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Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons] Simone (George) Ammons
Yan Kugel is joined by Paul Sarrazin, an esteemed expert in good distribution practices (GDP) within the pharmaceutical sector. Here, he provides a glimpse into his journey from a permanent employee to a consultant specializing in GDP compliance. With a strong background in bioengineering and a rich portfolio of collaborations with industry giants like GSK, UCB, and Takeda, Paul’s expertise in GDPs is rooted in his early consulting career and subsequent roles within pharmaceutical companies.
Table of Contents
Paul Sarrazin provides a glimpse into his journey of transitioning from a permanent employee in the pharmaceutical industry to becoming a consultant specializing in GDP compliance. With a strong background in bioengineering and a rich portfolio of collaborations with industry giants like GSK, UCB, and Takeda, Paul’s expertise in GDPs is rooted in his early consulting career and subsequent roles within pharmaceutical companies.
As the conversation unfolds, Paul sheds light on the advantages of being a consultant in the pharmaceutical industry, emphasizing the autonomy and diversity of projects that come with the role. While acknowledging the absence of managerial responsibilities, Paul highlights the potential for professional growth and expansion as a consultant.
Paul delves into the challenges faced by companies in meeting regulatory expectations and implementing various regulations. He underscores the impact of health authorities’ heightened understanding of distribution and transportation, stressing the importance of finding a balance in sharing information during submissions without overcommitting to specific equipment or transportation methods.
Insights from Paul underscore the critical role of risk analysis in submissions related to shipping and transportation. He emphasizes the need for companies to identify critical parameters and quality attributes while finding the right level of detail to include in their submissions. Balancing the amount of information shared and providing supporting documentation for risk analysis are pivotal for successful submissions.
In conclusion, Paul discusses the evolving perception of distribution and transportation within the pharmaceutical industry. He highlights the increasing awareness and training for quality personnel, operators, and carriers, while also acknowledging the emergence of superstitions and misconceptions as knowledge in the industry continues to expand.
As the pharmaceutical industry adapts to evolving regulatory expectations and quality standards, the insights shared by Paul Sarrazin shed light on the critical role of good distribution practices in ensuring the integrity and safety of pharmaceutical products.
Episode Chapters:
Please be advised that this is an AI generated transcript and may contain errors.
00:28 – 01:07
Yan Kugel: Welcome to today’s episode of our podcast where we have the pleasure of hosting a distinguished guest renowned for his expertise in good distribution practices within the pharmaceutical industry. Our guest Paul Sarrazin brings a wealth of experience from his latest projects, focusing on addressing the critical challenges that companies face in ensuring GDP compliance. With a keen insight into the current issues impacting the pharmaceutical supply chain, Paul will shed light on innovative strategies and best practices for maintaining quality standards and regulatory compliance. So join us as we delve into a discussion to the explorer, the evolving landscape
of GDP and the key insights that he has gained from his recent projects in the industry. So, Paul, welcome. Good to have you here.
01:18 – 01:26
Paul Sarrazin: Thank you so much, Yan. Always a pleasure to be here with Qualis 3 as well. And it’s always, always very nice. Always
01:26 – 02:01
Yan Kugel: very nice. Good to hear that. So this is not the first time we are talking. We had a pleasure working on a very interesting webinar, which was also concerning GDP and cooling technologies. And it was a great success and everybody enjoyed everything you have spoken about. So how did you come to this area of expertise and area of work? So what pushed you to become a consultant, especially in this niche?
02:02 – 02:42
Paul Sarrazin: Well, actually, when I started my career, I actually started as a consultant, like, like, in, I started the, well, I’m French, and I started working from, from Belgium, well, in Belgium, in my first position, where I was offered a position as a consultant and actually I arrived in GDPs because of 2 things. The first thing was a bit of an accident because I was not ready coming out of bioengineering school. I was not ready to work in cold chain and in trucks and everything. So that was kind of a happy accident where I was actually hired
02:42 – 03:19
Paul Sarrazin: because I knew how to speak English. That was 1 of the first things that really taught me a lot to work on everything and gain some knowledge quickly. That was a big thing in GSK back in the day, around 15 years ago or something. The second thing that brought me to it is actually my history, because thinking about everything, so I lived around 8 years in South Africa and Nigeria. So the distribution actually of medicines back in the day was not as good as it is now. There are still some issues with regards to diversion of
03:19 – 04:03
Paul Sarrazin: products and some counterfeiting. That’s what really brought me to start working in GDPs. When I was offered a first position as a consultant, I started working in maintenance. It’s a bit of distribution and qualification for, yeah, qualification related to shipping qualification. That started a bit like that because I knew how to speak English. And then, you know, things just moved forward and I was very happy and lucky to work in GDP within GSK, within UCB, within Takeda. I helped the Euro airport in Basel. In my previous works as a permanent employee as well in Catalan and
04:03 – 04:44
Paul Sarrazin: in Senexia. I was also helping with regards to distribution topics and things like that in addition to my job. And yeah, so that’s how it happened in terms of GDPs. For my work as a consultant actually. So I did 6 years as a consultant after I did 7 years in Catalan and Cenexia as a permanent employee. And that led me to wanting to bring more value to my environment through consulting. And that’s why now I’ve created my own company called P-Care Solutions. I am doing a lot of things mostly related to training. So I do a
04:44 – 05:17
Paul Sarrazin: lot of training. I have some partners for training, training companies that I partner with. I also do audits, GMP and GDP audits of suppliers, manufacturing companies, API manufacturers, API distributors, the whole thing, being GMPs and GDPs in the scope. And I also do some consulting mainly right now with regards to cold chain and distribution of pharmaceutical. And that’s it for me. That’s how I arrived here.
