Supplement manufacturing in-house, though desirable, may not be feasible. Materials and time are finite resources, and manufacturing expertise is costly. The former should not prevent your supplement production goals. 

Presumably, you stumbled across this post with the intent of learning more about supplement manufacturing and the resources available to you. Below we will detail two supplement supports new businesses often seek out as they begin their production process: 

• Contract Manufacturing
• Turnkey Manufacturing

The manufacturing models offer different levels of supports for business owners. 

Defining Contract Manufacturing

It is a form of outsourcing—an agreement between a manufacturer and company. The manufacturer will 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 then return the completed product. 

Contract manufacturing is a form of third-party outsourcing. 

Benefits of Contract Manufacturing

Contract manufacturing offers a solution to the finite nature of manufacturing and production. Though not exhaustive, below you will find the primary benefits of contract manufacturing:

• Secure Market Entry: allows companies to produce consistent, quality products
• Increased Field Knowledge: access expert knowledge while retaining ownership
• Lowered Costs: outsourcing decreases machinery and staffing expenses

Defining Turnkey Manufacturing

Turnkey manufacturing offers the same baseline supports as contract manufacturing. Agreements are made between a manufacturer and company. The manufacturer then makes products, or product components, on an agreeable, predetermined timeline. 

So where does turnkey manufacturing differ? 

Through additional secondary services—covering clients from production to fulfillment. While standard contract manufacturing only outsources the production of your product, turnkey services fulfill supplement composition, form, production, packaging and shipping. Explicit services vary by manufacturer. 

Benefits of Turnkey Manufacturing

In addition to the benefits offered via contract manufacturing—secure market entry, increased field knowledge and lowered costs—turnkey services support the following: 

• Efficient: outsourcing streamlines ingredient sourcing, production and distribution
• Preferable Packaging: they handle packaging, labeling and distribution for you
• Set Timelines: utilizing one manufacturer prevents delays and supports orderly turnover

Which is Right for You? 

Contract manufacturing and turnkey services offer varied supports for varied needs. If you have nutraceutical ventures you would like to pursue—contract or turnkey— contact Mineralife Nutraceuticals today!

Mineralife offers both services. 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. 

Good Manufacturing Practices (GMP) is a manufacturing system composed of procedures and documentation that guarantee product control within nutraceutical manufacturing. The FDA outlines evolving regulations that GMP certified facilities adhere to. It implements proactive steps that ensure the quality and efficacy of supplements, preventing contaminated and adulterated supplements from entering the market, promoting user safety. 

GMPs regulate each facet of the manufacturing process—supporting product legitimacy and consumer safety by preventing cross-contamination, mislabeling and other sources of product corruption. Manufacturing regulations create guidelines around the following scopes: 

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

But how can manufacturers ensure they are meeting guidelines in each scope above?

Five Components of GMP Manufacturing

GMP manufacturing functions through five facets—people, products, processes, procedures, premises—the five P’s. 

(1) People

Competent employees provide quality assurance for manufacturing facilities. Though the initial training poses investments of time and money, qualified workers employ proper documentation, equipment handling and sanitation once trained in GMP standards. They offer another level of product control through proper handling, record keeping and adherence to standard operating procedures. All employees fill an explicit roll in the manufacturing process. Routine performance reviews assess employee knowledge, competency and subsequent product control. 

(2) Products

One of the most important elements of nutraceutical production rests in the primary ingredients used to create final market products. GMP requires quality assurance of all raw materials before manufacturers distribute products to consumers. Master formulas exist to ensure product safety and legitimacy. Manufacturers perform regular testing and comparison of product materials at each phase of production—strictly adhering to audited operative regulations. 

(3) Premises

Facility standards support product control, quality assurance, employee and consumer safety. Proper sanitization and storage prevent contaminated and adulterated supplements from entering the market. Proper equipment handling and storage prevent employee injuries. Verifying equipment efficacy and function supports consistent production thus promoting product control. 

(4) GMP Processes

Auditors routinely inspect nutraceutical manufacturing facilities and laboratories for product control and quality insurance. Processes should be standardized, documented and accessible to respective employees. Manufacturers should keep written frameworks—standard operating procedures—of all manufacturing processes. Routine internal audits support compliance between extensive FDA audits. 

(5) Procedures

Manufacturers create standard operating procedures that outline detailed instructions and guidelines within an explicit manufacturing process. When the FDA audits a nutraceutical manufacturer, they scrutinize procedure documentation to test regulation compliance. Production processes in manufacturing facilities need to reflect documented operating procedures. Auditors expect procedures—and procedure documentation—to reflect current industry standards and regulations. 

Nutraceutical manufacturing requires product control and quality assurance. Manufacturers utilize the five components of GMP to guarantee industry compliance.

GMP Quick Facts

Implementing the Five P’s supports compliant GMP manufacturing.  

• People: trained and qualified workers prevent product and machinery errors
• Product: high-quality raw materials create effective products
• Premises: clean facilities and functional equipment support worker and consumer safety 
• Processes: standardized processes support product control and compliance
• Procedures: offer standardized documentation for employees and auditors.

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. 

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.  

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!

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.

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—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!

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!