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Preparing for and Handling anFDA Inspection at Your FacilityDawn TavalskySanofi Pasteur, Inc.
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Objectives             3
FDA’s Authority to Inspect                   4
FDA’s Authority to Inspect                   5
Inspection Process for Clinicals                   6
GMP Inspection Process     Types of GMP Inspection                 7
Types of GMP Inspection             Objective of the inspection!    Routine inspection!     Concise inspection!      Follo...
Types of GMP Inspection                       Routine Inspection!     Full inspection of all components of GMP!     Newly ...
Types of GMP Inspection                 Concise Inspection!  Consistent record of compliance with GMP!  Focus on limited n...
Types of GMP Inspection                 Follow-up Inspection!  Reassessment or re-inspection!  Monitor result of correctiv...
Types of GMP Inspection                        Special Inspection!   Spot check focusing on       one product, a group of...
Types of GMP Inspection                 Quality Systems Review!     Assess the quality assurance (QA) system!     Descript...
Types of GMP Inspection                   Frequency of Inspections!     Depends on type of inspection!     Inspectorate re...
Types of GMP Inspection                    Duration of Inspections!     Depends on type of inspection!     Inspectorate re...
Types of GMP Inspection     Announced and unannounced inspections!   Depends on type of inspection!   Announced     compr...
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Centers and Offices!   Office of the Commissioner Organization!   Center for Biologics Evaluation and Research Organizatio...
Office of Regulatory Affairs (ORA)        http://www.fda.gov/ora/                                        Headquarters:    ...
FDA Field Investigators     !  Conduct inspections to enforce the       Food, Drug and Cosmetic Act     !  Train themselve...
FDA Inspection Process     FDA Office                         Site Location   1.  Select Site                    4. Arrive...
Overview of FDA Enforcement Actions                 22
FDA Forms            23
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Selection Criteria                     27
Preparing for the Audit                  28
!  While there are several types of audits with several  different types of focus’:     !    Annual Flu Vaccine     !    B...
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INSPECTION DOsü DO PLAN FOR INSPECTIONü DO PROVIDE REVELANT DOCUMENTATIONü DO ANSWER QUESTIONS TO SPECIFIC ACTIVITYü D...
REFUSE FDA ACCESSØ  FINANCIAL DATAØ  SALES VALUESØ  PRICINGØ  PERSONNEL DATAØ  MANAGEMENT REVIEWSØ  INTERNAL AUDITSØ...
INSPECTION DON’Tsü DON’T OVER SPEAK OR SAY IT’S IMPOSSIBLEü DON’T ALLOW RECORDINGSü DON’T SIGN AFFIDAVITSü DON’T ALLOW...
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Preparing and handling an inspection

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Preparing and handling an inspection

  1. 1. Preparing for and Handling anFDA Inspection at Your FacilityDawn TavalskySanofi Pasteur, Inc.
  2. 2. 2
  3. 3. Objectives 3
  4. 4. FDA’s Authority to Inspect 4
  5. 5. FDA’s Authority to Inspect 5
  6. 6. Inspection Process for Clinicals 6
  7. 7. GMP Inspection Process Types of GMP Inspection 7
  8. 8. Types of GMP Inspection Objective of the inspection!  Routine inspection!  Concise inspection!  Follow-up inspection!  Special inspection!  Quality systems review 8
  9. 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 9
  10. 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 10
  11. 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 11
  12. 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 12
  13. 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 13
  14. 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 14
  15. 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 15
  16. 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 16
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  18. 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. 18
  19. 19. Office of Regulatory Affairs (ORA) http://www.fda.gov/ora/ Headquarters: Rockville, MD Regional Office: Philadelphia, PA District Office: Detroit, MI 19
  20. 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.” 20
  21. 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 Staff9. Write Report (EIR) 7. Present Findings10. Classify Inspection 8. Depart (483) 21
  22. 22. Overview of FDA Enforcement Actions 22
  23. 23. FDA Forms 23
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  27. 27. Selection Criteria 27
  28. 28. Preparing for the Audit 28
  29. 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. 29
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  43. 43. INSPECTION DOsü DO PLAN FOR INSPECTIONü DO PROVIDE REVELANT DOCUMENTATIONü DO ANSWER QUESTIONS TO SPECIFIC ACTIVITYü DO ESCORT THE INSPECTORü DO TAKE NOTESü DO COPY DOCUMENTS REMOVEDü DO STAMP THE REMOVE DOCUMENTSü DO COOPERATE WITH THE FDAü BE POLITE BUT FIRM WITH YOUR RIGHTS 43
  44. 44. REFUSE FDA ACCESSØ  FINANCIAL DATAØ  SALES VALUESØ  PRICINGØ  PERSONNEL DATAØ  MANAGEMENT REVIEWSØ  INTERNAL AUDITSØ  SUPPLIER AUDITS 44
  45. 45. INSPECTION DON’Tsü DON’T OVER SPEAK OR SAY IT’S IMPOSSIBLEü DON’T ALLOW RECORDINGSü DON’T SIGN AFFIDAVITSü DON’T ALLOW ACCESS TO FILESü DON’T GUESS AT AN ANSWERü DON’T ANSWER “WHAT IF ?”ü DON’T ENGAGE IN ARGUMENT 45
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