Ensuring Quality: Methyl-Life's Quality Assurance Practices in USA Manufacturing

The events of the past few years have seen people all over the world seek out new and better ways to optimize their health. Since 2020, sales of dietary supplements and nutraceuticals have soared. [1] 

Consequently, the role of quality assurance practices by supplement manufacturers has never been more important.

When comparing supplement brands, there are several important factors to consider. Along with reputation, cost, and valid research, a major indicator of efficacy is a brand’s quality assurance practices.

In the US, supplements are not rigorously regulated as pharmaceutical drugs. This makes robust quality management systems even more crucial. 

That’s where Methyl-Life® excels. Our dedication to customer satisfaction underpins our stringent measures to maximize the safety, efficacy, and reliability of our products. 

First, let’s explain the difference between quality assurance vs quality control.

What is quality assurance?

Quality assurance focuses on processes and systems implemented to ensure the overall quality of supplement manufacturing. It involves establishing guidelines, procedures, and standards to prevent defects and ensure consistency in the final product.

What is quality control?

Quality control involves inspecting and testing specific samples during production to identify and address any deviations from the established standards. 

So, how do we do it?

Our commitment to quality

As one of the world’s best-known methylfolate supplement manufacturers, Methyl-Life® is 100% dedicated to the Good Manufacturing Practices (GMP) set by the US Food and Drug Administration (FDA). These practices encompass rigorous testing, quality control, and adherence to standardized procedures during manufacturing, packaging, and distribution. 

Before we work with a supplier, we conduct a thorough evaluation of their credentials and certifications. We ensure they are compliant with regulatory standards and have proven track records in delivering quality ingredients. 

This assessment provides us with the transparency we need to be fully informed about the origins of our ingredients and production processes. It is imperative that every single component of our products meets the required quality benchmarks so that we can stand behind our promise to customers. We also strive to minimize the risk of harmful substances or impurities being present in our ingredients so that we can fully safeguard consumer health.

Every ingredient we use in our products undergoes third-party testing to confirm that it matches every detail on the Certificate of Analysis. If any ingredient doesn't meet the standard COA, we don't use it. 

Our determination to provide only the best is what led us to Cerebrofolate™. Cerebrofolate™ is an exclusive, patented methylfolate that has been tested in a recent study as the most potent methylfolate in the world. 

Cerebrofolate™ is superior to other L-methylfolates for many reasons. It’s a crystalline (Type I) calcium salt form of (6S)-5-methyltetrahydrofolate (or L-5-MTHF) and comprises >=80% “free methylfolate”. Other forms of methylfolate (such as L-5-MTHF, glucosamine) comprise only ~52% or less of “free methylfolate”. 

In addition, Cerebrofolate™ is produced in a CGMP facility which is FDA-registered and audited, FSSC22000, kosher, halal, and ISO9001 certified. FSSC22000 represents the highest level of

quality and certification for ingredients used in dietary supplements. And, while most companies employ skip-batch testing (testing once every determined number of batches), every single batch of Cerebrofolate™ is tested for impurities, heavy metals, potency and purity. 

Unsurprisingly, Cerebrofolate™ has been shown to retain its stability for up to two years when stored at room temperature.

These factors make Cerebrofolate™ not only one of the purest but also the most potent methylfolate on the market today, which is why we’ve chosen it as our primary ingredient. 

Technological proficiency

Our laboratory technicians apply strict testing procedures throughout our manufacturing process so that all of our products meet - or even exceed - industry standards.

This includes sophisticated analytical techniques to identify and quantify individual compounds within a supplement. This allows us to verify the potency and purity of active ingredients.

We also test for potential contaminants to ascertain that the supplement contains the intended ingredients without any unexpected or harmful substances.

Our stability testing involves subjecting our products to various environmental conditions (such as temperature, light and humidity) to assess their shelf life and ensure every supplement remains effective and safe over time.

