GMP V. cGMP Manufacturing

GMP and cGMP Contract manufacturing is a form of outsourcing. It is an agreement between a manufacturer and company to make products, or product components, on an agreeable, predetermined timeline. 

After the contract manufacturer completes their manufacturing portion, the outsourcing company will use the product in their own manufacturing. If the contract manufacturer is wholly producing the product for the outsourcing company, they will return the completed product. 

If you choose to outsource supplement production within your business, ensure that you partner with accredited manufacturers that value product control. Seek out cGMP certified facilities to guarantee product legitimacy and quality. 

Contract Manufacturing Regulations

The Food and Drug administration enforces regulations. All reputable nutraceutical manufacturers abide by the set regulations to ensure proper monitoring, control and production measures are taken within the facility. If you are looking for a contract manufacturer that abides by FDA regulations, seek out GMP or cGMP certified facilities. 

What is GMP?

GMP stands for Good Manufacturing Practices. GMP certifications require nutraceutical manufacturers take proactive steps that guarantee product contents, safety and quality. These regulations function to prevent cross-contamination, labeling errors and other sources of product error. Strict regulations support consumer safety and experiences. 

What is cGMP?

cGMP stands for current Good Manufacturing Practices. As with GMP, these practices ensure proper monitoring, control and production measures are taken within the facility. Current Good Manufacturing Practice certification ensures product legitimacy and quality. Beyond the scope of standard GMPs, certified cGMP facilities must incorporate modern technologies that comply with evolving FDA regulations. 

The goal: manufacturer the highest quality supplements through continual improvement. 

GMP V. cGMP

The two regulation standards function similarly. Each ensure product control by preventing contamination errors, labeling errors and other sources of product corruption. Both manufacturing models create guidelines around the following scopes: 

  • Cleanliness
  • Complaints
  • Documentation
  • Equipment 
  • Inspections
  • Qualification
  • Record Keeping
  • Sanitation

However, the two differ in standards and cost.

Standards

  • GMP ensure product control meets the minimum nutraceutical industry standard
  • cGMP ensures product control meets, exceeds and evolves with changing FDA standards

Cost

  • GMP evolves slowly and meets industry standards with less expensive technologies
  • cGMP requires additional testing and expensive technologies that quickly evolve

Both regulations ensure product legitimacy and support consumer safety. cGMP requires greater investment. But it allows manufacturers to abide by continually evolving industry regulations and standards. 

Is cGMP Certification Important?

In short…YES!

When dealing with nutraceuticals, cGMP certification is crucial. It ensures the quality and efficacy of supplements—preventing contaminated and adulterated supplements from entering the market, promoting user safety. 

If you choose to outsource supplement production within your business, ensure that you partner with accredited manufacturers that value product control. Seek out cGMP certified facilities to guarantee product legitimacy and quality

Mineralife Named Top 10 in Contract Manufacturing

Communication, customer service and the ability to be completely transparent with our customers. These are only some of the reasons Mineralife Nutraceuticals was named a Top 10 Contract Manufacturer by Manufacturing Outlook.

Founder and Owner, Neil Butterfield has been a leader in the dietary supplement industry for more than a decade. He does not plan on slowing down anytime soon. Mineralife has specialized in custom supplements and powder capsule formulations for quite some time. The goal is always ultimate bioavailability.

After all, you are not what you take. You are what you absorb.

What’s Next for Mineralife Contract Manufacturing?

In 2022, Mineralife Nutraceuticals has been working hard to offer even better turnkey solutions to its customers. With an expanded raw material database, and building long-term relationships with key packaging suppliers in the industry Mineralife strives to keep costs low and turnaround times reasonable for its clients.

Soft gel manufacturing will begin nearing the end of Q4. The sky is the limit for both Mineralife and our customers. We will be one of the very few manufacturers to offer customizable soft gel products at a low minimum order quantity. Mineralife expects a full roll-out early 2023 for this service.

Of course, we did not get this far by saying ‘yes’ to everything. The process of taking on new projects for clients is selective. Mineralife chooses to work with clients based on research and development projects, respect towards regulatory compliance, and a shared dedication to quality. Luckily, Mineralife Account Coordinators are there for clients every step of the way. They will guide our customers through each of these processes.

Offering a turnkey custom manufacturing solution, we pride ourselves on quality, honesty, and hard work. A large database of raw materials is at our fingertips and grows by the day. We can guide our customers towards an effective powder capsule formulation. Equipped with a great team of label regulatory experts, we can steer both Mineralife and our customers in the right direction.

What can we create for you?

