DOs and DON’Ts          ofHandling FDA Inspection    Dr.Arun Purohit
HANDLING FDA INSPECTIONDOs and DON’TsDOs Do be professional and confident Be well dressed and neat. Be presentable (sha...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Feel confident of your company’s ability to meet and  exceed not only the audit ...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Treat audits with the professional pro-active  ‘do-diligence’ exuberance, and en...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Escort the inspector at all times Act in a courteous and professional manner R...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Provide documents in an accurate and timely  manner Handle document requests wi...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Review the requested record before sending  into the room for the investigator. ...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Check that no undue paper is appended to the  record. Ask for clarification whe...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Check that no undue paper is appended to  the record. Ask for clarification whe...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Have all relevant documents/raw data readily  accessible – preferably assembled ...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Make scrupulous notes of  comments/concerns/ deficiencies pointed out  by the in...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Do balance cooperation with wariness Be cooperative with the investigator to th...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Try to Develop a “Relationship”. You know  the product better than FDA and that ...
HANDLING FDA INSPECTIONDOs and DON’TsDosWhen a question is asked Take a deep breath Listen carefully to the Inspector’s ...
HANDLING FDA INSPECTIONDOs and DON’TsDOsWhen a question is asked (cont…) Request clarification to questions not understoo...
HANDLING FDA INSPECTIONDOs and DON’TsDOsWhen a question is asked (cont…) Speak slowly and clearly-one word at a time Kee...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Assume a friendly, cooperative attitude - but do not  overdo it. Avoid creating ...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Focus on the positive aspects of a situation  rather than getting defensive abou...
HANDLING FDA INSPECTION DOs and DON’TsDOs If the inspector is ‘digging’ or asking the same  basic question, provide more ...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Acknowledge and document areas that you  know need development. Implement a tho...
HANDLING FDA INSPECTIONDOs and DON’TsDOs Do provide timely and carefully prepared  written responses to 483s, and to any ...
HANDLING FDA INSPECTION DOs and DON’TsDON’Ts Do not try to “Snow” the inspector, wrong  information is worse than no info...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Avoid language using typically, normally,  generally, and usually, as possibl...
HANDLING FDA INSPECTION DOs and DON’TsDonts Do not write and implement Standard  Operating Procedure that are overly comp...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Don’t try any distraction techniques Speak unless asked for. Guess, lie, de...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Don’ts Attempt to answer “What if?” questions  or hypothetical questions Don...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Don’ts Allow FDA inspectors to go through  your files on their own. Ask them ...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Do not try to hinder the progress of the Auditor by  time consuming idle conv...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Ask questions to the auditor Show off your knowledge. Say that something is...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Be nervous Lie to the Inspector – it all ends in tears Get aggressive or be...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Argue or extensively debate with the Inspector Argue with others when the In...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Correct other people in front of the Inspector Do not initial/sign any error...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Use the Inspector as your consultant Challenge the auditor’s judgment Defen...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Never allow unescorted “roaming” Volunteer information Get uptight. Fear is...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Pass slips / notes to each other. Hurt the ego of the investigator. Attempt...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Don’t have food in the lab Have clutter in your work area Quote what the SO...
HANDLING FDA INSPECTION DOs and DON’TsDON’Ts Leave inspectors alone while they are in your  plant Tell inspectors that r...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Do not provide excuses or shift blame (either  on previous employees, staff m...
HANDLING FDA INSPECTION DOs and DON’TsDON’Ts Do not try to hide, misplace, or make documents  unavailable to the Auditor(...
HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Try not to argue with the Auditor as arguing  with an Auditor is like wrestli...
HANDLING FDA INSPECTIONDOs and DON’TsDonts           When reviewing Records Point out errors Correct errors during the r...
HANDLING FDA INSPECTION  DOs and DON’TsDonts                The language muddle Never speak behind the auditor in a langu...
HANDLING FDA INSPECTIONDOs and DON’TsConfrontation Avoid confrontation You can not win So win him over to your sideTake...
HANDLING FDA INSPECTIONDOs and DON’Ts                 Dr.Arun Purohit   44
HANDLING FDA INSPECTIONDOs and DON’Ts   Choose your responses correctly“Not us, another dept has done it ………”     Remembe...
HANDLING FDA INSPECTIONDOs and DON’Ts    Choose your responses correctly     “To be really honest with you ………..”         ...
HANDLING FDA INSPECTIONDOs and DON’TsBe wary of the “Long silence technique” Auditor asks you a question You answer Aud...
HANDLING FDA INSPECTIONDOs and DON’Ts         Unofficial is also official Never speak any so called unofficial thing  wit...
Conclusion Be prepared to MANAGE the inspection – Establish roles and responsibilities before    the inspection – Have th...
