Member Article

Taking the headache out of pharma packaging updates

When time and resources are in short supply, how can pharmaceutical companies best approach the management of looming packaging updates?

New regulations unveiled in 2016 have increased the number of elements that now need to be incorporated into packaging for prescription and Over The Counter (OTC) medicines to include: serial number, product code, batch number and expiry date. It is hoped that these new requirements will help to protect patients by guaranteeing the authenticity of approved medication. However, this update, along with the introduction of anti-tampering and security devices, may lead to a higher number of labelling updates of a complex nature. How can we ensure that existing packaging formats can be changed quickly and efficiently to comply with these new legislative demands?

Managing packaging design and production is a challenge in any industry – the process involves many stakeholders, multiple tasks and countless rounds of approvals – all of which can contribute to potentially compromising the speed of getting new packaging to market.

For pharmaceutical manufacturers and brands, this challenge is made even greater by the industry’s strict regulation and compliance. The printed packaging has to accommodate many mandatory elements, with strict guidelines as to how long a licence holder has to implement a label change after market authority approval. There are also ergonomic and accessability design considerations for certain product packaging – for instance, rheumatoid arthritis patients might struggle to open a badly designed bottle.

Pharmaceutical packaging also needs to be user-friendly for pharmacists. This means ensuring the end of the pack is labelled as clearly as the face-side, to make it easy to select the right option when medicines are stacked on the pharmacy shelf.

With so many industry specific considerations to factor in, being able to track a project from start to finish is essential – not only for the project manager, but for all key members involved with development and decision making. Many pharmaceutical companies still manage their projects manually, which makes it difficult to run processes efficiently and accurately, slowing down productivity. Where speed to market is key for new product introductions or safety changes, a manual system is stretched to the limit.

A better way to manage pharmaceutical product packaging and design production is to invest in a workflow management system, which can ensure all stakeholders are working from a central system. Workflow management software that can be accessed by all parties is a cost-effective and efficient way to keep everything on track – rather than being dependent on information being passed from department to department, which can often lead to miscommunication and result in errors being made.

Choosing a workflow management system that can be fully customised to current and future business processes is key, so that the system can be used to enforce standard operating procedures. A good solution will automate approval processes, so that market based regulatory approvers needing to sign off tasks are notified as soon as an action is required. Project managers or coordinators may have full oversight of every task, whereas certain team members or external companies, such as artwork agencies, can be restricted to a view of the tasks that only affect them. For organisations with a large number of stakeholders involved in packaging design and production, it is important to select software that does not limit the number of users that can use the system. The workflow management system will become the store for the approved artwork files for the packaging labels and will become a valuable store of GXP information used by regulatory departments through to production and QC control.

In addition to greater visibility and reducing the margin for error, using a central workflow management system has further benefits. It has the potential to speed up the end-to-end process, which is vitally important to pharmaceuticals when needing to process updates to existing packaging against tight deadlines.

Working from a single dashboard, in which design assets can be uploaded and stored centrally, improves version control, ensuring that only the final, compliant packaging designs are approved and sent to print. A good artwork management system will have the technology and capability to support the approval of the final print ready PDF file within the workflow, removing the risk of the incorrect print tools being sent to the supplier after the routing and approval of a low resolution PDF. In addition, it will be compliant with electronic records / electronic signatures (ERES) legislation removing the requirements to hold paper records.

Ultimately, the requirements to maintain quality, meet tight deadlines and achieve high levels of accuracy will never end for the pharmaceutical sector, but workflow management technology is enabling designers and manufacturers to manage this process in a more seamless manner.

This not only lays the foundations for quicker production times, which are especially valuable when faced with industry deadlines, the efficiencies made can reduce project costs. And a better managed, more productive and more profitable environment will have a positive impact across the whole business.

This was posted in Bdaily's Members' News section by Joe Simons .