Page 35 - Packaging Controls
P. 35

GMP Training – Packaging Controls by www.gmpsop.com



                            GOOD TO KNOW – RECONCILIATION USING NUMBERS

                 An  alternative  to  using  a  reconciliation  as  a  percentage  is  using  an  actual

                 number of units unaccounted for. For example:

                     0 in < 5000 units


                     1 in 5,000-7,500 units

                     2 in 7,500-10,000 units

                     3 in > 10,000 units


                 This  is  a  "tighter"  specification,  because  when  batches  are  larger,  the
                 percentage method allows for increasing numbers of unaccounted for items.






























                                         Copyright©www.gmpsop.com. All rights reserved
                Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited.
                                                         Page 35 of 37
   30   31   32   33   34   35   36   37