Evolution of audit in pharmaceutical industry

In the ever-evolving landscape of audit in pharmaceutical industry, the dynamics between pharmaceutical companies, third-party audit firms, and suppliers are undergoing a significant transformation. This transformation presents both opportunities and potential risks to each stakeholder in the supply chain as they work towards regulatory and industry compliance.  

Initially, the primary focus was on the relationship between pharmaceutical companies and audit firms. The establishment was much more linear that audit firms would take audit orders from pharmaceutical companies, complete the audit on-site and return the audit reports to pharmaceutical companies.  

However, there has been in recent years a noticeable shift towards emphasizing the relationship with suppliers and building up a stronger supplier network, which offers several clear advantages. By developing closer ties with suppliers, third-party audit firms can streamline the audit process, reducing the frequency of supplier audits and thus fatigue of all parties involved. This enhanced collaboration leads to increased efficiency, and when suppliers allow third-party audit report access to multiple pharmaceutical companies, the audit process is far much expedited, resulting in a more mutually beneficial partnership for all stakeholders from the shared audit practice. For the pharmaceutical companies, costs are lower from shared audits, providing better insights into budget optimisation.  

Nevertheless, this close collaboration between audit firms and suppliers also presents some challenges. A significant one is the potential compromise of impartiality. When the relationship becomes overly familiar, concerns regarding integrity may surface. Upholding high integrity is essential to ensure the accuracy and reliability of the audit process and results. An audit firm might make decisions or actions that are not concluded on unbiased circumstances, jeopardising the much-valued integrity of an independent audit firm, as well as the trust of pharmaceutical companies hold in the firm. 

As industry is on constant evolution, working under this more collaborative approach is inevitable for everyone. While enjoying the boosted efficiency and collaboration benefits, it is imperative to implement measures to safeguard the integrity and impartiality of the audit process from compromise. 

At Eurofins Healthcare Assurance, we have stringent procedures in place that monitor and manage our worldwide teams’ integrity and impartiality, delivering high standards of pharmaceutical audits with our expertise and knowledge. 

Check out the full range of audits available. Make audit book or join shared pharma audit at our audit platform anytime!