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Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons] Simone (George) Ammons
Yan Kugel is joined by Simone Ammons, a dynamic engineer, technical writer, and entrepreneur who has navigated through diverse industries with finesse. She’s the founder of the QuneUp, a data-driven software tool that reduces equipment downtime and boosts productivity in the pharmaceutical industry. In this episode, we will be discussing data and FDA warning letters trends across the years with Simone.
Table of Contents
Simone shares her career journey, from starting in chemical engineering to transitioning into the pharmaceutical industry. She discusses her experiences in the oil and gas industry and how she ultimately found her passion in pharma. Simone also talks about her transition to becoming a full-time technical writer and the development of the QneUp platform.
Simone addresses the impact of the pandemic on the pharmaceutical industry, noting the disruptions in supply chains and the challenges faced by companies. She emphasizes the importance of upholding standards and regulations, especially in the context of patient safety.
Simone shares her insights on the potential increase in FDA warning letters and the need for companies to remain vigilant and compliant. She emphasizes the significance of meeting requirements and exceeding standards to ensure the safety and integrity of pharmaceutical products.
Episode Chapters:
00:27 – 01:05
Yan Kugel: Welcome to our podcast where we delve into the intriguing world of pharmaceutical industry. Today we have the pleasure of hosting Simone Ammons, a dynamic engineer, technical writer, and entrepreneur who has navigated through diverse industries with Finesse. She’s the founder at the QNAP, a data-driven software tool that reduces equipment downtime and boosts productivity in the pharmaceutical industry. And today we are going to chat with her about data and FDA warning letters trends across the years. So Simone, welcome to the QualiTalks podcast.
01:06 – 01:09
Simone Ammons: Thank you so much. Thank you so much for having me, Yan. Thank you.
01:10 – 01:36
Yan Kugel: It’s my pleasure. So, you had a very interesting career. So, you started in the medical school, then you moved to be a chemical engineer, then the oil industry, and then found yourself in pharma. So before we go into the data, so a bit about yourself, How did your career cycle for all this? How was it?
01:36 – 02:08
Simone Ammons: Yeah, thank you. Yeah, absolutely. Well, I wish I’d gone to medical school, but engineering school. Actually, I always tell people, had I not been an engineer, I would have been in medicine. So hence how I ultimately ended up in pharma. But yeah, my undergraduates from Texas Tech University is in chemical engineering. At the time I also got a minor in mathematics and a minor in bioengineering. So that should already tell you like where my mindset was as far as an engineer. Coming out of Texas Tech, I started in the, I was in Texas, so I started
02:08 – 02:42
Simone Ammons: in the oil and gas industry, in the chemicals industry. I was there for quite some time, about 7 to 10 years as a process engineer. So in the chemical plans, doing investigations, doing troubleshooting, installing new pieces of equipment. And then I thought, let me go back to what I always liked, which was biology. Excuse me. I took my master’s degree in biomedical engineering. And that’s when I switched from the chemicals and oil and gas industry into pharma. And in pharma, I was still a process engineer, but now the decisions that I was making was impacting the
02:42 – 03:15
Simone Ammons: patients at the end of the day. Previous to that as a process engineer in a chemical plant, yes, we were impacting people, but it was more like products, making products that were useful to people. But in pharma, we’re making products that you actually inject, ingest, or interact some with the human body. So I felt like the stakes were higher. Everything was more precise. Everything was more accurate in the pharmaceutical industry. I really, really loved it. The other thing that also happened, people also told me how good I was at writing as an engineer, which is kind
03:15 – 03:50
Simone Ammons: of weird. So I started to write a lot of investigation reports. I wrote the summaries, I wrote the SOPs for the Fortnite operators. And so now I leverage that now and do it full-time as a technical writer, which also led me to develop this platform called QNAP, where we use QR codes, think of a QR code, that will take you to a website or to LinkedIn, but instead we take you to an equipment landing page where you can get access to equipment information, such as manufacturer, date of manufacturer, calibration date, basically all the information that you
03:50 – 03:59
Simone Ammons: would need to make a decision and start the troubleshooting process. So it’s been quite the journey, Yan, and I wanna see where this journey ends up.
04:00 – 04:48
Yan Kugel: Right, so, hey, your journey is looking very positive. So you are doing so well on LinkedIn and you’re doing so many speaking and keynotes and you have a podcast and it’s so great to see. So we had a great webinar together year back and it was a very positive, very interesting session. And it also revolved about risk and data. And as an engineer, you probably think a lot about data, how to use it and how to improve and design. And 1 of the things that you also did a couple of months ago, you shared an interesting
04:48 – 05:14
Yan Kugel: post on LinkedIn, which addresses the trends of warning letters across the last decade. And there are so many interesting things that we see there, right? And it’s so great to look at data and try to learn from it what’s going on with the industry. It’s so insightful. So can you give us in it for us an overview of what you have identified over the last years?
