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How Will the Revised Annex 1 Impact Your Contamination Control Strategy

Marc García Gómez December 15, 2021 538

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In this podcast episode, our guest is Marc García Gómez, a pharmaceutical contamination control strategy consultant. He is also the author of various articles in Spanish pharmaceutical magazines about cleaning and disinfection. During their talk, Marc discussed with Yan Kugel about the EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products draft and how it would affect pharma companies and their current contamination strategies.

Here are some of the things you’ll learn about listening to or watching the podcast:

  • A new dawn for microbiologists in the pharmaceutical industry
  • What critical ideas Annex one introduces
  • What new roles will the Maintenance department, upper management, and operators have
  • The importance of validating aseptic agents
  • How to start preparing for the Annex 1 launch

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AI-Generated Podcast Transcript

Yan Kugel


Marc. Hi, welcome to the Qualitalks Podcast?


Marc Garcia Gomez




Yan Kugel


I’m fine. Thank you very much and yourself?




Yeah. Thank you.


Yan Kugel


So thank you very much for joining me today after a long day at work, where you deal with contamination control strategies. And so it’s, it sounds really cool. So what basically do you do?




Well, I have like almost 12 years of experience helping the companies to perform a good cleaning and disinfection programs. Okay. So my intention here is to help the people, how to approach this very difficult thing, because the new annex one is increasing. Let’s say the difficulty of doing that. And I think that I could help them in, in facing this, this, this new issue. It’s not new, but sometimes a lot of people don’t care. Let’s say about these by now, these will be essential for the CCS for the end contamination control strategy.


Yan Kugel


So how does the new annex one, the at least the draft. So we don’t have the final version yet, but how, from your point of view, it would change the way people do contamination control. Let’s say back up a bit, what new challenges does eat, introduce.


Marc Garcia Gomez


Yeah. Now the, for me as a microbiologist, I’m, let’s say I’m, I’m proud to say that now the new draft of the earnings one is saying that the microbiological properties of your aseptic processes or nonassertive processes will be essential. So now the microbiologist is not a rare guy or a woman that it’s at the end of the corridor and just doing some media plate or something like that. But now a lot of people need to have microbiological knowledge, not maybe as a microbiologist, but you have to know if you are an operator, for example, what are the, the key, the key problems you could face if you’re not doing a good aseptic technique, for example.


Yan Kugel


Okay. So it basically gives more responsibility and makes people responsible for what happens to you. You mean that also the operators would have much more responsibilities?




Yes. Because sometimes a lot of let’s say some operators are not, or maybe only let’s say the engineers or maybe some top quality or top, top heads in the company, don’t know a lot of things in micro in terms of microbiologists. So I think that now this new annex one is facing new challenges for these people because the, the normal answer is say, okay, this is only micro. I only need to read my immediate plate. And, and that’s, and that’s all, that’s not true with the new drop of the, another one. I don’t know what happened with the new route, but I assume that the 95% of disruption will not move. And I think that my coverage issues will not move. And also the creaming and his infection now is expanding because I, I don’t remember right now, but I think now it’s like a double of the texts than before. It’s not a lot of text, but it introduces a lot of new concepts or new ideas that in the past were not implemented.


Yan Kugel


Can you summarize some of the main ideas?




Yeah. Now, maybe in the past, I, when I visited some companies, let’s say 50% of them, 20% of them do not have an Asian on the inside, the claiming an entity in patient programs. And now with the new draft, it is clearly stated that you have, you have to have a agent in your cleaning and disinfection program. This is one idea. The other idea is that you have, you need to have cleaning, cleaning residues program. Very, very well validated because as you know, the disinfectants, not the alcohol, but the other edit infect, and by yourself, the agents leave residues. So now you have to clean it because if not, you are creating corrosion on your metallic suitcases. So, so now you have to, to think about that and to avoid the corrosion, because if not, you are increasing the likelihood to have always on deviations, et cetera. So it’s critical now to know all of these things. And I think that from the last two, three years, the state of mind of the, or the pharma industry is changing. And I’m, I’m very happy for that, but it’s, we are in a very, let’s say in the beginning only. So I think that it has to be improved a lot and the companies need to understand why they buy your shadow agents could help your process, but also damage your process.


Yan Kugel


Right? So w what you say that the companies should do more. So do you feel that the, the annex one, its revision is a very positive for the industry? So can you maybe summarize maybe from your perspective, the positive and the negative sides of it?




