Distributing Pharmaceuticals 2026 Podcast Part 8

Question 8: Does having a competent RP give you a competitive edge?

 

Victoria Emerton (VE) – Making and Distributing Pharmaceuticals:  

“Final question, does having an RP give you a competitive edge? Obviously, you need an RP to be compliant and avoid fines and suspensions, etc. But is a distributor going to have a competitive edge for having, you know, a competent RP who’s doing what they need to do? Are you going to be talking about that at all at the event in April?”  

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

“Certainly! If you have the right RP, then you can have a competitive edge. You can have a quality edge. You can have a waste reduction edge. You can have someone that you can go and talk to in confidence about the things that are going to happen. They can help you plan for the future, and they can support you with the various different activities that you’re doing.  

Quality is for life, not just for Christmas!  

A lot of the things that we have within quality systems, you can apply within real life.  Change control: I have moved house a lot during 20 years of working in a lot of different places as I was going to different roles, and it was horrific. But now, in my head, I have a perfect change control for moving home: How to pack the boxes having your essential coffee milk and whatever, your chargers and your electronic devices  and things  making sure you’ve got the right internet. If you have the right person who has a lot of this experience, and again, I want to stress that there are very few people that can do everything, and the people that do claim to be experts say they can do everything, generally can’t.  

“I tend to like people who have a bit of anxiety, not crippling anxiety, because they won’t take action. A lot of people out there who I talk to are told they have imposter syndrome because they they’re not sure they’re good enough but, I think that’s a good thing that can give them an edge because they will double check things. As long as they’re within that kind of range, I think you’ll find people at one end that are so confident that they’re dangerous; they’re confident but not competent!  

Then you’ve got other people who are so scared that something’s going to happen that they can’t take action. If you find that person who’s in the sweet spot, where you find a hybrid team that’s within that sweet spot, they can do so much for you. When it hits the fan and your shipment is on a boat somewhere and it’s been unplugged… An RP is supposed to be continuously contactable, but that doesn’t mean you have to pick the phone up all the time! It just means you can’t disappear like this guy that we think was probably down the pub most of the time. But if you have the right person then they can stop horrible things happening. They can help you develop the business they can help you save money.  

“Of course, there is a cost to quality but there’s also a far higher cost to poor quality. I’ve done talks in the past on the cost of getting it wrong. Remember it costs over £4,000 per inspection. So, if you’re on a six-month inspection schedule, that’s over £8,000.  
You’ve also got the cost of remediation. Can you do it internally? If you can’t do it internally, you’re probably going to get suspended. You’ll get the inspection letter . If your RP doesn’t know how to review the letter… This is why we (Paradigm Shift) do a lot of free letter reviews for people. .  

“It also keeps us on the edge of what’s going on. Sometimes we spot a new deficiency pop up, which is going to be adopted by other people. There aren’t that many surprises. I mean, I’m not surprised anymore at the incredibly stupid things that some people do. We see a lot of the big issues where people are either greedy, commercially focused and quality blind and desperate; because things have gone wrong.
We’ve seen people who are doing a particular type of business and then all of a sudden, it’s been legislated against. For example, products coming in from one territory and it’s been stopped.

Or they’re just ignorant; “if you can’t describe what you’re doing as a process, you don’t know what you’re doing.” It was Deming who said that. It’s a quote that I have in my training. I think really it is so, so important. You can’t know everything. I did have a Licence Holder who once said to me, “you don’t need to be a mechanic to drive the car.” No, but you do need to know what the pedals do, you do need to get it serviced, you do need to pass your driving test.

“Although there is no real stipulation within the guidelines about the Licence Holder, there is within Human Medicine Regulations 2012 under section 43 and onwards, a whole load of things about the Licence Holder responsibility. If you don’t want to put them through training, at the very minimum, get them to read their responsibilities and kind of sign that off.  

I think my best advice for people is don’t believe everything you read! CVs and gold standard certificates don’t mean an awful lot. Finding someone who’s a good fit, whether you have a round of interviews and whether you get them to do a mini project, or get them to meet the quality team. There are people who are kind of ‘glory hogs’; they want to go out there and win at life and they’ll trample on whoever , and this is one of the things I don’t like about corporate because, for my business, we’re kind of a collective.  

Nobody really works for me because, whilst I do have a few  people, most people are consultants in their own right. I wanted them to learn how to make their own money and how to learn as many things as possible, so when we put these teams together, we can learn from each other.  

“I learned a lot of interesting stuff recently when we had Nick Geary of Lunda Tempchain do a free
webinar on qualification versus validation temperature control boxes last week. We had 85 people on that free webinar through the GDP Association. I learnt a few new things there as well, which was really good. 

I’d say ultimately, understand what your business is doing, that it’s not just about the numbers. I know the numbers don’t lie, I know the numbers are important and I know the numbers will probably be what will take your career further within pharma. But, if you don’t maintain that quality, you don’t have the right people, they’re not supported, you’re not visible in the quality system, your career may take a dive.”

VE: 

“All gems! Really interesting. And believe it or not, there is more to be said at the event in April, isn’t there Dave?”  

DR: 

“Oh yes, absolutely!”

VE: 

“So really, really interesting to talk to you. I’ve learned a lot from doing these podcasts actually and today is definitely no exception to that. So just a reminder that the Paradigm Shift Group and the UK GDP Association will be on stand 100 at Making Pharmaceuticals, Distributing Pharmaceuticals. Thanks so much for your time today, Dave. I’ve really enjoyed talking to you.”  

DR: 

“You’re very welcome. And thank you for everything you’re doing to support. You know, you’re supporting quality. It’s really hard to get budget for things. I’ve had people say, “do you want to come to Madrid for this RP course?” It’s £5,000. I’ve got £1,000 for the year, what am I supposed to do with that? But the fact that you’re doing such a great job and seven inspectors is pretty legendary. They don’t have the
resources to do their own symposium, but I think that’s a great reflection on the good work that you’re
doing. So, thank you, too.” 

VE: 

“They’re covering all sorts of topics. So, yeah, please do check out the programme on the website. I really look forward to seeing you in Coventry, Dave, in April and everyone else. Come to Coventry on the 21st and 22nd of April.”  

DR: 

“Thank you very much. We’ll be there. Thank you.” 

Registration for the event is currently open and free, and the interactive conference programme is live at www.makingpharma.com or www.makingnutra.com.  

By coming to the event in Coventry, you have access to over 240 exhibiting companies and nine streams of conference running across the two days, including seven MHRA speakers.