Validation
The terms validation and verification are used in many industries. In this post, we are referring to them in the context of the converting industry,…
Good Automated Manufacturing Practices (GAMP) are the guidelines for manufacturers and users of automated systems in the pharmaceutical industry. Because of the regulatory nature of…
All devices as defined by 21 USC 321 (h), i.e., a “medical device,” are subject to the requirements of the UDI rule unless an exception…