From podcast: Quality Assurance Means Quality Built In
In my role I am always hearing about the importance of the industry to achieve the highest standards of quality. This obviously effects interactions with state boards and the FDA as well as patients and the publics perception of the industry. Through out the years we have had many sessions on achieving quality through process and procedure. Today we are going to talk about quality assurance means quality built in, this is a lead-up to a longer discussion that we are going to have in our October event. I wanted to have this session because I think it is important to get the ball rolling on this topic and gain understanding of what this means to 503As
Amy Summers 1:21
Hello, I am Amy summers, I am a consultant at Restore Health Consulting. And I have a background in 503A. pharmacy compounding, I was also a director at a 503B outsourcing facility, and I also have some manufacturing experience, I love compounding, I want to keep it in our family and keep the businesses going. So basically, it’s my mission to keep compounders still going and keep them out of trouble from a regulatory perspective. And really, that starts with quality, I have a great passion for quality. And I also like to help with operations and efficiencies and business and everything. But really, it’s quality. That is a very important aspect.
Vivian Juter Frankel 2:02
Thanks, Amy. That’s really great. I think quality is such an important issue. I hear it over and over again, it’s one of the things that seems to be hardest to achieve, and especially integrating it into all the processes and procedures. You’re going to be talking about this again in October at our grand salon. Your sessions called quality assurance means quality built in. So what does that actually mean? And what does it mean for compounders?
Amy Summers 2:25
has a good question. You know, the word quality, I always thought that I knew what it meant. Funny enough, as a pharmacist, and I think even technicians, we don’t really receive a lot of training in quality, what is quality, I think that this is an interesting topic. And we’ve all had to learn on the job, especially as regulations become tighter, and there’s just a higher expectation of patient safety. So essentially, quality means that your confidence as a compounder that whatever you’re producing is high quality and it’s reliable, it’s reproducible. If I make something or if you make something, we’re gonna end up with the same product and the same attributes. And so the only way to be confident in this is to have quality built in to every single process and procedure, from the raw materials to the equipment that you use the facility even that you compound in the processes or SOPs that you follow, and even the training that you receive, everything is connected. And honestly, there’s a lot that can go wrong. So having a deeper understanding of quality and applying those concepts to practice will basically reflect the compounds that you produce.
Vivian Juter Frankel 3:33
Excellent. Thank you. That is a really great overview 503A facilities like compounding pharmacies, infusion pharmacies and hospitals are generally supposed to follow USP, are you saying that it’s not enough?
Amy Summers 3:44
Well, USP is a good start. But it is just a minimum standard. And oftentimes, in a lot of cases USP is telling you that there’s only one way to do something. And what I found, and what I see that regulators find as well is that one size does not fit all. So essentially, I also realize that pharmacists and technicians, they would much rather just follow a checklist or a protocol. I mean, that’s what we love, even just generally, like clinicians love to follow protocols. But these days, we’re finding that it’s just not working anymore. And so basically, what I’m saying is that in order to have quality built in, you have to use science to back up everything you do. You can’t just follow the checklist and say, Oh, I follow USP Isn’t that enough? Well, you have to have, let’s say the data or you have to perform the qualifications and validations to really help justify that your process is working, that the compounds you produce actually do meet a level of high quality. It’s basically a new way of thinking and I know that it may not be something that everyone wants to achieve or look into, and that’s okay. But for those who want to absolutely ensure patient safety and regulatory compliance, this is actually the way to go.
Vivian Juter Frankel 4:56
We actually have another session that is a panel discussion ongoing Past USP 797 protocols. So you’re not the only one who’s talking about this. But I think it’s something that a lot of leaders are really trying to promote. I hear there is some resistance, but it’s good to see there’s a movement of trying to improve industry standards, and encourage pharmacies to go a little bit farther than what USP is requiring. With that I do hear of an increase in inspections and stricter regulations. So this is probably something everyone should be doing anyway. Would you agree with that?
Amy Summers 5:28
Absolutely.
Vivian Juter Frankel 5:29
You’re saying the elements of a quality system are the facility equipment, materials, processes, and personnel? Which of these parameters would you say is the most important for a 503A compounder?
Amy Summers 5:41
Oh, gosh, that’s tough. Yeah, I’ve said all those things, every single one of them is important. So if I had to actually pick one, I think for any business, this is true, not even just compounding. But I would definitely say that people are the most important asset to your business, and especially compounding because historically and even still, now it’s primarily a manual based process of human intervention. So we don’t use machines or automatic biller type of technologies, we’re using our hands. So if we’re not following our processes, or we don’t care, then we’re not going to end up with a quality product. So people are the most important I would say,
Vivian Juter Frankel 6:22
join us for the Compounding Pharmacies, Grand Salon talks on leadership inspections, quality and environmental monitoring. Live discussions are October 5-8 and presentations are on demand CE accredited for pharmacists and technicians. For more information, go to www.pharmasalon.com/compounding.
So training comes up a lot and the struggles of continued education and a lack of engagement in the process via videos, interactive quizzes, games, etc. What have you seen in terms of training systems or techniques that engage people, so they want to achieve these higher levels of equality? And like you said, not just check things off of a list?