HANDLING FDA INSPECTIONDOs and DON’Ts                 Dr.Arun Purohit   50
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Handling FDA Inspection - Do's and Dont's

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Handling FDA Inspection - Do's and Dont's

  1. 1. DOs and DON’Ts ofHandling FDA Inspection Dr.Arun Purohit
  2. 2. HANDLING FDA INSPECTIONDOs and DON’TsDOs Do be professional and confident Be well dressed and neat. Be presentable (shave, hairs, nails,etc.) Be decent and polite Be courteous at all times Correct all errors/miscommunications as soon as possible Dr.Arun Purohit 2
  3. 3. HANDLING FDA INSPECTIONDOs and DON’TsDOs Feel confident of your company’s ability to meet and exceed not only the audit requirements, but the regulatory requirements. Your confidence of being compliant should be radiant throughout the course of the audit. If the company or the company personnel are not confident of their ability or meet regulatory compliance, then this too, becomes evident during the course of an audit and a good auditor can spot this. Dr.Arun Purohit 3
  4. 4. HANDLING FDA INSPECTIONDOs and DON’TsDOs Treat audits with the professional pro-active ‘do-diligence’ exuberance, and enthusiastic demeanor. Do not shy away or hide from the process. This demeanor can radiant throughout the course of the audit. Dr.Arun Purohit 4
  5. 5. HANDLING FDA INSPECTIONDOs and DON’TsDOs Escort the inspector at all times Act in a courteous and professional manner Require that all requests from the inspector go through your inspection team Dr.Arun Purohit 5
  6. 6. HANDLING FDA INSPECTIONDOs and DON’TsDOs Provide documents in an accurate and timely manner Handle document requests with care Limit the inspector’s access to the records, facilities and materials that are subject to inspection Attempt to clarify or correct misunderstandings or assumptions Dr.Arun Purohit 6
  7. 7. HANDLING FDA INSPECTIONDOs and DON’TsDOs Review the requested record before sending into the room for the investigator. Check that the record is the one asked for. Send only the record and not the entire file. Check for any missing signatures or entries or missing pages Dr.Arun Purohit 7
  8. 8. HANDLING FDA INSPECTIONDOs and DON’TsDOs Check that no undue paper is appended to the record. Ask for clarification when necessary Avoid undue traffic in and out of the room. Remove records which have been reviewed from the room Show one record at one time Dr.Arun Purohit 8
  9. 9. HANDLING FDA INSPECTIONDOs and DON’TsDOs Check that no undue paper is appended to the record. Ask for clarification when necessary Avoid undue traffic in and out of the room. Remove records which have been reviewed from the room Show one record at one time Dr.Arun Purohit 9
  10. 10. HANDLING FDA INSPECTIONDOs and DON’TsDOs Have all relevant documents/raw data readily accessible – preferably assembled in one central location. Be very familiar with content and location of all reports/data, SOPs etc. Long delays in responding to questions are undesirable. Dr.Arun Purohit 10
  11. 11. HANDLING FDA INSPECTIONDOs and DON’TsDOs Make scrupulous notes of comments/concerns/ deficiencies pointed out by the inspector. Have all records organized and available. Give the inspected only those records specifically requested Clarify or attempt to resolve issues as they are made known. Dr.Arun Purohit 11
  12. 12. HANDLING FDA INSPECTIONDOs and DON’TsDOs Do balance cooperation with wariness Be cooperative with the investigator to the extent possible, but politely disagree when appropriate Be brief in what you say-no stories Appear confident-think before you say Always tell the truth Dr.Arun Purohit 12
  13. 13. HANDLING FDA INSPECTIONDOs and DON’TsDOs Try to Develop a “Relationship”. You know the product better than FDA and that needs to be conveyed. Challenge yourself with the “Difficult” questions. Have Brief, Coherent, Logical explanations available. Dr.Arun Purohit 13
  14. 14. HANDLING FDA INSPECTIONDOs and DON’TsDosWhen a question is asked Take a deep breath Listen carefully to the Inspector’s questions Pause and formulate a proper response Answer only after the question is fully stated. Be confident of your answer. Dr.Arun Purohit 14
  15. 15. HANDLING FDA INSPECTIONDOs and DON’TsDOsWhen a question is asked (cont…) Request clarification to questions not understood Answer only what was asked Provide a clear, concise, and honest answer Only answer questions within your job responsibilities otherwise direct the question to “Subject Matter Experts” Dr.Arun Purohit 15
  16. 16. HANDLING FDA INSPECTIONDOs and DON’TsDOsWhen a question is asked (cont…) Speak slowly and clearly-one word at a time Keep unnecessary conversation to a minimum Answer briefly to the question only Answer only if you are sure. Communicate clearly and effectively Focus on positives Dr.Arun Purohit 16
  17. 17. HANDLING FDA INSPECTIONDOs and DON’TsDOs Assume a friendly, cooperative attitude - but do not overdo it. Avoid creating an adversary relationship. Project an attitude of confidence and professionalism. If management is seen as "uncooperative," the investigator may well become suspicious and more zealous. Review pertinent plant policies e.g., policies pertaining to cameras, recorders, wearing apparel, and safety equipment during the opening interview Dr.Arun Purohit 17