05:14 – 05:53
Simone Ammons: Yes, Yes, absolutely. So what he’s referring to is the FDA 483 warning letters. I did a post recently about that. And in the US, I know we have some European listeners on the line, but in the US is the organization that overlooks drug administration, drug manufacturing, biologic manufacturing is called the FDA, the Food and Drug Administration. And for us, the big, uh-oh, the big no-no is the 483 warning letter. That means that FDA investigator or inspector has come to your manufacturing side, and they’re there, they’re looking for SOP adherence, they’re looking for all of your changes
05:53 – 06:28
Simone Ammons: documented correctly. How do you train new people? Are your new people giving enough time to actually get up to speed on their information and the conditions of the process they will be working. How are your production crews and your maintenance crews in alignment as far as making sure all instrumentation that the production crew is using has been calibrated correctly by your maintenance department. So there’s a lot of interdepartmental things that are looking forward, a lot of end of the line things that are looking forward to being compliance with overall overarching FDA guidelines. But what was interesting
06:28 – 06:58
Simone Ammons: as we’ve all experienced the pandemic, it’s been 4 years. It was that we, it just happened. But a lot of people kept saying or feeling that it seems like, you know, the, the, not that the FDA wasn’t doing its job, but it feels like it was less of the output seemed a little bit lower. So I was like, let’s look at the data. When we first did our podcast, we did look at data as far as risk. Everything that we want to do needs to be data driven. And so on the FDA website, all of that
06:58 – 07:30
Simone Ammons: information is public, all of the records that they keep, all of the investigations that they perform, including the FDA 483 warning letters, all of that data is actually available on their website. But it’s just spreadsheets, it’s just a data dump. And so for a lot of times when it comes to quality and some of those stickier topics, it’s kind of hard to connect with people and let them know exactly what the FDA is looking at, what are the trends, what are the big pictures. So I decided to compile all of the data. They had gone back
07:30 – 08:04
Simone Ammons: quite a few years. I just looked at the last decade. So I did this in 2023. So going back to 2012, 2013, 10 years ago, I wanted to look and see where was the FDA’s focus. Was it on certain parts of the industry? There’s like several different components that the FDA is looking at. I focused mostly on biologics and drugs manufacturing. They also do medical device, animal and veterinary products. But for my focus, I wanted to look at biologics and drug manufacturing. So I looked, I focused on those 2 areas, and it was a ton of
08:04 – 08:40
Simone Ammons: data, 10 years of FDA audits and 41 in letters. And what I found was for the first 7, 6 years or so, the numbers were in the 700s, 800s when it came to that. For the biologics, interestingly, it was a lot lower in the 2 to 300s. So there was just a lot more, it looked like there was a lot more scrutiny on drug manufacturing, your APIs, your, your talent or your pills, you know, and your biologics and your injectables, your liquids, your newer sort of drugs on the market. But what was interesting though, even though
08:40 – 09:14
Simone Ammons: from an absolute number, there were 700s and 300s over the course of 6 or 7 years, coming into the pandemic 2020-2021, there was this huge dip. Like it just fell off dramatically coming out of those years. And you know, for good reason, right? Everybody was being quarantined or being, you know, got to remain home or a shelter in place. It was a crazy time. It was an unknown time. It was the whole world was going through something we had never experienced, at least in our lifetimes. So it was interesting to see how the trend mapped out
09:14 – 09:53
Simone Ammons: of the the the confusion and the the lack of public engagement and being able to go outside that we personally felt. And so that data was really, really interesting. However, though, what I also saw, because we’re in 2020, coming out of 2023, that the numbers have started to climb again. So don’t get comfortable, don’t get complacent, don’t think like the FDA is going away, they are back. Okay, so the numbers have started to climb back to their pre-pandemic levels. And it was interesting, it’s interesting, the same issues that they found pre-pandemic are the same issues that
09:53 – 10:30
Simone Ammons: are coming again post-pandemic. I did a follow-up post where I looked at 2023’s number, not just the numbers, but what were they looking at? So I looked at what were the keywords that kept popping up in their FDA, in the language used when they issued the FDA 483 warning letters. And, you know, no surprise, but procedures came up, Records came up, batch records came up. 1 of my colleagues, she’s in 1 of the validations space, she had me look at the medical device, same thing. Records, you know, changes to medical device and software was not documented
10:32 – 11:10
Simone Ammons: on the documentation that you submit to the FDA. So it’s coming back to the fundamentals, records, proper records. I know Yadam Kualistiri, you’ll harp on that a lot, like making sure you have excellent record keeping, making sure your SOPs make sense, they’re concise, they’re to the point. So it’s interesting to see that the same issues that had been coming up pre-2020, pre-pandemic, were again coming up again, coming out of 2022, 2023. So that just means that told me that the same intensity and the same focus that we had on the issues leading up to the pandemic,
11:10 – 11:16
Simone Ammons: we need to return to the same levels because the FDA is still looking at all of those factors moving out of the pandemic.
