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Dec
26

Nutrition Product Development

by Morgan Settle in Uncategorized Comments: 11


Development of nutrition products focus on efficacy, quality and purity. NaturPro has a broad base of knowledge in nutrition product development and production of nutrition supplements, healthy foods and natural products, spanning from raw material to finished consumer product.

We take the time to talk through your goals with you and clarify the kind of nutrition product you’re looking to develop and sell. A number of considerations go into developing successful, effective, safe and compliant nutritional supplements.  These include:

  • What does the product or food do?
  • What can be claimed about the product?
  • Is the evidence supporting the claims sufficient?
  • How safe is the product?
  • Who will benefit from the product?
  • How is the ingredient dosage determined?
  • Are the ingredients available at an acceptable quality, cost and volume?


Four Steps to Nutrition Product Development

There are four main points when developing nutritional products:

  • Dosage & Delivery We focus on the details that make your product and claims stand out from the rest.
  • Market Analysis, Competitive Analysis and Positioning. Making your product stand out from others.
  • Supplement Testing and Analysis. NaturPro Scientific, as an UnLab, partners with expert analytical laboratories to conduct specific testing.
  • Contract Manufacturing Advocacy – Qualifying and negotiating with contract manufacturers

Sufficient time spent in the planning phase is the difference between success and failure.

Product formulating plans often coordinate the knowledge of supplement consultants and experts, review regulatory status of the product and evaluate the available scientific evidence.  A good development plan will identify not only opportunities, but also gaps and risks that may prevent success.

Contact us for more information on our Nutrition Product Development Services



Additional Reading:

Food and Supplement Claims with Confidence

Dietary Supplement Formula Development

Dietary Supplement Ingredient Regulatory Status

Supplement Manufacturing Consulting

Creating Natural Product Intellectual Property

Dec
20

Nutrition Formulation Consultants

by Morgan Settle in Uncategorized Comments: 11

NaturPro Scientific stands out as consultants who work for our clients. Creating a successful product is a lot more than creating a list of ingredients that mix well together.

Our history: We have more than 30 years experience in developing the scientific aspects of nutrition products to support human health.

NaturPro has a broad base of knowledge in consulting services and nutritional product development, healthy foods and natural products, spanning from raw material to ingredient, to finished nutrition product.

A number of considerations go into developing successful, effective, safe and compliant dietary supplements, foods, and food and dietary ingredients.  These include:

  • What does the nutrition formula do?
  • How safe is the product?
  • How is the ingredient dosage determined?
  • What can be claimed about the nutrition product?
  • Is the evidence supporting the claims sufficient

Nutritional Product Formulation Consultants

Top 7 Nutrition Product Development Tools

Nutritional Formulation Consulting Services requires a ‘toolbox’ of analysis including the following

  1. Market Analysis, Competitive Analysis and Positioning
  2. Regulatory Status / Safety Assessment
  3. Claims Development and Substantiation
  4. Ingredient Readiness, Supplier Qualification
  5. GMP’s, Specifications, and Analytical Testing
  6. Manufacturing Feasibility
  7. Contract Manufacturer Qualification and Negotiation 

Contact Us

Dec
10

Nutritional Supplement Formulation Services

by Morgan Settle in Uncategorized Comments: 11

We lead our clients in the right direction, by helping to manage all (or parts) of the process for nutritional supplement formulation for dietary supplement and health food products.

Creating a successful product is a lot more than creating a list of ingredients that mix well together.

NaturPro has a broad base of knowledge in nutritional supplement formulation services, from seed to shelf, from a unique idea, to the finished consumer product.

Nutritional Supplement Formulation Services

Our client list includes companies of all shapes and sizes, from startup to large corporation.

