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


                                             QC

                                                 Printed matter must undergo QC inspection in the

                                                same way as starting materials.

                                                 Each company will have specific sampling plans for
                                                different  printed  matter,  e.g.  labels,  product
                                                information leaflets, cartons.


                                                 Printed  matter  samples  are  compared  directly  to
                                                official, company-approved sample standards.

                                                 During inspection, printed matter must be stored
                                                in quarantine and not issued for use.


                                                 Printed matter must be released by the inspection
                                                team, and status-labeled "Approved" before it can
                                                be used.



               Issue of materials


               The issue of  approved materials must be performed only by designated staff.
               Other staff should never "help themselves". If an incorrect materiel is issued, a
               disaster such as a mix-up or product failure may follow.


               Here are some important GMP rules regarding issue:

                   Materials  should  only  be  issued  from  the  store  by  authorised  persons
                   following a written procedure.

                   Records of the quantities receipted into stock and the quantities issued to

                   manufacturing must be maintained.

                   Inventory records should be maintained in such a way that any discrepancy
                   between the quantity received and the quantity issued can be clearly seen.


                   Discrepancies are to be reported and investigated.




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