11:17 – 11:37
Yan Kugel: Right, And do you think that the number of expected warning letters will surpass the pre-pandemic because a lot of companies fell asleep behind the wheel during this time, they felt very comfortable, they forgot to keep improving. What’s your feeling there?
11:37 – 12:15
Simone Ammons: I pray it doesn’t, but there were so many disruptions during that time. Your newer engineers, quality professionals coming in or the school had tiers of disruption, right? They did not get to see the flow and the field and get that hands-on training like we did, you know? And then on the higher end, your veterans, your established professionals in the field, you know, Sometimes they were forced into retirement because of the situation, or they succumb to the different events from the pandemic, or they’re just no longer as engaged just due to health complications. So you have this,
12:15 – 12:55
Simone Ammons: to me, this perfect storm of your new course of replacement, energy replacement, professionals are maybe not as trained on the practical side because of 2 years of disruption. And in the higher end, we’ve lost a lot of our seasoned experienced veterans in the field. So I pray the numbers don’t exceed pre-pandemic, but the numbers are climbing. It wasn’t a slow climb. It was like an immediate climb. I am worried that if people fell asleep behind the wheel, as you said, that they’re in for a rude awakening. They are back, the numbers are climbing rapidly. If you
12:55 – 13:00
Simone Ammons: fell asleep, now is the time to wake up. Don’t get caught, I’m off guard. That’s what I would
13:00 – 13:19
Yan Kugel: say. Right, so that’s wise. Yeah, And what you have said, I didn’t think about it actually. So this is a very good observation that during this time, many professionals left the scene and there probably was lack of training of a newer professional.
13:20 – 13:20
Simone Ammons: The handover.
13:21 – 14:07
Yan Kugel: The handover probably gets stuck somewhere. Probably after the pandemic, 1 year it was quite chaotic for companies. They work from home on many occasions, so not in the manufacturer itself, but there was a cool down in manufacturing because not many people are allowed to be in 1 room. So they cut up the hours, cut out the personnel and now they need to come back. And, you know, there are lack of new personnel because, as you said, there was some pause in the academics because not everybody could finish their degrees. Oh, so that’s also additional points that
14:08 – 14:48
Yan Kugel: probably impact all the industries, right? So, right, and we still see it, right? And so how do you think it will also play out? So during the pandemic, there was a lot of cases where there was drug shortage, right? Because of a disruption in the supply chain routes and the supply of raw material, et cetera, et cetera. So do you think that the FDA might take this into consideration when they would say, okay, in any other time we would shut down the plant, but this time we will maybe observe better, come back, give them more, you
14:48 – 14:54
Yan Kugel: know, a breather or something like this, or do you think this will not play?
