Non-compliance issues that have made the headlines can be traced back to incorrect labelling, lack of batch control, ageing chemicals, products close to expiry, and cross-contamination due to cleanroom or process failures. While perhaps not as newsworthy, variable product quality (for example, net weight of individual units) is also critical. As well as the clearly understood human and legal ramifications, each of these issues impacts your profitability, efficiency, and reputation.
In other words, the very future of your business.
So, what does the future look like?
It’s now almost impossible to operate a compliant pharmaceutical manufacturing plant (as a profitable operation) without using digital technologies.
Yet despite the significant manual effort required to ensure compliance, and the room for error, many companies have still to adopt technologies to automate and control these activities with scrupulous precision.
Introducing technology to all aspects of a manufacturing operation is often not a priority until an issue occurs; it’s the pill so many are reluctant to take. And the longer it takes to automate, the more difficult and expensive it becomes to backtrack and retrospectively tick every compliance box.
So, what are some of the primary compliance processes that technology can improve?
Cross-contamination and clean rooms
ECA Academy, an information source for GMP/GDP, reported at a 2015 seminar on the new EU requirements for the use of multipurpose equipment that “cross-contamination is one of the highest risks for patients using pharmaceutical products. Not only the presence of small amounts of antibiotics or other highly potent compounds in medicines can cause severe damage but also carryover of products into another pharmaceutical product is of high risk to the patient. According to the Medicines & Healthcare Products Regulatory Agency in the United Kingdom, product contamination is the second to third highest reason for recalls in the UK in recent years.”
The necessity to adequately clean between product runs is obviously of critical importance from a cross-contamination perspective, but optimising the run order to minimise downtime between cleans, is essential from a productivity and profitability perspective. For example, two four-hour micro clean-downs in a row can severely impact scheduled output.
While it’s not uncommon for manufacturers to rely on an experienced employee to manually schedule product runs, it’s a decision that is not without its risks. Best intentions aside, people make mistakes. They resign, retire, go on holiday, and become ill.
Introducing a digital solution that optimises cleaning, by correctly analysing the category of each raw material to determine the level of clean required, provides certainty that cross-contamination can’t occur.
And critically, if you can avoid even one four-hour clean a week, your production capacity (based on a 40 hour week) immediately goes up by 10%.
Variations in product weight are not only a quality issue, but a profitability one. In an age where the average templating machine can make 20,000 pills a minute, reject products chew up raw ingredients, increase machine and resource costs, and require factored in overruns to make up for volume shortfalls.
By capturing and reporting machine data through data warehousing, you can determine when quality issues occur and identify trends. For example, Machine A may always take 15 minutes at the beginning of each day to warm up. And during this time, each pill is slightly under or overweight or contains too much moisture. Using data to establish and report on patterns helps solve problems more quickly.
The outcome? With real-time analysis, the ability to spot an issue and rapidly make the decision to calibrate or service Machine A more frequently can minimise expensive recurring quality issues.
Technology can also streamline the validation process, reducing costs and speeding up approvals. For example, replacing the first person in a two-person weigh out with a digital scale to provide the first approval signature removes one person from the process, while still achieving compliance.
Raw materials, expiry dates and inventory
If you are constantly juggling levels of raw material in stock, introducing automated inventory in conjunction with production scheduling can calculate precisely what you need to buy in – and by when - for a production run.
This helps minimise your materials inventory and allows for a just-in-time approach to a product run, rather than taking a just-in-case approach to holding surplus raw materials which are of no value until complied.
And given that most retailers expect a minimum of 60% remaining shelf life, holding more than four to six weeks of finished goods in stock (and refrigerated if required) – or not being aware you even have them - can be an expensive mistake.
Automation allows you to take a nimbler approach to what you run and when, what materials you order in, and to ensure you never end up having to discount stock to move it off your warehouse shelves.
Batch control and testing compliance
Batch control is increasingly seen as something that should be part of your quality process, not sitting outside it.
Your LIMS software ensures that your testing regime is compliant and allocates a pass (green) or fail (red) to each batch. The traditional approach to managing this pass/fail process has been for the QA department to manually apply a green or red sticker to the physical product. Unfortunately, this requires QA to locate the stock in the warehouse, and often wait for an available warehouse person to provide access when it’s on a high shelf.
By integrating your LIMS with batch control, the status of a product run can be electronically identified and tracked by its unique batch disposition code. This code limits the progress of the batch through your warehouse. Until allocated a ‘pass’, the stock is put on hold (so it can’t be reserved or picked) until your quality assurance system electronically releases it for sale and distribution. In addition, a batch that has not been approved for release triggers an alert when scanned for packing, eliminating room for human error.
With batch control technology, you can also track down every raw ingredient consumed, precisely which products it was compiled into, and when and where those products were despatched to – in minutes, not hours.
If you’re not using technology to its fullest extent, why not?
In their comprehensive article on ‘Maintaining value in pharmaceutical compliance’, Deloitte reports that “Use of digital technologies in compliance is an exception rather than the rule.”
It’s only through the introduction of digital technology into pharmaceutical manufacturing processes, that you can control and manage the cost and effort of compliance.
Ironically, it’s perhaps because the pharmaceutical manufacturing industry is so busy ensuring they comply with legal requirements (which extend far beyond those mentioned in this article) that they have few resources to spare to undertake the one activity that will help them the most. That is: using technology to do what it does best. Streamlining and automating processes, eliminating human errors, adhering to rules, and reporting on everything in real-time.
In effect, a reluctance to change or invest in improving your capability to comply could undermine your success and ability to thrive in a highly competitive industry. And as we all can appreciate, (business) failure is a bitter pill to swallow.