GMP CERTIFICATION EXPLAINED

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GMP CERTIFICATE

2021-2024

Issued by: UL/NPA (Underwriter's Laboratories / Natural Products Association)

Conformance to: 21 CFR Part 111: 2020

Certificate Number: i18-299368-1

Issued:   Oct 26, 2021 / Expires:  Nov 13 2024

 

Purpose of Combined UL/NPA cGMP Dietary Supplement Certificate –

What it means for our customers:

Procuring a vetted supplier for your products lowers the cost of doing business and provides security knowing your suppliers are in compliance with global regulatory requirements. GMP* certification provides a route to vetting Mineral Logic as a supplier for the nutraceutical, food, and beverage industries. The certification also protects our intellectual property and our brand.

 

Mineral Logic chose the specialized UL/NPA GMP* accreditation program to establish the highest international manufacturing credentials for our company and products. It is recognized in all fifty US states, Canada, Mexico, Europe, Australia, the Middle East, and Asia. The UL/NPA certification is a comprehensive, rigorous analysis of our entire business and manufacturing processes. We are audited annually by UL to maintain our certification. The accreditation is comparable to ISO 22000* or FSSC 22000*.

 

Mineral Logic has made this investment for the following reasons:

  • To guarantee the highest product and manufacturing standards

  • Achieve global recognition for excellence

  • Build customer trust in a reliable, sustainable, safe product

  • Rigorous quality controls with established standard operating procedures.

  • Brand protection and acceptance by formulators, ingredient suppliers, and contract manufacturers

  • Commitment to quality

  • Regulatory compliance

 

The attached PDF from NPA describes the scope of inspection criteria and the required compliance to achieve accreditation. An audit is performed annually. A summary of the categories of inspection are listed below:

  1. Personnel

  2. Physical Plant and Grounds

    • Water supply

    • Pest control

    • Processing rooms

    • Maintaining hygienic practices of personnel and workspaces, air filtration, and building mechanical systems.

  3. Equipment and Utensils

  4. Production and Process Control System

    • Expiration dates

    • Reserve samples

    • Quality control system

    • Packaging and labeling

    • Master Manufacturing Record

    • Batch Production Records

    • Holding and Distributing

    • Sanitation

    • Returned product

  5. Accounting and record-keeping

  6. FDA compliance

  7. Quality Control Critical Checkpoints

 

FSMA Plan (Food Safety Modernization Act)

In addition to our cGMP certification, Mineral Logic abides by an FSMA plan. The United States Food and Drug Administration FSMA is a set of regulations mandating that manufacturers of food products are consistently conforming to high-quality standards to prevent food safety problems by identifying potential risks and implementing appropriate controls to avoid any contamination proactively.

 

HACCP (Hazard Analysis Critical Control Point)

HACCP is a management system in which food safety is addressed by analyzing and controlling biological, chemical, and physical hazards from raw material production, procurement, and handling, to manufacturing, distribution, and consumption of the finished product. Regulated by the US FDA, it is a legal requirement in the US for all food businesses. It covers the following seven principles:

  1. Conduct a Hazard Analysis

  2. Identify Critical Control Points

  3. Establish Critical Limits

  4. Monitor Critical Control Points

  5. Establish Corrective Actions

  6. Establish Record-Keeping Procedures

  7. Establish Verification Procedures

 

*cGMP

Current Good Manufacturing Practices. cGMP is a product quality standard focusing on production and quality control. It means that the manufacturer has demonstrated a strong regulatory commitment and compliance to international GMP standards.

 

* UL – Underwriter's Laboratories

Established in 1894, UL is a global safety certification company. It is one of several companies approved to perform safety testing by the US federal agency OSHA (Occupational Safety and Health Administration). It is a global leader in advancing sustainable audit and certification services within supply chains worldwide. It provides independent, third-party manufacturing and process assessments against a defined standard that aims to minimize risk, protect brand value, and promote consumer and product safety.

 

*NPA – Natural Products Association

Founded in 1936, the NPA is the United States' largest and oldest nonprofit organization dedicated to the natural products industry. NPA represents over 2,000 members accounting for more than 10,000 retail, manufacturing, wholesale, and distribution locations of natural products, including foods, dietary supplements, and health/ beauty aids. NPA unites a diverse membership, from the smallest health food store to the largest dietary supplement manufacturer.

 

*ISO 22000 is a Food Safety Management System that can be applied to any organization in the food chain, farm to fork. Becoming certified to ISO 22000 allows a company to show their customers that they have a food safety management system in place. This provides customer confidence in the product. This is becoming more and more important as customers demand safe food and food processors require that ingredients obtained from their suppliers to be safe. The UL/NPA certification along with HACCP, and FSMA cover the same criteria as ISO 22000.

 

*FSSC 22000 is a Food Safety Management Certification Scheme, managed by Foundation FSSC 22000 and governed by an independent Board of Stakeholders which consists of representatives from several sectors in the food industry. FSSC 22000 is used to control food safety risks. The UL/NPA certification along with HACCP, and FSMA cover the same criteria as ISO 22000.