Our Manufacturing Process
1. Ingredient Research
- Methyl-Life looks to find the best active ingredients available in the world.
2. Ingredient Purchase
- Methyl-Life only buys top ingredients from cGMP-compliant ingredient manufacturers.
- cGMP stands for “current Good Manufacturing Practices” as determined in a set of standardized guidelines for process and procedure. These are handed down from the FDA in a pamphlet. The manufacturing guidelines indicate that manufacturing facilities need to have SOPs in place (or “Standard Operating Procedures”) which ensure the facilities are in compliance with the FDA standards for “Good Manufacturing Practices”.
3. Ingredient Shipment
- After purchase, the active ingredients go directly to cGMP certified contract manufacturing facilities in the USA where Methyl-Life products are developed and created.
4. Ingredient Acceptance
- The cGMP contract product manufacturing facilities in the USA only accept the ingredients after using a testing lab to verify all of the below (if anything fails, an ingredient is rejected and not used, instead it gets sent back to its original manufacturer):
- Identity – to ensure it’s the material that was purchased and 100% matches its specification sheet or Certificate of Analysis (CofA)
- Purity – to ensure the ingredient actually matches the stated purity ratios indicated on the specifications sheet (CofA)
- Potency – to ensure the material matches the stated potency ratios listed on the CofA
- Microbes – to ensure the ingredient has not been contaminated by bacteria, mold, or other pathogens (i.e. e Coli, Salmonella, etc.)
- Metals – to ensure the material does not have any heavy metal content above the FDA limits
5. Product Formulation
- The cGMP contract product manufacturing facilities in the USA works closely with Methyl-Life to ensure the formula that customers need is indeed correctly calculated, measured, blended, tableted/capsuled, weighed, tested, sealed, and successfully passed all quality control requirements with flying colors.
- It is worth noting that Methyl-Life takes an extra measure of care to ensure that our formulas are created with a 10-20% active ingredient overage. This is so the products will survive a 2-year shelf life and still be able to easily pass a potency test, which proves it meets its label claims. The FDA only requires a 5% overage.
- A little known fact … many companies are using generic methylfolate ingredients that are amorphous salt based (even some patented ingredients are amorphous salt based) – these amorphous salt based ingredients can lose up to 16% potency per year because they are less stable. And if these companies don’t formulate with a very large amount of the overage in the formula, the product will not be as potent as the claim on the label says it is. However, Methyl-Life uses an internationally patented crystalline salt based methylfolate, which should not lose more than 2% potency per year due to its superior stability.
- Another little known fact is that 3rd party lab testing on finished products is not required by the FDA or the cGMP process. However, at Methyl-Life, we feel this is extremely important as it allows us to validate the work of our contract manufacturers and it’s just another check we can do to ensure our products are made to the standard we require for our customers. So Methyl-Life pays additionally to have these tests done on each production batch that gets run. The products are sent away to a specialized lab that can measure the exact potencies in the product and further verify our products meet and in fact often exceed their label claim.
6. Finished Product Shipment
- Once the cGMP contract product manufacturing facilities in the USA finalize the Methyl-Life products, the products get shipped in their fully sealed and final packaging to the Methyl-Life Fulfillment Center.
- And from our Fulfillment Center, the products get shipped out to you upon order.