  18. 18. HANDLING FDA INSPECTIONDOs and DON’TsDOs Focus on the positive aspects of a situation rather than getting defensive about negative aspects. Avoid uncontrolled interchanges between personnel and the inspector. Make a complete write-up of the inspection. Pass the question to your senior if you do not have the answer Dr.Arun Purohit 18
  19. 19. HANDLING FDA INSPECTION DOs and DON’TsDOs If the inspector is ‘digging’ or asking the same basic question, provide more information as answers may not be complete. Talk about what is and not what might be or should be. If a problem has surfaced, point out where GMP and quality system controls have worked and how improvements have been made. Dr.Arun Purohit 19
  20. 20. HANDLING FDA INSPECTIONDOs and DON’TsDOs Acknowledge and document areas that you know need development. Implement a thorough communication strategy. Provide information on relevant policies and procedures to staff involved in the inspection in advance. Dr.Arun Purohit 20
  21. 21. HANDLING FDA INSPECTIONDOs and DON’TsDOs Do provide timely and carefully prepared written responses to 483s, and to any letters issued by FDA regarding violations identified as a result of the inspection. Often, it is appropriate to include a plan for corrective action. FDA wants to see that management is taking these issues seriously. Dr.Arun Purohit 21
  22. 22. HANDLING FDA INSPECTION DOs and DON’TsDON’Ts Do not try to “Snow” the inspector, wrong information is worse than no information. Don’t try to control the conversation Don’t try to lead the inspection Don’t try to change the agenda Dr.Arun Purohit 22
  23. 23. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Avoid language using typically, normally, generally, and usually, as possible Do not make Major changes to policies and procedures in the weeks leading up to the inspection. Dr.Arun Purohit 23
  24. 24. HANDLING FDA INSPECTION DOs and DON’TsDonts Do not write and implement Standard Operating Procedure that are overly complex and above the required standards. You will be inspected to your SOPs as well as the regulatory requirements. Failing to meet your SOPs will result in inspection finding even if you are meeting the regulatory requirements. Where possible use ‘guidance’ instead of rigid SOPs Dr.Arun Purohit 24
  25. 25. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Don’t try any distraction techniques Speak unless asked for. Guess, lie, deny the obvious, or make misleading statements Engage in unconstructive argument. (Avoid win/lose or legalistic confrontations.) Dr.Arun Purohit 25
  26. 26. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Don’ts Attempt to answer “What if?” questions or hypothetical questions Dont become argumentative or, worse, hostile or make threatening remarks. Engage in arguments with peers in the presence of inspectors Dr.Arun Purohit 26
  27. 27. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Don’ts Allow FDA inspectors to go through your files on their own. Ask them what they want and provide it for them. Refuse appropriate requests from inspectors, but try to narrow the scope of the request when possible Dr.Arun Purohit 27
  28. 28. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Do not try to hinder the progress of the Auditor by time consuming idle conversations, lengthy presentations or non-relevant alternate agendas. Do not challenge the auditor’s understanding of the requirements and regulations. If challenges are warranted, then those challenges must be made in writing during the audit report’s resolution responses. Dr.Arun Purohit 28
  29. 29. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Ask questions to the auditor Show off your knowledge. Say that something is impossible or couldn’t happen. (This is a red flag that challenges the inspector to find a way it could happen.) Don’t waste inspector’s time Dr.Arun Purohit 29
  30. 30. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Be nervous Lie to the Inspector – it all ends in tears Get aggressive or be ‘clever’ Fidget, shift around, touch your face etc. Chat in places the auditor may be i.e. toilets, corridors etc. Do not sign affidavits Do not allow pictures Dr.Arun Purohit 30
  31. 31. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Argue or extensively debate with the Inspector Argue with others when the Inspector is present Answer “off-the-record” questions Guess or provide approximate answers Interfere with the Escort/Inspection Team Dr.Arun Purohit 31
  32. 32. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Correct other people in front of the Inspector Do not initial/sign any error Interrupt someone else’s answer Interrupt the Inspector’s comments and explanations Provide your opinions Answer for someone else Dr.Arun Purohit 32
  33. 33. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Use the Inspector as your consultant Challenge the auditor’s judgment Defend your answer by giving reference of guideline or book. Contradict your colleague. Joke with the investigator Dr.Arun Purohit 33
  34. 34. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Never allow unescorted “roaming” Volunteer information Get uptight. Fear is inappropriate, although genuine concern may be expressed Murmur or whisper in presence of auditor. Do not speculate why the investigator is conducting the inspection Dr.Arun Purohit 34
