Quality audits remain a necessary function for raw materials that support both clinical drug candidate manufacturing and commercial drugs/therapies, as well as, for drugs themselves.
For raw materials, depending upon the criticality, this may require annual inspections to be conducted although these can be leaned out to 2/3 years once a database of exemplarity results has been established and compiled.
These Quality Audits are often expensive and time consuming to conduct, especially where overseas travel is required, so companies are always looking to establish credible alternatives which can make this lean which saves time and expenses.
Enter Covid-19. From our own experiences we determined after hundreds of remote domestic and international audits that virtual audits could be an alternative. In February 2020 we established a protocol that used live streaming and remote password protected document repositories to enable review of the type of documents normally inspected during an inspection. Using this protocol, we established that it was possible to deliver a reliable audit outcome which could meet compliance expectations.
Following this, we reported our findings at the CMOA meeting in Washington, DC in October 2022. In short, we suggested that the future of auditing post Covid-19 could be readily achieved via virtual mechanisms and suggested a 1:3 audit frequency for the audit v virtual audit, might be possible for well-established suppliers.
This technique is now well accepted and with the establishment of new remote documents review rules by the FDA, it appears that its legitimacy, at least in part is accepted.
With the coming of AI, we might expect even further advances, especially in the reporting of deficiencies and how this will be monitored and regulated. This should provide positive input which improves compliance and improves overall efficiency.
Let’s see how quickly such ideas can be adopted and implemented by industry to provide impact on a quality function that has not altered for decades.
