Validation
Validation Essentials: Three Must-Dos to Achieve Compliance
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…
How FDA Mandate on UDIs Will Impact Medical Device Manufacturing
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…