Distributing Pharmaceuticals 2026 Podcast Part 7

Question 7: Will you be discussing what a Gold Standard Audit trail looks like when it comes to proving that a licence holder has fulfilled their duty?

Victoria Emerton (VE) – Making and Distributing Pharmaceuticals:

“You’ve mentioned the Gold Standard a few times . The regulators are increasingly looking for evidence of oversight. Are you going to be discussing what a Gold Standard audit trail looks like at the event when it comes to proving a License Holder has fulfilled their duty? What does a Gold Standard look like? Don’t tell us everything now, you can flesh it out in April!”

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

“Alan Bentley, who is an ex-Lead Senior Inspector of the MHRA, would possibly say, “maybe it would have been better not to have called this sort of training, the Gold Standard.” I had a guy who had been involved in the supply of falsified medicines, who had done a 2-day Gold Standard course, call me and send a photo saying, “I’m Gold Standard” that day. No, you’re not. For a lot of people where it says ‘Gold Standard’, you have a certificate that has the MHRA logo and it says ‘Gold Standard’, but all it is, is a two, three or five day course .

There are some courses that are better than others. I’ve been sitting on creating a Gold Standard course myself; my team ask when are we going to do it? But I’ve been watching and waiting to see what’s been going on. We’re going to do I think, a very different take on how other people .

“When it comes to training, I have actively turned people down. I’ve had people come up to me and say, “I want to come on your webinar. When I’ve done the webinar, will I be an RP?” I ask, “do you have a year of experience in a previous operation?” They answer “no”. “Are you a pharmacist?” “No.” So I tell them, “then you won’t and I don’t think you should do my course.”

They say, “Oh! Well, don’t you want my money?” And I say, “It’s not about that. It’s about being realistic.” There’s one quite well-known company, where I think they have a disclaimer in their handbook, saying something along the lines of, ‘just because you pass this course doesn’t mean you’ll pass an MHRA assessment’. I think that’s a massive vote of no confidence in yourself. I wouldn’t put disclaimers like this. I would try and understand who’s coming and what they need to learn. So, in relation to Gold Standard, I think that people feel I need to do the Gold Standard training.

“I did it a number of years ago. It got me a certificate. I did have an inspector saying, “why did you do it? You don’t need to do it.” I’d organise it to help someone else out and there was a group of people. We look at doing things differently. We won an award last year at the Pharma Awards UK for Pharma Education Training Provider of the Year. We try and look at things that are operationally based, you know, real life stories. And I think I’m very well placed for that because we’ve seen so many horrible things. I think I’ve got the largest repository of what I call “naughty letters” outside the inspectorate because we do free reviews of letters.

If someone is in trouble, we’ll look at them. I just give them my honest opinions, you know; “you’ve done what you’ve done, tens of thousands of pounds of the products – falsified products – which is of each patient level we call millions of pounds of damage. There’s no coming back from this, you know.”
You go to another consultancy, we’ve seen independent consultants take on some of these jobs, keep someone in suspension for 18 months it ends up having the inspector coming out twice getting increasingly fed up until the license is revoked. You know, revoked license the MHRA take it off you because you’ve been so naughty!

“I feel that the way things are that the inspectors are under so much pressure now you know, as the license holder looking at your RP and the Gold Standards and what you’re doing for your company is that much more important. We don’t have enough resources in the marketplace. I’ve got people calling me every week saying, “oh I haven’t had my inspection now for seven years and I’m a bit worried that something’s coming on.” And it’s nice when they ask for an audit because their fear level has increased because they’ve gone one or two years over their schedule. But as I say, when people call us because they get a letter, this lastminute.com thing? It doesn’t really help them.”