No two clients or projects are the same, but there are some common approaches found in our Product Formulation Toolbox:

Nutrition Supplement Toolbox: Top 7 Formulation Tools:

Nutritional Formulation requires a ‘toolbox’ of analysis that includes the following:

  1. Market Analysis, Competitive Analysis and Positioning
  2. Regulatory Status / Safety Assessment
  3. Claims Development and Substantiation
  4. Ingredient Readiness, Supplier Qualification
  5. GMP’s, Specifications, and Analytical Testing
  6. Manufacturing Feasibility
  7. Contract Manufacturer Qualification and Negotiation 

Contact Us

Dec
10

Dietary Supplement Product Development and Formulation Consultants

by Morgan Settle in Uncategorized Comments: 12


As Dietary Supplement Consultants we often are asked what we think of a product concept. The thought process to develop an answer is generally similar, regardless of the type of product, and whether its finished product, or an ingredient or raw material.

A number of considerations go into developing successful, effective, safe and compliant dietary supplements, foods, and food and dietary ingredients.  These include:

  • What does the supplement or food do?
  • How safe is the product?
  • How is the ingredient dosage determined?
  • What can be claimed about the product?
  • Is the evidence supporting the claims sufficient?
  • Who will benefit from the product?
  • Are the ingredients available at an acceptable quality, cost and volume?


The 4 Initial Steps to Dietary Supplement Product Development

There are four basic elements to developing a groundbreaking product:

  1. Begin with the finished product in mind. Determine in full detail how the product will be marketed, what the desired product claims will be, and how the product will address an unmet market need.
  2. Intimately understand the product value and market positioning compared to the competition. How will the product address an unmet need, or be different than what is already found on the market?  How will the product be priced compared to the competition? A full competitive analysis is important to determine positioning.
  3. What language will be used to describe the product? (This language, found on product labels and on webpages, is considered to be part of product claims.)
  4. In what country(s) will the product be marketed?  Regulations in different countries vary, and it is important to understand the unique requirements of each location.

The Secret of Getting Ahead is Getting Started.

Product developing plans often coordinate the knowledge of supplement consultants and experts, review regulatory status of the product and evaluate the available scientific evidence.  A great plan will identify not only opportunities, but also gaps and risks that may prevent success.

Contact us for more information on our Dietary Supplement Formulation and Development



Additional Reading:

Food and Supplement Claims with Confidence

Dietary Supplement Formula Development

Dietary Supplement Ingredient Regulatory Status

Supplement Manufacturing Consulting

Creating Natural Product Intellectual Property

Oct
27

AOAC ERP of the Year to Kombucha Alcohol Group

by NaturPro in Uncategorized Comments: 1

NaturPro Contributes to Expert Panel Receiving AOAC Award: “ERP of the Year” to Kombucha Alcohol Group

The AOAC Expert Review Panel (ERP) charged with reviewing methods of analysis for ethanol in kombucha initially met in September 2016 to review methods against AOAC SMPR 2016.001 (Determination of Ethanol in Kombucha). At this meeting, the ERP adopted an Official Method of Analysis for First Action status, AOAC 2016.12 (Determination of Ethanol in Kombucha) using gas chromatography with flame ionization detection (GC-FID). The selection and validation of this method was coordinated by NaturPro Scientific and performed by Covance Laboratories, Wisconsin.

kombucha tea testing alcohol ethanol

Method adopted for kombucha tea testing for alcohol in validated labs

AOAC states: “The ERP’s work directly impacts the resolution of urgent and key issues identified by industry, and serves as a forum where both the kombucha industry and government work together.

“The ERP was selected because its open and thorough scientific scrutiny of methods and its output clearly demonstrate the culmination of an industry-wide effort that facilitates regulatory and industry engagement for addressing urgent analytical disputes and facilitating trade. All ERP members receive the award, and publicly receiving the award on behalf of the group is the ERP chair, Sneh Bhandari.

“The Expert Review Panel (ERP) of the Year Award recognizes an ERP for achieving and completing signicant milestone(s) (e.g., Final report, First Action Method, Final Action Method), highlighted by some unique or particularly noteworthy aspect of a review panel report, such as innovative technology or application, breadth of applicability, critical need, difficult analysis, or timeliness.

“The report demonstrates significant merit as to the scope of the project, diversity of the panel, or an innovative approach to difficult analytical challenges. The report must have been submitted within the last 3 years.”

 

 

Oct
20

Cannabis Consultants

by NaturPro in Uncategorized Comments: 21

NaturPro Scientific stands out as consultants who work for our clients.

