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Dietary Supplement Regulatory and Compliance Consultants

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NaturPro is known for customized quality and compliance solutions, including:

Regulatory and Compliance

Dietary Supplement Regulatory Compliance Consultants

NaturPro Scientific are Dietary Supplement Regulatory Compliance Consultants

  • Conduct Audits (paper and in-person)
    • Compliance & Preparatory Audits
      • Good Agricultural and Collection Practices (GAP/GACP)
      • Good Manufacturing Practices (GMP) (21 CFR 117, 111)
      • Good Laboratory Practices (GLP) (ISO 17025)
      • Organic (NOP)
      • Non-GMO (NGP)
    • Proprietary audits
  • Standards Development and Benchmarking
    • Manufacturing SOP and Records Development
  • Regulatory Status Assessment (GRAS, NDI, ODI, IND)
  • Regulatory Responses (FDA, FTC, TTB)
  • Adverse Event Reporting (AER/SAER)
  • Product and Ingredient Risk Assessment
  • Independent Product Quality Investigations and Corrective Actions/Preventive Actions
  • Quality Assurance Toolbox  for Startups (SOP, Forms)

 

Dietary Supplement Regulatory and Compliance Consultants

Spec Verified™

Ever wonder how your ingredient specifications measure up to regulatory and industry standards?

Spec Verified™  Supplement Ingredient Verification is one of the first independent verification services focusing on evaluating and developing specifications for dietary supplement ingredients.


Dietary Supplement GMP Good Manufacturing Practices

NaturPro Offers Audits of Dietary Supplement GMP Good Manufacturing Practices (21 CFR 111)

The UnLab

NaturPro Scientific is a lab testing advocate for our clients as one of the few “UnLabs” not limited to a particular set of instruments or limitations of a single lab. Working with multiple labs allows us to advocate and work on behalf of our clients, to ensure that correct methods and results are obtained.



Supplement GMP and Quality Assuranc
e

GMP’s now apply equally to supplement manufacturers, ingredient manufacturers, and non-manufacturers who only hold or distribute supplements.  Getting compliant requires a minimum investment and commitment, but we can make it relatively painless.


 

Ethical Sourcing Review™

In collaboration with  standards development firm IDDI and ethnobotanist Trish Flaster from Botanical Liaisons LLC, NaturPro Scientific recently developed the Ethical Sourcing Review™, one of the most comprehensive and stringent standards developed to improve sustainability and traceability of botanical and natural dietary ingredients from the earth.

Spec Verified – Supplement Specification Verification

by NaturPro in Comments: 0

Ever wonder how your ingredient specifications measure up to regulatory and industry standards?

Supplement and Ingredient Sustainability and Traceability

by NaturPro in Comments: 0

The Ethical Sourcing Review™ is one of the most comprehensive and stringent standards developed to improve sustainability of dietary ingredients from natural sources.

Supplement and Ingredient Sustainability and Traceability

The following outline covers subject matter covered in the 100-part ESR™ Sustainability Questionnaire. ESR™ standards are derived from the International Labour Organization Labour Principles of the United Nations Global Compact, the UN Forum on Sustainability Standards, WHO GAP, NOP Organic, USP <561> and US FDA 21 CFR 111.

Product:

  1. Contact information
  2. Product name
  3. Specifications, nomenclature
  4. Sourcing origin
  5. Land use and inputs
  6. Harvest practices
  7. Plant population care
  8. Raw material processing and labeling

Relationships

  1. Type and controls
  2. Prices and wages
  3. Non-discrimination
  4. Reciprocity
  5. Communications

Employment

  1. Labor practices
  2. Fair wages and prices
  3. Child labor
  4. Harrassment
  5. Working conditions
  6. Worker safety

Environment

  1. Legal requirements
  2. Policies and communications
  3. Management responsibilities
  4. Waste management
  5. Emissions
  6. Energy usage

Management and Supply Chain

  1. Written policies
  2. Training
  3. Supplier management
  4. Dealing with non-compliances
  5. Audit program
  6. Geographic risk
  7. Community improvements

 

Contact us for more information on NaturPro Scientific’s ingredient traceability and ethical sourcing programs. 

 

 

Supplier Quality Verification Program (SQVP)

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NaturPro Scientific has been working to develop a comprehensive Botanical Raw Material Supplier Quality Verification Program (SQVP).  The SQVP program stands on the shoulders of giants, combining the best of many prevailing quality standards.

The SQVP considers a number of questions and issues mentioned by industry in response to recent initiatives to develop universal standards for dietary ingredient raw materials and supplier qualification.  It combines previously developed standards such as Good Agricultural and Collection Practices developed by WHO and AHPA, Good Manufacturing Practices developed by FDA and other countries, and Risk Analysis tools like HACCP used for food and product safety verification. The SQVP Program Toolbox also include checklists and standards already developed for specific regulatory requirements, such as the SIDI workgroup documents used for dietary ingredients.

The SQVP meets the requirements of the Foreign Supplier Verification Program (FSVP) required under the new FSMA law put in place by the US FDA. 

The objective of this program is to apply global and US regulatory and quality requirements to provide a working system for large-scale, global sourcing and quality control of natural products intended to support human health. The SQVP is intended to be applied broadly to different types of supply chains for dietary ingredients, from a small mountain village in China to streamlined, vertically integrated operations in Europe.

The SQVP also attempts to list program components which may not be directly related to audit criteria, but are critical to the operational success of the program.

While the SQVP system is intended to provide a minimum mandatory level covering the areas of highest risk and regulatory focus, it provides a working model for a Sustainability Program which includes ways to recognize practices for raw materials that go above and beyond the minimum requirements, and also include some attributes from previous guidances that are considered lower-risk and are difficult to control.