Asking the right question begins in the preparation phase of the GMP Audit. An understanding of the requirements, the SOPs, work instructions and forms play a major role in asking the right questions. Use this information to generate a checklist that is meaningful. Before the GMP Audit, you should know what you are going to ask and what evidence you will be looking for.
GMP Audits can be disturbing, so keep in mind the reason for the GMP Audit review of Pharmaceutical Quality Management System (ICH Q10), not the auditee. You are trying to identify areas for improvement. And you must avoid an atmosphere of blame.
Ask one question at a time, and listen for the answer. Don’t be surprised if the auditee answers question one and question four in their response. If you listen you will know they answered question four, if you were too busy thinking about the next question you will not. Later when you get to question four, the auditee will be irritated with you.
Likewise the auditee might answer the wrong question, or their answer might have nothing to do with the question asked. This may be due to their lack of understanding. Your question must be clear to the auditee.
Make sure your questions are understandable. Avoid leading questions, where the answer is part of the question: “Now, your management review meetings are scheduled for every three months, right” Likewise avoid questions that have no correct answer. Questions also must not be accusatory in any way.