Updated 14 January 2022 Jae Haroldsen

GMP Certification, Is that Important? 

The U. S. Food & Drug Administration (FDA) regulates the manufacturing process of food, drug, cosmetic, and dietary supplements. The FDA has established current Good Manufacturing Practices (GMP) for manufacturing, packaging, holding, and labeling dietary supplements. These practices can be found in the Code of Federal Regulations Title 21 part 111, often referred to as 21 CFR. 

Like pharmaceutical manufacturers, supplement manufacturers must be registered with the FDA. However, FDA does not administer nor require a dietary supplement manufacturer certification program.  

The 1994 Dietary Supplement Health and Education Act (DSHEA) regulates dietary supplements more like food than drugs. According to DSHEA, supplement manufacturers are responsible for the purity and safety of supplement ingredients and that claims made on packaging or in advertising are substantiated by adequate scientific evidence. 

To enforce GMP regulations, the FDA monitors:  

  1. Dietary supplements’ product information given on product labels, package inserts, or online marketing for accuracy and appropriate claims; 
  2. Consumer reported adverse events; 
  3. Safety Literature; 
  4. Random laboratory analysis of marketed supplements to determine if product contents match the nutrition information on the label.  

When problems are detected with a dietary supplement, the FDA investigates with facility audits and third-party laboratory analysis. 

 

Benefits of Private Third-Party GMP Certification Programs 

Since there is no FDA GMP certification or accreditation program to acknowledge GMP compliance, how can you know if a manufacturer is up to snuff? Especially since the brand owner is ultimately responsible for the purity, quality, and safety of their products. It is the brand owners’ merchandise that is subject to expensive recalls if a product is deemed unsafe or has false or misleading claims or nutrition labeling.  

You can put your mind at ease when contracting with a manufacturer with third-party GMP certification. For GMP compliance assurance, private third-party companies like NSF International, Underwriters Laboratory (UL), Consumer Lab, and U.S. Pharmacopeia (USP) have developed certification programs for supplement manufactures. 

These private companies' certification programs require: 

1- Audits of the manufacturing facility for conformity to GMP requirements, including proper documentation, training, quality control measures, equipment cleaning, and testing. 

2- Third-party testing of raw ingredients and manufactured products for product purity, quality, and safety. These analyses also include testing for banned ingredients and determining if the supplement’s contents meet labeling claims. 

 

FDA GMP Requirements 

The FDA enforces GMP in 21 CFR 111 to assure quality standards are met in the proper design, monitoring, and control of pharmaceutical production by regulating the supplement manufacturer’s physical plant, equipment, personnel training, production processes, quality control systems, packaging and labeling, holding and distribution systems, supplement returns, and documentation and record-keeping. 

FDA approved

Testing is part of the FDA GMP quality system and includes; identity testing of incoming materials and micro testing to rule out undesirable organisms. Additional testing may be required depending upon the substances in question. These regulations assure consumers of the identity, strength, quality, and purity of the produced dietary supplements and drug products. 

 

FDA Audits Dietary Supplement Manufacturers 

The FDA randomly audits supplement manufacturers and targets any manufacturer with filed complaints. When auditing, the FDA looks for facilities in good condition with properly maintained and calibrated equipment, fully trained and qualified employees, reliable and reproducible processes, and clear and complete documentation. 

 

Third-Party GMP Certification Not the End All 

In the end, full compliance with GMP regulations is up to the manufacturer. The FDA enforced the January 2020 massive recall of a New York dietary supplement manufacturer’s products. When commenting on this, Kenneth Colt, business manager of NSF International, says, “It’s important to remember that GMP audits are a snapshot of a moment in time.” 

Regardless of whether or not the manufacturer has third-party GMP certification, ask questions and then ask more questions to determine if they are the right manufacturer for your brand. An honest manufacturer will be open about what they can and cannot manufacture and package. 

  

Additional Certification Options for Supplement Manufacturers 

Another indication of a manufacturer’s character is their additional quality certifications. Organic, kosher, and/or halal certifications are cost-effective to obtain and demonstrate to consumers/brand owners the manufacturer’s adherence to good practices. These certifications require precise equipment cleaning to avoid contamination, detailed documentation of ingredients’ identity and purity, and additional quality testing. 

 

The Reality of GMP Certification 

GMP certification by a private third-party company assures that the manufacturer strives to be compliant. Additional questioning and research on your part ferret out companies that do not live up to their ‘snapshot in time’ in their third-party GMP audit. 

In the end, what matters to brand owners is that the manufacturer complies with FDA’s GMP regulations and manufactures high-quality supplements at a fair price. 

Inspect

Origin Nutraceutical is one of the best Utah supplement manufacturers. We comply with GMP regulations, as shown by our NSF-GMP certification. In addition, we maintain organic, kosher, and halal certifications. We also have established supply chains to get you high-quality raw materials at the best prices. 

We know customer service is the origin of success. As such, we happily answer all potential clients' questions and concerns. If we do not manufacture or package what you want, we will gladly refer you to a trusted manufacturer who does. Contact us today. 

 

 By: Jae O. Haroldsen 

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 

  • 21 CFR 111. April 1, 2019. Code of Federal Regulations Title 21. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=111 
  • Loria, Kevin. 2019. “How to Choose Supplements Wisely.” Consumer Reports. https://www.consumerreports.org/supplements/how-to-choose-supplements-wisely/ 
  • Dinato, Nichole. 2019. “What is a GMP Certification?” Career Trend. https://careertrend.com/facts-7166463-GMP-certification-.html 
  • “Backgrounder on the Final Rule for Current Good Manufacturing Practices (CGMPs) for Dietary Supplements.” FDA. 2018. https://www.fda.gov/food/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements/backgrounder-final-rule-current-good-manufacturing-practices-cgmps-dietary-supplements 
  • Myers, Steve and Long, Josh. Spring 2020. “Massive Supplements Recall Raises Questions About GMP Certifications.” National Products Insider. https://www.naturalproductsinsider.com/regulatory/supplement-maker-subject-massive-recall-was-gmp-certified 
  • “Facts About the Current Good Manufacturing Practices.” FDA. 2018. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about 
  • “What You Need to Know about Dietary Supplements.” FDA. 2017. https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-dietary-supplements