Fda Inspection

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How to prepare and handle a FDA Inspection. When the FDA conducts an audit of your company, you need to be prepared. This presentation shows you what to do when your are faced with a FDA Inspection. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-inspection/

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Fda Inspection

  1. 1. FDA Compliance:FDA InspectionsA Practical GuideA Practical GuidebybyCompliance Insight, Inc.Compliance Insight, Inc.513-860-3512513-860-3512www.Compliance-Insight.comwww.Compliance-Insight.com
  2. 2. Preparing for the AuditYou should always be prepared for anYou should always be prepared for anaudit!audit!If you only prepare things just prior to an audit,If you only prepare things just prior to an audit,it is very apparentit is very apparentfresh paint over poorly prepared materialfresh paint over poorly prepared materialall documents just signed or signed very recentlyall documents just signed or signed very recentlyvery apparent that hurried work was performedvery apparent that hurried work was performedLast minute general cleaning and organizing isLast minute general cleaning and organizing isexpectedexpected
  3. 3. Preparing for the auditMost inspections are not announcedMost inspections are not announcedGeneral GMP inspections are performed approximatelyGeneral GMP inspections are performed approximatelyevery two yearsevery two yearsPre-Approval Inspections (PAIs) are performedPre-Approval Inspections (PAIs) are performedfollowing submission of filings with the FDAfollowing submission of filings with the FDAANDAANDANDANDAFor Cause Inspections performed following an issueFor Cause Inspections performed following an issuerecallrecallcomplaintscomplaints
  4. 4. Preparing for the AuditSome general things toSome general things tokeep in mindkeep in mindA place for everythingA place for everythingand everything in itsand everything in itsplaceplaceFirst impressions areFirst impressions arevery importantvery importantHave documents readilyHave documents readilyavailableavailable
  5. 5. Preparing for the AuditMake sure any prior observations fromMake sure any prior observations fromauditors are completedauditors are completedWere they completed on time?Were they completed on time?Were they effective in resolving the problem?Were they effective in resolving the problem?If there were any issues, make sure they wereIf there were any issues, make sure they wereexplained.explained.If things are not done, make sure you have aIf things are not done, make sure you have agood excuse!!!good excuse!!!What have you done in the interim???What have you done in the interim???
  6. 6. Preparing for the AuditConduct mock inspectionsConduct mock inspectionsinternal personnelinternal personnelcorporate personnelcorporate personnelconsultantsconsultantsEvaluate your quality systemEvaluate your quality systemprepare for a systemic inspectionprepare for a systemic inspection
  7. 7. Preparing for the AuditPAIPAIPrepare a “war room”Prepare a “war room”Pull all documents relevant to the filingPull all documents relevant to the filingbatch recordsbatch recordsstabilitystabilityvalidationvalidationraw material receiptsraw material receiptstesting datatesting datacleaning validationcleaning validationraw material supplier auditsraw material supplier auditsPM recordsPM recordscalibration recordscalibration recordschange control fileschange control filesFiling (final)Filing (final)water/HVAC datawater/HVAC datainvestigationsinvestigationsuse/cleaning logsuse/cleaning logs
  8. 8. During the AuditReceive FDA Form 482Receive FDA Form 482Notify all partiesNotify all partiesRetrieve information as requestedRetrieve information as requestedPAI - Don’t drop off the FDA in your “warPAI - Don’t drop off the FDA in your “warroom” and let them look through everything.room” and let them look through everything.Gather data quicklyGather data quicklyevaluate data prior to giving it to the inspectorevaluate data prior to giving it to the inspectorTrain people how to communicate with theTrain people how to communicate with theFDAFDA
  9. 9. During the AuditBe prepared to walk through the facilityBe prepared to walk through the facilityHave someone there to take notesHave someone there to take notesKeep copies of whatever copies you give toKeep copies of whatever copies you give tothe inspectorsthe inspectorsBe aware that the inspector is looking atBe aware that the inspector is looking atprevious commitments and has read the EIRprevious commitments and has read the EIRFDA should approach issues systemicallyFDA should approach issues systemically
  10. 10. During the AuditGeneral items evaluatedGeneral items evaluatedReturned goodsReturned goodsreason why and dispositionreason why and dispositionCompliantsCompliantsInvestigationsInvestigationsBatch RecordsBatch RecordsValidation ProtocolsValidation Protocols