05:18 – 05:21
Yan Kugel: Right, In this nice hut where you’re sitting right now.
05:21 – 05:31
Paul Sarrazin: Yeah. Yeah. Very nice hut. Very comfortable. Super nice. It’s not as technological as your office, you know?
05:31 – 06:06
Yan Kugel: Yeah. Yeah. So to those who are just don’t are not watching the video, he has a very nice background with a nice hat there. Very cozy, probably in comparison to the very modern office where he right now sits at his clients. And so tell me, Paul, so comparing your life as a full-time employee to a consultant, can you shed light from your perspective on the benefits of being a consultant in regard to being an employee? What are the pluses, minuses for each side?
06:07 – 06:51
Paul Sarrazin: I think there are pluses and minuses in both cases. The thing is that I feel a bit more free with regards to what I’m doing right now as a consultant because I’m working for, I have a main project currently with 1 of my customers but I also have the luxury of being able to conducting audits, trainings and other quick missions with some other customers who are trusting me in my decisions. So that’s a very nice thing, the variability of what I’m doing on a day-to-day basis. The other thing that I really like about being a consultant
06:52 – 07:35
Paul Sarrazin: is also that when you reach a certain level of seniority, you also get the, how would I say this, the trust from your colleagues when you go to consulting, when you go to your companies, you really earn their trust directly. But the counterpoint of that is that they have high expectations with regards to what you’re doing because you’re representing a high cost as well. So that’s the points for consulting. The thing that I miss the most with regards to permanent positions is management. Because right now I’m a self-employed consultant. So, and I am not doing any
07:35 – 07:41
Paul Sarrazin: kind of management activities at this stage. Doing a lot of expertise things, but not management.
07:43 – 07:58
Yan Kugel: Right. So are you considering growing your consultancy in a way that you could have assistants and bigger projects that work with you and assist you in such project? Is it something that is viable and happens?
07:58 – 08:23
Paul Sarrazin: I think it could happen in the future, but it’s not really what I’m looking for right now. What I’m looking for right now is to have a solid base of customers who trust me and to make sure that I can bring the added value that I want. And I’m not sure that hiring less senior consultants at this stage would work with the trademark that I’m selling right now.
08:24 – 08:49
Yan Kugel: Right. And you mentioned you gain quite quickly the trust of the client. And does it happen that there are some challenges with other employees that feel that you’re stepping on their toes? Because let’s say other QA employees that you come and try to correct their way of doing this. So do you encounter such challenges?
08:50 – 09:26
Paul Sarrazin: Yeah, sometimes it happens, especially now because right now I’m working. I’m part of business right now. You know, even if I have a lot of QA experience right now, I’m part of the business side of things within supply chain. But so, yeah, it happens. It happens, but it happened at the very beginning of my current project, but actually discussing with QA and showing them that, well, I’m lucky in the project that I’m in that all the things that they’re basing their expertise on are actually things that I created back in the day 7 or 10 years
09:26 – 09:51
Paul Sarrazin: ago. So I have the history, I have a lot of insight with regards to other practices in other companies, which helps them a lot. And so they understand that I’m not overstepping I’m just trying to give some insight on what happens in other companies and how we could make things better on our side both in terms of business and QA and that works up until now it works so I’m very happy for that.
09:53 – 10:24
Yan Kugel: Right so that’s a very good to hear that and then you quickly can find common ground there right And so you mentioned you have been working in quite a lot of companies in the consultancy role. So what would you say right now are the most significant challenges that companies face in terms of regulatory expectations and the implementation of different regulations that they need to do at the moment?
