Tag Archives: FDA Guidance for Industry

CHINESE API MANUFACTURING FACILITIES RECEIVE WARNING LETTER (MARCH 30, 2011)

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 … Continue reading

Posted in FDA Compliance, Warning Letters | Tagged , , , , , , , , , , , , ,

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

Posted in New Guidances for Industry | Tagged , | Leave a comment