The world of pharmaceuticals is a high-stakes game. Every pill, every vial, every treatment carries the weight of human lives. To ensure these life-saving products meet the highest standards of quality and safety, a rigorous system of safety and quality conformance has emerged: GXP audits that include Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice and other schemes. These internationally-recognised audit standards act as guardians which hold manufacturers and suppliers accountable for strict regulatory compliance, and allow industry practitioners to benchmark and exchange on aligned standards effectively. 

Rising compliant inspection in GXP

In recent years, the number of GXP audits has been on a steady climb. Pharmaceutical companies themselves are conducting more internal audits (first-party audits) to proactively identify potential weaknesses in their own systems. The European Medicines Agency (EMA) has reported a significant rise of 497 GMP inspections (up 19% against last year) conducted by its member states in 2019, prior to Covid period. Similarly, the US Food and Drug Administration (FDA) has documented a growing trend of internal audits within American pharmaceutical companies. 

This increased scrutiny is further fueled by the globalized nature of the supply chain. With suppliers scattered across the globe, pharmaceutical companies need to ensure consistent quality standards. This has led to a surge in audits conducted by external parties (second-party audits). Industry leaders report a substantial increase in these external audits in recent years. 

This tightened focus on quality control has led to the rise of another compliance approach: the resale of GXP audit reports. Pharmaceutical companies can now purchase pre-existing audit reports on potential suppliers, saving them valuable time and resources from initiating brand new audits. Imagine having the factsheet of the suppliers on hand in just a few clicks – a detailed report offering insights into a supplier's manufacturing sites, production processes, and overall quality control practices.  

Challenges of GXP audit reports reselling

With a growing pool of reports available, pharmaceutical companies can choose from a wider variety, catering to different GXP audit types, geographic regions, and company sizes. Online platforms have sprung up to connect buyers and sellers, streamlining the process.  

However, this newfound marketplace comes with its own set of challenges around data quality and confidentiality. A shoddy audit report could lead to basing critical decisions on faulty information and causing significant risks in products’ quality. In addition, these audit reports often contain sensitive details about a supplier's operations so how such information is protected is crucial. 

Looking ahead, the trend of GXP audit resale is poised to continue. For pharmaceutical companies, it presents a valuable tool to streamline their supplier selection process. The key is always to choose reliable sources with high-quality reports. 

Choosing reliable resell partners

GXP audit services providers who work on fair and transparent audit system with qualifications are partners that you should be looking for. Guided strictly by guidelines, policies and proactive monitoring, these services providers maintain high level of integrity and quality in the GXP audit delivery, thereby ensuring quality GXP reports that you can count on.  

Eurofins Healthcare Assurance is an qualified GXP audit services provider where we offer high quality reports through professional teams in a global network. Check out our online GXP directory to look for available reports anytime!