10:25 – 11:14
Paul Sarrazin: Well, right now, of course, in Europe, Annex 1 is definitely a major, major, major challenge that we’re seeing everywhere. I’ve worked a lot on it when I was in Cinexie, not that much now. The points that I see since I’m working in the last 6 months mostly in GDPs and distribution, I see a few challenges that are coming or that have been there, but that companies are facing more, let’s say more challenges, they’re facing more challenges, more challenges, sorry, with regards to the expectations of the authorities in the management of marketing authorizations. Right now I’m doing
11:14 – 11:59
Paul Sarrazin: a lot of work with regards to streamlining the process for the, and the wording used for the, for the, let’s say transport related parts of the submissions related to transport conditions and definition of transport conditions. The wording with regards to the cool boxes that we’re using to transport everything, the making authorities understand the critical role of shipping lane risk assessments and how you manage your shipping lanes. Because there’s some kind of an understanding in a lot of companies that you basically qualify your box to maintain temperature, and then the work is done, where it’s more complex.
12:00 – 12:50
Paul Sarrazin: And I’m very lucky to work at a customer who has understood all of the implications of logistics in pharmaceuticals, but they’re still facing some challenges by the authorities. So that’s the first point. It’s related to the submissions themselves. So the second point I’m facing in terms of challenges right now in GDPs is related to the understanding that since everyone is basically coming from manufacturing. And so even if good distribution practices are around 10 years old or a bit more than that, 2014 in Europe, well, people tend to use the same vocabulary and have the same, let’s
12:50 – 13:28
Paul Sarrazin: say, reflexes that they have with regard to manufacturing. And so making people understand that not everything can be validated in terms of processes, especially for distribution and transportation where you have a lot of different challenges due to the environment is a bit difficult right now. But people tend to listen and understand in the end that we have some controls and that even if you have a remaining risk, you still can have mitigations to make sure that you are covering that risk in the best of ways. Yeah, so that’s that second point.
13:28 – 13:37
Yan Kugel: Right. So you At the beginning, in the first part, you also mentioned a new regulation that came out, right? So what was it again?
13:38 – 14:25
Paul Sarrazin: It’s not really a new regulation. It’s more that health authorities like the FDA tend to have more knowledge now of distribution and transportation. And so they challenge us more when we do our, when we write our marketing authorization, we submit them. And so a lot of companies are facing issues. Maybe sometimes they basically shared a bit too much, or sometimes they share too less. And sometimes it’s in between. Like I faced an authorization that I reviewed not so long ago where they were discussing a lot about the mechanical issues related to transportation, everything that can happen
14:25 – 14:54
Paul Sarrazin: with regards to vibration shocks and everything that can have impact on your container closure. But they were not giving a lot of information with regards to cold chain management, which led to questions, which is normal. And so I’m part of the people who are accompanying the regulatory guys to have a more streamlined process with regards to these submission tasks?
14:54 – 15:14
Yan Kugel: So usually the companies bring you in when they face issues with the regulators for new drugs that they want to export or move? Or sometimes you are also brought for new drugs that are coming out for the market and they want you already to help from the beginning with the supply chain?
15:15 – 15:58
Paul Sarrazin: Well, right now, what came at the start of my assignment right now was related to the fact that they’ve had strategies in place that are still okay, but they’re implementing new biological products, which brings new risks to the table. And they want to make sure that they identify these risks and that they have the correct level of mitigations in place to make sure that they’re spending the right amount of money, energy, and everything to reach that specific level of compliance and making sure that the patient is not at risk. So that’s the first point that made
15:58 – 16:14
Paul Sarrazin: me start this assignment And now discussing with regards to the submissions, that’s where they took the opportunity since I was here to take some insight, let’s say, and profit from my experience with regards to these topics.
16:17 – 16:24
Yan Kugel: Right, so you mentioned that sometimes companies share too much information, so can you give an example for such an occasion?
16:27 – 17:04
Paul Sarrazin: I had an occasion where That was a few years ago where they actually, so I talked about the cool boxes that we use for transportation and everything. And so at that time, they said that they were specifically for a market, I don’t remember, it was South America, I think Panama or Latin America or Central America. I think it was Panama, but I’m not sure. But they were saying that they were always sending product through this box, which was a huge, huge commitment. And so in the end, they had to do a variation because of course the
17:04 – 17:29
Paul Sarrazin: box manufacturer stopped manufacturing the box. And so they had to pay significant amount of money to have that variation approved and a lot of effort to explain the whole strategy they had again. So that was 1 of the things that I saw, where there’s too much information and let’s say committing a bit too much.
17:29 – 17:40
Yan Kugel: Right. So it means that you shouldn’t, if you don’t have to, you shouldn’t commit to specific types of equipment or types because you should
17:40 – 17:41
Paul Sarrazin: leave room.
17:41 – 17:52
Yan Kugel: You should have some specification of what is required, but you shouldn’t mention that a specific type or a model because you would like to interchange them. Right.
