Inspection Readiness: What's Next?

by: Daniela Tatangelo, GMP Compliance Expert @PQE Group


The impact of globalization and the COVID-19 pandemic on pharmaceutical inspections and audits cannot be overstated. These two elements alone have accelerated a monumental shift in the industry's regulatory framework, leading to more international cooperation and reliance on foreign competent authorities. The Mutual Recognition Agreement (MRA), a culmination of a push toward closer cooperation, played a key role during the pandemic, fostering collaboration between nations at such a critical time. The 2023 EMA programming document forecasts the next five years to be characterized by close ties within the scope of the MRA to promote inspection information exchange, as well as hybrid inspections and more collaborative programs by ICMRA as pilots are underway. This article examines the effects.


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The effect of globalization and the COVID-19 pandemic in the field of pharmaceutical inspections and audits 

Due to the impact of globalization in the pharmaceutical sector, facilities manufacturing products for multiple markets are in place, resulting in the need for extended regulatory oversight of each jurisdiction. Through international co-operation and collaboration, the willingness to rely on work results produced by foreign national competent authorities (NCAs) has increased over the past 10 years, promoting trade in goods between nations and increasing market access. 

Thanks to the mutual recognition agreement (MRA), this exchange of GMP inspection information between nations, avoiding the need for duplication of effort, was greatly amplified during the COVID-19 pandemic and led to a new MRA on January 12, 2023 between the United States and Switzerland.  

  • As part of ongoing activities, an international EMA objective is to expand the MRA with the US FDA to include veterinary medicines, vaccines and plasma-derived pharmaceuticals. 

The framework of Inspection Readiness in a post-COVID-19 world has changed and adapted to incorporate the lessons learned from inspections during the pandemic. Conducting remote assessments is no longer a rare exception but a well-accepted option. So is any other form of virtual and remote review and communication, as well as information sharing and reliance upon international regulatory bodies. 


What is the forecast for the next few years? 

Based on the 2023 EMA programming document*, which summarizes the activities and objectives of the Agency for the coming years, the forecast is a recovery of coordination of inspections and certificate requests. 

  • The expected outcomes for the coming years (2023-2025) are to improve the exchange of information among MRA and Pharmaceutical Inspection Convention  partners (PICs) through international programs, such as the API International Programme and PICs and International Coalition of Medicines Regulatory Authorities (ICMRA) initiatives on hybrid inspections, in order to increase collaboration on reliance and hybrid inspections as needed*. 

In July 2022, ICMRA initiated a pilot program for testing collaborative hybrid inspections. The assessment of this pilot program proceeds throughout Q1 and Q2 2023 and a third pilot application is planned for 2023, ideally starting in Q3. Once all pilots are completed, the findings will be published on the ICMRA website, including lessons learned, best practices and standards, etc. 

The FDA’s roadmap for 2023 includes resuming routine world-wide operations and increasing the focus on management responsibility and risk management**.  


In Conclusion: “be” proactive and “stay” proactive  

Many companies need assistance in creating an executable Inspection Readiness plan, one which truly understands the needs of inspectors and helps to improve their Quality Management Maturity and good business practices. 

Proactivity also means practicing how to handle an unannounced inspection: companies should regularly conduct “mock inspections” and document reviews to remain in a state of inspection readiness, including identifying the best subject matter experts for potential interactions with an inspector. 


**“Drug Manufacturing Inspections” CPM-7356.002 

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