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Vitamin Manufacturer | Liquid Supplement Manufacturer | Skin Care Manufacturer

High Level cGMP Compliance

High Level cGMP Compliance

What most manufacturers recognized as an insurmountable obstacle to cGMP compliance, Healthy Solutions saw as an opportunity. Manufacturing is a system, cGMP compliant manufacturing is an exponentially more complex system and design, development and operation of complex systems are what the owners of Healthy Solutions excel at.  High level cGMP compliance & True Finished Goods Quality requires exhaustive raw material analysis, extraordinary process controls and unparalleled access / transparency to the massive amounts of data collected at each step of the cGMP Manufacturing Process.

Exclusive access to our proprietary cGMP managment system

Healthy Solutions™, LLC offers a one of kind computer-driven Quality Control and production system designed to eliminate the human error variable during the manufacturing process. Many companies opt for “off-the-shelf” quality control systems that cannot deliver the level of technical sophistication necessary to deliver the best possible product to the consumer. We invest heavily in manufacturing technology and the professionals responsible for managing that technology. Our in-house staff of expert programmers are constantly updating and creating new product manufacturing programs and processes to assure that you receive the highest quality products on time, every time.

Exclusive access to our proprietary cGMP managment system
“Well done is better than well said.”Benjamin Franklin

10+ YEARS AHEAD OF THE CURVE

Preoccupied by the costs, time & energy necessary to bring their facility into compliance, manufacturers failed to consider the affect that cGMP’s would have on their clients. Healthy Solutions however, did the exact opposite. We knew that our ability to provide automated solutions could be a huge competitive advantage. We knew that the True Value of a Manufacturer 2010 or 2015 would be radically different from that of 2003. However, we didn’t know exactly how.  AN EXHAUSTIVE REVIEW OF THE CGMP’S, FDA GUIDANCE DOCS, INTERVIEWS, RESPONSES TO INDUSTRY INQUIRIES, ETC…LED US TO THE FOLLOWING CONCLUSIONS:

  • Connector.Connector.

    A Manufacturers True Value will soon be defined by their ability to supply Brand Owners and Regulatory Agencies with the quality and quantity of data necessary to satisfy the requirements of Title 21 CFR part 111.

  • Connector.Connector.

    Creation and Implementation of Customized Systems will be the Key to Maintaining High Level cGMP Compliance and Providing Customers with the Aforementioned True Value.

10+ YEARS AHEAD OF THE CURVE
10+ YEARS OF CUSTOM CODE

10+ YEARS OF CUSTOM CODE

Healthy Solutions system continues to evolve. It’s a customer driven process wherein all of our clients are encouraged to ask for data or request system improvements / modifications. The Healthy Solutions team of IT professionals will review each requests, determine its feasibility, scalability and priority. If the request is something which may benefit the majority of our client base it will be prioritized for production. If it’s a customer specific request, you’ll receive an estimate for the cost of development as well as a timeline to implementation.

“We fail to see how any manufacturer could achieve high level cGMP compliance without a system of this sort.”Healthy Solutions Ownership

REVOLUTIONARY CGMP MANAGEMENT & TRANSPARENCY

Healthy Solutions offers a one of kind computer-driven Quality Control and production system designed to eliminate the human error variable during the manufacturing process. Many companies opt for “off-the-shelf” quality control systems that cannot deliver the level of technical sophistication necessary to deliver the best possible product to the consumer. We invest heavily in manufacturing technology and the professionals responsible for managing that technology. Our in-house staff of expert programmers are constantly updating and creating new product manufacturing programs and processes to assure that you receive the highest quality products on time.

REVOLUTIONARY CGMP MANAGEMENT & TRANSPARENCY
More Valuable Than Ever

More Valuable Than Ever

FDA’s inspection and enforcements of Brand Owners continues leave Brand Owners shocked and dismayed at the inability or unwillingness of their “cGMP Manufacturer” to Provide Tangible Proof of Compliance Sufficient to Satisfy the FDA. Furthermore, the FDA has been reaffirming the need for Brand Owners to maintain the quality and quantity of documentation necessary to meet the Brand Owner requirements of title 21 CFR part 111. The day may or may not come when you are in need of the information a responsible manufacturer like Healthy Solutions, LLC is able to provide. If you are not already contracting with Healthy Solutions, LLC we would strongly encourage you to review the Brand Owner requirements of title 21 CFR part 111, contact your current or prospective manufacturer with a list of required items, documents, reports etc. and see how comfortable you would feel with their response given that the FDA in your office making those same requests.