17:53 – 18:31
Paul Sarrazin: Yeah. And you can explain a part of your strategy, but it doesn’t mean that you have to overcommit within the marketing authorization because your procedures are going to change, your people are going to change, the regulations are going to change. So there are things that will definitely change and that you will improve in your strategies. So It’s all a matter of finding the right granularity of information that you want to provide. To say, okay, we know the risks, we’ve identified them, we have mitigated them through a strategy that we have in place, And that’s it. You
18:31 – 18:50
Paul Sarrazin: can give examples of what you’re doing, but especially if you’re in a non-binding section like the 1 that shipping should be into, but you need to make sure that you’re addressing the right section of your CTD and with the right amount of information. That’s it.
18:52 – 19:06
Yan Kugel: Got it. Okay, so that’s a quite a good tip. And you started also talking about some additional thing that you’ve seen that people over share? Another example.
19:07 – 19:48
Paul Sarrazin: Another example, here it’s a bit of, yeah, it’s between over sharing and a slight mistake where a company who contacted me said that they, there was a miscommunication basically between the technical guys and regulatory. And so in the end, they said that they were sending, let’s say a cool box that is maintaining the temperature of your product or it’s a drug substance around minus 80 with dry ice and so they said that they were using a temperature control truck to put that box into where it wasn’t the case and they realized that it was a mistake
19:48 – 20:25
Paul Sarrazin: afterwards. And so now they’re obliged to send the box in a 1525 truck, which costs significantly more than with an uncontrolled sealed truck. And so now, yeah, they have to provide data every time they’re sending their drug substance and they want to do the variation but since the product has been approved since, I don’t know, maybe 3 or 4 months max. They don’t wanna start doing a variation right now. So they’re spending a lot of money for nothing.
20:26 – 20:31
Yan Kugel: Right, so it’s another case of committing to 1 type of transport or
20:31 – 20:31
Paul Sarrazin: equipment.
20:31 – 20:52
Yan Kugel: Exactly. So this is 1 of the biggest pitfalls for I understand. So how do you write and submit the right information which is not too little, not too much? So what is the strategy here from your point of view?
20:53 – 21:40
Paul Sarrazin: It’s kind of like when you’re submitting for manufacturing. You need to know what your critical parameters are. Your critical quality attributes are. It’s basically applying the same approach. You need to have a shipping lane that is defined. Well, you don’t need necessarily to define your shipping lane, etc. That’s overcommitting, definitely. But you can say already that you explain what shipping is from where to where in general. You’re sending, I don’t know, from the last manufacturing site to the market. And you use qualified containers. The qualified containers are qualified using an approach maybe with laboratory testing and
21:40 – 22:14
Paul Sarrazin: performance qualification that you’ve done. Explain a bit of the results for an example of some kind, but really write that it is an example. You know, it’s saying that you have controls in general over your supply chain, that you have a process for the security of your supply chain, for the process for the monitoring of your product during shipping and that allows you to make sure that the right product reaches the right place within the right conditions. That’s it.
22:16 – 22:36
Yan Kugel: Right, So would you say it’s better to undershare and then get comments and requests and just give more information or the regulators might look, I don’t know, a bit negatively on that if you share too little, so you need to find a balance or…
22:36 – 23:23
Paul Sarrazin: Yeah, you have to find the balance. You have to find the balance. That’s definitely it. Because when you undershare, I saw… Just talking about just length of what you’re sharing, I think that shipping in general can be shared between everything related to product integrity and everything related to temperature. I think everything can be shared within 4 to 5 pages maximum. What I would do is explain things if it’s feasible and if you have that in your company, have a bit of, sometimes a drawing is much more, has much more worth than words, and sometimes just a
23:23 – 23:37
Paul Sarrazin: quick process flow explaining what you’re doing or the general process for shipping that’s more than enough than writing 10 pages or 20 pages of submissions.
23:40 – 24:03
Yan Kugel: Yes. And in regards to risk management, risk analysis, you mentioned that this manufacturer needs to know the process and needs to explain the controls that they have. So is the risk analysis part of the material that you submit or the reports of risk analysis? How does it work in this regard?
24:04 – 24:52
Paul Sarrazin: It really depends on the company. I would be keen to send the risk analysis that you have as part of supporting documentation. Once again, you’re not over committing, but you’re saying, okay, we have a risk analysis in place, we’ve identified the risk points, we address those risk points through mitigations, and so these mitigations allow us to ensure that our critical quality attributes that are basically physical integrity and temperature management are insured. That’s it. It’s really about making them understand that you have understood the shipping process basically in the same way as you understand your manufacturing process.
24:53 – 25:13
Paul Sarrazin: Not more, not less, and that you’re putting the right mitigations and strategies in face of each well in in in balance with the risk and that you’re mitigating your risk to make sure that everything is going to be fine that’s it that’s it.
