority warnings, and fines. According to the data by the US Food and Drug Administration (USFDA) over a six-month period, there were a total of 455 recall notices, of which 51 per cent were attributed to mislabelling and 13 per cent to faulty packaging, which sometimes root back to Artwork inefficiencies.

Due to tough regulatory requirements and heavy investments in innovative or generic products, pharmaceutical and life sciences companies across the world must have established and defined artwork processes in place that guarantee zero errors and secures timely approvals for quick market entry of the products. These can truly be possible by implementing technology-driven robust processes that help to efficiently integrate the areas of repository management, data management, label regulatory control, authoring, and design control.

Artwork process challenges

It is quite evident that when it comes to Artwork management there are certain challenges. If these challenges are not timely addressed, there is a risk of regulatory fines and recall, increased time-to-market, loss of competitive position, and damaged brand equity. Here are a few of them:

1. Compliance burdens: Artwork and labelling compliance is probably the biggest challenge for pharma companies of any size. From keeping abreast with the ever-evolving local or regional regulatory authority updates to adapting to the new market requirements is a huge and complex task. For a company, whose core focus is to innovate medicinal products, it is challenging to track the regulatory updates.
2. Recall risks: Product recall is a terrible experience for a manufacturer. As per research, it is believed that more than 50 per cent of product recalls are due to labelling or artwork packaging, and more than 60 per cent of all recalls are caused by human errors. The consequences of product recalls are dire. Also, such errors may cause serious risks to patient safety, which may result in fines, reputational damage, and even job losses.
3. Multiple artwork revisions: Reworks can be costly, time-consuming and ultimately cause delays in the artwork review and approval process. When a job card is initiated without much information on the drug, there will be delays and errors, resulting in rework. Also, reactive and poor communication are the major reasons that cause unnecessary revision cycles that consume resources bandwidth and delay the artwork design output.
4. Poor tracking of the process: The artwork process flows across many facilities and regions globally making it difficult to track. Hence, it is challenging to track accurate information and report and measure performance. It calls for a necessity for process centralisation, to enable visibility throughout the product lifecycle for identifying any bottlenecks and process inefficiencies.
5. Difficulty integrating with partners: Integrating with partners and global expansion will be highly difficult to achieve without a standardised artwork workflow. Also, improper communication with the partners results in more reworks that delays the entire process, which in turn may cost much to a partner.
6. Delayed time-to-ma