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  • Analysis: FDA Warning Letters in 2011 Mostly Focused on Batch Failures

    An analysis of US Food and Drug Administration (FDA) warning letters issued in 2011 shows the majority of all facilities receiving a warning letter were deficient in areas relating to batch failure investigation , reports In-Pharma Technologist . "In the manufacturing-related warning letters analyzed by in-Pharma Technologist, FDA made 211 numbered observations," of which 10% were related to the company not investigating batch failures. Despite only 10% of all obs...
  • New EMA Guideline on Real Time Release Testing

    The European Medicines Agency (EMA) released a final guideline on real time release testing (RTRT), aiming to provide better guidance for regulatory professionals to ensure their products consistently meet necessary specifications. "RTRT is a system of release that gives assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control," explained EMA ...