pace of change and differences between written regulations and actual enforcement practices and timelines make tracking and planning difficult, so companies may find it worthwhile to invest in global regulatory specialists.

2. PROVIDE TRAINING TO ENSURE COMPANY-WIDE COMPLIANCE Regulatory compliance is only as strong as the weakest link in the company. In order to ensure compliance across the company, staff from lab technicians to the CEO should have an understanding of how their daily jobs affect regulatory compliance. As a best practice, staff should be trained

By Mark Keogh, VP Buildings & Industry for Ireland, Schneider Electric


he life sciences and pharmaceutical industry continues to face increasing

challenges amid a myriad of regulatory scrutiny. Companies are often under the microscope when they seek to push the boundaries of innovation, developing new products to meet the evolving needs of customers for which there are little to no regulations. In fact, a recent Deloitte study found that without clear regulatory guidelines, life sciences companies are cautious about bringing technology innovation to patients. Pharmaceutical companies in the

market today need to comply with a huge array of regulations – in most regions, Irish manufacturers must follow the Health Products Regulatory Authority’s (HPRA) Good Manufacturing Practice (GMP), as well as Good Documentation Practice (GDP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Companies need to be able to ensure data integrity and product integrity, or else they put patients at risk and face costly regulatory violations – penalties can include not only heavy fines, but also banned products. In addition, the reputational cost of non-compliance can be significant. Currently, the life sciences industry in

Ireland is working tirelessly to drive investment and collaboration to accelerate testing and treatment for Covid-19. It’s important the industry continues to also advance pipelines and


rethink ways of bringing treatments to patients – earning clean bills of health when it comes to regulatory compliance for manufacturing complex, critical products is essential to this. With that in mind, here are three steps

that companies can take to improve regulatory compliance:

1. REMAIN UP-TO-DATE ON REGULATORY REQUIREMENTS ACROSS DISPARATE REGIONS With many pharmaceutical companies operating, distributing or partnering across country borders, it’s not enough for manufacturers to know local and national regulations. Companies also need to have a thorough and up-to-date understanding of the latest regional and international regulations that are in force or pending. In Ireland, for example, Brexit will require pharmaceutical products to be tested and certified at the point of import into the EU. Recently, The UK government and the

European Commission (EC) reached an agreed approach on a phased process for implementing medicines regulation in Northern Ireland following Brexit. This will allow companies to prepare and look towards improved traceability of products, accurately recorded data in a central system and implementing digital batch management. Not only will this provide regulatory consistency and flexibility, it will also drive digitisation in the pharmaceutical industry.

Pharmaceutical companies in the market today need to comply with a huge array of regulations

on not just the “what” and “how” of regulatory compliance within their sphere of operations, but also the “why” rationale behind each action to enable a more resilient corporate approach to compliance.

3. DIGITISE OPERATIONS Digitising operations can also provide significant compliance benefits. As one example, when Fujirebio, a manufacturer of biomarkers, replaced their existing paper-based GMP record system with a digitised solution with integrated workflow, they were able to significantly improve regulatory compliance. Before, the paper-based system was slow and prone to human error. Switching to a digitised system reduced errors and fulfilled the electronic system requirements needed for Fujirebio to maintain 21 CFR Part 11 compliance and the facility’s ISO 9001 and 13485 certification. Ireland has needed to navigate through

the impact of Covid-19, economic instability and Brexit negotiations which has been no easy feat. In the path to recovery, the Irish pharmaceuticals and life sciences industry has an opportunity to upgrade and digitise their supply chain and business. There is a greater focus on adopting new technologies within plant and production environments to support workers, and now is the time to continue accelerating digital transformation plans. Pharmaceutical manufacturers are

expected to adhere to stringent compliance standards, but by keeping their staff and business streamlined and looking out for ways to optimise end-to- end operations with the use of new technology – the industry will see continued improvement.

Schneider Electric


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