The author describes the benefits and challenges inherent to cleaning in place (CIP). The article also describes the development and validation of a CIP cycle. Today’s pharmaceutical and ...

This article is part of PharmTech's supplement "Injectable Drug Delivery." Aseptic processes are some of the most difficult processes to conduct in the pharmaceutical industry. Because of the nature ...

Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that ...