The formulation, product development and dietary supplement manufacturer included some resources in the kit such as examples of key documents, procedures and regulations necessary for cGMP compliance.
Adel Villalobos, CEO and Founder of Lief Labs told NutraIngredients-USA that the GMP Starter Kit initiative aligns with the company's mission. “ Our vision is to make a positive impact on our industry. We want to help our partners be positive contributors to the health of consumers while ensuring they are good stewards of the industry. Providing our regulatory know-how to the industry is a small step in that direction.”
When brands partner with Lief Labs, they are provided with a GMP Starter Kit that includes three critical SOP (Standard Operating Procedures) guidance documents that Lief designed to help brands get their own regulatory framework and quality unit started. Following the initial complimentary GMP Starter Kit, Lief customers will then have the option of purchasing seven additional critical SOPs. The additional SOPs offer a range of compliance initiatives that can be used to start off the regulatory compliance process.
Villalobos said some of the supplement brands must have SOP’s in place that ensure they properly audit their contract manufacturing partners, handle an audit, manage adverse event reporting as well as properly manage and investigate consumer complaints.
Villalobos added, “A lack of knowledge and non-compliance with FDA regulations places a brand’s reputation and inventory at risk and can also lead to product recalls and account suspension on vital distribution channels, such as Amazon. Lief wants to help build brands that are not only innovative, sustainable and marketable, but also industry compliant and we've developed the GMP Starter Kit to put companies on the right path to cGMP compliance from the start.”
But it’s not just about a brand’s individual reputation. Villalobos said compliance is crucial for the industry as a whole: “All it takes is one bad player to ruin it for the rest of the industry in terms of consumer trust. We need to police ourselves to ensure the industry delivers to consumers and maintains their trust.”
“The industry has come a long way in terms of compliance. I’m not concerned with the industry as a whole. But it is few bad players. All industries have their bad apples. But, Lief, together with industry stewards and trade organizations like the Natural Product Association (NPA) will continue to spread the word and work hard to grow the industry the right way.”
The free GMP starter kit can be found here.