Our history: We have more than 30 years experience in developing the scientific aspects of botanical products to support human health. So when we started to work on cannabis, hemp and CBD products in 2013, it was second nature.

There are a lot of things to consider when developing cannabis products or hiring a consultant.

  1. Whether your partners understand regulations, compliance and quality assurance, and how to balance these with business. We help you meet the legal requirements and regulations, without breaking the bank.
  2. Scientific expertise and experience across all the function platforms of health product businesses. Whether it’s the science, regulations, communications, validation or due diligence needed, you need someone who’s going to share expert opinions with honesty and transparency.
  3. Inside knowledge of industry standards through active participation on committees of industry standards-setting organizations like American Herbal Products Association, ASTM International and the U.S. Hemp Roundtable. We have a solid reputation in the food, supplement, CBD and cannabis  industry as someone you can trust.
  4. Experience consulting and working efficiently with companies of all sizes and types. Our clients ultimately value our knowledge of both the ideal and the practical, and helping to bridge the gap between efficiently and cost effectively.

Contact us today to learn more about how our expert consultants can help drive your cannabis firm and products to groundbreaking innovation, compliance and success.

——————-

Cannabis Consultants and Experts in Innovation, Product Development and Regulatory Compliance

——————-

Quick Links:

——————–

 

NaturPro Scientific is a recognized leader in regulatory compliance, GMP and quality assurance on CBD, cannabis, botanical drugs, dietary supplements and foods.

What are Good Manufacturing Practices?  Good Manufacturing Practices (GMP) ensures products are consistently produced and controlled to the quality standards and conform to all applicable regulatory requirements.  Good Manufacturing Practices are fundamental to any manufacturing industry and are often required to be implemented in plants and factories by national governments.  Our team of experts can assist you with the development and evaluation of GMP programs  for cannabis, marijuana, hemp and CBD products.

We help you to train qualified staff, get in-depth and correct understanding of standards, and establish comprehensive management systems.

Audits for GMP and Quality Assurance

Here are some of the services we offer for cannabis compliance:

  • Audits
    • Preliminary Gap Analysis
    • Facility GMP pre-audits
    • Internal Audits
    • Third-Party Audits
    • CAPA Audits
  • Quality Management
  • Materials Testing
  • Process Approvals
  • Documentation and SOP
    1. Quality Manual
    2. Recordkeeping
    3. Document Control
    4. Traceability & Recall
      1. Formula Records
      2. Batch Records
      3. Certificates of Analysis
    5. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
    6. Supplier Qualification
    7. Preventive Controls
    8. Product Approval & Rejection, Material Inspection
    9. Complaints & CAPA (Corrective Actions)
    10. Quality Issue Investigation and Resolution
  • Training and Hiring
  • Investor Due Diligence

cannabis-consultants-extraction-GMP

NaturPro Scientific are cannabis consultants for extraction and GMP

NaturPro works closely with our clients to provide the most cost effective way to achieve GMP certification and an edge in the market.

The 4 main benefits of our audits (among many) include:

  1. Understanding where you are may not meet regulatory requirements
  2. Provide reviews and recommendations from a fresh perspective
  3. Train your staff on dealing with regulatory audits
  4. Reduce the risk of a food safety issue or costly product recall.

Audits are an integral part of the licensing and ongoing regulatory compliance process for cannabis, marijuana and CBD products. Cannabis audits can be rigorous, and are seen as a true ‘stress test’ on your quality system.

Pre-License Audits
Prior to issuing a license (e.g.,  Cultivation, Processor, Retail), regulators may require demonstration  compliance with the relevant cannabis regulation, and to ensure implementation of critical regulatory requirements such as physical security requirements, recordkeeping and good production practices. Licensed cannabis firms are required to demonstrate regulatory compliance at these audits in order to achieve (and maintain) their license.

Introductory Audits

An introductory audit may be scheduled after the pre-licensing audit, when the licensee is ready to start production. NaturPro Scientific is often hired to participate in and support our clients before, during and after regulatory audits. This audit is conducted to verify compliance against regulations in addition to inventory control/activities.