We love to set up frequent calls with our clients to check in on progress, provide real-time updates to their project and discuss forecasting. Transparency is important to us, and we know it is important to our customers as well.

We closed 2021 by achieving a third-party cGMP certification and a third-party USDA Organic Handler certification. Entering 2022, we are dedicating the honor of being named a Top 10 Contract Manufacturer to our dedicated staff, long-term customers, and everyone else who has supported us along the way. We are excited for what this new year will bring.  

Softgel Supplements: What Are They?

Dietary supplements function to close nutrient gaps in our diets. But supplement efficacy depends on successful delivery. Softgels support nutrient sufficiency via oral delivery mechanisms. 

They have been used pharmaceutically for over 75 years—precisely delivering capsule contents.

Please Note: softgel capsules deliver both nutraceuticals and pharmaceuticals. This blog pertains to and discusses only nutraceutical delivery.

What Are Softgels?

Soft gels deliver nutrients orally via specialized capsules. They utilize a gelatinous shell that holds liquid vitamins and minerals within. The gelatinous texture allows the capsule to easily break down once it reaches the intestinal tract. Once the softgel dissolves, the encapsulated nutrients are released and absorbed into the bloodstream for efficient use by the body. 

Benefits of Softgels

Though this list is not exhaustive, below are some of the benefits of softgel capsules: 

  • Increased Bioavailability: stabilizing techniques allow for controlled release
  • Easy To Swallow: flexible & smooth exterior with no taste or smell 
  • Rapid Release: promotes fast dispersion & absorption into the bloodstream
  • Air Tight Seal: hermetic seal protects nutrient contents from light & oxygen
  • Precise Dosage: accurate dosing supports the effectiveness of low & ultralow doses

Gelatinous capsules offer precise delivery. Their structure dissolves rapidly once it reaches the intestinal tract, increasing bioavailability and supporting absorption. Softgels offer precise dosages, supporting individuals with low-dose needs. 

Afterall, you are what you absorb!

How Are Softgel Supplements Made?

Softgel supplement manufacturing requires extensive pharmaceutical and machinery knowledge. Below we offer a simplified version of the average softgel manufacturing process: 

  1. Internal components—the supplemental nutrient—undergo quality-control checks
  2. Gelatin, glycerin and water are blended to create the capsule base
  3. Nutrient fills—what goes in the softgel capsule—are diluted to the correct potency
  4. The capsule base is cooled into two gel sheets & formed into the desired capsule shape
  5. As the two sheets come together, the nutrient fill is injected into the capsule
  6. A rotating drum minimally dries the softgels until they maintain a consistent shape
  7. The capsules then undergo a controlled air-dry outside of the rotating drum
  8. Once dried, the softgels are packaged for delivery and consumption

Though softgel manufacturing offers standardized supplement capsulation, procedures and machinery may vary by manufacturer.  

Quick Facts about Softgel Supplements: 

Nutraceuticals support nutrient sufficiency by supplementing deficient vitamins and minerals. Softgels deliver nutrients to the body via gelatinous oral capsules. 

Benefits of softgels include the following: 

  • Easy To Swallow: smooth & tasteless exterior is easier to swallow than chalky tablets
  • Increased Bioavailability: stabilizing techniques allow controlled & precise delivery
  • Air Tight Seal: protects nutrients from light & oxygen to maintain viability

Softgel supplements may support a positive supplement experience. If you have individual concerns, speak with your healthcare provider about what supplement delivery mechanisms best suit your personal needs!

Tablets vs Softgels

Dietary supplements close nutrient gaps by supplementing deficient vitamins and minerals. Supplements come in varied forms, supporting diverse individual needs. But…what are the benefits of softgel supplements versus tablets? And what delivery mechanism best supports your needs?

What Are Softgels?

Softgels deliver nutrients orally via specialized capsules. They utilize a gelatinous shell that holds liquid vitamins and minerals within. The gelatinous texture allows the capsule to easily break down once it reaches the intestinal tract. After the softgel dissolves, the encapsulated nutrients are released and absorbed into the bloodstream for efficient use by the body. 

Benefits of Softgels

Though this list is not exhaustive, below are some of the benefits of softgel capsules: 

  • Increased Bioavailability: stabilizing techniques allow for controlled release
  • Easy To Swallow: flexible & smooth exterior with no taste & smell 
  • Rapid Release: promotes fast dispersion & absorption into the bloodstream
  • Air Tight Seal: hermetic seal protects nutrient contents from light & oxygen
  • Precise Dosage: accurate dosing supports the effectiveness of low & ultralow doses

Gelatinous capsules offer precise delivery. Their structure dissolves rapidly once it reaches the intestinal tract. This increases bioavailability and supports absorption. Softgels offer precise dosages, supporting individuals with low-dose needs. 