  11. 11. During the AuditAsk as the day progresses or at the end ofAsk as the day progresses or at the end ofthe day about observations or questionsthe day about observations or questionsThis give you a chance to make corrections orThis give you a chance to make corrections orclarify misunderstandingsclarify misunderstandingsKeep on top of thingsKeep on top of thingsDon’t become overconfidentDon’t become overconfidentMany small observations can lead to “the strawMany small observations can lead to “the strawthat broke the camel’s back”that broke the camel’s back”
  12. 12. Following the AuditMake sure you return ALL informationMake sure you return ALL informationpulled for the inspectionpulled for the inspectionDon’t dispose of any documents until youDon’t dispose of any documents until youhave accounted for everythinghave accounted for everythingYou may want to have a master list ofYou may want to have a master list ofdocuments pulled to reference when youdocuments pulled to reference when youstart returning thingsstart returning things
  13. 13. Following the AuditCorrective Action Plans (CAP)Corrective Action Plans (CAP)Direct response to investigatorDirect response to investigatorfindingsfindingsInitiated by and based on the 483Initiated by and based on the 483or Warning Letteror Warning LetterLimited in scope to the systemsLimited in scope to the systemsthat FDA reviewedthat FDA reviewedCorrective Actions to beCorrective Actions to beperformed as committed in timeperformed as committed in timeframe committedframe committedResponse to FDA is public recordResponse to FDA is public record
  14. 14. Following the AuditGMP Enhancement MasterGMP Enhancement MasterPlans (GEM)Plans (GEM)Preparation may be unrelated toPreparation may be unrelated tothe FDA inspectionthe FDA inspectionInitiated and controlled internallyInitiated and controlled internallyAn overall comprehensiveAn overall comprehensiveassessment of the firms Qualityassessment of the firms QualitySystemsSystemsCorrective Actions can be plannedCorrective Actions can be plannedand modified as necessaryand modified as necessaryMay be held as Confidential andMay be held as Confidential andProprietary InformationProprietary Information
  15. 15. The Close Out MeetingWho should attendWho should attendRegulatory AffairsRegulatory AffairsQuality AssuranceQuality AssuranceProductionProductionUpper ManagementUpper ManagementAny other pertinentAny other pertinentindividualsindividuals
  16. 16. The Close Out MeetingDecide in advance on responseDecide in advance on responsestrategystrategyGo through each itemGo through each itemIf errors are present, commentIf errors are present, commentCorrections made during theCorrections made during theinspectioninspectionCorrected and verifiedCorrected and verifiedCorrected and not verifiedCorrected and not verifiedCorrection promised by ___Correction promised by ___No commentNo commentCommit to a written responseCommit to a written responsewithin a given time periodwithin a given time period
  17. 17. Re-establish CredibilityEvaluate the current state ofEvaluate the current state ofcompliance in light of the FDAcompliance in light of the FDAinspectioninspectionCollectively analyze each citationCollectively analyze each citationReview prior FD-483s to determineReview prior FD-483s to determineif all commitments were indeedif all commitments were indeedmetmetNote any repeat observationsNote any repeat observationsIdentify the Root CauseIdentify the Root CauseRelate each issue to the appropriateRelate each issue to the appropriateCompliance and Quality SystemsCompliance and Quality Systems
  18. 18. Re-establish CredibilityDevelop a correctiveDevelop a correctiveaction plan (CAP) aroundaction plan (CAP) aroundthe entire scopethe entire scopeSecure required resourcesSecure required resources– financial and personnel– financial and personnelAssign responsibilitiesAssign responsibilitiesand accountabilityand accountabilityDo not makeDo not makecommitments that can notcommitments that can notbe honored.be honored.Notify FDA of any setNotify FDA of any setbacks or missed timelinesbacks or missed timelines
  19. 19. Prepare to be ReinspectedAssure that the firm metAssure that the firm mettheir commitmentstheir commitmentsAssure that the resolutionAssure that the resolutionencompassed the rootencompassed the rootcause and that it wascause and that it wascomprehensivecomprehensiveMonitor warnings to otherMonitor warnings to othercompanies, regulatorycompanies, regulatoryactions, and GMP trendsactions, and GMP trends
  20. 20. Root Cause of the 483Root Cause of the 483With the FDA’s new systemic approachthe FDA wants a systemic review of all yoursystemsdon’t just “fix” the issue, determine the root cause,evaluate the solution and implement correctiveactionsevaluate across the boardare there other systems with the same or similar problems
  21. 21. The End?Any Questions???Any Questions???www.Compliance-Insight.comwww.Compliance-Insight.com513-860-3512513-860-3512Call us for a free consultationCall us for a free consultation

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