GMP Audit 
This type of audit assesses compliance against established Good Manufacturing Process (GMP) guidelines. Our experts have extensive experience with GMP audits to assist cultivators and processors  identify gaps against the regulations/standards, and putting appropriate corrective and preventative actions in place.

Quality Assurance
NaturPro has FDA-trained food safety experts (PCQI) and chemists on staff, and we are often called to perform duties of a Quality Manager for our clients. We handle and interpret lab testing, support supply chain and supplier qualification based on best practices for cannabis and botanical drugs.

 

Standard operating procedures (SOP) for cultivation, processing and testing operations can be challenging. NaturPro Scientific’s experience with SOP helps you get to your desired outcome quickly and efficiently.

Our experience in cannabis includes:

  • Currently serve on ASTM International and American Herbal Products Association (AHPA) Cannabis Committees
  • Supported the development of operating standards and wrote standard operating procedures (SOP) for Good Manufacturing Practices (GMP) for cannabis standards‐setting organization, currently under review by ASTM International
  • Currently serve as regulatory and quality assurance consultant for hemp industry and trade organizations
  • Founding member of new self regulatory organization for hemp and CBD products
  • Coordinated initial R&D, production, quality assurance and regulatory affairs for a cannabis startup with operations in Washington, Colorado and Nevada
  • Assisted in development of cannabis license applications in New York, Florida, California, Colorado and Louisiana
  • Established analytical testing standards and guidelines for potency and purity of cannabis products
  • Audited cannabis analytical laboratory data according to ISO 17025 standards
  • Developed in‐house formulas, materials lists, manufacturing processes, manufacturing records and operational guidelines for cannabis extract and finished product production
  • Developed R&D for and commercial processes for large‐scale extraction and purification of cannabinoids and terpenes from cannabis

CBD Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging or testing business. Startups who invest in solid standard operating procedures (SOP) find themselves several steps ahead, running efficiently, with well-trained staff, and don’t suffer any costly mistakes.

CBD SOP are required by each state where cannabis, marijuana or hemp are regulated.

Any cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of controls, from seed to shelf. NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.

  1. Cultivation or Processing
    1. Management
    2. Applicable Regulations
    3. Operations
    4. Training & Safety
    5. Hygiene
    6. Sanitation & Cleaning
    7. Farm or Facility
    8. Equipment
    9. Seeds and Propagation Materials
    10. Agricultural Inputs
    11. Pre-harvest practices
    12. Harvesting
    13. Post-harvest practices
    14. Drying & Milling
    15. Sampling
    16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
    17. Waste Management
  2. Quality Management Systems
    1. Product Quality Policy/Manual
    2. Recordkeeping
      1. Document Control
      2. Formula Records
      3. Batch Records
      4. Certificates of Analysis
    3. Traceability & Recall
    4. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
      3. Supplier Qualification
      4. Intentional Adulteration
      5. Preventive Controls
    5. Product Approval & Rejection, Material Inspection
    6. Complaints & CAPA (Corrective Actions)
Oct
20

CBD Quality Consultants and Experts 

by NaturPro in Uncategorized Comments: 5

In a world where everyone claims to be an expert, NaturPro Scientific stands out as consultants who work for our clients.

Our history: We have more than 30 years experience in developing the scientific aspects of botanical products to support human health. So when we started to work on cannabis, hemp and CBD products in 2013, it was second nature.

Our experience: There are a lot of things to consider when developing cannabis products or hiring a consultant.

First, is whether your partners understand regulations, compliance and quality assurance, and how to balance these with business. We help you meet the legal requirements and regulations, without breaking the bank.

Second, is scientific expertise and experience across all the function platforms of health product businesses. Whether it’s the science, regulations, communications, validation or due diligence needed, you need someone who’s going to share expert opinions with honesty and transparency.

Third, is inside knowledge of industry standards through active participation on committees of industry standards-setting organizations like American Herbal Products Association, ASTM International and the U.S. Hemp Roundtable. We have a solid reputation in the food, supplement, CBD and cannabis  industry as someone you can trust.

Fourth — is experience consulting and working efficiently with companies of all sizes and types. Our clients ultimately value our knowledge of both the ideal and the practical, and helping to bridge the gap between efficiently and cost effectively.

