Quality Systems
Advisory Committee for Blood Safety and Availability
              Mary Malarkey, Director
    Office of C...
Quality Systems:
          Industry Perspective


Time is money     Reduce Time
Failure is Time   Reduce Failure
Quality B...
Quality Systems:
  FDA Regulatory Perspective
“A quality system addresses the public
and private sectors' mutual goal of
p...
Quality Systems


Ultimate goal is consistent between FDA
and regulated industry
Draft Guidance
    Guidance for Industry:
 Quality Systems Approach to
  Pharmaceutical Current Good
Manufacturing Practic...
Quality System Principles
Robust quality systems are designed to:
  Prevent product quality defects before they occur
  De...
Prevention
Robust donor screening and testing
Process control
  Validation of manufacturing processes, assays and facility...
Detection
Procedures for sampling, testing, and
acceptance of incoming materials
In-process controls of the manufacturing ...
Relevant Data?
Deviations/failures/non-conformances
In-process and final product data
Environmental data
Product complaint...
Correction
Investigate deviations in manufacture prior to
distribution of product
Investigate all product complaints; incl...
Reporting
Report deviations in manufacture and
unexpected or unforeseen events that are
discovered after the product is di...
Reporting
Report blood recipient or donor fatalities
Report Adverse Events/Reactions required
by the regulations
Report de...
Labeling
Regulations require that labeling provides
information to the end user to ensure
proper administration:
  Adequat...
Other Activities
Proprietary name reviews – review of
newly proposed trade names/trademarks
for biological drug products t...
Final thought


“Quality means doing it right when no one
is looking.” Henry Ford
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Quality Systems Quality Systems

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Quality Systems Quality Systems

  1. 1. Quality Systems Advisory Committee for Blood Safety and Availability Mary Malarkey, Director Office of Compliance and Biologics Quality, CBER, FDA August 30, 2006
  2. 2. Quality Systems: Industry Perspective Time is money Reduce Time Failure is Time Reduce Failure Quality Builds Success Invest in Quality
  3. 3. Quality Systems: FDA Regulatory Perspective “A quality system addresses the public and private sectors' mutual goal of providing a high-quality drug product to patients and prescribers. A well-built quality system should prevent or reduce the number of recalls, returned or salvaged products, and defective products entering the marketplace.”
  4. 4. Quality Systems Ultimate goal is consistent between FDA and regulated industry
  5. 5. Draft Guidance Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations September 2004 http://www.fda.gov/cber/gdlns/qualsystem.htm
  6. 6. Quality System Principles Robust quality systems are designed to: Prevent product quality defects before they occur Detect product quality defects before distribution Correct manufacturing systems to prevent recurrence Take appropriate action if defective products are distributed Most important - be proactive rather than reactive
  7. 7. Prevention Robust donor screening and testing Process control Validation of manufacturing processes, assays and facility systems Qualification of equipment to ensure consistency of manufacturing; Design controls Personnel Adequately trained and educated Engaged & empowered to detect problems and bring to management’s attention Procedures are established and are followed Record keeping Management actively involved provides needed resources to ensure compliance
  8. 8. Detection Procedures for sampling, testing, and acceptance of incoming materials In-process controls of the manufacturing process Monitoring of environmental conditions (as appropriate) Regular review and trending of all relevant data to detect negative trends Performance of audits – internal and external
  9. 9. Relevant Data? Deviations/failures/non-conformances In-process and final product data Environmental data Product complaints Adverse event reports Reportable deviations Product recalls Audit and inspectional results Personnel proficiency testing results
  10. 10. Correction Investigate deviations in manufacture prior to distribution of product Investigate all product complaints; including review of manufacturing records; Investigate all fatalities and unexpected AERs Implement corrective actions, as appropriate, to prevent recurrence Assess the effectiveness of your corrective action
  11. 11. Reporting Report deviations in manufacture and unexpected or unforeseen events that are discovered after the product is distributed Again, thoroughly investigate the deviation, including how it was missed, and carefully consider impact on marketed product – recall?
  12. 12. Reporting Report blood recipient or donor fatalities Report Adverse Events/Reactions required by the regulations Report deviations and unexpected or unforeseen events required by the regulations Notify agency if recalling product
  13. 13. Labeling Regulations require that labeling provides information to the end user to ensure proper administration: Adequate directions for use Circular of information Recent addition of the bar code label requirements to the regulations
  14. 14. Other Activities Proprietary name reviews – review of newly proposed trade names/trademarks for biological drug products to identify potential for “mix-ups” (e.g. similar name/same dosage form/clinical setting may result in medication errors) and advise of findings/recommendations.
  15. 15. Final thought “Quality means doing it right when no one is looking.” Henry Ford

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