Disadvantages of Softgels

  • Nutrient Limitations: moisture-sensitive nutrients may become unstable in the gelatinous shell
  • Expense: typically more expensive to manufacturer than tablets
  • Nutrient Formulations: only inclusive of liquid form nutrients—no powders

What Are Tablets?

Tablets orally deliver supplemental nutrients via compressed powders. The compressed power typically consists of the supplemental nutrients and bonding additives. Tablets often come coated to prevent early breakdown and support targeted delivery. Because tablets often come in chewable and dissolvable forms, they may better support individuals that have difficulties swallowing whole pills. 

Benefits of Tablets

Though this list is not exhaustive, below are some of the benefits of tablets: 

  • Chewable & Dissolvable: beneficial for those with difficulties swallowing whole pills
  • Multiple Delivery Mechanisms: immediate release, extended release, delayed release
  • Easy To Split: smoothly split when needed and/or recommended
  • Inexpensive: often cheaper to manufacture than softgel capsules

Tablets are formed by compressing powdered nutrients with bonding additives. So, they tend to have more durable shelf lives. Tablets often come in chewable and dissolvable forms, supporting individuals with swallowing difficulties. 

Disadvantages of Tablets

  • Taste: aftertastes & chalky texture may be unpleasant
  • Unpredictable: dissolve & release nutrients inconsistently which may affect efficacy
  • Slow Absorption: often absorbed slower than quick-release softgels

What should I recommend to my customers?

Supplementation exists to close nutrient gaps in our diets, supporting body health. If the supplemented nutrients are not absorbed, your body will not experience the desired health and wellness effects. When deciding if you should supplement softgels or tablets, keep in mind…

You are what you absorb!

One delivery mechanism does not inherently trump the other. The best delivery mechanisms—softgel or tablet—is the one that best serves your supplementation needs. Consider the pros and cons. Then decide which mechanism will best support your customers goals.

Softgel FAQ

We are offering answers to frequently asked questions (FAQ) regarding softgel supplements. 

What Are Softgel Supplements?

Softgels deliver nutrients orally via specialized capsules. They utilize a gelatinous shell that holds liquid vitamins and minerals within. The gelatinous texture allows the capsule to easily break down once it reaches the intestinal tract. After it dissolves, the encapsulated nutrients are released and absorbed into the bloodstream for efficient use by the body. 

How Are They Made?

Softgel supplement manufacturing requires extensive machinery knowledge. Below we offer a simplified version of the average manufacturing process: 

  1. Internal components—the supplemental nutrient—undergo quality-control checks
  2. Gelatin, glycerin and water are blended to create the capsule base
  3. Nutrient fills—that will go in the capsule—are diluted to the correct potency
  4. The capsule base is cooled into two gel sheets & formed into the desired capsule shape
  5. As the two sheets come together, the nutrient fill is injected into the capsule
  6. A rotating drum minimally dries the softgels until they maintain a consistent shape
  7. They then undergo a controlled air-dry outside of the rotating drum
  8. Once dried, they are packaged for delivery and consumption 

Though softgel manufacturing offers standardized supplement capsulation, procedures and machinery may vary by manufacturer.  

Is Manufacturing More Expensive?

Often…yes. 

Softgel manufacturing requires intricate technology and knowledgeable manufacturers. The expertise, machinery, quality and efficacy come at an increased cost. 

Benefits of Softgel Supplements

  • Increased Bioavailability: stabilizing techniques allow for controlled release
  • Easy To Swallow: flexible & smooth exterior with no taste & smell 
  • Rapid Release: promotes fast dispersion & absorption into the bloodstream
  • Air Tight Seal: hermetic seal protects nutrient contents from light & oxygen
  • Precise Dosage: accurate dosing supports the effectiveness of low & ultralow doses

Does Mineralife Manufacture Softgel Supplements?

Yes! Starting in 2023, Mineralife Nutraceuticals will offer softgel manufacturing services to our clients. Inquire with us today.

Mineralife Nutraceuticals Thanks YOU!

Mineralife—a company devoted to accessibility, wellness and community.

Quality product, communication, customer service and transparency base Mineralife Nutraceuticals. These standards pushed our company into the Top 10 Contract Manufacturers by Manufacturing Outlook. Our company is honored by this achievement.

An achievement made possible by you…our customers, suppliers, employees and families.

Each of you plays an important role in the Mineralife family—from timely suppliers to intentional employees to loyal customers. We are grateful for each of you and appreciate your dedication. 