14:54 – 15:29
Simone Ammons: I don’t because coming out of the pandemic, like in the US, we had the baby formula and milk shortage. And we had the shortage because the FDA came in and said, shut it down in the middle of the pandemic. So you had moms, moms who probably for the first time had the time to even think about having children. And then now you can get like basic formula to feed your child because the FDA said the Contamination risk was too high. I spoke at another event where there is not just the US But if you have contract
15:29 – 16:09
Simone Ammons: manufacturers outside of the US the tentacles of the FDA go far. It’s your US operations need to meet those requirements. And so they’re going beyond the borders of the US and going to wherever it is that the the excipients or the preliminary drugs or whatever version of the drug or the components are being manufactured and saying, you’re not meeting our standards. And yes, we had a pandemic. Yes, we had a disruption, but they’re upholding the value and integrity of the patient at the end of the day. My kids are a lot older, and I feel for
16:09 – 16:42
Simone Ammons: those moms who had to. I mean, it was crazy what they had to go through. But at the end of the day, we did not have another scare, which is babies, infants, the most vulnerable in our society, getting contaminated products. Can you believe as a mom, you think you’re feeding your child this nutritious meal, and they end up something happening, or God forbid, something worse, because the FDA did not do its job. So while I, you know, as a veteran in the space, I do think there needs to be some leeway. At the end of the
16:42 – 17:19
Simone Ammons: day, it’s the patient, right? It’s that infant. It’s that older, you know, cancer survivor who’s much older, who has, you know, immunocompromised. That’s who those drugs are going to. That’s who those immunotherapies are going to, the biologics, the serums. And so if our focus is not necessarily on what the FDA is and isn’t doing, but on your neighbor, your grandmother, your child, your uncle, your husband, your wife, that’s who you’re making a product for, then I think it’s a no brainer. We just scale up, we just meet those requirements and we exceed those requirements. I think
17:19 – 17:55
Simone Ammons: personally meeting requirements is half the battle. We should be exemplary. We should be the beacons, you know, for other manufacturing facilities in the US and around the world. So, And I mean, to be fair, in response, a lot of these US companies are doing what they call unshoring. So a lot of parts of the supply chain was fractured and globally distributed. I think the weaknesses and the complexities of the supply chain around the world came to life, you know, painfully so painfully so during the pandemic. And so people are now reinvesting that energy into like, do
17:55 – 18:31
Simone Ammons: we actually know every single touch point for our product, every part of the product? Do we know where it’s coming from? Do we know that it met those FDA regulations at every single touch point in our supply chain? And I think we may have taken it for granted that it was happening, but now we know that’s not the case. Not just on a supply issue, but the quality of the supply of all of those ingredients and intermediate drugs. So I would say get, wake up, get back on the wheel. The FDA is not playing. I think
18:31 – 18:43
Simone Ammons: they’re taking everything into consideration, but they are locking it down. It came as far as infant formula. They said, no, we’re shutting you down. So if that’s an example of what’s to come, I think we’ll see more of that.
18:44 – 19:28
Yan Kugel: Yeah. And I support that if there is risk to people, you know, they should shut it down, or is it’s better not to have it in the market than have some many people getting hurt by it, right? So it depends, of course, on, you know, they need to do the risk, right? The benefit versus the danger that can be, right? And you also mentioned that you see some data about the various findings. So do you see some peaks in some specific areas that companies get warning letters for or is it part of the findings?
19:29 – 20:10
Simone Ammons: Yeah, absolutely. Especially, like I said, I focus more so in the biologics and the drugs category. The recurring themes that I’m seeing there are records. I think an instrument is an instrument. Excuse me, a bioreactor is a bioreactor, you know, pumps are pumps, but the record keeping of the integrity of those systems, equipment, the people that interact with them, the SOPs, I feel the scrutiny is there. As I said, Farmer, if we didn’t write it down, it did not happen, right? And so, and I’m just looking at 2023 alone, which is, you know, 3 years coming
20:10 – 20:46
Simone Ammons: out of the pandemic where the people are resetting, maybe companies are kind of getting back in line in the rhythm they were pre-pandemic. We’re seeing what is interesting the same themes I’m saying in 2023 have kind of been the same themes pre-pandemic, right? It’s the record keeping, it’s the batch records, it’s the procedures. Even like I said on the medical device end, if you made a change to the device, to a software, to an update, you know, and you did not correspondingly make the updates to the documentation that supports that device, that drug, that new modification,
20:47 – 21:20
Simone Ammons: they’re flagging that too. So I think the focus here is when you’re making changes, whether it be to a medical device, the backend software, you’re making changes to your production flow, you’re switching from say a traditional stainless steel bioreactor to a single use 1, that’s a major change. Have you documented it? Have you looked at the risk steel point? Have you looked at the risk of changing over from 1 type of material to another? There have been a lot of studies looking at even for, I did a post on this on single use bioreactors where the
21:20 – 21:53
Simone Ammons: polymer leaches and actually impacts cell growth. So have you looked at that risk? Maybe it’s cheaper from the front end, from a capital investment end, but the risk of like switching over, have you looked at that? And then from the FDA perspective, have you documented that you’ve done that? What is your risk profile, your validation master plan, your risk management profile? And then are you following what you said you were going to do? Every time you make a change, you’re supposed to do a new internal audit or have a management of change or change control or
21:53 – 22:06
Simone Ammons: whatever it is. Are you actually following your own procedures, your own internal rules? The FDA is going to come in and hold you to your own standards, you know, on top of their own. So that’s definitely the trends that I’ve been seeing coming out of the pandemic.
22:07 – 22:26
Yan Kugel: Right. So you mentioned documentation, batch records. So and how was the change across the decade? So do we see more findings in this era in the in the last decade than maybe 20 years ago? Would you say?
22:26 – 22:39
Simone Ammons: I would say I only look back for the first 10 the last 10 years. That’s at least as the data they had readily available on their platform. Interestingly, it looked like it was more of the same.