25:13 – 26:04
Yan Kugel: Right so do you feel that at least until now people were looking at the distribution as a lesser part of the manufacturer, the drug lifetime. So we have of course the manufacturing so important so so many things can go wrong but also with the distribution, we know there is counterfeit, theft, mature excursions that can destroy it. So do you think that right now it’s people give it more attention and they bring more quality people to work with logistics to make sure that everything on top and 18 on it. Do you feel that right now the logistics
26:04 – 26:09
Yan Kugel: people who also work understand quality better? They’re more trained?
26:11 – 26:53
Paul Sarrazin: There’s a lot of questions in there. I’d say that the first point related to the understanding of shipping, definitely is better now than it was 10 years ago. Because 10 years ago, or even like, yeah, before we had the current GDPs in Europe, before the update of the USB 1079 and all of the documents related to Brazil and Australia and all of these countries in Canada, especially, a lot of things have been made clearer because people have started to share also their experiences. It is a very good practice to do some sharing between pharmaceutical companies. There’s
26:53 – 27:35
Paul Sarrazin: definitely something that helps. I think that people are understanding it better and better, especially in the CDMO business, where in the case of a lot of CDMOs, they don’t take responsibility for shipping. And so the understanding that they had for quite a few of them was that, okay, so we’re not responsible for shipping. So that means that we don’t have to care. Our people do not need necessarily to understand GDPs. They don’t necessarily need to understand whatever. All the things related to distribution. And That is something that is definitely changing right now, where we see a
27:35 – 28:16
Paul Sarrazin: bit more people being trained in distribution and transportation and so on in terms of QA, especially. Also the understanding in general of the operators, if I take people from warehouses or people from also carriers, I mean the actual drivers, they understand in a better way the implications that their job has. And it is also something, I’ve done a training of a company not so long ago where where They understand that it can have a real big impact the training and then the understanding of what you’re doing Because I was working with a company to train them
28:17 – 28:52
Paul Sarrazin: where because actually The the trigger for that training was related to the fact that they had an audit. They were a carrier company. They had an audit and basically their customer said, okay, We cannot continue working with you guys if you don’t have a basic training for GDPs. And I mean, the people were knowledgeable about the products that they were shipping. They knew a lot of different things, but they didn’t understand the implications of pharmaceuticals, where you need also to have the documentation to understand the risks, to have procedures for the management, I don’t know, with
28:52 – 29:17
Paul Sarrazin: complaints of nonconformances, temperature excursions, whatever. And so definitely the knowledge is becoming better. With that knowledge also comes superstitions, I would say, where people think they know where they don’t necessarily know. It’s also something that is coming.
29:18 – 29:21
Yan Kugel: So what usually people think they know that they don’t
29:22 – 30:09
Paul Sarrazin: know? There’s a lot of things going on with regards to… I’m not saying it cannot happen, but When you have 70 degrees under during, I don’t know, during the, or I’ll say something more plausible, like 60 degrees Celsius, when you’re in the tarmac of waiting for the train and you see like it’s 25 degrees outside and people think that they see a temperature excursion of their of their dialogue are saying that oh my god the temperature reached 50 or 60 degrees where they think okay that’s because the the palette was put right under the reactor of
30:09 – 30:50
Paul Sarrazin: the plane that’s that’s not the case in 99% of everything What happens in most cases is that they put their data logger in a nice plastic sheet that is under the sun. And then you have, of course, the greenhouse effect going on in there, putting and adding more and more and more temperature, where the actual temperature is not as much as what is expected and what is recorded at least. There are things like that. There are other superstitions with regards to, I don’t know, the logistics pharma service where people think that since it’s branded pharma, it’s
30:50 – 31:05
Paul Sarrazin: temperature controlled the whole way through where it’s not Stop believing that all planes are temperature controlled. That’s Definitely not the case. They’re not pressurized as well That these are things that people are in the hard way sometimes.
31:06 – 31:37
Yan Kugel: Okay. So for example, at this point that a supply chain doesn’t have to be always cooled and pressurized. So do you get the request to qualify such roots? And then you explain to the clients, okay, this is not viable, this doesn’t happen. And or specifically this specific drug doesn’t require these higher specifications, which are difficult to implement and costly.
