July 2nd 2025
The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.
SOCMA Hails FDA Action on Citizen Petition Regarding Inspections
November 5th 2009The Society of Chemical Manufacturers and Affiliates (SOCMA) reported last week that the US Food and Drug Administration responded to the association's citizen petition relating to the inspection process of foreign drug-manufacturing facilities.
Novartis To Invest $1 Billion in China R&D Institute
November 5th 2009Novartis (Basel, Switzerland) plans to invest $1 billion over the next five years to increase research and development activities in China, including a significant expansion of The Novartis Institute of BioMedical Research (CNIBR) in Shanghai.
Position Paper: Are We Abandoning IQ and OQ?
November 2nd 2009The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment."