Top 5 Tips for a FDA Inspection : Pharmaguideline

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Top 5 Tips for a FDA Inspection

Learn the tips to handle the FDA inspection successfully in pharmaceutical manufacturing unit.
It is being difficult to handle an FDA audit these days because a lot of warning letters are being issued to different pharmaceutical companies. Following are some tips to handle the FDA inspection properly.

1. During audit be confident, decent and polite. If personnel seem in-confident during the audit, a good auditor can guess it that can affect the overall audit performance. The attitude should be positive during the whole FDA inspection. Never try to show your knowledge to the inspector and challenge him. Don’t correct others in front of auditors.

FDA Inspection
2. Words like “I think”, I am not sure but”, “Usually”, “Honestly”, “It should”, “As per my opinion” should not be used because these show casual approach and auditor can focus more on the topic discussed casually. Never use “unofficial” word during the audit because everything should be official.

3. Questions asked by the auditors should be listened carefully and stick to the exact answer when answering. Your extra knowledge can confuse the auditor and it can generate more investigation areas for auditors because an auditor always finds questions from your answers. 

Understand the question properly before answering, you can ask the auditor to clear and specific question if unable to understand.

4. If you are unable to answer the question simply say it, don’t try to guess the answer or give wrong information. Always think that auditor knows everything about your company and system and he wants to check if you are aware or not. 

If you are not dealing with the question asked by auditor don’t try to explain and call the right person to explain the topic. Clear the thinks immediately and explain properly if investigator misunderstood something.

5. The documents requested by the auditor should be reviewed before sending it to the auditor. Check the document for its correctness (the document requested by the auditor), completeness and missing entries or signatures. Don’t allow the auditor to access your documents himself, ask him and provide the required documents.

During FDA inspection never speak in your regional language or in the language that auditor does not understand. If an operator or other personnel is unable to understand auditor’s language, translate it to the regional language and help him to understand.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

6 comments: Post Yours! Read Comment Policy ▼

  1. Ankur,
    Very good article. Keep up man.

  2. Can you write on Breach of Data Integrity in Pharma Industry!! your articles are very lucid and easily understandable dear Ankur!!! Awesome article indeed...Regards, Don Bheemasena Rao

  3. really impressed me.

  4. Thank for sharing related to audit information.


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