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Dose Content Uniformity: Parametric Tolerance Interval Approach

Dose Content Uniformity: Parametric Tolerance Interval Approach. Ajaz S. Hussain, Ph.D. Office of Pharmaceutical Sciences CDER, FDA October 21, 2003. Issues and Next Steps. International Pharmaceutical Aerosol Consortium on Regulation and Science (PAC-RS) Proposal

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Dose Content Uniformity: Parametric Tolerance Interval Approach

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  1. Dose Content Uniformity: Parametric Tolerance Interval Approach Ajaz S. Hussain, Ph.D. Office of Pharmaceutical Sciences CDER, FDA October 21, 2003

  2. Issues and Next Steps • International Pharmaceutical Aerosol Consortium on Regulation and Science (PAC-RS) Proposal • Proposal discussed and refined for about three years • Resolution challenges • OPS Executive decision • Need to resolve the remaining issues in next six months • If not resolved, step back to reevaluate options and approach • Merge this with the Quality by Design approach

  3. The Test • One of several end product test • “..designed to demonstrate the uniformity of medication per actuation or dose, consistent with the label claim, discharged from the mouthpiece of a sample of an appropriate number of containers from a batch (n=10 is recommended) • “Providing an overall performance evaluation of a batch, assessing the formulation, the manufacturing process, the valve, and the actuator” (MDA/DPI draft Guidance)

  4. Acceptance Criteria (draft Guidance) • N=10; not outside 80-120% of label claim for more than 1 of 10 containers; none outside 75-125; and the mean is not outside 85-115% • If 2 or 3 of 10 is outside 80-120%, none outside 75-125%, and the mean is not outside 85-115%, an additional 20 containers can be sampled. No more that 3 of all 30 determinations is outside 80-120%; none of the 30 is outside 75-125%, and the mean is within 85-115%

  5. Today: Framing Issues • Dr. Adams (FDA) • IPAC-PS presentations • ACPS discussion • We seek your input on a process to resolve remaining issues in the next six months • In your deliberations please consider • