White paper - Old production in the Life Sciences industry

1    INTRODUCTION

When  working  with  old  and  ageing  equipment   and   computer   systems,   many   immediate   concerns   come   to   mind;   availability   of   spare   parts,   operational   reliability,   lack   of  hard and/or   software   support   from   the   supplier…   However,   few   remembers  the  major  issue  currently  faced  by   many   old   pharmaceutical   production   sites. The   rapid   development   of   computer   systems   and  their  capacity  to  generate,  log,  and  store   information   about   the   process   and   the   outcome  of  any  given  batch  production,  have   given   computer   systems   an   increasingly   important   role   in   modern   pharmaceutical   productions.   However,   when   does   the   information   logged   by   the   computer   system   become   data?   when   does   the   data   become   GxP-­‐data?   How   can   we   trust   the   integrity   or   rather  validity,  of  the  data?  And  finally  how  can   we   document   that   the   requirements   to   the   data,  imposed  by  the  authorities  are  met?   This  paper  will  try  to  combine  the  information   available   from   FDA   (US   Food   and   Drug   Administration)  and  EMA  (European  medicines   Agency)   along   with   experience   gained   from   working  in  an  old  production  site,  with  the  aim   of  raising  awareness  about  the  issue.     3 DATA   The   following   will   try   to   elaborate   on   the   definitions  of  data  stated  by  FDA  and  EMA,  and   put  them  in  relation  to  the  data  flow  in  typical   computer  systems  in  a  production.   One  of  the  important  discussion  points  is  what   is  data?
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