Welcome to exceeding your benchmark. A podcast brought to you by benchmark products. Tune in as we explore life science industry relevant topics, discuss industry leading practices, and dive into cutting edge solutions the industry has to offer. This is the exceeding your benchmark podcast. Hello, everyone, and welcome to another episode of seating your benchmark, a podcast brought to you by Benchmark Products. I'm most for today, Gabrielle, and I'm thrilled to be joined right now by guest, Missyne Samuel, who's actually co founder and partner at Gxp Act Consulting. Today, we'll be exploring the fundamentals of validation in life science manufacturing From start ups to large scale operations. So you're joining us to share their expertise today is Naseem. So Naseem welcome. Thank you, Gabriel. I'm the same Samuel, co founder and owner of, Gxp impact consulting. My background, I've been in a industry for over twenty seven years, working on validation, and it's all is components, whether it's a qualification, commissioning, process validation, cleaning validation, and today, I will answer questions about validation and how we can help you navigate the compliance and validation world. Absolutely. Thanks again for joining us, and I wanna ask you As an expert in the field, could you explain to our listeners, particularly those who are new to the life sciences industry, what exact evaluation means in this context and just why it's so critical to everything from startups to large scale operations. Sure. I can answer that. So validation is the process of verification to safeguard that the product meets the requirements. And the design specification, which is the quality of the product, the safety of the product, the efficacy of the product, and the design of the the product how it's being done to make sure that when it gets to the patient, it's a safe and efficacy product that they can rely on. So the safety of the product is a key and validation is the science that we use to make sure that the product is, safe for the patient. Well, sure. As the regulatory landscape, it just keeps evolving and it continues. So what are some of the key challenges that you've seen companies face to maintain a compliance with current, but also future changes that may be coming. Share some examples that you might have from your experience where changes in regulations posed, almost pretty significant roadblocks or challenges. So the the the the changes in the regulation really, is always looking for the patient safety. So if there is added measures that the regulators put on industry, is to protect the patient's safety and ensuring that the data is available to answer the question. Is the product safe or not? I see, the word validation also is used in generality. Under the umbrella of validation, there is multiple things that happen from, and we can look at a startup for a facility that's starting with, you know, just an empty shell They're gonna build clean rooms. They're gonna add equipment. They're gonna, add utilities. All these elements support the product development and the product validation at the end of its, life cycle. You know, the the idea is to make sure that the facility is adequate the equipment is adequate. All the utilities, whether it's compressed air or, WFI water, that's gonna be added to the product. How do we validate these things? How do we ensure that the product gets a pure and safe product. When your experience, what are some of the main challenges that startup space in terms of building knowledge in house but also maintaining effective validation processes. How does this compare, to the challenges faced by larger, maybe more established companies by comparison? So, in a in a startup, validation is is a a later step in the process And, but, you know, we, as a validation professionals, we're always challenged that we're the end of the line. If the project doesn't go on time, we are being tasked with, you know, compressing our timeline. You cannot make up that time again. If you already have a date in mind for a product launch, and you need your facility qualified, and you're gonna have, inspections or audits All that hinges on, you know, how validation can be performed and ensuring, again, the quality of every element that's coming together, equipment, facility, and the the environment itself even matters. So all that needs to come together at the end And for startups, sometimes the the startup is looking into well, we we are phase one. We are phase two. You really don't get into validation till you're really ready to be commercialized. And that's on the product side. But you have commissioning for the facility. You have commissioning for the utilities. Then you have validation comes in towards the latter part of the formula before ready to launch product. And if you're a phase one, start up, you have, you know, you you don't have that requirement for validation, but a lot of companies they are electing to qualify their equipment or commission their facility to ensure that the same facility that they're doing the phase one and phase two is the same facility they will transition into phase three and commercial product. And my experiences having documentation early on and having the understanding of everything you're designing for your process. Will help you in launching the product successfully again. Nassim, could you talk about the potential implications, but also the risks of utilizing outside services for validation. So how does a company decide what aspects to outsource, but also what to keep in house? That that that's a that's a really great question because through my twenty seven years, I always try to keep process validation in house. The things that you can go and outsource are the early commissioning of the building because you have only one building. Once you commission as a company, you're done with with the commissioning. You're not gonna repeat it again. Unless you're scaling it to another site or you're getting to a bigger site, you you start the process all over. So process validation, you wanna keep in house and maintain that inside. I would like to talk maybe more about when you're designing your facility, the commissioning part is for the utilities, for the HVAC system, the environment itself All these things can be outsourced. And we we try to help companies with with planning that early on having the site validation master plan explaining what's gonna be included in the project and what's gonna be done at every phase from commissioning qualification cleaning process validation, all that needs to be spelled in your site validation master plan. But I strongly, recommend that the knowledge of the product stay in house. And that's a that's a completely unbiased opinion from from doing it for many, many years in the industry. The process is to make sure that we're really the company is benefiting and the patient is benefiting. So you wanna retain that in house, the process validation piece. All the earlier work can be outsourced. Absolutely. Well, as we start wrapping up the conversation here in the scene, lastly, as life science manufacturing continues to grow and evolve What strategies or practices can companies begin to implement to effectively manage that growth, but also ensuring validation and compliance at the same time? So validation is is a is a life cycle approach, you know, from beginning of commissioning of equipment, commissioning the facility, qualifying equipment and validating some of the utilities, validating your clean rooms, validating the process. All that is a is a life cycle management approach. And regulators allow companies to build their own infrastructure, come up with their own plans. But once you create these plans, you're adhered to maintain and follow these plans. So we at Gxp also help companies with putting in the commissioning the SOPs, the qualification, the validation. We we also help companies with asset management. How do you maintain your asset for its lifetime to ensure that this asset is reliable enough to produce the product day after day? So we are always looking for the full life cycle management for this experience for the clients as their starting their own new, ventures. Alright. Miss Seem, so here we are at the end of the podcast. Are there any last thoughts you wanna share with our audience, something important that maybe we left out. I I just wanna talk about, under the validation umbrella, there is the term CQV, and CQV stands for commissioning qualification and validation. Commissioner is a term used for facility and utility commissioning qualification is used for IQ OQ and PQ, which is the qualification of equipment, and validation is used for processes like product validation, cleaning validation, and environmental monitoring for the environment in the facility. Well, that wraps up the conversation for today. Of thank you in this scene for joining us to explore the fundamentals of validation and life science manufacturing from startups to large scale operations. It was a pleasure to have you on the podcast. Gabrielle. Thank you. Of course. Well, thank you to Seemid. If you want to learn more, please visit benchmark products dot com and look for this podcast wherever it is you get your podcast at. I've been your host Gabrielle. Thanks for tuning in.