  35. 35. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Pass slips / notes to each other. Hurt the ego of the investigator. Attempt to answer "what if" questions and other hypothetical questions. Comment on the quality of the inspection Dr.Arun Purohit 35
  36. 36. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Don’t have food in the lab Have clutter in your work area Quote what the SOP says, unless you’re 200% certain you know what you’re talking about Be intimidated or defensive Don’t leave documents out on your desk. Dr.Arun Purohit 36
  37. 37. HANDLING FDA INSPECTION DOs and DON’TsDON’Ts Leave inspectors alone while they are in your plant Tell inspectors that records are unavailable. You can say that you cannot locate the record Tell inspectors they are being unreasonable (even when they are) Ask questions such as, “Where does it say we have to do that?” Their response will likely be “Where does it say that you don’t?” Dr.Arun Purohit 37
  38. 38. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Do not provide excuses or shift blame (either on previous employees, staff members, etc) Do not answer questions which lie outside the authority of the Inspector (sales data, personnel information relating to salaries, performance reviews, etc) Dr.Arun Purohit 38
  39. 39. HANDLING FDA INSPECTION DOs and DON’TsDON’Ts Do not try to hide, misplace, or make documents unavailable to the Auditor(s). If a document does not exist, honestly inform the Auditor that the document does not exist or that the document is not available. Do not state that a non-existent document is not available for review, as the Auditor may request to see the document at a later date. Do not state that the document is currently in process of being drafted, as the Auditor may want to see the preliminary writings. If the Auditor senses false statements or finds no evidence of such statements, then this impression of a ‘cover-up’ may set the tone for the rest of the audit. Be honest, and forthcoming with the auditor(s). Dr.Arun Purohit 39
  40. 40. HANDLING FDA INSPECTIONDOs and DON’TsDON’Ts Try not to argue with the Auditor as arguing with an Auditor is like wrestling a pig in the mud, after a while the pig starts to enjoy it. If you would like to dispute an issue, then do so on the resolution section of the audit reports. Challenge the audit issue when and where appropriate Dr.Arun Purohit 40
  41. 41. HANDLING FDA INSPECTIONDOs and DON’TsDonts When reviewing Records Point out errors Correct errors during the review Comment or “apologize” for the quality of the data Comment on plans to improve recordkeeping practices, unless criticized by the Investigator Make constant references to planned SOP revisions, unless criticized by the Investigator Provide a detailed explanation/ translation, unless specifically requested Dr.Arun Purohit 41
  42. 42. HANDLING FDA INSPECTION DOs and DON’TsDonts The language muddle Never speak behind the auditor in a language not known to him If an operator is not able to understand the auditor’s language, you should let him know first that you will seek his response in the local language and then translate for him Watch your body language too – be polite, patient, attentive, respectful Auditor is a human being, and he is helping you Dr.Arun Purohit 42
  43. 43. HANDLING FDA INSPECTIONDOs and DON’TsConfrontation Avoid confrontation You can not win So win him over to your sideTake the bull by the horns? Dr.Arun Purohit 43
  44. 44. HANDLING FDA INSPECTIONDOs and DON’Ts Dr.Arun Purohit 44
  45. 45. HANDLING FDA INSPECTIONDOs and DON’Ts Choose your responses correctly“Not us, another dept has done it ………”  Remember you are not speaking to your boss  You are speaking to an auditor  Do not play games here  Will show lack of inter-dept co-ordination  Not an acceptable answer Dr.Arun Purohit 45
  46. 46. HANDLING FDA INSPECTIONDOs and DON’Ts Choose your responses correctly “To be really honest with you ………..” OR “To tell you the truth ………” Means previously you were not so honest and true Raises suspicion in the auditor’s mind He may ask for replay !! Do not break the trust you built in so far Not an acceptable answer Dr.Arun Purohit 46
  47. 47. HANDLING FDA INSPECTIONDOs and DON’TsBe wary of the “Long silence technique” Auditor asks you a question You answer Auditor listens Auditor maintains a long silence (purposely) You become anxious to break the silence You add more to the answers (mostly unwanted!) Auditor got enough to grill you! Don’t be over anxious to break the silence, answer only to the point, not a word more Dr.Arun Purohit 47
  48. 48. HANDLING FDA INSPECTIONDOs and DON’Ts Unofficial is also official Never speak any so called unofficial thing with the auditor There is nothing unofficial for an auditor when he is at your site, everything he sees and hears is official Dr.Arun Purohit 48
  49. 49. Conclusion Be prepared to MANAGE the inspection – Establish roles and responsibilities before the inspection – Have the necessary resources to accommodate the number of inspectors Dr.Arun Purohit 49
  50. 50. HANDLING FDA INSPECTIONDOs and DON’Ts Dr.Arun Purohit 50

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