Recall - Complex Events & Magnitude Management
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CCK Discussion Forum on "Recall Affairs & NDMA Emergence"
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Recall - Complex Events & Magnitude Management
- 1. Recall Complex Events & Magnitude Measurement CCK- Forum Sunday, Oct 6th Karachi Lecture 4
- 3. It reflects the views and understanding of presenter & may not be construed to represent the views or policies of organization or association to which speaker has ties Documents of US-FDA & Review Scientific Articles are used to construct presentation Disclaimer Reference
- 6. Ineffective Recall Effectiveness of recall will be closely monitored Government will be consulted in situation to make recall improved Day to day management of recall
- 7. Recall Audit Strategy Effectiveness check ….. Expectations quantum of recall Potential bumpers
- 8. Recall Alert Information • Product description • Recalling firm • Reason of recall • Government awareness date • Recall initiation date • Recall status • Voluntary or Involuntary
- 9. Recall Reason • How the product is defective • Share analytical findings • Refer inspectional or complain • Root cause status • Type of injury • Etc.
- 10. Hazard Evaluation • In particular situation • Any adverse event reaction reported • Any injuries reported • In similar situation • Any adverse event reaction reported • Any injuries reported
- 11. Hazard Evaluation • Is the problem easily identified by the user • What is the risk to general population (normal consumption pattern) • What segments of population are most at risk & why • Is there any known off-label use that would increase or change the population at risk
- 12. Hazard Evaluation • Within the population at risk, could individuals suffering from any particular conditions or disease be more or less at risk & if so why? For e.g. Immune system debilities, diabetes, cardiac problem, concomitant medication
- 13. Hazard Evaluation Explain & give literature reference • Life threatening (death has or could occur) • Permanent impairment of body function • Permanent damage to a body structure • Necessity of medical or surgical intervention • Temporary or reversible (without medical intervention) • Limited (transient minor impairment or complaint)
- 14. Hazard Evaluation Explanation • No adverse health consequences • Hazard cannot be assessed within currently available data
- 15. Hazard Evaluation Explain probability of an adverse event occurring • Every time • Reasonable probability • Remote • Unlikely • Unknown
- 16. Market Assessment • For potential drug shortage situation • Impact on treatment, prevention of disease
- 17. Product pose a serious life threatening risk Defect could harm the patient but not life threatening Defect is unlikely to produce harm No threat to patient safety Class 1 Class 4Class 3Class 2 Immediate 48 hours 5 days Alert advice Medicines & Healthcare product Regulatory Agency
- 18. Reasonable probability to see the serious adverse health consequences or death Class I Response Time Temporary or medically reversible adverse health consequences or remote probability of serious adverse health Class II Response Time Not likely to cause adverse health consequencesClass III Response Time US Food and Drug Administration
- 19. The product involves minor or no violation---- Withdrawal
- 20. Population Segment • Infant • Children • Elderly • Pregnant Women • Surgical
- 21. Seriousness of Hazards • Life threatening – death could occur • Severe - permanent significant disability • Moderate – transient but significant disability, permanent minor disability • Limited – transient minor disability, annoying complaint • None – no disability
- 22. Consequences • Immediate consequences • Long range consequences • Availability of the alternate therapy
- 24. ?• Inspection uncovered cross- contamination of API, what will be the next & what will be the scenario and how would we deal it If
- 25. ? It is beta blocker • Inspection uncovered cross- contamination of API, what will be the next & what will be the scenario and how would we deal with it If If
- 26. ?• Inspection uncovered cross- contamination of API, what will be the next & what will be the scenario and how would we deal with it If
- 27. ? It is penicillin • Inspection uncovered cross- contamination of API, what will be the next & what will be the scenario and how would we deal with it If If
- 28. ?• Inspection uncovered consistency issue particularly particle size distribution during manufacturing of API If
- 29. ? It is used in bio-batch • Inspection uncovered consistency issue particularly particle size distribution during manufacturing of API If If
- 30. ?• During investigation, biofilm was discovered in aseptic facility If
- 31. ? It is immunosuppresant • During investigation, biofilm was discovered in aseptic facility If If
- 32. ?• During cleaning sieve used in manufacturing of dry powder suspension ws found extensively broken If
- 33. ? It is For neonates • During cleaning sieve used in manufacturing of dry powder suspension ws found extensively broken If If
- 35. Fluoxetine 20 mg Capsules 5% Capsules of Batch number 15 were mixed with Batch number 16 of same product of same strength Batches were manufactured with 45 days difference Recall ?.. Y/N Recall if Y.. Class ? Recall if N ?.. Next?
- 36. Aseptic Product Media Fill found heavy growth of microorganisms. Biofilm presence in pipes were established upon investigations What will be the fate of product manufactured before media fill? Recall ?.. Y/N Recall if Y.. Class ? Recall if N ?.. Next?
- 37. Particles either on the lens or in solution Invisible Lenses may have been contaminated with particles Particles may cause Redness Irritation Damage
- 38. Recall type --- J&J .. 27th September 2019, MHRA
- 39. Potentially small pieces of plastic was contaminated during manufacturing process with the children medicine Recall Class ?
- 40. Complaint induced recall Recall on quality failure establishment Recall based on verified assumptions Recall based on unverified assumptions Recall
- 41. Thank You