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Consequently, the implementation of track and trace systems for pharmaceuticals is becoming more important as countries make it a legal requirement. For example, Turkey will require track and trace by 1 January 2009 and California is requiring the technology by 1 January 2011.
FDA – Process Validation Guidelines (published in January 2011) are crucial for maintaining the quality management system. assay result) meeting its predetermined specifications and quality attributes (i.e., accuracy, precision, etc.) Reagents should only be used for the purposes for which they were designed. temperature, air pressure, etc.)
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