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 3: Improving Batch Production Records

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 how it makes decisions when changes are made during the production process. Prismic Light International[…]

GMP Manufacturing of Dietary Supplements

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 follow cGMPs to ensure that packaging and labeling is done as specified in the master[…]