Distributing Pharmaceuticals 2026 Podcast Part 5

Question 5: Are there specific warning signs that Licence Holder oversight is failing?

Victoria Emerton (VE) – Making and Distributing Pharmaceuticals:

“So, we’re going to move on to ‘red flags’ in terms of oversight. I think this is quite a good time to cover that. Are there specific warning signs that a Licence Holder’s oversight is failing? What are the red flags that people should be looking for? And this is before an inspector turns up and finds all those deficiencies! How can people avoid finding themselves in that situation?”

Dave Rushton (DR) – Paradigm Shift Consulting/UK GDP Association:

“I think knowledge, and people say “knowledge is power”, but I know a lot of people with knowledge who don’t use it. I’m also a big believer that common sense is learned. You’re not instilled with common sense.

If we spoke to tribes of aboriginals about the lives that we lead, using processed food pumped full of chemicals and driving around these metal boxes to the jobs that they hate, you know, I kind of love what I do. It’s not a job, it’s a calling. But, if you try and explain these things to people, “oh, I live in an environment, there’s 300 people that live in my apartment block and there’s rats running around”, people would just think you are insane! You know, so common sense is learned and are also kind of conditioned into a lot of things.

“I think a lot of senior executives in corporates are conditioned into being money machines. You know, your job is to ‘do this’, to ‘do that’. They generally don’t know their role in relation to being a Licence Holder. The Licence Holder should be very visible with what they’re doing. It’s their role under the Human Medicines Regulations to make sure they have a suitable person in the eyes of the licensing authority, has the knowledge, experience and resource and independence to carry out their work. If you don’t have that, then you should probably ask for some help, or at the very minimum, do some sort of training. understand what your RP is doing.

If your RP is asleep at the wheel, it can be a horrific surprise. This one company had thousands of medical devices in the warehouse that were mislabelled because the RP hadn’t kept up with the regulations. a virtual manufacturer status, which was ultimately revoked because the RP had not been doing the work that they needed to do. A lot of people get this shock, but that’s because they’re not doing their job properly.

“So, red flags; if you’ve got a good quality team, you’ve got an RP who only comes in two, three times a year, that may be sufficient if things are running well. However, if you have no deviations, that may be a red flag because is it that it’s just not being captured? If you’re having no complaints, or there are no trends against the third parties, as well. We’ll see people with empty complaint folders saying, “oh, we never get complaints” or they “deal with things before they become a complaint”. I think these are the things that are swept under the carpet.

There is a requirement for the RP to approve third parties and also trend the activity of those third parties. If you’re using third party warehouse, using a transport company, using a regulatory company, ask your customers, “how’s your experience?”

We’ve seen people almost lose business because of the RP or quality being too strict or trying to dictate things, particularly to other territories or different EU member states where they have quite different rules. We’ve also seen quality teams walk because commercial are trying to bully them into things.

“But the key red flags, I guess, is if your people don’t know who your RP is, I would say that’s a big flag. Your RP should be someone. It’s like RPs and QPs. I think a good QP is someone walks the line, they’ll be known to people; “let’s see what’s going on.” They know the sounds, they’ll know the people, they don’t have to be nurturing. I think under the gold standard, they want people to have certain social skills. I know a lot of technically brilliant people who aren’t really “peoply” (people friendly), you know, or when they go out, they should wear the t-shirt, “it’s too ‘peoply’ out here” and their tone may not be appreciated by all, but they have that passion for quality.

I think if your people know who your RP is, if you’ve got contact, if you’ve got confidence that they know what they’re doing, then that’s a good start. And if you don’t really know who your RP is, you don’t sit in a meeting, or you’re not feeding the information they need to know to help maintain your business, because the quality system isn’t just for pharmaceuticals and I think people don’t recognise that.

“We also see people with ISO 9001, which is a general quality system for everything and then they have GDP, sometimes they’re even running them separately. It should be integrated, quality should be everywhere. People say, “Oh, it’s not like selling pizzas” but if you don’t manage the quality of your pizza, you don’t have that little plastic doll’s table, the lid might stick to the pizza. Or if your guy doesn’t know to deliver it the right way up, it could be upside down. It could turn up cold. It might not have the right ingredients on it.

So as far as I’m concerned, everything is quality and everything also should be customer service. I think part of our success over the years is that we try and understand what people want, it would be a case of treat people as you’d like to be treated. Well, I disagree. You need to treat people how they wish to be treated. You need to understand what it is that they need and help to deliver it. There are times that we have to say “no”, which often isn’t received that well, but we always try and give a pragmatic solution. There might be another option, say, “well, we can’t do this, but we could do this”.

“Back to the topic on red flags. If you don’t really know what your RP’s doing, you don’t see them very often or your team don’t know who they are, you don’t have oversight. Then I would say you’re prime for a potential IAG case, because there is that disconnect. And as a Licence Holder, it’s always your responsibility to make sure that person is experienced.

If you don’t have the knowledge, and you don’t have the experience, as I say when I do training, if you are not a good people person, not a good people manager, put someone in between you; delegate that responsibility to someone else, try and find someone who is going to be interested and passionate about it. You know, passionate about quality, but also making sure that things work. It’s a very narrow corridor. It’s very hard to find people that can fit in with that.

This is why we like to do a hybrid. So, we may have two or three or four people in a particular role who can hit those individual topics. And in that way, we can kind of create a hybrid star player who can hit many of these.”