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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 a 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.

FDA Inspection1. 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. 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.

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 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.

Related: How to plan for a GMP audit in Pharmaceuticals?

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 auditor), completeness and missing entries or signatures. Don’t allow the auditor to access your documents himself, ask him and provide the required documents.

Related: FDA Forms Generally Used in Pharmaceutical Inspection

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


4 Comments so far : Add yours...

Mootaz Halawani said...

Ankur,
Very good article. Keep up man.

DONROA said...

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

srinu vasu said...

really impressed me.

Ankur Choudhary said...

Thanks

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