Yeah. Maybe in the past, it’s on your own to have these cleaning ready-to-use program to, to, to have it or not, and it’s on your own, but now it’s clearly stated it’s written and you know, that GMP it’s like, give me paper GMP. So, so everything now must be written and must be followed, must be understood and also must be created because I, a lot of companies do not have these programs, these recipes, these cleaning brushes with problems. So now they have an opportunity to understand why they could have a lot of excursions in terms of sports, for example. And this is not only an issue of, to, to, to use again, this police or the Asian on, on the surface, or they buy yourself an agent and then you have the new media plate and says, okay, this is perfect now. Yes. But you need to understand why you have this problems day by day and every day. So, so it’s, it’s, it’s very important. It’s crucial now these new texts in the drug and also gives more opportunities for the martyr, the microbiologist to, to go to the engineers and also to the quality department and explain what kind of problems they could have in the future, or they are having now, and they can understand why they are having repeated e-sports contamination, for example.


Yan Kugel


Right. So do you see the additional requirements in cooperation between departments? So you mentioned that you have the microbiologists and the QA. So I understand that the companies would need to employ more microbiologists and make sure that, that there is a really good cooperation between the manufacturing, the SME is the microbiologists in this case and the quality assurance department.




Yeah. I think now the maintenance will be a new expert in microbiology because they are facing a lot of corrosion. I hope not, but let’s assume that you could have some corrosion in yours, in your surfaces. So the maintenance now is involved in this new issue. Let’s say also the hide management, because they need to know what’s happening in the aseptic area and also the, the operator itself, because they are not only using a biocide without knowing anything. They need to know now what they are using, why they are using and what, and how many times per week or per month or whatever they need to use the bio set of Asian X. And what is the purpose of that and why to clean these residues, why to use a detergent once every, I don’t know, every week, every two weeks, every month, what kind of water do you use to dilute or to wipe out the, this the third gen, or for example, there are a lot of different by a shadow Asians in the Marcet and how to choose them. For example, I need to use, for example, alcohol here, hydrogen peroxide there, quaternary ammonium there, and make sure offer acetic acid and hydrogen peroxide there, or maybe some cloth. It depends. Every bio site has its own properties. And not only the microbiologist needs to know these properties, these properties, also the operator, because the safety of these operator are, could be compromised depending on the chemical basis, et cetera.


Yan Kugel


Right. So it looks that things will get more complicated. So what does it mean for the validated status of current facilities?




Yeah, that’s a good question because maybe as I mentioned before, maybe 20% of the companies, 25% are not having the invite each other Asian validated. Okay. And this is, let’s say this is a very good target for the orbiters to, to warn you with a warning letter. Okay. So they are not willing to do so, but if you are not validating anything, for example, if you buy concentrated while signs of aging, you need to believe they did the elution et cetera. And you have to demonstrate that let’s say campaign per ad campaign or day by day. So you have to Bali date everything now, and also to demonstrate that you have for professional behind not only the disinfectant, but what’s behind the disinfectant, for example, the residue,


Yan Kugel


Right. So much more work for that. So, yeah. Do you think that tick, the regulators will give enough time for companies to prepare, eh, once it is live? So I think that many companies are already starting to realize what’s happening because the draft is a live and they’re doing the preparation is, and as you said, probably not much is going to change is wrong from your experience right now, from knowing the companies. Do you see that companies are already hustling? Are they preparing?




Yeah, I think that some of them, but, you know, there are people that are going in advance that is good, and some other people are reactive. So I think then the big problem will be for the companies that are reacting to this. It’s not a new problem, but we will. We want to talk about this, let’s say a new problem, because sometimes you can see maybe it’s like a dogma inside the pharma industry that no, no virus leaves any residue, and this is false. And they, and maybe some months after, or a year after, or two years after they are facing this kind of problems. So they have to validate everything to, to have everything in written and they are preparing, they are preparing and they are now validating the efficacies of the bio site. And it’s good because sometimes you, you can, you can discover that some companies only use, let’s say an, a specific product, but they don’t know why.




