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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. Number of batches, dosage units, sampling points, duration, storage conditions – Stability data and information (i.e., assay result) meeting its predetermined specifications and quality attributes (i.e.,
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