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GMP Training – GMP for Warehouse by www.gmpsop.com


                                                Sampling and testing:
                                                Laboratory  sampling  and  testing  confirm  that  the
                                                raw  material  received  meets  the  company
                                                specifications  for  quality.  There  are  specific  GMP
                                                procedures for sampling of raw materials to protect
                                                the  sampler  and  to  protect  the  batch  from

                                                environmental contamination.


                                                Status labeling:
                                                On initial receipt, raw materials should be labeled
                                                "Hold" or "Quarantine", and once they have passed
                                                QC  testing,  raw  materials  should  be  re-labeled
                                                "Released" or "Rejected". It is important that the

                                                storage  location  matches  the  status  of  the  raw
                                                material.  GMP  requires  that  only  "Released"  raw
                                                materials may be used in production.

                                                Storage:
                                                When  raw  materials  are  stored,  they  may
                                                deteriorate  if  they  are  exposed  to  elevated
                                                temperatures,  moisture,  or  are  stored  directly  on
                                                the floor, or are in contact with walls. GMP requires
                                                that  only  authorized  personnel  are  allowed  to

                                                remove raw materials from storage.


                                                Issue:
                                                Raw materials are issued against documentation or
                                                requisitions  provided  by  the  company.  GMP
                                                requires  that  all  issues  of  raw  material  are

                                                accompanied  by  the  correct  paperwork,  so  that
                                                there is no potential for mix-up. Incorrect selection
                                                of a raw material may result in significant problems
                                                in manufacture, or put the patient at risk.




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