Good Manufacturing Practices (GMPs)

Garden of Life works with these third party organizations to ensure the highest possible quality in the products we manufacture for your extraordinary health.

Are dietary supplements regulated?

Yes. The FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

On June 25, 2007, the Food and Drug Administration (FDA) published the dietary supplement current good manufacturing practices (cGMPs) final rule 21 CFR 111. The new regulations apply to all persons who manufacture, package, label, or hold dietary supplements, with the exception of persons who hold dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual customers. According to FDA, the cGMPs are intended to establish a comprehensive system of process controls, including documentation of each stage of the manufacturing process, which can minimize the likelihood of, or detect problems and variances in manufacturing as they occur, before the product is in its finished form. The process controls that are a part of cGMPs are essential to ensure that a dietary supplement is manufactured, packaged, held, and labeled in a consistent and reproducible manner.

Although the compliance date for medium size businesses such as Garden of Life was June 25, 2009, Garden of Life has operated under GMPs for several years.

What are GMPs?

GMPs or Good Manufacturing Practices (also referred to as cGMP or Current Good Manufacturing Practices), are a set of guidelines that address the principles required in the manufacturing and care of products intended for human use and regulated by the Food & Drug Administration (FDA). GMPs are established due to common standards set by the industry to ensure products are manufactured safely and with quality assurance.

How does Garden of Life implement cGMPs?

Garden of Life knows and understands the regulations; we have a Quality Department that oversees cGMPs. We have established manufacturing and operating procedures, documentation for following these procedures. We train employees on how to follow these procedures and have implemented processes for corrective actions and preventive actions (CAPA). Garden of Life works very closely with contract manufacturers and raw material suppliers, conducting GMP supplier audits, evaluating GMP status and identifying gaps; we confirm raw material identity and determine action plans to maintain and/or improve supplier's status. Garden of Life has created quality systems by establishing Standard Operating Procedures (SOPs), product specifications, implementing and following Good Documentation Practices and reviewing and investigating product complaints.

The safety and efficacy of our products is of utmost concern. All raw materials have strict specifications and their Certificates of Analysis are kept on record. As part of our testing protocol, we test all finished products for pathogens. Our premium quality products are manufactured in carefully selected facilities, and we work with manufacturers who have the highest quality standards and follow GMPs (Good Manufacturing Practices) set by the FDA. We have an extensive quality program that surpasses many industry standards in order to deliver the best product to our customers.

GMP Portal	Description	Pass	Fail
Finished Good Specifications	Microbial Analysis
	Heavy Metals
	Finished Good Specifications
Raw Material Compliance	Raw Material Supplier is Qualified and Audited
	Ingredient Tested and Identified
Production	Quality Policies / SOP's
	Adherence to Formula
	Equipment Calibration and Maintenance
	Production Record Compliance and Accountability
	Qualified & Trained Personnel
	Hygienic Environment
Quality Inspection of	Packaging Components
	Label Code
	Weight / Count
Physical Plant	Suitable & in Good State

*For more information regarding NSF Registered manufacturers, call 866-465-0051.

**To find products Certified Organic by QAI, search http://www.gardenoflife.com/ProductsforLife/DigestiveHealth/tabid/633/Default.aspx