It’s now more than twenty years since the term Good Manufacturing Practice, or GMP, emerged in the branding industry. Back then, agencies were just starting to think differently about how to provide artwork services to pharmaceutical clients. This meant developing a laser focus on quality and approaching the process in the same way as this group of clients.
The World Health Organization’s initial draft on GMP emerged in 1968 largely due to a series of high-profile incidents and tragedies resulting from drug contamination, not least of which included the Thalidomide scandal in the late 1950s—whereby a drug developed to ease morning sickness among pregnant women led to thousands of serious birth defects. The WHO finally recognised there was an urgent need for a global regulatory framework.
In the half century that has followed, GMP has evolved to reflect the many changes in the multitude of processes that are involved in getting a product to a consumer or patient, particularly those surrounding packaging artwork. GMP standards outlined in the pre-digital 1970s would have limited relevance if applied to the systems and tools used to develop artwork today. As the world continues its evolution from physical to digital packaging, so did GMP.
However, Good Manufacturing Practice is no longer just limited to the pharmaceutical industry—GMP applies to the practices required to conform to guidelines around the manufacturing and sale of food, beverages, cosmetics, MedTech, supplements, and pharmaceuticals.
Over time, GMP has become an integral part of preparing for a brand artwork audit, no matter the sector, creating a logical approach in the critical supply chain. But while creating a robust GMP audit system doesn’t happen overnight, the long-term benefits will prove a significant return on investment. We look at the GMP principles that will improve your go-to-market processes and ensure your organisation stays competitive in a constantly evolving market.
Though a brand audit can be daunting, it’s also an excellent opportunity to ensure that your Quality Management System is robust and well positioned to develop artwork. Any observations are opportunities for improvement, and how teams are trained in GMP is no exception.
While GMP can be easily incorporated into a Quality Management programme, the available resources tend to tackle the topic from a predominantly manufacturing perspective. Whether using bought-in resources or external trainers, the criticality of GMP in a purely manufacturing context is important for teams to understand its relevance to their work.
However, the context clues are essential so teams can see themselves as a valuable step in the product distribution. For example, statistics show that the largest number of failures in the pharmaceutical supply chain occur in artwork and labelling, so showing people wearing white lab coats in training videos is less effective. Instead, training that displays examples related to codes, fonts, and product strengths can better highlight the critical points around clarity for briefing instructions, the dangers of copy and paste, and correct use of proofreading software.
By adjusting GMP training to specifically address artwork development, teams can find far more relevance to the work they’re doing and see their perspectives valued and understood. Setting the scene with the historical context of GMP and how teams fit into the wider chain can be more easily brought to life by using examples taken from the tasks performed by each stakeholder.
In the early part of 2020, everyone’s world changed almost overnight. Organisations quickly switched workforces from a studio-based model to one almost entirely comprised of remote workers. Organisations had to rapidly validate and approve new software for pack artwork that facilitated homeworking, to ensure there was no risk to continuing operations. And while there is much truth in the GMP adage ‘if it isn’t written down it didn't happen’, this idea was fully tested in a virtual environment. Platforms like Zoom and Microsoft Teams became a vital tool in ensuring communication channels remained open, and activities like daily direction setting, root cause analysis deep dives, training, and many other key systems moved to a digital format.
For organisations that operate as part of a critical supply chain that provides essential food and medicines to consumers and patients, ceasing to operate during this time of upheaval was never an option. But organisations that applied GMP principles across a newly remote workforce discovered that they were able to transform quickly to the new normal and became essential to the continuity of supply.
Observations=Opportunities for Improving
In some ways, the changes triggered by the pandemic have provided additional benefits for organisations who already employed GMP standards. Remote self-inspection offered a different dynamic to the audit process, uncovering new improvement opportunities, and reducing the travel burden on external auditors. The digital security protocol risks are minimal and virtual meetings have improved record keeping with an audit trail of attendees, times, and automatic recordings.
Having a QMS firmly grounded in GMP principles can play a key part in improving working methodologies, whether it happens during or after a global pandemic. So, as we start to emerge from Covid restrictions that allow a switch to a hybrid model that combines in-person and homeworking, GMP principles can offer additional agility to move into the next phase of our global ways of working.
Creating accurate packaging artwork is a serious business. The consequences of getting it wrong range from incurring financial penalties, damaging a company’s reputation, and losing business, to more serious outcomes such as product recalls and even compromising patient safety. GMP exists to prevent these situations and is particularly integral in averting artwork errors that can resulting in some of these dire consequences. GMP: three little letters that can offer a great deal of confidence as organisations move through the stages of artwork creation.
About Paul Williams
Paul has more than twenty years’ experience in Quality associated to branding and graphics. Today he works as a Production & Quality Director of SGK Newcastle, focused on the Quality and Delivery requirements of clients. Specialising in quality assurance within the graphics supply chain, and with a proven track record of ensuring best in class cGMP compliance, he has extensive experience of both the Life Sciences and Consumer Packed Goods sectors.