Contact us today to learn more about how our expert consultants can help drive your cannabis firm and products to groundbreaking innovation, compliance and success.

——————-

CBD Quality Consultants and Experts Specializing in Innovation and Product Development and Regulatory Compliance

——————-

Quick Links:

——————–

 

NaturPro Scientific is a recognized leader in audits, GMP and quality assurance on CBD, cannabis, botanical drugs, dietary supplements and foods.

What are Good Manufacturing Practices?  Good Manufacturing Practices (GMP) ensures products are consistently produced and controlled to the quality standards and conform to all applicable regulatory requirements.  Good Manufacturing Practices are fundamental to any manufacturing industry and are often required to be implemented in plants and factories by national governments.  Our team of experts can assist you with the development and evaluation of GMP programs  for cannabis, marijuana, hemp and CBD products.

We help you to train qualified staff, get in-depth and correct understanding of standards, and establish comprehensive management systems.

CBD Auditors, GMP and Quality Assurance

Here are some of the services we offer for cannabis compliance:

  • Audits
    • Preliminary Gap Analysis
    • Facility GMP pre-audits
    • Internal Audits
    • Third-Party Audits
    • CAPA Audits
  • Quality Management
  • Materials Testing
  • Process Approvals
  • Documentation and SOP
    1. Quality Manual
    2. Recordkeeping
    3. Document Control
    4. Traceability & Recall
      1. Formula Records
      2. Batch Records
      3. Certificates of Analysis
    5. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
    6. Supplier Qualification
    7. Preventive Controls
    8. Product Approval & Rejection, Material Inspection
    9. Complaints & CAPA (Corrective Actions)
    10. Quality Issue Investigation and Resolution
  • Training and Hiring
  • Investor Due Diligence

cannabis-consultants-extraction-GMP

NaturPro Scientific are cannabis consultants for extraction and GMP

NaturPro works closely with our clients to provide the most cost effective way to achieve GMP certification and an edge in the market.

The 4 main benefits of our audits (among many) include:

  1. Understanding where you are may not meet regulatory requirements
  2. Provide reviews and recommendations from a fresh perspective
  3. Train your staff on dealing with regulatory audits
  4. Reduce the risk of a food safety issue or costly product recall.

Audits are an integral part of the licensing and ongoing regulatory compliance process for cannabis, marijuana and CBD products. Cannabis audits can be rigorous, and are seen as a true ‘stress test’ on your quality system.

Pre-License Audits
Prior to issuing a license (e.g.,  Cultivation, Processor, Retail), regulators may require demonstration  compliance with the relevant cannabis regulation, and to ensure implementation of critical regulatory requirements such as physical security requirements, recordkeeping and good production practices. Licensed cannabis firms are required to demonstrate regulatory compliance at these audits in order to achieve (and maintain) their license.

Introductory Audits

An introductory audit may be scheduled after the pre-licensing audit, when the licensee is ready to start production. NaturPro Scientific is often hired to participate in and support our clients before, during and after regulatory audits. This audit is conducted to verify compliance against regulations in addition to inventory control/activities.

GMP Audit 
This type of audit assesses compliance against established Good Manufacturing Process (GMP) guidelines. Our experts have extensive experience with GMP audits to assist cultivators and processors  identify gaps against the regulations/standards, and putting appropriate corrective and preventative actions in place.

Quality Assurance
NaturPro has FDA-trained food safety experts (PCQI) and chemists on staff, and we are often called to perform duties of a Quality Manager for our clients. We handle and interpret lab testing, support supply chain and supplier qualification based on best practices for cannabis and botanical drugs.

 

Standard operating procedures (SOP) for CBD processing operations can be challenging. NaturPro Scientific’s experience with SOP helps you get to your desired outcome quickly and efficiently.