Amy Summers 7:03
Yeah, so training, I would say is something that is often an afterthought, until maybe a regulator knocks on your door and you’ve got some remediations training can be really boring. You know, you’re sitting in there, if it’s in a classroom setting, it can be really boring, and you’re just being talked at, rather than just having some hands on or some real interactive conversations, what else would I say training is so important, and you have to be proactive, and there’s a whole series, you have to not just read and understand the SOPs. But you should also follow the subject matter experts, you should also try it yourself under the supervision of that expert, and you know, advance, get better and then test and show that you actually are competent in whatever it is that you’re trying to do. So you need to have that kind of training program in place. And it’s not just wait till the annual or the semiannual to do it, it should be constant. And often, you know, within the built into the operations,
Vivian Juter Frankel 8:00
you mentioned tests and being able to do it yourself. I presume that what you’re saying is when you do it yourself is you should run through the process and make sure it’s something that’s doable and viable. So what would you suggest to compounding pharmacies seeking to enhance their quality?
Amy Summers 8:14
I think you need to start by building a culture. I’ve personally been in instances where there’s just no quality culture, it’s all about the dollar, or, you know, how fast can you work, you know, efficiency. So if we have this new concept of quality culture, and that only can come from the top, I think you’re going to end up having a better outcome in your product. And also, I think that people will like it, too. But essentially, it’s all about having it ubiquitous, it’s got to be built into the org chart, the SOPs, the job description, it’s just got to have this cultural effect on everyone. And I know typically, pharmacies, they didn’t really earmark a lot of their budget for quality, because there was no need to it was all about profits and efficiencies. But as we know, quality can be very expensive. And it’s not a revenue generating type of department. So what we need to remember though, is that now more than ever, quality protects the business. And the patient,
Vivian Juter Frankel 9:13
you say is not a revenue generating department. But when things go wrong, it can be a huge source of lost revenue, right?
Unknown Speaker 9:19
Oh, yes. This is actually what we’re going to talk about in our session, we’re going to say, why do we care about quality? I’m going to ask you that question. And then the answer is going to be to relate to you. It’s the cost of not caring about quality, and then we talk about the money that you lose the time that you lose the opportunity loss, the product loss, the regulatory backlash, and etc, etc.
Vivian Juter Frankel 9:39
So everything is in the P&L statement. And what you’re saying is the P is going to be empty, but the L could be huge.
Amy Summers 9:46
Yes, yes. Well, and also I wanted to say, you know, I just mentioned that it’s going to protect your business and the patient. And then if you turn that into a positive, you could say that compounders that invest in quality, they’re going to enjoy a higher level of patient and provider satisfaction which indirectly helps the business flourish in the long run. So it takes time it takes money and people and technology to ensure that quality is built in. And that is the challenge to overcome. But I do think it’s worth it. In the end.
Vivian Juter Frankel 10:15
What do you think about 503A compounders, testing all their products like 503B’s do? This, again, speaks to going past 797? Correct?
Amy Summers 10:23
Sure. And even just in general, I mean, wouldn’t it be nice if we could test everything and know that everything was perfect, but I think what we’re saying here is how can a 503A test everything like a 503B does so especially for the 503A’s out there that are doing the single unit compounds, it’s going you know, you’re making one thing for one patient, and you’re dispensing it right away, essentially, I think that it is impractical, and sometimes just not even possible for five or three days to test all of their compounds like fiber freebies do, though testing does have its place in the computing world in terms of risk assessment, there is a division director at the FDA. And he has said that quality has to be built in, not tested in. And I really love this quote, I just think it is so intuitive. Ian Deveau, and he essentially goes on to say that what is tested is not sold, and what is sold is not tested. And so for example, let’s say that you have a batch of 30 units of a sterile compound, and you follow your testing requirements per USP or your state regulations. And then the units get tested. They’re the ones that get destroyed right in the testing process. And they don’t ever get to be dispensed to a patient because they’re destroyed. And the ones that are left over, they were never tested. And they’re the ones that actually get to the patient. So those are the ones that you should really be worried about, because they weren’t tested. So if you’re confident in your facility, engineering controls, processes, materials, all the things that we’ve been talking about today, then you’re going to be confident that the units that actually get dispensed, meet the requirements for things like sterility and potency and every other quality attribute that you care about. And so basically applying this kind of thinking, especially to computers that prepare single units, they’re the ones that they can basically enjoy this kind of concepts and apply it and not have to worry about testing as much.
Vivian Juter Frankel 12:20
Thank you for listening. At PharmaSalon we produce content and conferences for the compounding pharmacy industry that focuses on learning through conversation. It is our mantra that everyone’s experience is worth hearing and can benefit someone else in the industry and we’re the ones to facilitate those discussions. Our next event is the compounding pharmacies grand salon, four days for tracks, regulations, inspection, preparation and response, quality validation and design, environmental monitoring, and leadership. pre recorded presentations will be released on September 20. And live sessions will be October 5 through eighth CPE credits will be offered to both pharmacists and technicians. For more information go to www.pharmasalon.com/compounding
Transcribed by https://otter.ai
