Nick DelGiorno, Director of Quality, shares recent improvements and investments in quality at Epicur Pharma, designed to ensure sterility and consistency of 503B manufactured veterinary medicines.
Why did you choose to join the team at Epicur?
It was a completely new industry to me. I came from the pharmaceutical industry, and have a cGMP background, having worked in biologics contract manufacturing. During that time, I saw a lot of things that I’d do differently. When I saw the opportunity to create a quality department for an industry I wasn’t familiar with, I thought it would be an exciting challenge. I love constantly learning something new. That’s something that no one can take away from you. I appreciate this company so much for trusting me, listening to my ideas, and encouraging innovation. As a company, we want to constantly grow, and it shows in the employees. Personally, it brings me a lot of joy to feel like I’ve had a positive impact. I can rest my head at night a little bit easier.
How has your department changed?
I was the first hire three years ago, and now our department has 16 people. We’re learning and growing every day. It’s incredible how far we’ve come; it really is. We hire people not only with cGMP experience, but those who have new ideas and a willingness to grow and improve every day.
503B facilities are fairly new to the veterinary pharmaceutical market. Help us understand the difference between this and traditional compounding. What is a 503B and what do you mean by cGMP?
Traditional compounding pharmacies, known as 503A, must operate under standards put forth by the United States Pharmacopoeia (USP). In 503Bs, the FDA sets the standard for cGMP, or Current Good Manufacturing Processes, based on the Code of Federal Regulations part 210 and part 211.
There are fundamental differences between USP and cGMP standards, the biggest one being that the amount of testing required for potency, sterility, and endotoxins is far more extensive for cGMP. Though the FDA sets the standards for the codes, they don’t tell us how to get there. That’s where cGMPs come in.
In cGMP, how is “current” defined?
Current is defined as continuous improvement since regulations are dynamic and continue to develop with the industry. We’ve worked hard to establish a very sound facility with robust procedures, but we must work every day to keep identifying opportunities to improve. Training is key.
How are 503B medicines tested?
Our quality control department is responsible for testing product—from the materials that are coming in, to the finished product. When we’re doing any kind of aseptic or sterile process like filling a vial, we have environmental monitoring samples going on, so we’re testing surfaces, people’s hands, the gowns, and the air to make sure that there’s no microbial contamination that doesn’t meet our specific standards set for our us. With cGMP, we take into consideration global standards to build upon. Testing is always being incorporated in some way, shape, or form. If you can efficiently incorporate a test into the process itself, you can pinpoint any potential source of failure and stop the process so you can be more proactive than reactive.
What improvements have you put in place this year?
We’ve made a lot of changes to our gowning procedures, investing in higher quality, reusable gowning to reduce the potential for contamination from the shedding that disposable gowning is prone to. Our new gowning is made of sturdier cloth material that has antimicrobial properties. We’ve also implemented a multistage gowning process before entering a cleanroom. We’ve also added robust cleaning equipment and automation.
With 503B manufacturing, you have a lot more confidence in sterility. The process is less likely to contaminate the product, and you have greater consistency since a machine is filling and crimping the vial precisely every time. Everything we do centers around product quality, from the processes, equipment, training, and individuals’ qualifications. Those are the things that give me the confidence to provide the FDA and our clients the assurance that our product is sterile.
This must take a lot of training to ensure compliance.
We have training both in the quality department and the manufacturing department, as well as required training for everyone accessing aseptic processing areas. Additionally, training is specific to the process. Anyone working with product must be qualified to perform the manipulations for that process so they know exactly what they need to do during aseptic processing. We have the data to support it.
What would visitors see if they were able to tour a 503B facility?
With our facility renovations, the way we laid everything out, you can see the cGMP immediately. We have good process separation—we control the flow of people and materials to eliminate the ability to cross contaminate or commingle products. From the gowning levels and entry flow, to signage at every door, you can tell exactly who can enter a space and when. Gowning takes place in three rooms with multiple stages. All of the facility is laid out for unidirectional flow.
What other changes have been made this year?
We’ve added a filling line, and we’ve completed some facility changes to improve cGMP process flow, which are things you’d typically see in manufacturing versus traditional compounding pharmacies.
The cleanroom must be a great place to work at a time like this. What is it like to work here?
Working in a cGMP environment helps build a safe environment. There’s no guessing what you’re there to do. Knowing what you’re walking into every day, while having the ability to be a part of growth, in my opinion, makes the work highly satisfying. In process improvement, employees are the ones performing the process, so their input is valued. A lot of people want more than a paycheck—they want to know their value in the company itself. In this environment, they get to see their ideas implemented, and their role is visible in making the company great.
What does this mean to company culture?
There’s a lot of pride in a culture of quality. Quality is top of mind for everyone, not just the quality department.
What’s next? What trends and ideas are you working on?
When you look at Big Pharma, a lot of the pharmaceutical manufacturers have been established for decades, so their processes tend to be older and more conventional. There’s hesitation towards innovation because they do what works, which can be a hindrance since you can make great strides with new rapid test methods. I think we’ll see the industry begin to embrace these new technologies.
I think that’s one of the areas where we’re breaking ground. There is no template for what a 503B should be, but we’re trying to set a standard for the industry and show what a 503B can be. You can have a high level of quality and a lot of innovative test methods associated with it.
Another area we’re looking at is streamlining electronic documentation processes. Paper-based methods are validated because you have a physical signature on a signature log. We know what everybody’s signature looks like in the facility. But it’s cumbersome, difficult to track, and inefficient. Electronic documentation streamlines the process, allows for tracking and trending, and gives us a centralized database for traceability.
In the cGMP atmosphere, any improvements just get enhanced exponentially. It’s extremely valuable because you can’t prove anything without data. The FDA doesn’t tell us what we should be doing. They provide the end goal and requirements, but there are 1,000 ways to get there. It’s up to us and what we can validate with our data.
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