Thanks to COVID, the last two years have seen pharma GMP audits being carried out online, in order to maintain social distancing. Once all COVID safety protocols have ended, should audits be brought back into the manufacturing plant?
Some auditors are saying that they could continue their audits online, as they have developed tools that will help them do this. However, some aren’t convinced it’s the best way to go about things. Let’s see whether remote audits should end after COVID.
Pharma audits are an essential part of the manufacturing process, as they ensure that safety standards are being maintained at every point. During COVID, huge changes had to be made to the audit process, as auditors weren’t able to come into the plants due to social distancing regulations. As such, they had to pivot to doing the audits remotely.
Firstly, manufacturers were given a grace period, so they wouldn’t fall foul of compliance regulations while the new auditing systems were set up. Then, auditors would review documentation online and would be guided around the plant through video call so they could see the plant from their own homes.
This is what helped the industry maintain standards during the pandemic, but now that things are going back to regular operation, there is a question of whether the audits will go back to normal too.
The question is, can an auditor get the same amount of information from doing a site visit remotely, as they can through an in-person visit?
“Some auditors have found that it’s a lot easier to review documentation remotely” says Darren Tyne, a medical blogger at Write My X and 1 Day 2 Write. “They could take their time with it, and really ensure that everything was in line.”
This was a benefit, but the problem was the site tours. You certainly can have someone go round with the auditor on a video call, and tech has made that easier than ever. When you have someone else from the plant directing the tour though, they’re the person in control. As such, the auditor won’t be able to keep their eyes and ears open for everything that’s going on around them. As well as this, there’s the chance that whoever is directing the call can avoid showing any areas that could cause concern.
As such, a remote audit isn’t considered to be the best way to fully audit a manufacturer. However, some auditors are saying that they want to stick with a remote-only model, even after restrictions have been lifted. This has caused some concern for other auditors and manufacturers across the industry.
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So, if restrictions are going to be lifted and some auditors want to stay remote, what’s the best solution to the problem? Can the work be done remotely, to the same standards as an in-person audit?
“Many auditors are pivoting to a hybrid model, using both in-person and remote auditing” says Christina Samwell, a business writer with Origin Writings and Brit Student. “This way, they can get the best of both worlds.”
How would this work? If auditors are using a hybrid model, then they can take care of any tasks that can be done remotely from home, or their office. That will be things like reviewing documentation. They can be shared easily online by the manufacturer, and so it can be done before the auditor goes to the plant itself. Then, they can do their inspection and be able to see everything in real-time. As they’ve tackled a lot of the work first, that makes the inspections quicker and easier.
As such, it has a lot of benefits for both the manufacturer and the auditors. They can both get what they need, and make the whole process a lot more efficient in the meantime.
So, should remote audits end after COVID? Fully remote audits will have had their time, as they aren’t as thorough as in-person ones. However, auditors can start using a hybrid in-person/remote model to make the inspection process more efficient.
George J. Newton is a business development manager with Academic Brits and Thesis Writing Service, where he writes about best business practices. He also writes for Next Coursework.
