Page 68 - Getting Started
P. 68

Good Business Management Practices

       13.  commitment,  not  an  afterthought.  An  internal
           audit is not a GMP inspection. It is a deep dive

           of ensuring that the processes happening  on
           the  floor  reflect  the  requirements  of  the
           standard and that your documents reflect what
           is happening on the floor.

       14.  Not understanding your certification body’s
           corrective  action  timeline.  Be  sure  there  is
           a  clear  understanding  of  the  time  allotted  to
           make  corrective  actions.  Know  the  timing
           around:
            •  Days from close of audit to accept
              corrective  action (this is not the date that it
              is to be submitted, but that it is approved
              by the auditor and technical review).
            •  Days from close of audit to send the
              objective evidence (It is best to turn in
              corrective actions at least 7 days prior to
              the final deadline.)
            •  Days from close of audit to have the
              corrective action plan implemented
            •  Days from close of audit to close out of the
              audit
            •  When the auditor will receive objective
              evidence of effectiveness of corrective
              action plan implementation
                                              59
   63   64   65   66   67   68   69   70   71   72   73