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…
A paperless GMP manufacturing operation sounds counter-intuitive. Almost all operations use paper forms especially pharmaceutical GMP manufacturing. When you think about the simplest processes such as ordering and receiving materials there has to be paper in use. Or maybe not.…
When PharmaDirections undertook a project to design and build a GMP manufacturing facility that would become a site for InstantGMP™ production, one of the key considerations was designing a virtual quality system. The requirements were to have policies, procedures, documentation…
The concept behind InstantGMP started in 2004 when PharmaDirections was engaged to build a manufacturing facility that could be mostly operated with remote staff. The infrastructure for virtual drug development was getting better due to the maturity of the internet…