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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

                                                 reference standard  number must be recorded in
                                                 the test record.



                                                 In all QC testing laboratories, there will be a set al
                                                 published  and  approved  specifications  for  each
                                                 starting  material  and  finished  product.  When
                                                 calculating  and  checking  results,  the  analyst

                                                 should refer to the current specification to decide
                                                 the status of the sample. These specifications are
                                                 often  registered  with  the  regulatory  agency  and
                                                 cannot be changed.



               Role of the laboratory


               QC compliance encompasses many activities that are documented in the GMP
               rules.














                                                                                   Testing

                                                            QC
                                                     Compliance











                            Documentations                                   Reporting





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