22:39 – 22:41
Yan Kugel: More of the same.
22:41 – 23:13
Simone Ammons: I didn’t see like a huge spike, like, no, we’re talking about records and in 2013 we were not, we were still talking about records back then which is fascinating to me the more things change the more they stay the same. So like the F they did all of a sudden start looking at batches in 2013 and then now in 2023 they’re looking at I don’t know computer systems or whatever no it’s the same it’s the same thing. I think even as for the new companies, as new products come out, as new therapies are discovered, new cancer
23:13 – 23:28
Simone Ammons: breakthroughs, everything, we’re still saying this is the holy grail of standards and procedures and regulations that you have to meet, regardless of what your individual product is fixing or doing for patients, it’s still the same over the years.
23:29 – 24:00
Yan Kugel: Right. So, it’s interesting because I would say that over the last 10 years, there was the digitalization revolution or at least it’s happening right now, right? It means more companies go to digital records, they implement electronic quality measurement system, electronic fetch records. So I would think that we would see less issues with documentation, but you’re saying, no, it’s not happening. It’s staying the same.
24:00 – 24:02
Simone Ammons: So why? Why do
24:02 – 24:30
Yan Kugel: you think it is? So do companies don’t know how to use the systems right? Are the systems not good enough for them? But I don’t think that the issue, because usually they are approved. So the issue are the quality management systems or batch records, electronic batch records are not all up to the standards, like there are these variations or people just don’t use them correctly or in a timely manner. What would you say?
24:30 – 25:08
Simone Ammons: That’s interesting that you say that, because of course, in 2023, you are more digital as a general rule anyway in 2013 when you first looked at it. However, I think we should not hide behind digitalization as a fix for proper execution and adherence. So whereas it may be in 2013, you were wet signing an SOP and having to, I’ve had to do this like whenever it started back in 2012, 2013, I had to hand deliver, you know, print, you know, write the SOP or the validation master plan or whatever it was, print it out and hand
25:08 – 25:45
Simone Ammons: deliver to all of the managers who had to sign and get them to sign and sneak in during meetings and just like interrupt whatever was going on because we were out of time and I had to physically do those signatures. Fast forward to, you know, 2022, 21, when I worked in farmers again, those same managers are still just as busy. So I can’t just rely on electronic system to magically get their signatures. The efforts that has to be made to contact them outside of the platform or within the platform and say, hey, we have 2 CAPAs
25:45 – 26:18
Simone Ammons: coming down. We have this SOP that’s coming up, we have this validation master plan, we need to do this before we can start doing the IOQ, you know, all of the qualification activities. So I think it’s a misnomer to think that just because you’ve adopted a digitalization solution, which is great, right? Please, please don’t let us walk around with printed Word documents, okay? Please make it electronic. But the work of, you still need signatures, you still need reviewers, you still need to interact with the production crew. So maybe before you had to take the paper record,
26:18 – 26:52
Simone Ammons: you know, to the floor and talk to your operators. Now you send them an email, you send them an email to the supervisor, you have like a quick, you know, virtual meeting and you walk them through the changes of the SOP that work that human factor, you know, AI and everything that human factor still has to be held up high and still has to be executed. So I think we’ll be remiss if we just rely on digitalization to do the work and the execution and the compliance piece for us, it still has to be done, whether
26:52 – 26:54
Simone Ammons: we’re digital or paper.
26:54 – 26:58
Yan Kugel: Right. So the digital solution make it easier.
26:58 – 26:58
Simone Ammons: Yes.
26:59 – 27:24
Yan Kugel: Straightforward, but we still need to do it timely and correctly and follow up on this. So let’s say you have digital solutions for batch records and this and that. So what are the findings are about? Is it like people know the document correctly? Are they misleading with the information? Are they hiding information? So what usually they find?
27:24 – 28:08
Simone Ammons: No, no, what we’re seeing is they’re not following the procedures. So which is why I like digitalized solutions because on paper, you’re not supposed to backdate, but it’s harder to catch, right? If you backdate something or you slip in a signature after the date, like it’s harder, right? Cause there’s not this snapshot in a digitalized system where it is a snapshot of when a person logged in and interacted with the system. So the system, the digitalization system, eliminated some of those lower level issues where people were collecting signatures outside of the window or back dating things.
28:08 – 28:44
Simone Ammons: But the content of those procedures, the content of those batch records, the content of that medical device software documentation is still the same. It’s just now distributed digitally instead of like a physical paper or Microsoft Word or something. And so what the FDA is finding that What you said in your batch record, you said you would do x and then y. If you’re doing a and then b and then x, that’s what they’re calling out. It’s that we’re not in compliance with our own records. We said we would do x and we’re not doing it. We
28:44 – 28:55
Simone Ammons: made changes and we did not go through the proper risk revaluation or the revalidation or a new SOP had to be put out there. So that’s really what they’re catching.
