FDA Inspection Readiness.pptx

fda

1. FDA Inspection Readiness

2. FDA Inspection Readiness Before the inspection Set up for Inspection (Inspection team / Room setup) Opening Meeting FDA Readiness Tour of the facility Do’s and Don’t s During the inspection Typical Questions During Inspection Daily wrap-up and Final close-out After the inspection / Next Steps

3. FDA Inspection Readiness Before Inspection : Conduct Mock Inspection / Gap Analysis Create CAPA Plan for any Gaps Execute remediation Continuous walk through of the facility / cleanliness of the facility Be pro-active and Be Prepared / Know your job Do not shy away or hide from the process. Have SMEs trained to address inspectors questions

4. FDA Inspection Readiness What will they look at ? Validation, if compliant with CFR Part 11 Computers Appropriately approved and followed / periodical review Procedures Resolved and closed as per internal procedure Complaints Removed from inventory and isolated as per procedure Rejected batches Process / reference standards / method validation / method transfer / raw data Laboratory controls Storage & security / usage / consolidation Labels, Components Testing / QA oversight In-process materials Equipment / E-system / Computer software / Methods / Cleaning Validation processes Testing / Release of the final product Finished/released materials Appropriately assigned / Reviewed and approved Logbooks, records and documents Buildings, equipment, materials, cleaning procedures, HVAC, etc. Overall facility

5. FDA Inspection Readiness

6. FDA Inspection Readiness Inspection Front Room Presentation Name | CONFIDENTIAL Scriber 1 Scriber 2 Quality Head (Host) Auditor 1 Auditor 2 Document Controller Requested Document Files Index cards with Request # Request # Document s Being Reviewed Document Runner

7. FDA Inspection Readiness Inspection Back Room Presentation Name | CONFIDENTIAL Document Runner to Front Room SMEs Requested Document Files Document Request # Backroom Scriber 1 Backroom Scriber 2 Customer SMEs

8. FDA Inspection Readiness

9. FDA Inspection Readiness

10. Facility Tour During Inspection

11. Facility Tour During Inspection

12. Handling FDA Inspection - Do's

13. Handling FDA Inspection - Do's

14. Handling FDA Inspection - Do's

15. Handling FDA Inspection - Do's

16. Handling FDA Inspection - Do's

17. Handling FDA Inspection - Do's

18. Handling FDA Inspection - Do's DO’s 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 Presentation Name | CONFIDENTIAL

19. Handling FDA Inspection - Do's DO’s Acknowledge and document areas that you know need development. 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. Often, it is appropriate to include a plan for corrective action . Inspectors wants to see that management is taking these issues seriously.  Presentation Name | CONFIDENTIAL

20. Handling FDA Inspection – Don’ts DON’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 Avoid language using typically, normally, generally, and usually, as possible Guess, lie, deny the obvious, or make misleading statements Engage in unconstructive argument. (Avoid win/lose or legalistic confrontations.) Presentation Name | CONFIDENTIAL

21. Handling FDA Inspection – Don’ts DON’Ts 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. Don’t write rigid SOPs instead where possible use ‘guidance’ Presentation Name | CONFIDENTIAL

22. Handling FDA Inspection – Don’ts DON’Ts Don’t try any distraction techniques Speak unless spoken to or questions asked Attempt to answer “What if?” questions or hypothetical questions B ecome argumentative or, worse, hostile or make threatening remarks. Engage in arguments with peers in the presence of inspectors Presentation Name | CONFIDENTIAL

23. Handling FDA Inspection – Don’ts DON’Ts Don’ts Allow 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  Do not try to hinder the progress of the Auditor by time consuming idle conversations, lengthy presentations or non-relevant alternate agendas Don’t waste inspector’s time  Do not challenge the auditor’s understanding of the requirements and regulations. Presentation Name | CONFIDENTIAL

24. Handling FDA Inspection – Don’ts DON’Ts Ask questions to the auditor Show off your knowledge. Defend your answer by giving reference of guideline or book Get aggressive or be ‘clever ’ Joke with the investigator 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.) Chat in places the auditor may be i.e. toilets, corridors etc . Presentation Name | CONFIDENTIAL

25. Handling FDA Inspection – Don’ts DON’Ts Correct other people in front of the Inspector Do not initial/sign any error in front of the inspectors Interrupt someone else’s answer Interrupt the Inspector’s comments and explanations Provide your opinions Answer for someone else Presentation Name | CONFIDENTIAL

26. Handling FDA Inspection – Don’ts DON’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. Presentation Name | CONFIDENTIAL

27. Handling FDA Inspection – Don’ts DON’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?”  Do not answer questions which lie outside the authority of the Inspector (sales data, personnel information relating to salaries, performance reviews, etc ) Presentation Name | CONFIDENTIAL

28. Handling FDA Inspection – Don’ts DON’Ts 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 Presentation Name | CONFIDENTIAL

29. Handling FDA Inspection – Don’ts Choose your responses correctly “To be really honest with you ………..” OR “To tell you the truth ………” Unofficially… Off the record… Presentation Name | CONFIDENTIAL

30. Handling FDA Inspection – Don’ts Be 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 Presentation Name | CONFIDENTIAL

31. Typical Questions During Inspection… Question to expect… Quality Policy – What it is and how is it applied in the facility quality system? Job responsibility – how do you know what to do on your job? Deviations, Investigations, OOS, Complaints – How many in a quarter or past two years and how do you manage them? Relevant SOPs. Supplier Quality or How vendors are qualified and audited? Management Review, Frequency? Agenda? Participants? Training – How are employees trained for their job responsibilities and process for requalifications ? Laboratory – Instrument qualification, validation and/or calibration, test method validation Data Integrity Policy – how data is secured and ensure accuracy of it? Presentation Name | CONFIDENTIAL

32. Managing the Inspection – Daily Wrap up Daily Wrap up: Regroup and try to address the concerns / comments for the day Ask the inspector if there are any open issues for that day or any concerns not address during the day Confirm they are done with the topic Confirm next day start time Collect request of documents that they would like to review next day, so all can be available first thing next day Presentation Name | CONFIDENTIAL

33. Managing the Inspection – Final Close out Final Close-out: Request a closing meeting – Even it no issues found Confirm the date / time with the inspector and invite management This is not the time to argue with the inspector Ask questions as needed for any calification of any issues found or clear understanding of any concerns presented Request for final report or list of observation/findings from the inspectors Find out response deadline and next steps… Presentation Name | CONFIDENTIAL

34. After Inspection / Next Steps After Inspection Steps: Regroup with internal respective SMEs, and the management Clearly understand any findings or concerns raised by the inspectors at the close-out Initiate discussion on drafting constructive response with clear timeline and plan for any corrective actions needed Submit the response within allowed deadline. Do not wait for last minute submission. Goal is continuous improvement Presentation Name | CONFIDENTIAL

35. Be prepared to MANAGE the inspection – Establish roles and responsibilities before the inspection – Have the necessary resources to accommodate the number of inspectors  Presentation Name | CONFIDENTIAL

36. 36

37. Questions ? | CONFIDENTIAL