• Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers
• Increases senior management confidence in the preparedness of manufacturing facilities for FDA inspection
• Decreases the time and cost for companies selecting third-party testing and product certification if using an NSF GMP registered contract manufacturer 
• Manufacturers of dietary supplements that comply with GMP requirements receive certificates and are listed on the NSF website. 
• Available to all manufacturers of dietary supplements 
• Demonstrates independent third-party verification of continuing conformance to GMPs   www.usp.org 

What is ISO?

The International Organization for Standardization (ISO) www.iso.org/iso/home.htmis a worldwide federation of 111 national standards bodies whose primary objective is to promote the development of manufacturing, trade and communication among business organizations world wide through the development of standards. 

The term “ISO 9001” refers to a detailed set of quality management standards that a company must adhere to in order to meet the conditions of certification.

• Personnel are competent and have the applicable theoretical and practical backgrounds to properly perform their work
• Written procedures are used for the sampling, handling, transport, storage, and preparation of items to be tested
• When applicable, testing methods are those published as international or national standards
• Testing methodology is validated to confirm that it is appropriate for each particular test

Standard Operating Procedures (SOP’S)

The manufacturing process itself is performed under tight controls by a team of highly skilled, dedicated staff, who strictly adhere to written Standard Operating Procedures (SOPs) prepared in accordance with Good Manufacturing Practices (GMPs), as listed under Nutritional Supplements in the USP30. All manufacturing takes place in temperature and humidity controlled conditions, and is under constant supervision. To further ensure precision and accountability, our manufacturer electronically follow the entire manufacturing process, from the receipt of the raw material to the finished product. This allows us to track the progress of a product at all points through the production process and allows the various departments that work on the product to better interact, ensuring a quality supplement.

What is the United States Pharmacopea?

The United States Pharmacopeia (USP) www.usp.orgis the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. USP sets standards for the quality of these products and works with healthcare providers to help them reach the standards. USP's standards are also recognized and used in more than 130 countries. These standards have been helping to ensure good pharmaceutical care for people throughout the world for more than 185 years.

What is a Certificate of Analysis?
Certificates of Analysis are laboratory assays performed for dietary supplement manufacturers that attest to the purity and active ingredients in the supplement. A good rule of thumb to follow is that if a manufacturer of dietary supplements can supply a Certificate of Analysis, this often demonstrates their intent to sell only quality supplements. Certainly, there is abuse in this arena as well, since scientists can be bought and Certificates can be falsified.
Vendor Certificate Program Ensuring Raw Material Quality

Superior products begin with superior raw materials and every raw material that enters our manufactures building is inspected and quality control approved. All materials go through a rigorous inspection to ensure they meet predetermined standards that have been set for each raw material. As an additional step, our vendors meet face to face with raw material manufacturers on an annual basis as part of our Vendor Certification Program to ensure that we have a sound understanding of each material and can address any new advances that may have developed in the previous year. Unlike many other dietary supplement manufacturers, our vendor has its own in-house microbiological laboratory that is partitioned off from the rest of our facility and operates using a separate air-flow system. Before ingredients can be used in any product, they are subjected to testing in our microbiology lab for contamination including total aerobic plate count, yeast, mold, E. coli and other potential pathogenic organisms including staphylococcus, salmonella and pseudomonas to ensure that the materials meet or exceed the requirements of the United States Pharmacopoeia (USP). Only after quality control approval has been granted can the raw material be released for use in one of the finished products.

Public Health Security and Bioterrorism Preparedness Response Act

On June 12, 2002, the President signed the“Public Health Security and Bioterrorism Preparedness Response Act of 2002” into law. To see the text, go to http://www.fda.gov/oc/bioterrorism/PL107-188.html . This act is designed to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. It requires people possessing, using, or transferring agents or toxins deemed a threat to public health to notify the Secretary of the U.S. Department of Health and Human Services (HHS). It also requires people possessing, using, or transferring agents or toxins deemed a threat to animal or plant health and to animal or plant products to notify the Secretary of the U. S. Department of Agriculture (USDA). For USDA, the section of the new Act that pertains to agents and toxins that pose a severe threat to animal and plant health and to animal and plant products is called the “Agricultural Bioterrorism Protection Act of 2002.”

Physical and Chemical Laboratories

Our manufactures physical properties and chemical analysis laboratories ensure raw materials and finished products meet specific standards of quality, purity and safety. The physical analysis laboratory tests the weight, thickness, hardness, and disintegration of finished products, making certain that capsules and tablets disintegrate and release their nutrients in a timely manner. Using highly sophisticated analytical instruments, including HPLC (High Performance Liquid Chromatography), ICP (Inductively Coupled Plasma, used for mineral analysis), GFAA (graphite furnace atomic absorption spectrophotometry, used for heavy metals testing) and an FT-IR (Fourier Transform Infrared spectrophotometer), the chemical analysis laboratories test for the measurement of various vitamins, minerals and herbals to ensure that the products meet meticulous standards of quality, many of which exceed the limits defined in the USP.   To further enhance analytical capabilities our manufactures have upgraded their chemical analysis laboratory by purchasing new and more sensitive analytical equipment including a GFAA (Graphite Furnace Atomic Absorption spectrophotometer) and an FT-IR (Fourier Transform Infrared spectrophotometer). These new acquisitions allow them to measure additional analytes in both the raw materials and finished products. The GFAA is a highly sensitive instrument that can measure trace elements such as lead, arsenic and cadmium in the parts per billion range to ensure that the products meet the highest standards for quality and purity. The FT-IR is an interesting technology that is able to analyze raw materials to ensure the components match recognized standards. The addition of these two analytical instruments makes our manufacture’s laboratories one of the most comprehensive in the dietary supplement.  To further enhance analytical capabilities our manufactures have upgraded their chemical analysis laboratory by purchasing new and more sensitive analytical equipment including a GFAA (Graphite Furnace Atomic Absorption spectrophotometer) and an FT-IR (Fourier Transform Infrared spectrophotometer). These new acquisitions allow them to measure additional analytes in both our raw materials and finished products. The GFAA is a highly sensitive instrument that can  measure trace elements such as lead, arsenic and cadmium in the parts per billion range to ensure that our products meet the highest standards for quality and purity. The FT-IR is an interesting technology that is able to analyze raw materials to ensure the components match recognized standards.