31:38 – 32:25
Paul Sarrazin: Yeah, it’s 2 things. I think it’s mostly a point about design. The first point is related to the design of your product, but going from the solution to your primary packaging, secondary packaging, palletization, you have to understand that there are risks that are coming by your, I’ll take the example of biological injectable product for the sake of being understandable. So that means that I’m gonna call this the, the solution, I’m gonna call it the soup because it talks to a lot of people. So Your soup might be susceptible to be modified or changed by vibrations or
32:25 – 33:04
Paul Sarrazin: shocks, maybe because it is due to sensitivity to, I don’t know, oxygen, to even if it’s a biological product and you shake it a bit too much, sometimes you see that there are 2 phases coming out where it should be only 1. That shows that you have to have knowledge on your product first. Then you need to have knowledge on your primary packaging, especially with regard to SerR products. Is the container closure integrity maintained during shipping? And how is my product or how is my primary packaging affected by transportation? So you have some depressurization testing, you
33:04 – 33:38
Paul Sarrazin: can do vibrations, you can do a lot of different things with regards to that. Your secondary packaging, I don’t know, you have variable data. So let’s say your batch number or your expiry date that is printed or that is on 1 face of your secondary packaging. And then you see that during your shipping simulation or during transport, even worst case scenario, during your actual shipment of your first commercial batch, you have a complaint saying that you cannot read the expiration date because your box was there like this and it was the part that was facing with
33:38 – 34:20
Paul Sarrazin: the variable data was basically moving like that during the shipping and it erased the data. There’s also something to take account, You have to take account of it during your design phases. And then you do your shipping qualification. Usually you do vibrations, et cetera, using some standards like the ASTM standards and things like that. So what I think is that people tend to forget that it is that shipping is just part of the risks that the product will face. And So you need to make sure that you have a certain level of confidence with regards to
34:20 – 35:02
Paul Sarrazin: how your product will sustain that risk or sustain these issues that can happen. That’s the first thing. The second part was product. So the shipping lanes. That’s the second part. No, I’m I’m back The shipping part is mostly about people needing to Discuss with their with their carriers carriers. I won’t give names You have the big the big guys in the in the industry You have a lot of them, but you have some specific big guys in there. Just I don’t want to give too much publicity because If you have a problem with them, I don’t
35:02 – 35:39
Paul Sarrazin: want to be held accountable for that. But you have to trust also the knowledge of your suppliers. If they say that, I don’t know, they’re shipping, I don’t know, from Belgium to the US, Maybe they have 3 preferred routes where they’re going. I don’t know. Maybe through Frankfurt, through through through Zaventem in Belgium or through Amsterdam and then they’re shipping through this and this hub that they have. They know what’s going on on the shop floor. So if you want to do your risk assessments and identify the areas where you have some risk, where you need
35:39 – 36:14
Paul Sarrazin: to have mitigations, you need to understand and identify where those risks are. And so have your mitigations. I don’t know, you don’t have any kind of controlled temperatures at your hub airport between 2 flights. Then it means that you need to have a qualified shipping system or cool box that allows you to sustain that period of time. You know, it’s all about putting the right mitigations at the right points and making sure that your product is safe in the end for your patient.
36:17 – 36:20
Yan Kugel: Right. Sounds very easy, very simple.
36:21 – 36:22
Paul Sarrazin: It’s not.
36:23 – 36:28
Yan Kugel: If it was, then you wouldn’t have a job right now, right?
36:28 – 36:31
Paul Sarrazin: I’d be out of work. Definitely, I’d be out of work.
36:32 – 37:11
Yan Kugel: So when you come to a company, the difficulty of being a consultant is coming to a new company and really quickly understanding their processes and just jumping into the water there. So do you have a roadmap? How do you start the journey of understanding? What is the issue the client is facing in terms of GDP issues and how you address it? So what is your work roadmap from starting with a new client and helping them understand what’s going on and starting to help them out?
37:11 – 37:49
Paul Sarrazin: Well, as you know, and we’ve discussed before, I’m an auditor. I’ve been doing some auditing since the last 15 years, basically. No, 11 or 12 years. Let’s not exaggerate. And so I use basically the same mythology that I use during audits in the sense that I try to identify the risks. I try to, first of all, understand why the customer needs me. That’s 1 of the first things. Understanding why we’re there. If I would compare it to an audit, it’s really understanding what your, Let’s say you have a GDP audit to do and you need to
37:49 – 38:40
Paul Sarrazin: understand, I don’t know, maybe it’s an API distribution site. It’s basically the same approach. You need to understand what they’re doing, what is their purpose. It’s basically going through the process, identifying if there are some weak spots within the process on an operational level, then looking… It’s basically done at the same time, but looking at procedures, how they’re done, and then comparing them to what is expected from the regulators and what is expected from the text. Like, I don’t know, maybe you’re doing some qualification and you say that you’re complying to annex 15 and in the
38:40 – 39:20
Paul Sarrazin: end, you’ll look at the whole thing and okay, it’s a bit outdated now, but the V cycle is still something that is quite usable for at least doing a quick on having a quick understanding of what the qualification validation practices are, for example. And then you can go through that. And my, my idea is really to do a diagnostic of the issue. So it’s really about understanding what the problem is, how things happened. And this doesn’t need to take a lot of time. You need to Open your ears, open your mind, understanding what they have and
39:20 – 40:14
Paul Sarrazin: have a critical, doing some critical thinking, but also understanding the customer. Because if they call you, it’s because they cannot solve the issue themselves. So it’s a lot about communication at the beginning to understand everything and make sure that you have people on board with the project. And then it’s really about going to the facts. Process, procedures, risks, mitigations. That’s it. Well, that’s at least my way of working. I’m very emotional in general in my life, so I tend to go back to the basic things so that I understand things in the broadest way. That’s it.
