International regulatory collaboration has passed an important early test, providing the faintest glimmer of hope that the FDA might actually be able to achieve some of the conflicting goals handed ...

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide. The Pharmaceutical Inspection Convention ...

Pharmaceuticals are developed, designed, and commonly manufactured in laboratory settings. Laboratory testing is an essential need in almost every stage of pharmaceutical production and R&D, from the ...

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being ...