Should You Build or Buy a Manufacturing Execution System?

  This question can be answered after looking at the software level definitions in the GAMP guidelines. They define several levels of software which include three that are appropriate for end users. Each one has it pluses and minuses so it is useful to understand the differences. The first of these is “Standard Software Packages”[…]

GMP Compliance Series – Part 14: Training Documentation

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 and quality operations to be trained for their specific duties and tasks. The training may include[…]