Advancing GMP inspection reliance – from pilots to practice

Around the world, National Regulatory Agencies (NRAs) face mounting pressure to ensure access to and availability of high-quality medicinal products while confronted with an increasing number of sites to inspect, a demand driven by a need to strengthen supply resilience and manage limited inspection resources.

This position paper represents the views of the research-based biopharmaceutical industry on GMP inspection reliance and provides an overview the topic of GMP inspection reliance and provides an overview of the key enablers supporting implementation:

• Convergence of GMP standards
• International collaboration and pilot evidence
• Inspectorate networks - Pharmaceutical Inspection Co-operation Scheme (PIC/S), WHO Listed Authorities (WLA)
• Legal frameworks.

In addition, we provide practical recommendations that can foster the implementation of GMP inspection reliance:

• Use evidence of GMP compliance from trusted mature NRAs (based on WLA status and/or PIC/S membership) as the basis for reliance
• When necessary, advocate for adequate legislation and/or adapt guidelines to enable reliance
• Encourage reliance through collaboration and remote tools.