'You're Going to Need Clever Humans' // #1 - Kiran Dayaram // The Extraction Insiders
“What GMP brings is confidence in the manufacturing process because you’ve got so many checks and balances along the way...in the long term you actually save money because you have less non-conformances to deal with because you’ve got so many systems in place to catch things as soon as they happen.” – Kiran Dayaram
Connect with Kiran Dayaram:
Selected Links and People Mentioned from this episode:
Gastropod Podcast – creation of the U.S. Federal Food & Drug Administration (FDA)
GMP Intro Video from Vitalis
[00:05] Joel and Jason get right to it and welcome their first guest Kiran Dayaram.
[00:10] Seeing the opportunity that exists in the cannabis industry, Kiran and his fiancée embarked on an adventure that brought them from New Zealand to Canada.
[01:06] Kiran explains his role as the Guru of GMP (Good Manufacturing Practice), what GMP aims to achieve and why it is important for all consumers. Mishap breeds necessity.
[04:32] GMP compliance. Kiran sheds light on what is driving the current push and considerations for pivoting a non-compliant facility to compliant.
[06:55] Kiran’s advice for someone getting into the game of turning an existing manufacturing facility into a GMP compliant manufacturing facility. As with most undertakings, learn from the experience of others and engage the experts to guide you through the process.
[09:08] In the space of GMP compliance the importance of quality control and the integrity of each step in the process, from the origin to the end-product of the manufacturing chain, cannot be understated. From a risk perspective is it easiest to simply start from scratch vs. retrofit?
[11:00] Kiran gives examples of way to assess suppliers for GMP compliance and questions to ask in the important due diligence process.
[13:16] The thread of the GMP compliant manufacturer doesn’t rest with one, it weaves through every piece of the company and is reliant on the whole.
[15:30] Kiran explains the various levels of GMP and what products they apply to. A broad capability and forward-thinking facility generates opportunity to respond to evolving market demand.
[18:33] Expanding on the point of agility, Kiran, Joel & Jason talk about why setting up a one-horse facility that meets the minimum current standards won’t allow manufacturers to be nimble for the inevitable dance of changing rules and regulations.
[19:24] Ultimately GMP compliance inspires confidence in the integrity of the product for your customers. The checks and balances integral in the process from the raw material forward allow for the highest standard of quality control.
[23:24] Kiran provides examples of how hazardous it is without those process controls in place. Once those risks are attached to a product or brand, they may not be in business much longer!
[25:59] Consistent output proves far more difficult when the input material (in this case botanicals) is never the same. Kiran talks about automation in the hemp and cannabis space and the variance that needs to exist. Good news for clever humans, they are still vital in the process of extraction.
[30:25] Hear Kiran’s thoughts on implementing GMP for a small-scale operation.
[31:16] Global cannabis laws, how it relates to GMP regulations and accreditation and the critical importance of knowing where you will be selling your product. Cannabis is a growing, evolving industry still in its infancy and there is so much more to do and learn.
[34:25] As the extraction industry expands, Kiran identifies some of the key questions people should be considering and asking themselves as they get into the business. Having a market focus will be far more efficient for the bottom line.
[36:08] Kiran offers his insights into where the industry is headed, guidance to those entering the extraction space and the role that the extraction method may play in the ease of getting GMP certification. It goes back to being nimble and flexible.
[40:27] From the GMP perspective, Kiran shares the full-service experience a Vitalis customer can expect. The Vitalis GMP program is designed to educate their customers and offer a tailored experience based on their knowledge and user requirement specifications (URS).
[41:55] Providing tools like a URS template to give customers a head start and simpler equipment customization process for their particular extraction needs, is one way Vitalis strives to set their customers up for success.
[44:21] Kiran flips from interviewee to interviewer to talk about when Jason and Joel first heard about GMP, the difference in customer profiles from North America to Europe, the quality of questions improving with time and Vitalis’ forward-thinking approach.
[49:25] Ask Kiran! Reach out to him through the Vitalis website and check out not one, but two of Kiran’s GMP webinars.
Listen to this episode of 'The Extraction Insiders' at GetXtracted.com.