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Regulatory Roundup: ISPE issues ozone sanitization guidance and EMA amends incident management plan
ISPE has issued ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, a new guidance document on the design and use of ozone systems for pharmaceutical water sanitization. The guide offers insight on ozone sanitization systems, including regulatory considerations, system operation, and qualification of ozone systems, to allow pharmaceutical companies to better understand ozone systems.
The European Union Regulatory Network Incident Management Plan for Medicines for Human Use has been amended by EMA to reflect 2010 pharmacovigilance legislation. The plan, in operation since September 2009, explains how safety and other drug incidents are monitored and addressed by the EMA, the European Commission, and regulatory agencies across the EU.