Certifications and compliance

Methyl-Life’s® compliance with rigorous guidelines are reflected in our certifications and registration. We are FDA registered and audited, use NSF certified manufacturers, and follow cGMP best practices. 

We implement stringent quality control measures at every stage of the manufacturing process. We are committed to ensuring that our finished products meet the required standards of purity, strength, and composition.

Our cGMP best practices are followed to ensure that our facility adheres to FDA regulations and has passed all audits for quality control. The cGMP is essentially an FDA-recommended baseline for all supplement manufacturers as it proves we have the right safety practices in place to control risks and hazards. Third-party independent assessment confirms these safety practices and processes. 

Most importantly, the majority of our manufacturers are NSF certified. 

Methyl-Life® meets these criteria:

• Hygiene standards

Methyl-Life® manufacturing facilities maintain a high level of cleanliness and sanitation to prevent cross-contamination and ensure the integrity of our products.

• Trained personnel

We employ trained and qualified personnel who understand cGMP principles and follow the procedures to maintain product quality and safety. Our employees receive regular training on cGMP principles, safety protocols, and quality standards to uphold a culture of excellence and compliance.

• Documentation

All of our manufacturing processes, including equipment calibration, testing, and product formulations, are fully documented for traceability and accountability. 

• Raw material testing

All raw materials used in Methyl-Life® supplements undergo thorough testing to ascertain their purity and potency. These stringent quality checks allow us to identify and prevent potential contamination, adulteration, or mislabeling of products. 

• Third-party testing

Every product developed by the manufacturer has its own Certificate of Analysis based on post-production testing. In addition, every batch is also third-party tested for potency at an independent lab to ensure the results are consistent. 

• NSF certification

NSF certification is the highest assurance that a product has been tested by a trusted independent certification organization. This certification is well beyond FDA requirements as it ensures every aspect of a product's development is thoroughly evaluated. NSF certification is not a one-off: it involves regular re-testing of products alongside on-site inspections of manufacturing facilities. 

• Batch testing (NOT skip-batch testing)

Each batch of finished products undergoes testing to verify its compliance with quality standards before being released for distribution. Many companies only employ skip-batch testing (i.e., batches are tested at random). At Methyl-Life®, we test every batch, we believe our consumers deserve the very best. This ensures that our consumers receive products with accurate ingredient lists, appropriate potency, and minimal risk of harmful impurities.

• Environmental control

Our manufacturing facility is equipped with environmental controls to maintain conditions such as temperature and humidity, preventing sensitive ingredients from degradation.

• Supplier verification

We conduct regular audits and verification of our every supplier to establish their adherence to cGMP principles and the quality of their raw materials.

• Customer services

Methyl-Life® puts every customer first. We address every query and question promptly and thoroughly to provide a resolution as quickly as possible.

Evolving through feedback

Methyl-Life® takes feedback seriously. We actively encourage our customers to share their experiences with our products and services. This information contributes to our continuous improvement and our relentless pursuit of excellence. It also allows us to address any concerns. We’re always looking for ways to improve or exceed our customers’ expectations!

Our website includes several options for customers to contact us, including an inquiry form. Our internal support team is available via email, and live chat. We do not outsource our customer support to any contractors or third-party companies: our customer support is entirely in-house.

We get many questions from our customers regarding MTHFR, supplements, and other health concerns. Our team of qualified health professionals respond to these personally. We also address the most common questions on our Customer Support page. It’s all part of our commitment to going the extra mile for our valuable clientele. 

The takeaway

Methyl-Life® is proud to be wholly transparent about its manufacturing procedures. Our long list of credentials and certifications reflects our tireless commitment to creating safe and effective products. We seek to not only meet but exceed our customers’ expectations in every way. 

Our robust quality assurance practices play a crucial role in upholding the integrity of the US supplement industry and empowering consumers to make informed choices about their health and well-being.

Reference

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8416287/