28:56 – 29:09
Yan Kugel: Right, so you’re saying it’s not during the manufacturing itself, but it’s changes that they implement, but they don’t document well.
29:10 – 29:39
Simone Ammons: Right. Right. And also in the execution of those procedures. So if the procedure, the manufacturing batch record call for a certain order of steps to, to, occur those steps are not being done because now you in digital space. So there’s like a digital verification, a second eye per se for each of those steps that are not being done. And so the FDA is catching that saying what we’re putting down. We’re not, we’re putting it down, but we’re not doing it. You know, there’s that piece there too. So, yeah.
29:39 – 30:21
Yan Kugel: Well, I say it’s good, right? Because if there was not no digital metadata, then people would just not do it and then nobody would catch them. Right. So at least now, but it means that there is some problem with the process at that company because it means that how come they can release the batch without confirming that some step has happened. That means that there is some loopholes or some issues in the batch release process where people can adjust, maybe they did it on purpose, right? Because they just want to, they don’t want to have, there
30:21 – 30:36
Yan Kugel: is a piece too specific, right? There is the issue that companies have, there is a piece too specific, some not enough, or also the pros, they say, oh, You know what, we don’t want this as gatekeepers. Right.
30:37 – 31:15
Simone Ammons: Right. So for example, so let me read out some of the citations. So 1 of them is, failure to perform a thorough investigation to make a record of the conclusions and follow up with an unexplained discrepancy, a failure for a lot, the discrepancy was a failure for a lot or you need to meet any of its specifications. So we’re saying we will perform our investigation when we have an unexplained discrepancy like we didn’t meet you know a cell count or system concentration but we’re not following through with the investigation right another 1 was records are not
31:15 – 31:59
Simone Ammons: concurrently maintained with the performance of each significant step in the collection, processing, and testing of this component. So we are saying we have to do, let’s say, 10 things, but we’re not maintaining the concurrent records that are documenting that those things have been issued. Another 1, just to share the last 1 I’ll share, written standard operating procedures for all steps in the investigation of product deviations and record keeping were not established or maintained. So it’s not so much that the procedure is wrong or whatever, but when we write it and we say, we’re supposed to do
31:59 – 32:17
Simone Ammons: something, we’re supposed to launch an investigation, we’re supposed to do certain steps, we’re not cataloging that we’re doing that thing, we’re not cataloging where and when that part of that SOP was executed as the FDA is flagging that as an issue during the audits of the system.
32:18 – 32:45
Yan Kugel: Right. So if they get the warning letter, it means it’s systematic. It means that your processes are built that way with those loopholes and there’s issues within. So I’m just thinking, right, this company, if they got the war in literature, it means that at some point they got approval from the FDA to sell the air in the first place, right? It doesn’t matter
32:45 – 32:45
Simone Ammons: if
32:45 – 32:56
Yan Kugel: Iraq comes from the USA. In India, they got the approval. So how does it come to that? That they get the initial approval and then and then suddenly
32:57 – 32:58
Simone Ammons: it’s a mess.
32:58 – 33:09
Yan Kugel: And like, do they just drop the ball and they just relax too much? So or does the initial checkup is not good enough? What would you say? It seems strange, right?
33:09 – 33:48
Simone Ammons: Yeah, but you know, humans, people are people, right? And so it’s interesting. So this is this is what I was reading on was from 2023, right? So we’re 3, 4 years out of the pandemic. So what’s interesting is that maybe the, like I talked about earlier, maybe we had the personnel prior to, to execute, maintain those procedures, whether it’s paper or digitally, then we lost some of that workforce. And so the oversight and the energy and the big brother is watching, you know, from quality and other departments probably wasn’t there. I don’t think it’s malicious. I
33:48 – 34:26
Simone Ammons: don’t think it’s intentional. I think like, you know, I kind of help but think that the disruption to personnel availability and ability to work also manifested itself in the manufacturing space where we just don’t have the people to like execute those procedures and those guidelines that we set forth, you know, pre-pandemic because they’re not because what I’m reading, I’m not hearing that the procedure was incorrect. I’m not reading that it wasn’t, that it does not match, you know, the the SOP wasn’t written well. What I’m reading is that the SOP wasn’t followed, the steps were documented.
34:26 – 34:33
Simone Ammons: It’s that human execution piece where something is falling apart, you know, to the point of slipping behind the wheel.
