Pharmaceutical manufacturers need to avoid letting down their guard on supply chain integrity after a period of hyper-focus during the COVID-19 pandemic. That’s the view of Jim Fries, CEO of RX-360, who’s spoken on the topic at several conferences during the last few months.
“It’s human nature after going through a period of hyper-focus to take a breath and relax, but my message to the industry is to stay focused to avoid a downtick in quality,” he says.
According to Fries, the pharmaceutical industry adapted remote and hybrid audits during the pandemic to audit their supply chain without compromising on quality. This includes auditing suppliers of products ranging from the bags needed for single-use manufacturing to the barcoded labels attached to finished drug packaging.
“When the quarantines and lockdowns started, my phone started blowing up with texts and emails from people throughout the industry,” Fries remembers. “They were wondering what to do about existing scheduled audits as, although many organizations had remote auditing programs, these protocols in some cases were archived.”
New approaches they adopted included remote auditing by video link using software ranging from dedicated secure connections to a simple Facetime call on a mobile phone.
Post-pandemic, Fries has noticed the industry doing more on-site supply chain audits with no sign they’re relaxing on quality or supply chain integrity.
“I don’t see corners being cut,” he explains. “People want to see [raw materials/equipment] in person, if they have the opportunity, to ensure [supplies are] the highest quality.”
Companies are sometimes looking to remote audit where a supplier is well-known to them, or viewed as lower risk, but—in most cases—a lower-risk supplier just means reducing the frequency of audits.
“The post-pandemic process I’m seeing is [companies are] thinking, ‘can I go back onsite to see this supplier,” continues Fries. “And, if not, what are my alternatives?”
