26 October 2021 Jae Haroldsen

Welcome to Origin Nutraceutical! We are a fully functioning, state-of-the-art dietary supplement manufacturing company operating with NSF GMP Certification. Our vast experience, attention to detail, and excellent customer service provide assurance, flexibility, and superior product.

What is GMP?

Under 21 CFR 111, The Food and Drug Administration (FDA) established Good Manufacturing Practices (GMP) for the manufacturing, packaging, labeling, and storage of dietary supplements. GMP regulations set basic standards to ensure consumers of the quality and proper labeling of supplements.
Following set GMP, assures dietary supplements are manufactured in a consistent, controlled, and precise manner with detailed quality control measures and testing. To stay up to date with the most recent standards and technological practices, Origin Nutraceutical functions under current GMP (cGMP).
Following cGMP, means Origin is constantly seeking to improve our supplement manufacturing processes and quality assurance procedures. To this end, Origin has dedicated teams and processes in place to meet the needs of our constantly changing world.
Our Regulatory Team stays up to date with FDA requirements, educates employees, and monitors standard operating procedures for full compliance with cGMP. They also conduct regular in-house audits and mock recalls, review supplier qualifications, and update food safety plans.
Our Quality Assistance Team fine-tunes our daily process management to improve equipment cleaning, employee training, and high-quality supplement production.

 

What are the Main Components of GMP?

The FDA breaks GMP compliance into sixteen subparts. Eight subparts deal with process and control systems to ensure quality control measures are in place for:
ingredient components,
batch production,
manufacturing,
packaging and labeling,
laboratory testing at various stages of production, and
detailed documentation throughout the entire process.

The other GMP subparts outline requirements for:
Personnel, including detailed training requirements.
Manufacturing facility and grounds.
Manufacturing equipment and tools.
Ingredients and final product storage and distribution.
Procedures for product recalls and returns.
Dealing with product complaints.
Records and recordkeeping.

The FDA does not administer or require dietary supplement manufacturers to obtain GMP Certification. The FDA does monitor and target manufacturers with filed complaints. The FDA enforces GMP regulations through facility audits, fines, cease and desist orders, and criminal prosecution.

 

What is GMP Certification?

GMP certification programs are offered by third-party companies to assure consumers and supplement brand companies that supplements are developed and manufactured in compliance with FDA GMP regulations.
These third-party companies like NSF International, U.S. Pharmacopeia, Underwriters Laboratory (UL), and Consumer Lab offer GMP certification for dietary supplements and supplement manufacturers.

Who is NSF International?


National Sanitation Foundation (NSF) International has sought to improve global health since 1944. NSF operates in 180 countries and employs a team of public health experts, toxicologists, microbiologists, chemists, and engineers to develop public health standards and audit, test, and certify dietary products and services.


NSF operates an extensive testing and auditing GMP certification program for dietary supplement manufacturers. Choosing a dietary supplement manufacturer with NSF GMP certification assures supplement brand owners and users the supplement complies with NSF’s strict standards and procedures.
NSF GMP certification means the supplement manufacturer is subject to extensive raw materials and final product testing and unannounced facility inspections. During facility inspections, NSF reviews and approves facility management and processes, employee training, laboratory testing, and cleaning procedures.

 

Is it a Big Deal to be NSF GMP-Certified?

YES! To obtain and maintain NSF GMP Certification, supplements must be manufactured with the utmost attention to detail and integrity to GMP regulations. No shortcuts. No hedging. No sidestepping. Just safe dietary supplements manufactured honestly with pure and identified ingredients.
NSF GMP certification must be renewed annually. Continued certification requires regular facility inspections and laboratory testing of ingredients and products. NSF 3states, “If a product fails to meet a certification criterion, NSF will take action to notify the public, recall a product, or de-certify the manufacturer.”

Origin Nutraceutical Operates with NSF-GMP Certification


NSF International assessed and found Origin Nutraceutical in compliance with NSF GMP Registration Program Requirements of NSF/ANSI 173, Section 8, including FSMA and cGMP (21 CFR 111), (21 CFR 117).
Origin Nutraceutical is a full-functioning dietary supplement manufacturing company dedicated to building a healthier world one supplement at a time using sustainably sourced ingredients and processes.
To discover how we can develop and manufacture your dietary supplement brand with open, honest communication, contact Origin today.
Here at Origin Nutra, whatever is important to you, is important to us.

The content of Origin Nutraceutical’s website is for information only, not advice or guarantee of outcome. Information is gathered and shared from reputable sources; however, Origin Nutraceutical is not responsible for errors or omissions in reporting or explanation. No individuals, including those taking Origin Nutraceutical products, should use the information, resources or tools contained within to self-diagnosis or self-treat any health-related condition. Origin Nutraceutical gives no assurance or warranty regarding the accuracy, timeliness or applicability of the content.

Sources:
1“Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. FDA. 2010. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-current-good-manufacturing-practice-manufacturing-packaging-labeling

2“What is NSF Certification.” NSF. https://www.nsf.org/knowledge-library/what-is-nsf-certification
3”About NSF.” NSF. https://www.nsf.org/about-nsf