Our experience in cannabis includes:

  • Currently serve on ASTM International and American Herbal Products Association (AHPA) Cannabis Committees
  • Supported the development of operating standards and wrote standard operating procedures (SOP) for Good Manufacturing Practices (GMP) for cannabis standards‐setting organization, currently under review by ASTM International
  • Currently serve as regulatory and quality assurance consultant for hemp industry and trade organizations
  • Founding member of new self regulatory organization for hemp and CBD products
  • Coordinated initial R&D, production, quality assurance and regulatory affairs for a cannabis startup with operations in Washington, Colorado and Nevada
  • Assisted in development of cannabis license applications in New York, Florida, California, Colorado and Louisiana
  • Established analytical testing standards and guidelines for potency and purity of cannabis products
  • Audited cannabis analytical laboratory data according to ISO 17025 standards
  • Developed in‐house formulas, materials lists, manufacturing processes, manufacturing records and operational guidelines for cannabis extract and finished product production
  • Developed R&D for and commercial processes for large‐scale extraction and purification of cannabinoids and terpenes from cannabis

CBD Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging or testing business. Startups who invest in solid standard operating procedures (SOP) find themselves several steps ahead, running efficiently, with well-trained staff, and don’t suffer any costly mistakes.

CBD SOP are required by each state where cannabis, marijuana or hemp are regulated.

Any cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of controls, from seed to shelf. NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.

  1. Cultivation or Processing
    1. Management
    2. Applicable Regulations
    3. Operations
    4. Training & Safety
    5. Hygiene
    6. Sanitation & Cleaning
    7. Farm or Facility
    8. Equipment
    9. Seeds and Propagation Materials
    10. Agricultural Inputs
    11. Pre-harvest practices
    12. Harvesting
    13. Post-harvest practices
    14. Drying & Milling
    15. Sampling
    16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
    17. Waste Management
  2. Quality Management Systems
    1. Product Quality Policy/Manual
    2. Recordkeeping
      1. Document Control
      2. Formula Records
      3. Batch Records
      4. Certificates of Analysis
    3. Traceability & Recall
    4. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
      3. Supplier Qualification
      4. Intentional Adulteration
      5. Preventive Controls
    5. Product Approval & Rejection, Material Inspection
    6. Complaints & CAPA (Corrective Actions)
Oct
20

CBD and Cannabis Audits, GMP and Quality

by NaturPro in Quality Comments: 11

NaturPro Scientific is a recognized leader in audits, GMP and quality assurance on cannabis, botanical drugs, dietary supplements and foods.

What are Good Manufacturing Practices?  Good Manufacturing Practices (GMP) ensures products are consistently produced and controlled to the quality standards and conform to all applicable regulatory requirements.  Good Manufacturing Practices are fundamental to any manufacturing industry and are often required to be implemented in plants and factories by national governments.  Our team of experts can assist you with the development and evaluation of GMP programs  for cannabis, marijuana, hemp and CBD products.

We help you to train qualified staff, get in-depth and correct understanding of standards, and establish comprehensive management systems.

CBD and Cannabis Auditors, GMP and Quality Assurance

Here are some of the services we offer for cannabis compliance:

  • Audits
    • Preliminary Gap Analysis
    • Facility GMP pre-audits
    • Internal Audits
    • Third-Party Audits
    • CAPA Audits
  • Quality Management
  • Materials Testing
  • Process Approvals
  • Documentation and SOP
    1. Quality Manual
    2. Recordkeeping
    3. Document Control
    4. Traceability & Recall
      1. Formula Records
      2. Batch Records
      3. Certificates of Analysis
    5. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
    6. Supplier Qualification
    7. Preventive Controls
    8. Product Approval & Rejection, Material Inspection
    9. Complaints & CAPA (Corrective Actions)
    10. Quality Issue Investigation and Resolution
  • Training and Hiring
  • Investor Due Diligence

cannabis-consultants-extraction-GMP

NaturPro Scientific are cannabis consultants for extraction and GMP

NaturPro works closely with our clients to provide the most cost effective way to achieve GMP certification and an edge in the market.

The 4 main benefits of our audits (among many) include:

  1. Understanding where you are may not meet regulatory requirements
  2. Provide reviews and recommendations from a fresh perspective
  3. Train your staff on dealing with regulatory audits
  4. Reduce the risk of a food safety issue or costly product recall.

Audits are an integral part of the licensing and ongoing regulatory compliance process for cannabis, marijuana and CBD products. Cannabis audits can be rigorous, and are seen as a true ‘stress test’ on your quality system.

