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QA/QC Investigation of Raw Materials Lots, In-process and Final Product

All pharmaceutical products require process validation in which, as stated by the FDA (1987), “documented evidence which provides a high degree of assurance that a specified process will consistently produce a product meeting its pre-determined specifications and quality characteristics.”  RJLG’s expert staff can review clients’ processes to ensure that they meet those predetermined specifications consistently.  Our analytical techniques can determine if a product is uniform within its lot through validation testing.  From raw materials to final products, our technologists have a high level of process understanding permitting collection and analysis of data that is vital to pharmaceutical compliance.

 
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