1. Preparing for and Handling an
FDA Inspection at Your Facility
Dawn Tavalsky
Sanofi Pasteur, Inc.

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3. Objectives
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4. FDA’s Authority to Inspect
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5. FDA’s Authority to Inspect
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6. Inspection Process for Clinicals
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7. GMP Inspection Process
Types of GMP Inspection
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8. Types of GMP Inspection
Objective of the inspection
! Routine inspection
! Concise inspection
! Follow-up inspection
! Special inspection
! Quality systems review
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9. Types of GMP Inspection
Routine Inspection
! Full inspection of all components of GMP
! Newly established manufacturer
! Renewal of a license
! Changes:
 new product or product lines
 modifications to manufacturing methods
 key personnel, premises or equipment
! History of non-compliance with GMP
! Not inspected in the last 3-5 years
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10. Types of GMP Inspection
Concise Inspection
! Consistent record of compliance with GMP
! Focus on limited number of GMP requirements
 selected as indicators
! Identify significant changes
! Indicate attitude towards GMP
! Non-compliance
 should trigger comprehensive inspection
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11. Types of GMP Inspection
Follow-up Inspection
! Reassessment or re-inspection
! Monitor result of corrective actions
! 6 weeks to 6 months after initial inspection
 nature of defects
 work undertaken
! Specific GMP requirements
 not observed
– not adequately implemented
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12. Types of GMP Inspection
Special Inspection
! Spot check focusing on
 one product, a group of related products
 specific operations, e.g. mixing, labelling
! Complaints or recalls
! Adverse drug reactions
! Marketing approval or export certificate
! Information or investigation
 specific information
 advice on regulatory requirements
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13. Types of GMP Inspection
Quality Systems Review
! Assess the quality assurance (QA) system
! Description of the QA system (e.g. manual)
! Policy and standards to be observed
! Management structure
 implementation
! Procedures
 quality standards set for products
 correctly defined manufacturing processes
 records kept
 QC and QA functions are performed
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14. Types of GMP Inspection
Frequency of Inspections
! Depends on type of inspection
! Inspectorate resources (e.g. workload, number of inspectors)
! New facilities - before licensed
! All companies - regular schedule
 ideally annual
! Large companies
 several visits over a period, e.g. 5 years
 validity of manufacturing license or GMP certificate
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15. Types of GMP Inspection
Duration of Inspections
! Depends on type of inspection
! Inspectorate resources (e.g. workload, number of inspectors)
! Size of the company
! Purpose of the visit
! Days to weeks
! Number of inspectors
 including specialist support
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16. Types of GMP Inspection
Announced and unannounced inspections
! Depends on type of inspection
! Announced
 comprehensive inspection
! Unannounced
 routine inspection (depending on country policy)
 concise inspection
 follow-up inspection
 special inspection
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18. Centers and Offices
! Office of the Commissioner Organization
! Center for Biologics Evaluation and Research Organization
! Center for Devices and Radiological Health Organization.
! Center for Drug Evaluation and Research Organization
! Center for Food Safety and Applied Nutrition Organization.
! Center for Tobacco Products Organization
! Center for Veterinary Medicine Organization
! National Center for Toxicological Research Organization
! Office of Regulatory Affairs Organization.
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19. Office of Regulatory Affairs (ORA)
http://www.fda.gov/ora/
Headquarters:
Rockville, MD
Regional Office:
Philadelphia, PA
District Office:
Detroit, MI
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20. FDA Field Investigators
! Conduct inspections to enforce the
Food, Drug and Cosmetic Act
! Train themselves in “evidence
collection”
! “If it’s not documented, it didn’t happen.”
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21. FDA Inspection Process
FDA Office Site Location
1. Select Site 4. Arrive (482)
2. Contact Site 5. Review Records
3. Schedule Site 6. Interview Staff
9. Write Report (EIR) 7. Present Findings
10. Classify Inspection 8. Depart (483)
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22. Overview of FDA Enforcement Actions
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23. FDA Forms
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27. Selection Criteria
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28. Preparing for the Audit
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29. ! While there are several types of audits with several
different types of focus’:
! Annual Flu Vaccine
! Bi-annual audit
! Pre Approval Inspection (PAI)
! For Cause Audit
! Etc
! We will now discuss preparing for a PAI inspection –
however many of the points apply to any type of FDA
audit.
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43. INSPECTION DOs
ü DO PLAN FOR INSPECTION
ü DO PROVIDE REVELANT DOCUMENTATION
ü DO ANSWER QUESTIONS TO SPECIFIC ACTIVITY
ü DO ESCORT THE INSPECTOR
ü DO TAKE NOTES
ü DO COPY DOCUMENTS REMOVED
ü DO STAMP THE REMOVE DOCUMENTS
ü DO COOPERATE WITH THE FDA
ü BE POLITE BUT FIRM WITH YOUR RIGHTS
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44. REFUSE FDA ACCESS
Ø FINANCIAL DATA
Ø SALES VALUES
Ø PRICING
Ø PERSONNEL DATA
Ø MANAGEMENT REVIEWS
Ø INTERNAL AUDITS
Ø SUPPLIER AUDITS
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45. INSPECTION DON’Ts
ü DON’T OVER SPEAK OR SAY IT’S IMPOSSIBLE
ü DON’T ALLOW RECORDINGS
ü DON’T SIGN AFFIDAVITS
ü DON’T ALLOW ACCESS TO FILES
ü DON’T GUESS AT AN ANSWER
ü DON’T ANSWER “WHAT IF ?”
ü DON’T ENGAGE IN ARGUMENT
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