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Conducting an FDA audit these days is becoming difficult as many warning letters are being issued to various pharmaceutical companies. Below are some tips for handling an FDA inspection properly.
1. Be confident, polite and courteous during the audit. If employees seem confident during the audit, a good auditor can anticipate this, which can affect the overall audit performance. Attitudes should be positive throughout the entire FDA inspection. Do not try to show your knowledge to the examiner and do not challenge him. Do not correct others in front of auditors.
2. The words “I think”, I am not sure but”, “generally”, “honestly”, “it should”, “in my opinion” should not be used as they show a casual view and the auditor can focus more. . The matter was casually discussed. Do not use the word “unofficial” during an audit as everything should be official.
3. Auditors should listen carefully to the questions asked and stick to the correct answers while answering. Your extra knowledge can confuse the auditor and it can create more areas of investigation for the auditor as an auditor always finds questions from your answers.
Understand the question properly before answering, if you don’t understand you can ask the auditor to ask clear and specific questions.
4. If you are unable to answer the question, just say so, don’t try to guess the answer or give wrong information. Always assume that the auditor knows everything about your company and system and wants to check whether you are aware.
If you are not working with the questions asked by the auditor, do not try to explain and call the right person to explain the matter. Clarify thoughts immediately and correctly explain if the investigator has misunderstood something.
5. The auditor should review the requested documents before sending them to the auditor. Check the document for correctness (document requested by the auditor), completeness and missing entries or signatures. Do not allow the auditor to access your documents himself, ask him and provide the necessary documents.
