The GMP Auditor’s Role

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It is the GMP Auditor’s behavior that determines whether the GMP Audit is perceived as being credible. It is the GMP Auditor that the auditee sees, not the Audit administration. With that in mind there are seven steps an Auditor can take to help ensure credible GMP Audits. 

  1. Be responsive: Be responsive to the auditee. Answer their questions, provide information, and take their requests seriously. You must also be responsive to the GMP Audit plan and schedule.
  2. Be punctual: If you are scheduled to be in Quality Control Laboratory at 9:00, then be there. This also applies to the GMP Audit report. Make sure you keep the timeline, even if the auditee doesn’t!
  3. Be prepared: Before the GMP Audit, make sure you understand each step of the procedure, each question on the checklist, and every form that is used. This will increase the preparation time needed, but it will also show the auditee that you are prepared, and are professional

…To be continued