Gerardo Franchini examines how technological advances have made regulatory compliance less of a headache for the pharmaceuticals industry
As one of the most, if not THE most regulated industries in the world, the pharmaceutical sector is used to high levels of scrutiny from customers, consumers and regulatory bodies alike. Plus the cost of non-compliance is not only financial, but also detrimental to consumer trust and reputation, weakening profits and the ability to confidently develop new products. For pharmaceutical businesses, the fine art of balancing the need to achieve best practice when it comes to compliance alongside the ever-changing requirements of customers and a tumultuous global economic climate, adds even more pressure and greater complexity to already stretched manufacturing operations.
While industry regulations such as those under the FDA’s CFR21 have been around for some time, amendments have taken batch traceability and formula management to new levels of granularity. The good news for pharma companies is that technological advancements have meant that, to a certain extent, achieving full compliance is becoming easier.
Well aware that one-size-no-longer-fits-all, software developers are designing solutions to meet the very specific needs of the industries for which they’re intended. For example, when it comes to pharmaceutical products, they often involve the smallest volumes of ingredients, meaning precise weights are crucial to ensure quality in production, as well as precise batch processing and traceability, with the accuracy of the bill of manufacturing vital to ensure full compliance. The introduction and integration of weighing scales to some pharma-specific ERP systems simplifies and automates the entire process, increasing quality, ensuring accuracy and reducing scrap. Formula management is also built-in, allowing for the scalability of formulas and providing the granular level of detail required to adjust formulas, with any changes automatically communicated to inventory, production and planning.
The keeping of precise batch records, without the need for the error-prone rekeying of data, serves to further the benefits of the right ERP system. Previously, the need to gather information from multiple sources in multiple formats made accurate batch traceability an almost insurmountable task. Those systems specifically designed to meet the needs of process manufacturing industries, such as the pharmaceutical sector, have the ability to automatically amalgamate data from these different systems, speeding up the entire traceability process, and optimising the overall traceability capabilities of the organisation, again with accuracy built-in as standard.
It’s these new levels of accuracy and efficiency that allow new levels of rigour to be applied throughout the business. The ability to efficiently manage complex formulas, defining component and ingredient relationships to the nth degree, instills confidence that the figures are right first time. And, it’s not just the business itself which benefits from these higher levels of accuracy. If customers can experience just how robust the ERP system is, this in turn gives them greater confidence in not only the products, but the entire production process, making the right ERP system a real value-add for customers, and helping pharmaceutical manufacturers maintain their competitive edge.
By using the right systems and solutions, compliance need no longer be a thorn in the side of the pharmaceutical industry. Massive improvements and developments in ERP technology in particular have led to compliance becoming much more readily achievable, often with noticeably less effort. So having the right ERP system in place could soon be a deal-maker when it comes to doing business in the pharmaceutical industry.
One of our team will be in touch shortly.