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.…
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…
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…
GMP Problems: When the Dietary Supplements Health and Education Act came into law in 2007 and was fully implemented in 2010, it mandated that all dietary supplement manufacturers be in compliance with the current Good Manufacturing Practices (cGMP) regulations in…
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…
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…
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…
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…
GMP Problems The FDA has issued a number of warning letters FDA issued Warning Letters for GMP violations of the Dietary Supplement Health and Education Act, where they cited failures of the firm’s supplier and vendor certification programs. They issued…
Problems with Deviations Himalayan Institute, a dietary supplement manufacturer in NY, was issued a warning letter for violations of GMP regulations. The FDA noted in their investigations that several of the company’s batch production records showed deviations from the Master…