Regulatory Audit "Do's and Don'ts"

During regulatory audit in Pharmaceutical Industry it is very important to know each and every person of organization that what to do and what don't.

• Here some important tips are mentioned which we have to follow during audit. 

Remember:

"If it is not documented, it doesn't exist".

Do’s and Don't:

• Answer honestly with confidence. 


• Don't answer if you don't know or are not sure. 


• Avoid to use of phrases and Qualifiers during answering to auditor  for example....I think, Sometimes, Often, Usually, Generally etc.


• Answer only those question which is asked and Stop when question is answered.


• Ask for explanations 


• Control your temper during answering , even though auditor is not convinced with you. Don't make argument with auditor. 


• Maintain eye contact, it will give confidence to auditor. 

• Don't give volunteer Information.
• Investigator may read your body language, be aware of your body language. 
• Don't challenge the investigator. 
• Don't give false data, always tell the truth. 
• It is ok to say "I don't know".


• Don't attempt to answer “What If ?” or Hypothetical questions. 


• Don't stand around making face and looking worried.


• Don't interupt the investigator or employees when they are speaking.


• Don't point out deficiencies or errors.


• Don't become defensive or evasive.


• Don't look away, Fidget or look nervous.


• Don't make statements about your personal opinion of the FDA.

Apart from above precautions, there are many more things which should be taken care during regulatory audit. It is senior management responsibility to make aware down the line staff members.