Accompanied

On the road with Swissmedic's inspection team Taking a close look at ground level

Swissmedic's inspectors are not always welcomed with open arms – particularly if they've arrived unannounced. Nevertheless, Christian Schärer, head of Swissmedic's inspection team, believes that companies should see inspections as an opportunity to demonstrate that they have the manufacture of their medicinal products fully under control. We accompanied them for part of a routine inspection at Lonza's Visp site.

Welcome to the secure zone

Gaining access to the world of Lonza was challenging enough even before coronavirus. Accompanying a Swissmedic inspection in autumn 2021 involves extensive safety precautions ranging from a helmet and protective goggles to checks on general state of health before we can enter the pharmaceutical production facility. "Being ready for an inspection is a core area of our business", says Lonza media spokesperson Mathias Forny, explaining the precautions. "Safety – whether protecting patients or protecting the health of our employees – is always at the heart of everything we do. We attach great importance to inspections. As a production partner to the health industry, we would not be in business without a Swissmedic establishment licence, so the Swiss Agency for Therapeutic Products is always welcome at Lonza."

Moments of surprise

Today's visit by inspection team Christian Schärer, Markus Escandari and Susanne Wings had been announced, so Lonza management had been able to prepare for the inspection. In cases where there are grounds for suspicion, however, the inspectors can turn up unannounced. "Such situations are exceptional for everyone, especially if there's a suspicion that an offence has been committed", explains Schärer. "They're a challenge for us too because the inspection has to take place right then, regardless of whether the responsible people are there or not." In many cases, the sources of such suspicions are market surveillance signals, whistleblowers (such as former employees of a company), other authorities or journalists. Even if a company is warned of an inspection, there can still be plenty of surprises, which the inspectors take advantage of. For Schärer and his team, however, inspections are not just about checking up. "Companies can also show us how effectively they're working and that they're doing everything humanly possible to guarantee the quality of the medicinal products they manufacture."

"The exciting thing about our job is that we never know what to expect."
Susanne Wings

Standards

Any inspection in the medicinal products sector is about implementing the Therapeutic Products Act. Any company that manufactures or distributes medicinal products needs an establishment licence, and this is never issued until it has successfully passed an inspection. This involves compliance with international quality standards and ranges from having suitable staff and premises to the processes that help safeguard the quality of the finished medicinal product. "We inspect all manufacturers before they start operations, and we monitor them regularly", explains Christian Schärer. There is a total of 30 inspectors, some of whom are employed by Swissmedic and some by Switzerland's four regional inspectorates. "No less than 1,100 companies have a licence to manufacture or distribute medicinal products. We carry out 600 to 700 inspections a year. That means each of our inspectors spends a lot of days in the year at companies assessing compliance with legal requirements at ground level and not only relying on a review of documents submitted by companies."

The biggest challenges

"The very first thing we have to do is gain a general overview and establish who is responsible for which areas", explains Susanne Wings. "There is no fixed routine for that, the process is different at every manufacturer. Each company has its own way of implementing the applicable requirements, and that's what we have to examine in our inspection." But how familiar does the inspection team need to be with the things they inspect? "The more we know about them, the easier it is for us to identify risks and then determine what's crucial. We regularly attend training courses because the technology is constantly advancing and we need to keep pace with it. Every inspection also teaches us something new", says Christian Schärer. Professional skills are an important consideration when planning inspections and choosing a team. Language skills and availability also play a role. "We work in various permutations. Shuffling is important. In the case of Lonza, for example, we have nine qualified inspectors in the Swissmedic inspectorate that we can call on if we need to."

Markus Escandari, Christian Schärer and Susanne Wings

Markus Escandari, Christian Schärer und Susanne Wings

The effects

Christian Schärer and his team have seen quite a lot over the years, including plenty of moments where emotions run high. "Each inspection has its own story. We're always very close to the action and there have been cases where people have burst into tears", he tells us. "Small things can sometimes trigger something bigger, especially if we find critical shortcomings." "We've even forgotten to give the company a lunch break", recalls Markus Escandari. "The exciting thing about our job", adds Susanne Wings, "is that we never know what to expect. We regularly see things we hadn't bargained for. Sometimes companies are completely different from the image we'd formed while we were preparing for our inspection."

The example of Lonza

An inspection is always a random check. As far as the inspection team is concerned, preparation is everything. "We have to decide where we can use the limited time available to us most effectively to examine things in detail – what our focal areas should be and where, the risks that are involved in a particular manufacturing process and the type of products manufactured", says inspector Markus Escandari, summarising Swissmedic's expectations. The challenge at Lonza stems from the size and complexity of the production facilities. "Inspections here always take at least three to five days. As part of this one, we're inspecting a completely new production facility for highly potent active ingredients, so the safety precautions are correspondingly high", explains Christian Schärer. "We're assessing the suitability and operational capability of the entire new facility and manufacturing processes. That's absolutely crucial before we can give the go-ahead for production to begin." And how are things looking at the end of the first day of the inspection? "We've got a good overview and know where we're going to take a closer look. At the end, we'll document our findings in our inspection report." And what is Lonza's view of general inspections? "The COVID-19 pandemic has made it abundantly clear that close partnership between pharmaceutical companies and health authorities is the key to improving global health", explains Mathias Forny. "Our priority is to guarantee continuous compliance with international standards and requirements."

How to become a Swissmedic inspector

Candidates must have a university degree and several years' professional experience of medicinal products manufacturing. Successful applicants receive inspector training at courses held within Swissmedic as part of a comprehensive initiation and training programme. This is where they learn the theoretical foundations of the job. After that they accompany inspectors, progressing to the point where they are able to perform an inspection themselves. They also need to be able to approach things analytically, be good listeners, be able to quickly grasp situations on the spot and then ask the right questions, as decisions are made on site. Finally they need good people skills and must be able to control their emotions and remain objective at all times. Thus, the inspectors' aptitude is also regularly checked by independent agencies from outside Swissmedic.