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…
The InstantGMP MES software and SOPs were recently featured in an article by Hank Schulz, a writer for Nutra Ingredients-USA. His article entitled "Integrated data systems help cut cost of GMP compliance," discusses the challenges dietary supplement companies face…
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…
How much should you charge customers for private label and contract manufacturing of dietary supplements and pharmaceutical products? This question could be answered by a variety of methods. A common approach in contract manufacturing organizations is to look back at…
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…
Electronic manufacturing systems have been the choice for large manufacturing companies over the last twenty years. Electronic manufacturing systems are the industry standard for large pharmaceutical companies who are required to follow GMPs (Good Manufacturing Practices). While FDA legislation mandates…
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…
A dietary supplement company called Milk Specialties Global got an FDA warning letter after an inspection of its plant in Wautoma, Wis. According to the FDA, the company kept incomplete records of its batches of supplements and failed to record…
Posted by Rick Soltero A review of warning letter trends revealed that many are issued because firms not keeping proper Master Manufacturing Records (MMR). An example is in the Warning Letter issued to United Nutrition Labs, Inc in July. The…
GMP Manufacturing of Dietary Supplements Not everyone in the dietary supplement business is aware that the FDA now requires Good Manufacturing Practices (GMPs) in manufacturing, packaging, labeling, or holding operations for dietary supplements. Any company involved has to establish and to…