Distributing Pharmaceuticals 2026 Podcast Part 1

Question 1: Why is the focus on the competence of a Responsible Person a critical obligation of the Licence Holder and so timely? 

Victoria Emerton (VE) – Making and Distributing Pharmaceuticals:  

“Paradigm Shift Group and the UK GDP Association will be on stand 100 in the exhibition at Making Pharmaceuticals and Distributing Pharmaceuticals. And you yourself are involved in two sessions within the conference. The first one is a presentation called “Ensuring Responsible Person Competence”, a Critical Obligation of the Licence Holder. And the second one is a workshop which is called “Deviation Detectives – Cracking the Case with CAPAs.” And you’ll be very busy. They’re both on the first day, the 21st of April.  

So, we’re going to be talking a little bit about what you’ll be covering at the event. First of all, your title highlights competence as a critical obligation of the Licence Holder. Why is this specific focus so timely, and will you be discussing how regulatory expectations have shifted in recent years?” 

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

“Yes, 100%! Back in the day, you could largely become an RP by either just being a pharmacist or being nominated. The initial reviews that were in place were quite weak. If we look at the 1994 regulations, I think it’s 2,022 words, four pages.  

If you look at it now, it’s a far cry from the updated regs, 2013/C 343/01, which came in 2013, (now written into our legislation) and is now more like 8,000 words! But now we also have the Green Guide, and the 2022 version is the most recent version. We are hopefully going to get another one for 2027, but that’s around 400 pages. And that doesn’t even cover everything that you need to know.  

“So, if you look at the 2013-C regulation, it mentions change control in one place in chapter one, on “substantial quality management” and there is possibly one paragraph, three very small lines on change control; it doesn’t make up half a page. Something that’s half a page in a 400-page book, which has to be extrapolated, is a very big piece of what you do. It indicates what a broad topic it is.  

When I started in 2009 working in pharmacy, I was possibly part of the problem! I was unconsciously incompetent. We’d been working with a company who helped the pharmacy retain a WDA to work; basically, to harvest product, which was being sold into the EU for parallel trade. 

I did a number of inspections. We had six sites and a warehouse and each time I had an inspection, “oh yeah, I’ve got it now!” But I’ve recognised over the last 15 years and as the new regs coming in 2013, it’s a massive topic. 

“You know we see people who are purporting to be experts. I know I could probably act as an expert witness in court, but I don’t personally like the term. Tony Orme is the previous Expert Inspector, Peter Brown is the current Expert Inspector of the MHRA.  I think they’ll both be happy to say that they don’t know everything! 

So, with regulation now, the expectation is if you replace a Responsible Person, they either have to be a pharmacist, or have a year of management experience within a business with a similar business model. They should have full authority, they should have access to all areas, they should be appropriately resourced. 

“And then since Brexit, we have the Responsible Person for import. Due to the lax measures, should we say, that were in place to be able to appoint an RP before, you now have to be an RP for two years. If you’re not, say, a pharmacist and a member of Royal Pharmaceutical Society, then you either need to be a member of the Chartered Institute for Logistics and Transport or the Chartered Quality Institute, and you’d have had to have carried out a Lead Auditor course as well. We have eight in our team. We’ve done them with Dominic, who we know and love from Inspired Pharma. (A plug for you there, Dominic!)  

“But the issue is there are a lot of legacy people . We do a lot of remediation. We’re probably best known for our work doing remediation for companies that have failed inspections, or had critical issues. And I’ll frequently have someone saying, “well, I’ve been an RP for 20 years.” 

It doesn’t matter if you’ve been an RP for 20 years or you’ve been an RP for two years, do you know what you’re doing?  

So yes, the expectations have leapt. And unfortunately for a lot of companies, you have Licence Holders, where they may have a little bit of knowledge. They’re largely put in place to manage the company, develop the company, hit the numbers. So, their GDP knowledge may be 5%, or 10%. Some people have more. Some people are very actively involved. 

“But on the whole the Responsible Person, even if they have 40% knowledge, is going to seem almost like a world leader to many of these people. And it’s only when they have a critical incident that they find out that they didn’t. So we’re hoping that this talk is going to give more insights to managers and leaders. I don’t know how many we’re going to get to, but we’ll certainly be posting content on LinkedIn, and we will be trying to pass through our network that it’s so, so important.  

 “You see a lot of companies who also think they have unicorns. So, my Quality Director does devices, does pharmacovigilance, does GMP, does GDP. We liken it to owning a Pokemon card or a Top Trumps card, rather like you know, football players and scoring, passing, defense. Pretty much nobody’s going to be in the 90s for everything! And then once that person’s been in a senior role for a number of years, their scores are going to drop because they’re not actively working on the ‘coalface’.  

“So, it’s a challenge. It is a challenge. It is also a challenge for the inspectorate I think, when they’re faced with somebody who is not performing the way they should. It creates work for the inspectors.  

The inspectors are not paid overtime. If they come in and they do an audit with you, you’ve got a couple of ‘others’, they’ll probably be a lot happier when you’re turning up three critical deficiencies; they know that their workload is going to jump potentially 20% for no extra money and it stops them actually getting out to see other people as well, so there is a roll-on effect from that and of course, you don’t want to be in a position where your company has a poor reputation.”

Victoria:  

“No, definitely not! So, it sounds like there’s a lot resting on the RP shoulders in terms of them being competent and the license holder needs to be certain at all times, that that competency is in place. So many license holders assume that if an RP is on the license, then they’re competent.”