34:33 – 34:46
Yan Kugel: Right, right, right. So, from 1 side, I would say that’s great because the pandemic, the QA department might have been less involved. There were less internal audits.
34:47 – 34:47
Simone Ammons: So
34:47 – 35:17
Yan Kugel: people were just, you know, they were at the end, when they were filling out the bench records, but they were the steps between the shortcuts, they were in court, right? But on the other hand, you’re saying, you know what, the worry letters are coming back to the pre-pandemic. They have not yet, you know, over seeded, right?
35:17 – 35:18
Simone Ammons: Right, right.
35:19 – 35:23
Yan Kugel: So it means also before the pandemic, there was the issue, right?
35:23 – 35:23
Simone Ammons: Right. But
35:23 – 35:36
Yan Kugel: we cannot say, you know, it’s only the pandemic because it’s helped. It’s maybe, you know, the situation got worse, right? But it was not peachy before. Right, right.
35:37 – 36:16
Simone Ammons: Which is great to your point. So before the pandemic, we were maintaining 700, 500, just for the sake of argument. And then we dropped drastically. We’re in the hundred single digits, right? And then in 1 year, 2020 to 23, we’re exponentially almost back to pre-pandemic level. So that, So it wasn’t like a slow rise, right? And then another thing that you said, you talked about a systemic issue. So just like I hate when people say human error and we’re blaming production or like, no, no, no, it’s a systemic issue. What is systematically happening in your entire
36:16 – 36:55
Simone Ammons: organization where a simple SOP, an execution, a batch record, something in the supply chain, something on the production floor is not being done, right? It seems like we have the systems in place, but the execution and the oversight and the adhering to compliance, not just internally, but externally to the FDA is not happening. So I think organizations need to go a step higher than just, like they say in SOPs, but as a physical document or electronic document, what is happening around it that an SOP is not being executed to the letter? Is it training? Is it
36:56 – 37:28
Simone Ammons: staffing concerns? You know, you’re short staffed. Is it people don’t feel they have to do it because they’ve done it all the time. This way, we don’t have to read the SOP. The people not understand, is it not trickling down that the FDA will come in and can shut us down if we’re not in compliance? Like, so I think for companies to your point, I wouldn’t tear apart like single words, but look at the system perspective. How are we as an organization making sure we’ve empowered our people, our staff, our departments, maintenance, quality, engineering, supply chain,
37:28 – 37:48
Simone Ammons: VPs, every part of it in your beautiful intro. It takes so many different departments and people to make a drug, make a drug therapy, make a biologics drug, that how, in that entire system, how are we filling the people that are holding up that system? I think that’s the question we need to ask.
37:50 – 38:19
Yan Kugel: Right. So the department needs to be more involved in really do very good internal audits and take it seriously, right? And a question regarding the company. So let’s not name names, but would you say it’s well established, the old companies or would you say it’s a varied or it’s a more smaller companies that get those letters?
38:21 – 39:07
Simone Ammons: At least from what I could see, that identifiable data wasn’t part of the data. At least I could see, and if somebody else sees something else, please let me know. However, I also looked at recent fines issued by the FDA. And they went from European countries, Middle Eastern countries, Asian countries, US countries. I could not tell a difference just from the fines. I mean, we passed a warning letter, there was a fine, there was a contamination product, people died. Unfortunately, those fines were millions of dollars. And some of them were small manufacturers. Some of them were
39:07 – 39:48
Simone Ammons: big, bigger names that I recognize. Others were contract manufacturers, externally outsourced manufacturers, somewhere in the US. And I’m talking about millions of dollars being fined because of, a lot of times it was media where the impact reached the media. It wasn’t just like an internal SOP compliance issue or something was it got as far as patients being compromised with that drug. So from that perspective, not so much from the one-in-a-letter side, but from how they do their fines, it doesn’t seem like they don’t discriminate against between big and small. However, I do have to say, the
39:49 – 40:22
Simone Ammons: more established larger companies, you have a lot of data and a lot of experience, a lot of people who’ve done this forever, right? So I feel maybe they are better prepared. What we’ve seen in the last 10 years, to your point about digitalization, these newer companies coming online who may not have the 20, 30 years depth of big pharma, as they call it in the US. And so maybe there you’re just entering a new field, you have the shiny new electronic platform, not realizing the maintenance of that platform, the execution of the documents from that platform,
40:23 – 40:59
Simone Ammons: not just adopting digitalization, but supporting this continuous evolution also needs to be done. So to my point about that disruption in the new professionals coming onto the scene for 2 years after the pandemic, I feel sometimes, and I’ll have to look for the data on this, but my general feeling is that there was this loss and we’re recovering from this loss. The FDA is giving some wiggle room but the fines have not stopped either and the newer companies, the newer professionals, you know like this quality story podcast and the webinars that you do, I think it’s
40:59 – 41:27
Simone Ammons: important that we take it upon ourselves to continuously learn even though we’ve been doing this for 10, 20 years, or we’ve been doing it for 1 year, continuously learn and close that gap. Because the FDA is not going to say, well, you’re new, we’re going to give you a break. No, they’re going to say you need to meet our regulations. You know, you’re trying to put a drug into, like I was saying, into a patient, into an infant at the end of the day. And that’s who they’re ultimately protecting, not necessarily the company, but the final
41:27 – 41:30
Simone Ammons: patient at the end of that supply chain and production journey.