40:14 – 40:33
Paul Sarrazin: Going back to the facts, to the shop floor, discussing with the people. A lot of people tend to think that operators don’t know a lot where they’re the heart of the business. That’s 1 of the things. And you have to make them understand that you’re on their side as well. That’s it.
40:33 – 40:57
Yan Kugel: Yeah. 100%. So everything you said is very crucial, very to the point, I think. And it’s a very good roadmap to start with the basics and really go through each of the manufacturing to the warehouse and just understand the flow of everything so it makes sense right and
40:58 – 41:36
Paul Sarrazin: it’s also I just like to add that as a consultant it’s also I think a great addition to tell your customer when they come to you and they explain their problem, if you don’t know how to solve that problem and you don’t think you’re the right person to do that, that you can also say it. I don’t know, I mean, if I were being called for a specific, I don’t know, a specific training to, I don’t know, aseptic practices within grade A and B, That’s not my entire area of expertise. You need to have the right
41:36 – 41:53
Paul Sarrazin: people in front of the right audience. And that’s where as a freelancer and as a consultant, I think it’s good to have a lot of people in your entourage, I’d say, in your network to make sure that they can contact the actual good people for that.
41:55 – 42:13
Yan Kugel: Right, that’s very good to involve also your colleagues and understand your strengths and have a good network and have the client in mind knowing, OK, if you’re not the right 1, get the right 1 and you have this network referral. So it’s a good win-win for everybody.
42:13 – 42:47
Paul Sarrazin: I had a very funny experience. It was 3 months ago where a customer told me, okay, we need to have a discussion. We started discussing and the whole thing took something like 45 minutes. And then I was like, okay, but you know who would be better for that? It’s that person that I know who’s a freelancer. I’m not sure if she’s available, but you should contact her because she’s definitely the best person I know who can help you. And they were like, yeah, but don’t you want to make money? I was like, money is a thing.
42:47 – 42:55
Paul Sarrazin: But if I bring you some crappy advice it’s not gonna change a thing and my reputation is on the line as well.
42:55 – 43:09
Yan Kugel: Right, right. So it’s you know when dealing with life-saving drugs or drugs in general you know fake it till you make it it’s not the right place. It’s not the right place to wing it, right? Yeah, never forget your
43:09 – 43:10
Paul Sarrazin: patience in the end though.
43:10 – 43:41
Yan Kugel: Right. And as you mentioned, it’s a small world and our niche is very small. Your reputation is crucial here. So if you mess up very quickly, it will spread like fire. So a lot of consultants told me that. So reputation is crucial, especially if you’re a, you know, when you’re a consultant is everything because you are your own business and you know, you don’t want to get a Yelp review on that.
43:41 – 43:41
Paul Sarrazin: Oh, yeah.
43:45 – 44:01
Yan Kugel: And Paul, so if companies strive to enhance their GDP practices, what do you believe should be their primary focus from the top of your head, from your experience, something that always comes up, companies miss it?
44:02 – 44:38
Paul Sarrazin: First thing, training, always training the people at the heart of the industry. If you don’t train them properly Don’t expect to do something in something good in the end. That’s the first thing. The second thing is really product knowledge Gain some product knowledge and then move to the steps that will help you maintain that knowledge about your product. That’s it. That’s it for me at least. I think that a lot of companies are sometimes missing that opportunity during development to understand what their product is sensitive to.
44:39 – 45:05
Yan Kugel: Yep. Okay. That’s good. And if you’re looking ahead into the future of the GDP landscape. Do you foresee some changes in either regulations or the way things are going to be done differently by companies or even technologies that arise? So is there something that you feel is interesting is going to happen?