Want The Right Vitamin Manufacturer? Ask the Right Questions!


Healthy Solutions, LLC. Does not Utilize Skip Lot Testing.
NO! Skip-lot testing is a major liability to you as a business owner and us as a contract manufacturer. Skip lot testing is a schedule of testing wherein you only test the first few lots of raw material received from a supplier. Then, you “skip” testing the next few lots.  Healthy Solutions DOES NOT perform skip lot testing.
  • All Incoming Raw Materials are Micro’d!
Answer: Healthy Solutions performs microbiological analysis of ALL incoming raw materials. Our standard microbiological testing protocol includes:
  • Aerobic bacteria
  • Staphylococcus
  • Coli
  • Salmonella
  • Yeast & Mold
  • Coliforms
  • Enterobacteriaceae
Healthy Solutions analyzes the moisture content of ALL appropriate raw materials. These analyses include loss on drying via use of a drying oven and laboratory balance.
Healthy Solutions performs a myriad of qualitative tests including some or all of the following depending on the raw material.
  • NIR (Near Infrared Spectroscopy)
  • Organoleptic analysis: Taste, Color, Odor, Appearance, Feel (when applicable)
  • Specific gravity of ALL incoming lots (when applicable)
  • Brix analysis of ALL incoming lots (when applicable)
  • pH of ALL incoming lots
Healthy Solutions performs a myriad of finished goods testing which typically includes all of the following:
  • High/Low quantitative assay on each finished good in order to validate the homogeneity of the blended and previously assayed ingredients (for example: if the formula contains 100mcg of Vitamin B12 and 1000mg of calcium we will assay each of those ingredients in the finished goods to validate appropriate mixing of the small weight and large weight ingredients within the batch).
  • NIR (Near Infrared Spectroscopy)
  • Organoleptic analysis: Taste, Color, Odor, Appearance, Feel (when applicable).
  • Microbiological analysis: Aerobic Bacteria, Staphylococcus, E. Coli, Salmonella, Yeast & Mold, Coliforms, Enterobacteriaceae & sometimes Pseudomonas
  • Viscosity (when applicable)
  • pH
  • Specific gravity
Testing, Testing & more Testing! While many companies claim to provide you with quality, only a few actually have the equipment and expertise to do so. Unfortunately, there are only a handful of manufacturers in the nation who perform the extensive raw material and finished goods testing that we do. Visit other facilities and Visit Healthy Solutions. Pay special attention to the lab, the difference will be clear.
Our Actions Align with our Words Healthy Solutions has a strong reputation. The vast majority of our business comes from referrals. We’ve put our money where our mouth is in that while many make bold statements about their “quality process” few have made the $500,000 – $1,000,000 investment in laboratory equipment and personnel. Healthy Solutions finds it hard to believe that a manufacturer can fully satisfy the cGMP requirements without a fully stocked analytical lab and multiple expert analytical chemists.
Extensive In-House Laboratory & Expert Analytical Chemist Healthy Solutions has an extensive in-house laboratory composed of state-of- the-art equipment and multiple, expert analytical chemists. The Healthy Solutions Lab is complete with the following:
  • UV-Vis (Ultraviolet-Visible Spectrophotometry)
  • UPLC (Ultra High Pressure Liquid Chromatography)
  • ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
  • NIR (Near Infrared Spectroscopy)
  • Automatic colorimetric titration
  • Karl Fischer titration for determination of moisture content
  • Accelerated Stability (shelf life) Chambers
  • Microbiological (Plating, Incubation etc…)
  • Moisture analyzers
  • pH Meters
  • And much more!
  Answer: Healthy Solutions performs microbiological analysis of ALL incoming raw materials. Our standard microbiological testing protocol includes:
  • Aerobic bacteria
  • Staphylococcus
  • Coli
  • Salmonella
  • Yeast & Mold
  • Coliforms
  • Enterobacteriaceae
Healthy Solutions performs Analytical/Quantitative analysis of ALL incoming Vitamins, Minerals & Standardized Botanicals. Our standard testing protocol includes quantitative assays to determine activity and potency.

