Tips for FDA inspection in Pharmaceuticals

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Pharmaceutical professionals should be learn tips to handle successfully FDA inspection in pharmaceutical manufacturing.

fda-audit

Do’s and don’ts during FDA inspection

  • Dealing FDA investigators we should demonstrate knowledge and confidant in quality system.
  • Be decent and polite and attitude should be positive.
  • Never give false data and be aware what are you saying and doing.
  • Never try to show your knowledge to the inspector and challenge him. It only motivate curiosity and questions. Argue with investigator is not productive when responding observation or question.
  • Don’t use “unofficial” word because everything should be official.
  • Don’t show causal approach using word like “I am not sure”, “I think”, “it should”, “I think”, “honestly”, “As per my opinion”, “Usually”.
  • Don’t use phrase such as “What you are say is not true”, “Typical”, “As I recall”.
  • Don’t feel nervous during audit. It may be wrong.
  • Act not defensive should be confident and proud.
  • Don’t try to help by answering if a fellow employee is being questioned.
  • When fellow employee and investigator are speaking then don’t interrupt. Don’t speak loud or talk with others when investigator mind consecrate to read and review document.
  • Investigator question should be listen carefully and stick to the exact answer when answering.
  • If you don’t unable to answer of investigator question simply say it. Don’t guess or give wrong information. If you are not dealing with question don’t try to explain and call right person to explain it.
  • Don’t show extra knowledge. It can confuse the investigator and generate more question for auditors. An investigator always finds questions from your answer.
  • If investigator misunderstood something, clear things immediately and explain professional manner.
  • Don’t allow the auditor to access your document himself, provide the required document yourself. Document should be reviewed before sending it to auditor.
  1. Be aware your body language
  2. Communication
  • Verbal                -7%
  • Paralinguistic    -38%
  • Non-Verbal        -55%
  1. Phrase to refrain from
  • It is a probably a mistake
  • Who, me?
  • …uh, no
  • Off the record
  • I probably should not say this but….
  • That’s the way we have always done it
  • We do not have enough time or resource to follow that procedure
  • If you think that is bad you should see this
  • We fixed that problem by firing the person
  • That is not my problem that is Quality Assurance problem

Documents and Records

fda-audit-the-do-and-dont-list-28-638

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