Good Manufacturing Practices 101: The Lowdown on Preventing Low Quality Products

  Good Manufacturing Practices, better known as GMPs, are a system of minimum requirements set by the Food & Drug Administration (FDA) to ensure safe products of consistent quality. However, they can be intimidating to many due to their complexity. Each FDA-regulated industry features its own standards for GMP compliance, but they all have several[…]

Master Manufacturing Formula for Vitamin B Complex with Vitamin C Tablets

The vitamin B-complex is a group of water-soluble vitamins that play important roles in cell metabolism.  “Vitamin B” was once thought to be a single nutrient that existed in extracts of rice, liver, or yeast. Later research showed that they are chemically distinct vitamins that often coexist in the same foods. A Vitamin B complex[…]

GMP Compliance Series – Part 14: Training Documentation

  InstantGMP Compliance Series-Training Documentation for GMP Manufacturers of Dietary Supplements from Richard Soltero on Vimeo. Training Documentation Training and documentation of training is an essential element of Good Manufacturing Practices. The FDA expects all personnel who are in manufacturing and quality operations to be trained for their specific duties and tasks. The training may[…]

GMP Compliance Series – Part 13: Testing in Dietary Supplement Manufacturing

GMP Problems: The FDA inspects dietary supplement manufacturers to ensure they are in cGMP compliance. After they inspected Sterling USA Neutraceutical Lab they cited them for failing to conduct at least one test or examination that would verify the identity the dietary ingredients used in their products. Testing each dietary ingredient prior to its use[…]

GMP Compliance Series – Part 12: Facility Areas

GMP Problems: When the Dietary Supplements Health and Education Act that came law in 2007 and was fully implemented in 2010, it mandated that all dietary supplements manufacturers in compliance with the current Good Manufacturing Practices (cGMP) regulations in the act. These regulations extend to the layout, location and operation of the various areas in[…]

GMP Compliance Series – Part 11: Facility Design for Dietary Supplement Manufacturing

GMP Problems: Dietary Supplements manufacturers have to be in compliance with the cGMP regulations specified in the Dietary Supplements Health and Education Act that became law in 2007. These regulations extend to the design, location and operation of the manufacturing facility. Many dietary supplement companies were is business before the regulations came into full effect,[…]

GMP Compliance Series – Part 10: Maintaining Equipment

GMP Problems: Dietary Supplements have to be manufactured under the cGMP regulations specified in the Dietary Supplements Health and Education Act that became law in 2007. Many manufacturers or distributors of dietary supplements have been inspected by the FDA since 2010 and at least 50% get citations for failing to be in compliance with GMP[…]

GMP Compliance Series: Part 9: Packaging and Labeling

GMP Problems: Packaging and labeling of dietary supplements was not controlled by the FDA until 2007 when the Dietary Supplements Health and Education Act (DSHEA) became law. In 2010 the act applied to all packagers and distributors of dietary supplements who had to be in compliance with GMP requirements. Since that time, the FDA began[…]

GMP Compliance Series: Part 8 – Product Complaints and Recalls

GMP Problems The identification of the key issues in product complaints is a tool for overall quality improvement. The primary principle is that the manufacturer must assume responsibility for the quality of their products to ensure that they are fit for their intended use. Complaints must be handled quickly and positively and after careful review[…]

GMP Compliance Series: Part 7: Supplier and Vendor Qualification

GMP Problems The FDA has issued a number of warning letters FDA issued Warning Letters for GMP violations of Dietary Supplement Health and Education Act where they cited failures of the firm’s supplier and vendor certification programs. They issued one to Global Sweet Polyols, LLC, a dietary supplement manufacture,  when they found the firm had failed[…]