SYSTEMS BUILT FOR SANITY

Our entire business model, systems and procedures are designed to ensure that every product we make, every action we take is monitored by our proprietary cGMP Process Management Software. There is no other system of this kind. For more than a decade, we’ve been working to ensure that when a challenge is identified, a process (program) is implemented to ensure that challenge never happens again. We can say with confidence that while statistically speaking we’ll never be perfect, so long as we work within the confines of the system there is little which can go wrong. No other manufacturer can offer you the same peace of mind. Computer controlled quarantine and material release. Computerized weigh out to prevent a small miscalculation from becoming a huge liability. Barcode controlled retention sample process. Automated recall procedures. And much, much more!

SYSTEMS BUILT FOR SANITY
YOUR COMPETITIVE ADVANTAGE

YOUR COMPETITIVE ADVANTAGE

Healthy Solutions™, LLC offers a one of kind computer-driven Quality Control and production system designed to eliminate the human error variable during the manufacturing process. Many companies opt for “off-the-shelf” quality control systems that cannot deliver the level of technical sophistication necessary to deliver the best possible product to the consumer. We invest heavily in manufacturing technology and the professionals responsible for managing that technology. Our in-house staff of expert programmers are constantly updating and creating new product manufacturing programs and processes to assure that you receive the highest quality products on time, every time. Complete material traceability from the receiving dock to the bottle via barcode scanning.

AUTOMATED COMMUNICATIONS


PO Confirmation


Customer Supplied Materials Needed


Customer Supplied Material Received


Shipping Confirmation w/ Tracking


Post Production Accounting


Ultra-Fast Access to Reports, Test Results

Healthy Solutions


  • Yes

  • Yes

  • Yes

  • Yes

  • Yes

  • Yes

“cGMP” Certified Competitors


  • No

  • No

  • No

  • No

  • No

  • No

Transparency and Reporting


Provides Raw Material Specifications


Provides Customers w/ Raw Material Test


Provides Customers w/ OOS Reports


Customer Supplied Inventory


Finished Goods Qualitative Analysis


Customer Specific Reports Available

Healthy Solutions


  • Yes

  • Yes

  • Yes

  • Yes

  • Yes

  • Yes

“cGMP” Certified Competitors


  • No

  • No

  • No

  • No

  • No

  • No

Automated Client Reports


Batch / MMR Raw Material Usage Reports


OOS, Deviation, Unexpected Events


C of A’s, Packing Slips, BOL, etc.


Pre-Production Acclerated Stability Reports


Finished Goods Qualitative Analysis


Customer Specific Reports Available

Healthy Solutions


  • Yes

  • Yes

  • Yes

  • Yes

  • Yes

  • Yes

“cGMP” Certified Competitors


  • No

  • No

  • No

  • No

  • No

  • No

QC LAB / ANALYTICAL


Inductively Coupled Plasma Mass


UPLC – Ultra High Pressure


Ultraviolet-Visible Spectrophotometry


NIR – Near Infrared Spectroscopy


Titrator – Automatic colorimetric


pH, Brix, TDS, Viscosity, Refractive

Healthy Solutions


  • Yes

  • Yes

  • Yes

  • Yes

  • Yes

  • Yes

“cGMP” Certified Competitors


  • No

  • No

  • No

  • No

  • No

  • No

All your gmp compliance information at your finger tips!


You can’t beat a quality conscious system designed to simplify all documentation required to remain cGMP compliant.  Peace of mind and unequivocal quality are what makes Healthy Solutions the premier contract manufacturing partner.  If you have any questions about our system or how we can easily plug into your existing system with our in-house team of IT  experts, please click the button below and submit your information through the contact form.  One of our IT specialist will follow up with you.


Plug and Play
NSF-Dietary-Supplements-GMP-Registration
FDA-Bioterrorism-Registration-of-Food-Facilities
Certified-KOSHER
NPA-MEMBER
USDA Certified Organic Vitamin Manufacturer Liquid Dietary Supplement Manufacturer

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