From Pharmaceutical and Manufacturing Packing Sourcer, winter 2019
With so much at stake when companies let even the tiniest error get through in their product packaging and labelling, it seems astounding that as many as 15% of organisations still perform proofreading and/or final artwork checks manually. And that’s in an advanced market like the US.
Far too frequently life sciences brands have to withdraw products from the market, at great cost and risk to their reputation. This is usually because errors have slipped through, which could have a bearing on patient safety. So why is this still happening, and what’s needed to ensure companies get high-quality and compliant products onto the market promptly and efficiently? Schlafender Hase’s Marc Chaillou explores the challenges and charts a way forward.
In this age of automation, it seems astounding that some fundamental tasks such as packaging and labelling quality checks are still handled manually to at least some degree. Yet this is the case even among some of the biggest pharmaceutical brands. That’s despite the high regulatory standards designed to protect patients, and the reputational risks and steep costs if errors slip through the net.
So what is going on? Why aren’t strict quality controls being applied to packaging content, and what can be done to improve this?
It isn’t that pharmaceutical companies are taking shortcuts, or lack process controls. Rather the issue tends to be that approaches and measures are inconsistent across the packaging production lifecycle, which spans multiple steps – each involving different teams, ways of working and supporting software tools. So, even if most functions have robust controls and make use of some form of smart automation, if there is anywhere along the packaging production line that defaults to manual checks, risks can arise. Ultimately, the calibre of the packaging and labelling that is finally issued will only ever be as reliable as the weakest link in the production cycle: leaving any aspect of the quality control process to chance is to render the end product vulnerable to error or omission.
By contrast, the earlier in the cycle a mistake or inconsistency is picked up, the more quickly, easily and cheaply it can be rectified, minimising the impact and avoiding a loss of position in the printing queue – and potential delays in getting products to market.
The risk profile: a step-by-step breakdown
So where might any breaks in the chain appear? This is likely to vary by organisation, depending on its set-up and resources.
In the pharmaceutical industry, Medical Information teams tend to be responsible for generating product content, which is checked by the relevant national or regional regulatory agency for accuracy and safety compliance, and by the internal Regulatory Affairs team for regulatory content, meaning, grammar and so on. At this point, content is likely to exist in a Word file and initial wording perhaps checked using spellcheck or dictionary tools.
The accepted text is then flowed through to a graphic design team – in-house, or an agency – which will create a PDF Artwork file with live text – after which Regulatory Affairs or the wider Artwork team will compare the transposed text and graphical elements to check that nothing has gone awry during the creative process.
Following this process of text verification and basic graphic comparison, the approved content will be converted to a vectorised Artwork file. After this point, quality control checks will rely on pixel-by-pixel comparisons – which might be conducted by Regulatory, Artwork or Quality Assurance teams, before the content is signed off and sent over to the printer.
Even here, the editing process continues – as the PDF image is tweaked to fit printing press parameters, which triggers another control between the Artwork file and the printer’s proof.
Too many cooks
Although having many sets of eyes on packaging and labelling content as it passes along the production process might suggest that anomalies would be picked up, the human eye can subconsciously over-compensate for omissions. Also, it is human nature to assume that glaring errors will have been picked up earlier down the line so the more people involved, the less accountable individual team members may feel.
When there are high volumes of labels and patient information leaflets involved, and/or variants for different markets or patient groups, the scope for discrepancies or errors being overlooked increases exponentially.
The role of automation
Taking chances with patient- or healthcare professional-facing content has an impact not only on safety but also on the eventual efficacy of the product. Manual proofreading makes no sense when there are reliable automation tools such as intelligent text and graphics verification applications that can ease the burden. Tools which can perform minute, discrete comparison checks at very high speed, and high volume, and flag anomalies for further, targeted investigation and possible correction.
This last point is critical. Promoting automation does not mean replacing the skill and experience of professional regulatory and quality assurance teams – but rather focusing their time and attention where it is actually needed. Automated proofreading and cross-checking tools are designed to perform initial rounds of checks quickly, methodically and comprehensively. They remove the risk of assumptions about no new mistakes being added in previously-reviewed text extracts, or the chance of missing errors that may be small in size but large in consequence. Automated software tools offer the reassurance of a keen, dispassionate, never-tiring eye.
Encouraging a uniform approach
Diluting the reliance on human checks is an important part of attempts to improve accuracy, accelerate labelling and packaging production, and eliminate unnecessary risks and costs. But another priority should be to introduce greater uniformity and consistency to the way checks are made – and how they are traced and reported. For maximum improvement and payback, companies should be working towards a more harmonised approach to text and graphics verification along the entire packaging preparation and printing process – that is, across and between Medical Information, Regulatory Affairs, design/artwork, and printing stages.
Advantages include fewer gaps in the quality process where mistakes could drop through; and a clearer line of sight across checks and approvals, and issues and resolutions, as a traceable workflow.
Above all, though, this is about driving out the risk of error. While cases of patients being put at risk are thankfully rare, recalls or delays to market are more common than they should be because of an over-reliance on manual or fragmented processes and disparate toolsets. Take the fairly recent case of a European cough medicine manufacturer that, due to an error in its labelling, was unable to get supplies to market in time for the peak winter season. Although it avoided a product recall, the manufacturer lost out on a season’s revenue once out of stock – with the likelihood that habitual patients switched to an alternative brand out of necessity.
Factors to consider
Applying consistency and rigour to text and graphics/pixel comparison from one end of the packaging and labelling production process to the other should be accepted business practice, to avoid the stress, panic, risk and cost of mistakes that can so easily be prevented.
For maximum efficacy and impact, companies should look for the full spectrum of capabilities when choosing a software supplier – e.g. Word to Word, Word to PDF, and text-based PDF to vectorised image comparisons, and any combinations thereof (managed natively, rather than as the result of file conversion, which violates regulatory requirements to maintain data integrity). Otherwise firms are likely to become reliant on workarounds – for instance, converting one format to another to enable checks to happen. Processes which, in themselves, can introduce new issues and create even more work.
A further consideration is the global picture: being able to check packaging and labelling accuracy no matter what language it is in, reducing reliance on local affiliates to take ownership of quality control.
Finally, it is crucial that organisations get the right advice and support for their unique set of circumstances. It may be, for instance, that a particular quality control tool is favoured or needed for one aspect of the packaging production process – perhaps because an agency has already invested in it, or a legacy system in one department still needs to deliver its payback. The important thing here is to establish how this can become part of a more integrated, consistent and traceable scenario, to avoid creating a quality or visibility gap. A knowledgeable vendor with experience gleaned first hand from across the pharmaceutical industry, will be in the best position to suggest an appropriate way forward to ensure the overall impact.