It’s just because it’s been used for the last 15 years, for example, but, but they don’t have any kind of a validation study and they are now preparing, because I think now the auditors also are having more microbiological, let’s say concepts or, or ideas, or maybe a studies, something that is, and they are now, you know, putting the finger in the bone now. And they are not only engineers. They are microbiologists also. So I think that maybe sooner than later, you have to validate everything, not only for the draft, it’s just for your process. And also for the patients, you have to believe that everything. So imagine that the annex one is not saying anything about that, but it doesn’t mean that you don’t have to do it.


Yan Kugel


Right. So the coincidence is that they should have done it before, but we know that there are many facilities that are producing the drugs for many years, say the same name, the same production processes running for tens of years. And usually when you approach such a people for changes or advances, they say, okay, that’s, we’ve been doing it for 20 years and the process validated itself by itself. Right?




Yeah. And also I am facing more, this kind of things w for in a non-sterile facilities, because you know, the aesthetic areas are very strict and you can find some company that is not validating the biocycle Asian, or maybe the residue, but the non-essential areas are, are more critical because they are sometimes it’s difficult to find a non-essential area with everything validated because you know, they can afford more contamination inside. So, but it doesn’t mean that you don’t have to do it because if you ever build a new annex, one drop it’s, it’s perfectly stated that this is not only for aseptic areas. Right. So I think then the next step for the auditor, I don’t know, could be not to, to have the same vision for the city areas that, and for the non aseptic areas. But let’s say that the normal trend is to, to treat them as not the same, but maybe the non-essential areas at the 75% than the aesthetic areas or something like that.


Yan Kugel


Right. So we know that drew is a reason for these annex one revision, right? So we even talked about it before. So there are countless warning letters by the FDA and the many issues Europe. So it’s not for nothing. Right? So, so the regulators learn from hard evidence that something is leaking and probably in many companies. So that’s why a better contamination control strategy is required.




Yeah. I think that you say the perfect words is the CCS, the contamination control the strategy and the cleaning and the infection for instance, is just one part of this big holistic issue. You have to think about it now. So, but I think that cleaning and disinfection will be one of the top three, top four, top five issues for the next year, for the next years. Because as far as I know, there are not a lot of microbiologists inside pharmaceutical industry. For sure. There are companies that have a very strong pharmaceutic microbiological department in QC, but I think that some of them good team good have to improve and to, to, to take, to introduce more people or to introduce new ways of thinking in micro, because the new one is annex. One drive will be not a lot, not, not very strict, but it’s giving you some new clues.




As, as I mentioned before, in terms of residues, in terms of validation, in terms of, if you’re using concentrated or ready to use and disinfectants, et cetera, you must think about this. And also for the gowning, for example, now the gowning is increasing. Let’s say the level you have to check every day that everything is perfect. So, and also the gloves for the isolators, every, every shift you have to test them that everything is fine, that you have a hole or, or, or something like this. So I know that some companies are doing this for, for many, many years, but it’s not perfectly implemented in all of the companies. And maybe some companies could say, okay, I am doing this for 20 years. So it’s not, not, not any new for me now, but some others, I think that if they are not taking all the issues very seriously, could face some problems.


Yan Kugel


Okay. And do you see any big difference between how it’s done in the USA, if you compare it to the CFR and the current state of the annex and the new draft. So do you see some correlation, eh, is, eh, do the regulators now try to catch up with the USA or it’s going into different directions? So what’s your opinion that,




Well, I think the, the main focus for the USA, I also for the European union and for Japan, Canada, et cetera, is to have more or less the same vision for all the wall. Okay. For sure. The, the mentality of the USA is not the same for him, for the and European people and also for the Japanese, but it’s more or less the same story you have to Bali date, everything the USA needs you to validate in. Let’s say using one kind of procedure, okay. One kind of norms, et cetera. And for the enemy in European union, it’s not perfectly say that you have to follow this specific procedure, but the 90% of the companies are following the same procedure using the Aeon norms. Okay. So, but it doesn’t really matter what kind of procedure you do use because the final solution is to validate everything. So the, the most important, let’s say the main focus there is to be aligned using the same. And I think that maybe not for the new, this new drug or maybe for the next year, I think that we don’t care if we go to America or to Europe or to Asia. I think that let’s say that the conditions will be more or less the same.


