Publisher's Synopsis
While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages.
Highlights from Liquid Products, Volume Three include:
- practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing
- access to what an FDA auditor would be looking for during a liquid manufacturing audit
- issues that may arise during a US FDA inspection
- the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines
