What happened with pharma plant inspections during Covid?
The outbreak of Covid-19 in the early months of 2020 played havoc with the inspection of pharmaceutical plants in Ireland and globally. The two main regulatory agencies that carry out inspections in Ireland, the domestic Health Products Regulatory Authority (HPRA) and the US Food and Drug Administration (FDA), were forced to abandon their customary physical site inspections in what was an unprecedented change of approach.
While they are unlikely to have known it, the final physical inspection of a pharmaceutical or medical device facility in Ireland, pre-Covid, was Abbvie’s plant in Manorhamilton, Sligo, and Takeda’s facility in Bray Business Park, both happening in February 2020. Data provided to Konnect by the FDA shows that both of these inspections took four days. After that, the FDA staff did not travel to Ireland again and 2020 was a peculiar period where physical site inspections effectively closed down from an FDA perspective.
The inspections had not resumed well into 2021 either, no doubt impacted by travel restrictions between Ireland and the US. Those restrictions are now lifted and it is understood inspections have resumed. Interestingly, the HPRA took a different approach, effectively putting their inspection regime online, in a form of inspection known as a ‘distant assessment’.
This process involved electronic copies of documents and other information being provided to the HPRA inspector for review. A very novel approach to these inspections was the addition of a virtual review of physical facilities, equipment and manufacturing operations.
While much of the inspection work was done online, the HPRA still utilised on-site inspections in certain cases. In a communication sent to pharma and medica device plants, the agency said in certain circumstances a ‘hybrid approach’ was adopted’. Clearly inspection remains a key tool in ensuring safety and quality control in healthcare production and manufacture, but the dramatic disruptions wrought by Covid have arguably changed inspection protocols forever. Quite simply the balance between online work and physical inspection work is likely to look different post Covid.
Ireland has a strong track record in the area of inspection and quality, and FDA warning letters for plants in Irish jurisdiction are relatively rare. For example only two warning letters have been sent to a facility in Ireland in the last four years.
One of these was for a gel manufactured in Tullamore and the other for seafood processing factory in Co Clare. In contrast six warning letters have been issued to Puerto Rico in 2022 alone and five to China in the same period. Countries like France, Switzerland and Spain however have also avoided the dreaded reputational impact of an FDA warning letter. For government policy makers and IDA healthcare staff, the biggest reputational risk of all is a warning letter to a ‘big pharma’ operator with a substantial operation in Ireland. This has not taken place for many years. Its a record the Irish ecosystem will want to protect.
Clearly Covid-19 has not been eliminated and there is always the chance inspections will be disrupted again, but the system has demonstrated a great degree of resilience, both domestically and overseas, with the use of technology in particular enhancing that resilience.