Pre-License Audits
Prior to issuing a license (e.g.,  Cultivation, Processor, Retail), regulators may require demonstration  compliance with the relevant cannabis regulation, and to ensure implementation of critical regulatory requirements such as physical security requirements, recordkeeping and good production practices. Licensed cannabis firms are required to demonstrate regulatory compliance at these audits in order to achieve (and maintain) their license.

Introductory Audits

An introductory audit may be scheduled after the pre-licensing audit, when the licensee is ready to start production. NaturPro Scientific is often hired to participate in and support our clients before, during and after regulatory audits. This audit is conducted to verify compliance against regulations in addition to inventory control/activities.

GMP Audit 
This type of audit assesses compliance against established Good Manufacturing Process (GMP) guidelines. Our experts have extensive experience with GMP audits to assist cultivators and processors  identify gaps against the regulations/standards, and putting appropriate corrective and preventative actions in place.

Quality Assurance
NaturPro has FDA-trained food safety experts (PCQI) and chemists on staff, and we are often called to perform duties of a Quality Manager for our clients. We handle and interpret lab testing, support supply chain and supplier qualification based on best practices for cannabis and botanical drugs.

Aug
15

Food and Supplement Product Manufacturing Feasibility

by NaturPro in Product Development Comments: 11

Knowing whether a material will be able to be made into a product is a key step to product development. A lot of natural products are unstable, insoluble, non-flowable, terrible tasting, or otherwise challenging to mix into the desired product form.

In today’s ‘clean label’ demanding market, many of the additives used to make a high quality tablet or beverage are no longer salable.

Food and Supplement Product Manufacturing Feasibility

Related to the exercise of understanding manufacturing feasibility, we also offer a number of production-related services:

  • Source and qualify bulk raw materials
  • Raw material quality verification program
  • Supplier verification program
  • Facility design and GMP
  • Formula/recipe development
  • Project management
  • Manufacturing process design
  • Equipment qualification, sourcing, IQ/OQ/PQ
  • Contract manufacturer qualification
  • Materials selection & sourcing
  • Packaging & label development
  • Documentation & systems

NaturPro’s core experiences are in understanding how to make better products and better ingredients. Contact us to learn more.

Food and Supplement Product Manufacturing Feasibility

Food and supplement product manufacturing feasibility is the first step in understanding whether the product of your dreams can become a reality.

Jul
26

The Regulatory Patchwork of Dietary Supplements

by NaturPro in Quality Comments: 11

In the United States, dietary supplements and their ingredients are subject to a patchwork of regulations, industry guidance, voluntary certifications and audit programs. With some exceptions, few standards for dietary supplements have been developed with expert consensus and  broadly implemented by the dietary supplement industry.

FDA’s dietary supplement GMPs (good manufacturing practices) are part of the exception and have made today’s supplement products generally a higher level of quality than at any time before.

Dietary Supplement Deming Opinion

In Dietary Supplements, Data is Needed to Support Compliance

Making A Quilt from the Regulatory Patchwork: What Successful, Resourceful Firms Do

Yet few industry standards are clearly understood, consistently applied and sufficiently comprehensive to cover all the ground.

One primary example is the gap between compliance requirements for dietary ingredients (under food GMPs) and dietary supplements, whose GMP framework is derived from that for pharmaceuticals. The underlying litmus test for the level of safety demanded for supplements and foods are different—that of “non-adulteration” versus “safe for human consumption,” Respectively. Maybe due to the differences, supplement GMP audit programs can overlook the food GMPs that govern ingredients. It is not uncommon for a manufacturer and a supplier to speak completely different quality languages. Audits for supplement GMPs are frequently unable to determine to a reasonable degree of certainty whether a particular ingredient, based on its certificate of analysis (CoA), should be expected to meet supplement requirements once it is placed inside a capsule or tablet.

As could be expected, an unintended consequence of this major gap is the common practice of a raw material CoA being duplicated as the manufacturer’s raw material specification.

