2. Good Laboratory Practices and Inspection Readiness Paul Swidersky President/Sr. Consultant Quality Associates, Inc.

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4. GOING BACK IN TIME  1978 – Final FDA GLP Regulations  1987 – Final Revised FDA GLP Regulations That is 34 years, and 25 years ago… and yet…

5. Form FDA 483 Failure to document… Failure to document… Documentation was incomplete… Documentation was incomplete… Results were not included in the report… Results were not included in the report… Records were falsified… Records were falsified… (2010)

6. 3211132111 GLP

7. Testing Facility Management failed to…Testing Facility Management failed to… The Study Director failed to…The Study Director failed to… The Quality Assurance Unit failed to…The Quality Assurance Unit failed to… You failed to…You failed to… (2010)

8. Knock-knock ! What now ? Too late to prepare !!!

9. PREPARATION Know the GLP regulations!Know the GLP regulations! SOP on regulatory inspectionsSOP on regulatory inspections Training of personnel for inspectionTraining of personnel for inspection Manual at receptionManual at reception Mock FDA inspectionMock FDA inspection Know what to do ! Train and rehearse !

10. SOPs to Address Facility Security and ReceptionFacility Security and Reception GLP Coordinator dutiesGLP Coordinator duties Escort processEscort process Records requestsRecords requests Photocopy processPhotocopy process Facility tour and questions to staffFacility tour and questions to staff

11. Security and Reception “This is FDA.”  May I see your credentials ?  Please sign visitor log.  Please wait so I can notify.  This way to a conference room.

12. OPENING CONFERENCE IntroductionsIntroductions Review credentialsReview credentials Inspection scopeInspection scope FDA Form 482FDA Form 482 Schedule (calendar, hours)Schedule (calendar, hours) Escort expectationsEscort expectations Location of bathroom and coffee/tea/waterLocation of bathroom and coffee/tea/water

13. SPONSORS NOTIFICATION if You’re a CRO  Studies on FDA Form 482  Notify the sponsor first and get permission!!!  Where are the study data archived ?  Where are samples and specimens archived ?

14. FACILITY TOUR  Led by GLP Coordinator  Prevent: –Compromise of ongoing work –Disturbance of animals –Contamination of test articles –Health hazard to inspector (& others)

15. Handling Inspection Questions Assume a courteous and cooperative attitude Always be positive and patient Do not become argumentative Be prepared to admit mistakes where appropriate Don’t try to answer questions for someone else’s data if you aren’t sure Only answer the question ask Never lie or try to cover up

16. QUESTIONS TO STAFF Answers controlled by GLP CoordinatorAnswers controlled by GLP Coordinator Redirect question to appropriate personRedirect question to appropriate person Rephrase question if not clearRephrase question if not clear Lead response if off trackLead response if off track Interrupt answer as soon as completeInterrupt answer as soon as complete

17. STAFF ANSWERS Only answer when qualifiedOnly answer when qualified –Qualifications –Current duties –Knowledge of company SOPs –Tasks and assignments performed If not sure, ask GLP Coordinator’s helpIf not sure, ask GLP Coordinator’s help Refer to SOP when appropriateRefer to SOP when appropriate

18. EXIT CONFERENCE  If no FDA Form 483… thank inspectors –Do NOT open new issues !  If FDA Form 483… thank inspectors –Solicit details and boundaries –Clarify basis from regulation –Discuss possible corrections –Present corrections implemented –Discuss schedule for responses

19. RESPONSE TO EIR  EIR reviewed by FDA Management Any finding is now official positionAny finding is now official position  Warning Letter (or Private Letter) may be issued before or after EIR  Respond to all issues in EIR, if issued first

20. WARNING LETTER

21. RESPONSE TO WARNING LETTER  Respond quickly  Respond completely  Finalize corrective actions  Document all responses  Review responses… (QAU audit ?)

22. CLOSURE Implement all corrective actions FDA will come back !

23. Knock-knock !