GMP Compliance Series Part 2: Better Compliance through Better Master Manufacturing Records

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 FDA cited them for numerous violations including failing to provide any documentation of changes to[…]

InstantGMP™ Compliance Series – Introduction to Good Manufacturing Practices

InstantGMP™ Compliance Series – Introduction from Richard Soltero on Vimeo. The Food and Drug Administration (FDA) started enforcing Good Manufacturing Practice requirements for all Dietary Supplement manufacturers in 2010. Since then, they have published the results of their inspections and the warning letters they issue when manufacturers fail to come into compliance.  The experts at InstantGMP™[…]

GMP Compliance Series: Part 1: Improving Documentation of GMP Procedures

Posted by Rick Soltero The FDA inspections of dietary supplement manufacturers have resulted in 1 in 4 producers getting a Warning Letter that could shut down their business. We have analyzed the inspection notices from these manufacturers and wrote this series of articles in the hope that we can give you some ideas for improving[…]