Re: FDA Audit - SOP
Yes instead of a procedure perhaps a yearly training session to keep everyone sharp and focused. Here are a few things to think about to get things started:
- Examine the credentials of the inspector (identification). Look but don’t photocopy.
- Contact the RA/QA Manager to alert them to the inspector’s presence.
- Set the proper tone. Be available, professional, polite and cooperative.
- Provide the inspector with a place to work. Keep the room free of clutter. If there are any cabinets or drawers in the room, keep them locked.
- Have records and source documents available. Provide only requested records.
- Confirm with the inspector his/her preference for handling issues and queries.
- Provide the appropriate pager number and paging instructions in case he/she needs to reach you prior to the agreed meeting time. Remember to track all requests from the inspector and make photocopies, if appropriate.
- Do not volunteer information; just answer all questions briefly, honestly and accurately.
- Know what you are talking about before you say anything and can back it up with documentation. If you are not sure how to answer a question or do not feel comfortable answering a question, do not be afraid to say “I will have to get back to you on that.” Then seek advice on how to answer the question.
- Escort the inspector at all times during the audit.
- Limit your hospitality. The inspector may interpret your actions differently than you intended them.
- Appoint someone to document the information from the Exit Interview. This person should not be distracted by participating in the discussion. Remember tape recorders are not permitted.
- Be diplomatic when pointing out any observation that has been corrected since the beginning of the audit. Being argumentative will not be constructive and could make things worse.
- If any observation noted deals with not meeting FDA regulations, carefully point out that the regulations are subject to interpretation.
- If it is clear that corrective action is necessary on an observation, and it is clear what the action to be taken is, indicate that you plan to take appropriate corrective measures on that observation immediately.
- Do not commit yourself to a future action that you do not intend to make or cannot undertake.