45:07 – 45:49
Paul Sarrazin: Technology is definitely a thing. You see more and more, if I give the example of back in the day, like 15 years ago, when you were talking about a data logger, you had like Elpro and Temtel fighting in there and saying, okay, they had 90% of the market. Now you have some innovations in these companies and also in some of their, you call that like their other companies building data loggers. That’s 1 thing. What I see, yeah, so GPS now. So you have GPS and some data loggers. Is it necessary up until now, depending on your
45:49 – 46:27
Paul Sarrazin: type of drug and depending on the risk that you have? Maybe. Maybe if you have some narcotics or some controlled drugs, Maybe you want to make sure that you have the GPS on the data logger just to make sure that if anything happens, that you know where it happened. But not in all cases. That’s 1 example of technology coming. A lot of things that are going on also now is related to falsification where I think there’s going to be more and more apps to allow your customers as pharmaceutical company, so your customers themselves, so the distributors
46:28 – 47:13
Paul Sarrazin: and so on, to make sure that everything went right, everything related to serialization, everything related to all of these things. And even I think these things are going to come, they’re already coming to the patients since a few years now, But I think that it might become 1 of the things that is coming more and more Things related to distribution technology of the product so you have more and more medical devices coming on for the for the dispensing of your product that are also very susceptible to be damaged by transportation. I’m talking about like the, you
47:13 – 48:02
Paul Sarrazin: have some devices where you have like springs inside, where you have mechanical things relate to auto injectors, or even like you have some devices now, like the insulin for people who have diabetes, where you have their pump and everything, where now you have basically a probe that is taking your measures in terms of whatever data you need to make sure that you’re dispensing the product automatically to your patient. I see that happening a lot now. There’s definitely something that will change things. The evolution of products themselves. Yeah, so there are things here. I think that in
48:02 – 48:57
Paul Sarrazin: terms of regulations things are going to get more and more into traceability because there are some points in the distribution network that are a bit of a black box. I think we also need to make sure that when reviewing these regulations, we also take care of understanding that, okay, you have the pharmaceutical regulations, but you also have the actual law, transportation law, that is also taken into account. Like I don’t know, your product might be controlled by, I don’t know, customs. Will there be any changes in terms of technologies for customs? I see, I know that
48:57 – 49:34
Paul Sarrazin: there’s a lot of changes going on with X-rays, which are tending to disappear, being replaced by other technologies that are basically other technologies to make sure that what you’re transporting is the actual thing that you’re transporting. So that means that if we have these new technologies, do they have any kind of impact on our product? There, there’s going to be a lot of questions with regards to new technologies and their impacts both on the product, but yeah, yeah, everything related to the product and everything. So I think regulations are going to come with regards to that.
49:34 – 49:35
Paul Sarrazin: That’s for sure.
49:35 – 50:03
Yan Kugel: Right. So new technologies and regulations would follow to cover those as well. Yeah. So it’s a highly fascinating field. I think we can talk hours upon hours on that field. But I think we covered quite a lot for this nice talk with you. So thank you for taking the time to chat with me. And if people want to reach out to you for some advice, What is the best way to reach you?
50:04 – 50:28
Paul Sarrazin: LinkedIn, definitely either through my company. So you have my LinkedIn for P-Care solutions or directly through my LinkedIn. I’m setting up my website. It’s going to come in the next few months, but it’s still taking a bit of time. I want to make sure it’s very nice and very understandable. So that’s probably the best of ways through LinkedIn.
50:28 – 51:02
Yan Kugel: Nice. Great. So please check our podcast information for this episode. You will see Paul’s LinkedIn there, LinkedIn his name. So feel free to check there or just search him on LinkedIn, whatever is comfortable for you. I am sure you will not regret having Paul giving you advice on this interesting, but complicated topic, although for coming from him, it seems very simple. So again, Paul.
51:02 – 51:04
Paul Sarrazin: It’s like everything, yeah?
51:05 – 51:10
Yan Kugel: Exactly, You need the experience for that. Right. So Paul, thank you very much for this chat.
51:11 – 51:44
Paul Sarrazin: Thank you so much. And I’m very happy to be part of the Qualis 3 family at a point, you know, being able to talk in your podcasts. I really believe that Qualis3 is bringing some very good added value to the market. I try to attend to all of the podcasts I can see whenever I see Qualis3 podcasts. I’m like, okay, let’s go, Let’s go. Sometimes I’m not able to achieve that sadly, but I’m always amazed by the quality of what you’re sharing. So I really feel it’s an honor to be part of the speakers.
51:45 – 51:45
Yan Kugel: Thank you very much.
51:45 – 51:50
Paul Sarrazin: It’s really something I know. Thank you very much. Always appreciate
51:50 – 51:55
Yan Kugel: you among our webinar attendees and you always have great questions, always.
51:56 – 51:58
Paul Sarrazin: Sometimes a bit tricky, but.
51:58 – 52:04
Yan Kugel: Yeah, but it’s good. Let the speakers work for a further time,
52:04 – 52:06
Paul Sarrazin: right? Yeah.
52:06 – 52:23
Yan Kugel: Great, so thank you. We’ll chat more. We’ll see you on our webinars and hopefully we will chat more on a podcast and maybe as well have you talking on some of our webinars when we have something on the GDP area.
52:24 – 52:24
Paul Sarrazin: Thank you so much.
52:25 – 52:26
Yan Kugel: Thank you. Good
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