As you serve us, Mineralife aims to serve you. 

We want to acknowledge your timeliness, quality product, commitment and consistency. These attributes foster success year after year. 

For a decade of wellness, manufacturing and community—and to the years of growth to come—we sincerely thank you!

Contract Manufacturing – How Can Mineralife Serve You?

Though manufacturing supplements in-house is desirable, it is not always feasible. Materials and time are finite resources and contract manufacturing expertise is costly. The former should not prevent your supplement production goals. 

Mineralife Nutraceuticals supports global accessibility to health and wellness. We are a cGMP supplement manufacturer. We are here to help others source, create and reach their supplement goals via contract manufacturing. 

What Is Contract Manufacturing?

Contract Manufacturing is a form of outsourcing. It is an agreement between a manufacturer and company. The manufacturer makes products, or product components, on a predetermined timeline. 

Regarding partial manufacturing, the manufacturer completes their portion, and the outsourcing company uses the partial product to complete their own manufacturing. If the contract manufacturer is wholly producing the product for the outsourcing company, then they will return the completed product for distribution.

What Is A cGMP Supplement Manufacturer?

A cGMP supplement manufacturer is a supplement contract manufacturer that holds cGMP certification. Current Good Manufacturing Practice (cGMP) certification, ensures product control within a company with subsequent quality standards.

cGMP Certification ensures product legitimacy and quality.

Mineralife Nutraceuticals is a cGMP manufacturer with over 30 years of experience in formulation, manufacturing and packaging capsule supplements. We are an FDA-registered and inspected facility. 

Why Should You Partner with Mineralife Nutraceuticals?

Mineralife ensures all operations and processes are carried out above and beyond regulatory requirements. It is capsule manufacturing that you can trust. Below are our key attributes and offers: 

  • Quality Ingredient Sourcing from Around the Globe
  • Manufacturing in Colorado Springs at Our Own Facility
  • Competitive Pricing and Reasonable Turnaround Times
  • cGMP Compliant and FDA Registered Facility Practices
  • Third-Party Testing, Shelf-Life Stability Testing and more
  • Label Control and Regulatory Compliance

Beyond capsulizing, we offer turnkey supplement manufacturing. Our facility can support your supplement production via turnkey services—producing both powder- and liquid-based products. We offer the following services: 

  • Powder Capsule Supplements
  • Quality Ingredients from Around the Globe
  • Liquid Mineral Supplements
  • Global Supply Chain and Raw Material Procurement
  • Vitamin Manufacturing
  • Quality Control

Quick Facts: 

Contract manufacturing is a form of outsourcing. Companies that lack time, funding and expertise outsource supplement production to private label manufacturers.

Mineralife offers the following: 

  • cGMP Certification: ensuring product control and quality standards
  • Turnkey Supplement Manufacturing: manufacture your supplements start to finish
  • Types of Supplements: we create powders, capsules, tinctures and liquids to support your unique company

If you have nutraceutical ventures you would like to pursue—custom manufacturing, CBD, white-labeling, co-packaging services—we would love to help! Contact us today about your contract manufacturing needs!

Mineralife is Hiring 📢

Mineralife Nutraceuticals is looking to hire a Soft Gel Manufacturing Expert with experience in food or cGMP dietary supplement manufacturing—21 CFR 111 or 21 CFR 117. 

Who is Mineralife Nutraceuticals?

Mineralife Nutraceuticals is a nutraceutical company dedicated to creating, sourcing and making accessible cGMP certified goods. 

Mineralife Nutraceuticals LLC was founded in 2008 to help bring honesty and transparency into the world of dietary supplements and nutraceuticals. We strive to deliver hope that customers can count on. People buy supplements—hoping—that they will actually work for them. 

Our mission is to deliver hope by helping develop products that actually work.

Our team is composed of individuals dedicated to health and wellness—in their own lives and the broader community. Whether our team members are canyoneering or walking local trails, they are dedicated to the pursuit of wellness. Personal and professional comradery allow the Mineralife team to work together—creating goods that support the wellness of the global community. 

Our Philosophy: You Are What You Absorb

When you choose to supplement—it is not what you take—but what you absorb that counts. Mineralife understands the importance of absorption in creating a positive supplement experience. 

Our personal retail brand is formulated with ingredients that support the absorption of essential nutrients. We use advanced delivery systems that mirror nature to supply the nutrients your body needs. We ensure the product is highly bioavailable within the body.

Interested in working with Mineralife Nutraceuticals? Tell us a little bit about you by filling out the form below and we will reach out.