In this scenario, an ingredient specification has been developed according to food requirements and, often without further analysis or verification, it is assumed to meet the requirements of the finished supplement. The result is a supplement that is essentially of no better quality than the “food-grade” ingredients put into it.

Especially for botanicals and animal-derived raw materials: cultivation, harvesting and processing before the final ‘transformation’ adds another dimension..

Confirming identity and purity is a complicated problem, particularly for a global supply chain of agricultural materials susceptible to contaminants during farming, harvesting, processing, storage or transportation to the ingredient processing facility.

In many poorer countries, the supply chain, and contaminants are not as well regulated as in advanced nations, and are freely shipped with no knowledge of their destination. Likewise, the final manufacturer or end user may have no information on the source of the material beyond the previous dock. In an uncomfortable way, the U.S., with its more lax regulations, often receives the materials rejected by Europe. Thus, potential contaminants may not be necessarily listed on the specification or controlled by the food GMPs, yet they can cause the products to which they are added to be adulterated.

Dozens of standards have been written for agricultural products, many of which don’t (or can’t) apply to the small family farmers who are a predominant source of botanical raw materials. In addition to recent requirements for fresh produce established by the Food Safety Modernization Act (FSMA), which don’t really apply to dried agricultural materials, we also have: USDA good agricultural practices (GAPs), which are intended for large farms and seldom fully practiced in the United States; certified organic, which requires no testing for contaminants like pesticides that may cause a product to be adulterated; independent farm standards like Global GAP, which arealso intended for large, modernized industrial farms; and, dozens of good agricultural and collection practices (GACPs) for medicinal plants that have been independently written by various nations and trade groups.

Some experts say the mess of standards, the dynamics of the industry and the law of entropy do not support the possibility of a clear and unified regulatory structure.

Others recognize the limitations, yet remain busy sewing the patches together into a quilt that is greater than the sum of its parts.

Fortunately,

initiatives are in process or recently completed that contribute to the integrity of our industry quilt and have provided free information. Just in the past couple years:

•             The U.S. Pharmacopoeia (USP) and American Herbal Pharmacopoeia (AHP) developed monographs and methods for testing dietary supplement ingredients.

•             USP also developed a Food Fraud Mitigation Database that lists adulterants common for food ingredients.

•             AOAC International developed analytical methods for dietary supplement ingredient potency and contaminants.

•             The National Institutes of Health’s (NIH) Office of Dietary Supplements (ODS) website became a valuable source of information and resources.

•             Trade groups such as the American Herbal Products Association (AHPA) and American Botanical Council (ABC) made enormous efforts to educate and guide the industry on issues around botanical dietary ingredients and adulteration, including a recently updated draft GACP from AHPA, and the ABC-AHP-National Center for Natural Products Research (NCNPR) Botanical Adulterants Program.

•             The Supplement Online Wellness Library (OWL) was established by the Council for Responsible Nutrition (CRN), to allow labels for supplement products on the U.S. market to be put into in one place.

•             The Supplement Safety and Compliance Initiative (SSCI) was formed as a broad industry initiative, with wide support from trade associations, to address some of the gaps for supplements that aren’t sufficiently covered under other standards. SSCI is led by experienced players in retail, manufacturing and supply, and includes a focus on identity, risk assessment and quality for raw materials.

•             In response to consumer demand, leading retailers, manufacturers and ingredient suppliers invested significant resources into traceability and quality, and are now able to make meaningful claims to these effects that are not only important to consumers, but also serve as a reliable way to differentiate from the competition.

Today’s movement toward a greater level of education and transparency includes a firming of the gaps, especially where raw material traceability and quality are concerned. Successful companies across the entire supply chain are actively improving and adopting new standards, building a level of quality and integrity that provides lasting value to their business. Those who are upping their game are piecing together a quilt of their own, leveraging their quality advantages into claims that deliver marketing value. On the other side, those who continue to rely on ignorance or a lack of regulatory clarity as reason to take no action are increasingly left behind.

In an industry where faceless online product marketers are more common than they should be, and where a list of the tens of thousands of products available on the market is just getting online, our combined efforts to fill in the gaps of the collective regulatory patchwork benefits everyone.

This article was previously published in Natural Products Insider, July 2017.