NINGBO SMART PHARMACEUTICAL RELEASE WITH INCOMPLETE C of As Comment The Ningbo Smart Pharmaceutical Co. Ltd, Ningbo China, received an Active Pharmaceutical Ingredient (API) audit between October 25-29, 2010. During this audit, the investigator identified significant deviations from CGMP for the manufacture of APIs. They … [Read more...]
FDA’s Guidance for Industry Process Validation Issued Today
JUST RELEASED -- January 24, 2011 Guidance for Industry Process Validation: General Principles and Practices; Current Good Manufacturing Practices (CGMP), Rev 1. January 2011. Please contact: Barry A Friedman, PhD at barryafriedman@aol.com for a copy … [Read more...]