Liposomal Delivery FAQ

We are offering answers to frequently asked questions (FAQ) regarding liposomal delivery.

What Is Liposomal Delivery? 

Liposomes were created to deliver nutrients to our cells. Their structure allows them to withstand the digestive tract. Thus, ensuring the nutrients reach their intended destination in the body. They have water soluble heads and water avoidant tails—making them fat-soluble. Their dual nature allows manufacturers to encapsulate nutrients for targeted supplement delivery. Liposomes increase bioavailability. Increased bioavailability allows for increased nutrient absorption. 

What About Nutrient Absorption? 

Oral supplements typically come in a capsule, tablet or liquid tincture form. Standard oral supplements cannot withstand our stomach acidity—thus promoting early release. Early release decreases bioavailability. Decreased bioavailability decreases potential nutrient absorption. 

Liposomal supplements encapsulate nutrients in fat-soluble membranes. This allows them to withstand harsh environments and accurately deliver nutrients. Liposomal delivery increases bioavailability. Increased bioavailability allows for increased nutrient absorption. Remember…

You are what you absorb!

To experience the benefits of supplementation, your body must absorb the nutrients. Liposomal delivery supports absorption. Therefore, it is the ideal supplement delivery mechanism. 

Is it More Expensive?

Manufacturing liposomal supplements comes at a cost. But it is a cost worth paying. While the upfront production costs are higher than standard tablet supplements, liposomal supplements sell at a higher price point. The cost returns twofold. Consumers are willing to pay the higher price point as efficient absorption allows smaller doses of quality liposomal supplements to function more effectively than high dose tablets.

Benefits

  • Bioavailability: higher absorption than other oral supplements
  • Increased Delivery: increased intracellular delivery
  • Inclusive: ideal for those who cannot swallow tablets
  • Adjustable: allows for incremental dosing for all ages
  • Cost Effective: lower dosages offer the same effect

Does Mineralife Nutraceuticals LLC Practice Liposomal Delivery?

Our founder always states…

It is not what you take, it is what you absorb that is important!

So, YES!

Mineralife Nutraceuticals functions on the belief that the most important thing is absorbing the nutrients inside the supplement. They practice liposomal delivery to ensure their customers consume—and clients create—effective supplements. 

Glutathione: Reduced VS. Liposomal

The body runs best when fueled with all necessary nutrients—vitamins, minerals and antioxidants. Individuals take supplements to ensure their bodies receive adequate nutrients. A supplement only offers a positive effect when absorbed into the bloodstream. 

You are not what you consume but what you absorb!

There are many supplement delivery mechanisms. Your optimal delivery mechanism correlates to your supplement absorption and general health needs. Today we are looking at two different delivery mechanisms—reduced and liposomal—to deliver the antioxidant glutathione. 

What Is Glutathione?

It is an antioxidant. Antioxidants neutralize oxidative stress, protecting cells from free radicals. Because it is concentrated in nearly all body cells, it is considered the most powerful antioxidant. Glutathione is both endogenous and exogenous. Our body produces it from within. But we also consume it by eating whole foods. 

Benefits include: 

  • Antioxidant: protects cells against free radicals
  • Detox: essential in neutralizing and eliminating toxins from cells
  • Energy: protects mitochondria from oxidative damage and free radicals
  • Aging: supports skin elasticity and a youthful appearance

Natural sources include green vegetables, turmeric and sulfur-rich foods. If you struggle to consume enough in your diet, you might consider supplementation. Supplements function on two primary delivery mechanisms—reduced and liposomal. 

Reduced VS. Liposomal

The primary glutathione supplement delivery systems are reduced and liposomal.

Below you can find a chart that quickly compares the mechanisms. 

Both mechanisms support supplementation. The primary difference is the delivery mechanism and consequent absorption. Reduced L glutathione performs well when supplemented through suppositories. However, bioavailability decreases when taken orally. 

Reduced loses concentration while traveling through the digestive tract. 

Liposomal delivery protects the glutathione in a phospholipid bilayer—a liposome. This prevents supplement degeneration when traveling through the digestive tract. The liposome increases bioavailability by releasing the glutathione in an optimal location. This increases efficacy. 

Liposomal glutathione increases bioavailability and consequent absorption. 

Should I Supplement with Reduced or Liposomal?

Supplementation functions to increase explicit nutrients in the body to support body health. If the supplemented nutrients are not absorbed, your body will not experience the desired health and wellness effects. After all…

You are what you absorb!

When discussing oral supplementation, liposomal glutathione better supports absorption. 

If you have concerns—or questions about what supplement mechanism will best serve you—please reach out to your healthcare provider!