41:31 – 42:06
Yan Kugel: Right. So to summarize, what would be your advice for companies that are expecting an FDE audit? What can they do before it happens? And from all the data you’ve seen, they may not have an audit for several years now. Say there are new colleagues there, some have forgotten what it is to get the N FDA inspection. So what should they do with the steps to avoid it?
42:06 – 42:43
Simone Ammons: I think if you’re already in a position where you’re unsure, there’s a saying that says stay ready so you don’t have to get ready. But if you are getting ready, the FDA is definitely looking closely at your records, your record keeping and your adherence to your records. So not just that you have an SOP or you have, you know, certain documentation, but that you’re actually adhering to what you say that you’re gonna do. So I would look at that and then your entire system. Let’s not focus on individuals or even the individual departments as a whole
42:43 – 43:14
Simone Ammons: as a company. How is the company making sure each of those departments and people on the floor, in maintenance, in quality, each of these people have all the tools that they need and the interfaces and interaction that they need to be successful. So that’d be 1 thing as a system from a systematic point of view. The other thing like I have done and I’ve presented this on LinkedIn and other platforms is study what the FDA did pre-pandemic and what they’re continuing to do post-pandemic. The data is available on the FDA website as far as 43 warning
43:14 – 43:50
Simone Ammons: letters, But also take a step back and look at if you have that data from previous audits, what did they say you did well? Let’s double down on that. Are your batch records always immaculately executed? Everything is signed and dated electronically or wet signatures or otherwise? Do you follow 5S, for example? Everything is clear and accessible and ready to go, making your production team efficient. What are those 1 or 2 or 5, 10 things that the MD has consistently given you the green light on, giving you positive feedback on? Double down on that, learn from that
43:50 – 44:21
Simone Ammons: system or process or part of your unit that’s doing so well and let’s leverage and translate some of those successes and wins into other parts of your organization that may not be in the best of light when it comes to the FDA. It’s your entire organization. If they should plan on this, your entire organization that goes on and gets impacted financially or otherwise. Under recovery in the media, you have to think of everything is social media. Now, it’s going to get away from you before you can like bring it in. So that’s what I would say.
44:21 – 44:56
Simone Ammons: So first just, if you’re coming up, look at what your successes and your wins prior to, double down on those, leverage your successes to the other areas of your systems where you may have some gaps to close. And then stay informed on what the FDA is doing. Who are they looking at? What, when they have looked at certain people, what are they saying? Who are they finding? What are they finding people for? There’s contamination rates. So what are your documentation, your material data sheets looking like is everything cataloged is everything documented is everything clear don’t take
44:56 – 45:28
Simone Ammons: it for granted you know I do your man I your managers empowered to like and force those those those FDA you know regulations is not you’ve been mean everybody thinks qualities being mean they’re not being mean okay They’re trying to uphold the standards to the FDA because at the end of the day, it’s the patient, right? That’s the only goal. If your focus is on the patient, then your focus is not interdepartmental, your focus is on making the entire, all of the departments rise. So that challenge to your next FDA audit will be a breeze, hopefully.
45:29 – 45:49
Yan Kugel: Right. Very wise words, Simone. Great. So thank you very much for this insightful talk. And we touched some very important points here and hopefully we’ll see some change and we’ll see some of the foreign letters trends going down. So thanks a lot for this insightful
45:49 – 45:54
Simone Ammons: chat. Thank you so much, Yan. Thank you for having me on your podcast. Thank you so much.
45:57 – 46:11
Speaker 1: Thanks for listening to the Qualitalks Podcast. If you enjoyed the show, please leave us a five-star review. If you want to learn more about GMP, please visit us at www.qualisteread.com. Stay compliant and see
46:15 – 46:15
Yan Kugel: you
Yan Kugel is joined by Ben Coverdale, PhD, a seasoned global account director at Patsnap with a strong background in the life sciences and innovation and intelligence sectors. Ben brings […]
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