Yan Kugel


Right? So this is the vision, right? So in Europe and you say, so we have the mutual recognition agreements, which slowly are being deployed in various European countries. So it’s not everywhere yet, but it’s getting there with time. But as you said, there should be no full harmonization here. If we want to be on the same level and save work and there, and acceptance. And I think it comes this mutual recognition agreement comes in a really good time because especially because of Koran, right. So I think we have also the impact that so many facilities have remained and inspected, and there is such a bottleneck. There is a big danger that many companies may sleep because there is no danger. Okay. If there is not COVID, it’s okay. We can relax and then they it’s going to hit them. Right. So the idea is here is




Yeah. And also there are some American companies that are established here in Europe and, and vice versa. So they have to, to, to have a nice chat between them and to explain the same situation and using the same standards. So at the end of the day, you maybe you’re using Ian norms, or maybe you are, you are using FDA norms or something like that. But you know, the main goal is the same.


Yan Kugel


Okay. Yeah. So that makes complete sense. And then hopefully we will get for the full harmonization. So just to finalizing the summarize, what would be your key points from the, and what would be your suggestions to companies for an effective strategy implementation? If we look at the helicopter view, because of course you need to look at each company and see, but where would you start looking? Okay.




It’s difficult to say, but I think that the first, the first question is to have, let’s say, a weekly meeting or every three days meeting or something like that with all the departments involved, just to share experience, to share the knowledge and to explain what’s happening inside the, the aseptic processes or the non SAP processes. Because if not, it’s impossible for the company to develop a good contamination control strategy. Yeah. For example, if QA is overseeing, let’s say one part of the process, or maybe they are not, they do not have a good knowledge in terms of maintenance or what kind of operation is doing the maintenance department or something like that. I think that this is, this is, let’s say issue that a lot of pharmaceutical companies must, must face. Because if not, as I said before, it’s impossible for you to enter the local contamination control strategy then to give so more importance to the microbiology, because I know that it’s important, but now will be critical.




Okay. Also to understand all the steps inside your process, just to control everything. For example, one, let’s say one is special thing that you can have, or you can discover here in the new annex. One is that you have, you need to have an, a specific and specific list of items that you can introduce in your area. For example, maybe in the past will be easy for you to implement a very, let’s say, quick change control or something like that, to introduce a new specific wipe that you don’t have, or maybe you have the other wipe or maybe another editing then another globe, or because of the shortage of the company that is giving you this material or something like that. And now you have to write everything in a perfect condition and you have to also qualify all the people. I know that in aseptic areas is perfectly done, but maybe they don’t accept the curious or not. In some, sometimes they are not fulfilling this, this, this issue perfectly.




I think that now the ICH Q nine and the ICH Q 10 will be essential for, for the, for this new era, let’s say new era of pharmaceutical industry. And also to have smart people doing risk analysis and to know everything, as I said before, all the process, because if not, it’s impossible for you to develop a good strategy and also a good risk analysis, risk assessment and a good outcome. And that will lead to a good cuppa. So everything is connected. Okay. But I think now the microbiology will be more important than, than before, and also to be together once per week or something like that, and to understand the whole process.


Yan Kugel


Okay, great. Perfect Marc. Thank you so much for giving an overview for this important topic of annex one in its connection to contamination control strategies. And I think people should have several takeaways from this discussion and, eh, have something to think about, especially as you mentioned, you know, weekly meetings, daily meetings, to understand and plan ahead because it, it is a crucial,




Yeah. And also in terms of buyers agents, to understand what you are purchasing, this is critical because sometimes you are seeing some technical data sheets and some or safety data sheets that it’s difficult to believe that they are being used inside for my industry, with people at the same time inside the area. So it’s just, it’s not a joke, but I mean, it’s very important to qualify the vendor. Also, it’s clearly stating this new unexplored. You have to qualify your vendor and also qualify your, your product, your commodity, or your white, for example, you’re a globe. You have to work to qualify everything.


Yan Kugel


Right. Very good point. Perfect Marcet. So is there anything else that you would like to add to this discussion or a, Hey, we covered everything. That’s a,




No, I think that everything is covered and I hope that maybe in the future we can develop new meetings for new issues in terms of cleaning and disinfection or CCS. And maybe there, we can develop more, more sequenced, more and more issues or circumstances for, for, for the CCS.

Yan Kugel


Right. So Marc, thank you very much again, for coming to the show, sharing from your expertise and I wish you best of luck.





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Marc García Gómez

Marc García Gómez, a pharmaceutical contamination control strategy consultant. He is also the author of various articles in Spanish pharmaceutical magazines about cleaning and disinfection.

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