Typically, pharma manufacturing plants would have to comply with strict inspection regulations. In Europe for example, the max amount of time to go between inspections should be three years. Thanks to COVID though, the industry had to go to a virtual inspection model as an emergency measure.

As we are now looking towards the future where COVID is at lower levels, there is talks of inspections staying virtual. Should that be the case? What benefits could it provide?

How Virtual Inspections Have Worked

How have virtual inspections worked in the pharma industry during COVID? In regular times, inspectors would come to the site to perform their inspections and ensure that everything is up to code. No site would ever expect to be inspected without someone coming to the site physically. Of course, COVID changed all that.

Thanks to social distancing measures, inspections were made remote as a temporary measure. This allowed for grace periods for manufacturers, so they wouldn’t run afoul of regulations during this time. Inspections were then moved online so standards could be maintained while still keeping people safe.

Of course, this was designed to be a temporary measure, but there is now consideration being made to make it a full-time measure instead. “This has worked in the short term, but manufacturers are concerned about inspections being remote in the future,” says Lauren Barrowman, a project manager at Write My X and 1 Day 2 Write. “They’re concerned that they won’t be able to uphold standards fully going forward.”

Concerns With Remote Audits

What are the concerns when it comes to remote audits? There has been research to see what both auditors and companies think when it comes to remote inspections.

The biggest issue is that no matter how well a remote inspection is done, it just can’t catch all the issues that may come up when it comes to a site. An inspection needs to be done physically, so auditors can see everything that’s going on. Online, it just isn’t possible to do this in the same way. As such, major problems can be easily missed. This can lead to problems down the production line, that compromise safety and health.

As the site manager can’t take the inspector around for a physical tour, then they have to do it virtually. They can still pick up a lot as an inspector, thanks to the use of mobile technology, but the fact is they won’t be able to spot the smaller issues, or the issues that they intentionally aren’t being shown.

“As an auditor, you will have a ‘sixth sense’ about something that needs to be investigated more,” says business writer Andrew Somerville, from Origin Writings and Brit Student. “That’s something that you can’t use over an internet connection.”

On the client side, they are worried about technology issues when it comes to inspections. They’re concerned that malfunctions or dropping signal during inspections, and how it would affect their inspection.

As such, there are plenty of concerns when it comes to remote inspections. It worked as a temporary measure during COVID, but how will it work as a full-time measure?

The Hybrid Approach

As a new measure, some are proposing that auditors use a hybrid approach to doing inspections. That means that some routine aspects, such as sharing documentation, could be done remotely. Then, the on-site inspection can be done physically.

The benefit of this option is that you get the best of both worlds. Online inspection is very quick and simple for some aspects, such as checking that documentation. That can be dealt with before the inspection, so visits can be quicker and easier overall.

Many clients and auditors are interested in trying a hybrid approach. It lets them take what they learned during the pandemic, and use it to improve the inspection process as a whole.

Remote inspections had their time during the pandemic, but now we’re looking at the other end of it they aren’t the best way to carry out inspections. There are aspects that do work well remote though, so it looks like a hybrid approach will be in use in the near future to inspect pharma plants.

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George J. Newton is a business writer for Write my case study and Thesis writing service, where he covers management skills and news. He also writes for Next Coursework.