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Defining Quality of a Pharmaceutical Product

Defining Quality of a Pharmaceutical Product. Janet Woodcock, M.D. September 17, 2003. Common Definition of Quality. A product or service that meets/exceeds customer’s needs. Regulatory Context: Pharmaceutical Quality.

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Defining Quality of a Pharmaceutical Product

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  1. Defining Quality of a Pharmaceutical Product Janet Woodcock, M.D. September 17, 2003

  2. Common Definition of Quality A product or service that meets/exceeds customer’s needs

  3. Regulatory Context: Pharmaceutical Quality • Customer/market can’t easily or rapidly evaluate critical attributes of performance (e.g., safety & efficacy) due to nature of products (“market failure”) • Much is at stake (life, health) so don’t just let market sort it out

  4. Regulatory Context: Pharmaceutical Quality • Therefore, by statute, FDA stands in for the customer and establishes & enforces quality standards in the realm of “clinical performance” • Clinical performance = delivery of efficacy and safety as described in the label, derived from the clinical trials • Not aesthetics, price, other consumer-defined attributes

  5. Who are the Customers? • Primary = people who take medicine (and their parents, caregivers, relatives, etc) • Secondary = overall, public has a stake health professionals who prescribe and dispense medicine

  6. Regulator’s Definition of Quality • Outcome based – delivers clinical performance as expected • Surrogate = “fitness for use” • Regulators define “fitness for use” via standards promulgated and attributes regulated

  7. A product that is “fit for use” meets its established quality attributes standards, including • Purity • Potency/strength • Identity • Bioavailability/delivery • Labeling/packaging • Physical performance (including aspects that influence adherence and acceptability

  8. Another regulatory quality attribute: “made in compliance with cGMPs”

  9. From the point of view of the customers: An important quality metric for a pharmaceutical is availability

  10. Issue: How does surrogate “fit for use” relate to ultimate metric “clinical performance”?

  11. Relationship has several dimensions: • Qualitative • Quantitative • Probabilistic

  12. Qualitative • What quality attributes are selected as critical to performance? • How is this decided? • Determines usefulness of surrogate

  13. Quantitative • Per attribute, what is the relationship between values of the attribute and safety or effectiveness? • Usually nonlinear, often unknown

  14. Graph A Minimal Acceptable Level Improved Safety Or Effectiveness Content uniformity How to set minimum acceptable level per attribute?

  15. Graph B No improvement in performance Safety Or Effectiveness Increased rigor of attribute

  16. GRAPH C Level qualified by toxicology studies IMPROVED SAFETY unknown Increasing impurity level

  17. Graph D NOT OK Drug Safety OK Determined by Convention % Contamination by inactive metabolite

  18. Graph E Safety Or Effectiveness Other Color Ink (readable) Right Color Ink

  19. Probabilistic relationship between measurements or surrogate markers for attribute and medical performance a. Testing b. GMP Compliance

  20. Probabilistic Relationship: Testing • Ordinarily, don’t evaluate attribute for each unit. Take sample and extrapolate from sample • What is the probability that X test result will predict Y outcome?

  21. Probabilistic Relationship: cGMP Compliance • Inspection leads to set of observations about quality practices of organization • How does set of facts [x] about cGMP compliance relate to probability of [y] outcome on safety or efficacy?

  22. Relationship: Fitness for use – Clinical Performance • We generally lack information except at the extremes • “Fitness-for-use” not a complete surrogate due to lack of information

  23. Quality by Design: A Way Forward • Prospectively designate critical quality parameter during development (product & process) • Evaluate and refine • Create robust link between process parameter, specifications and clinical performance

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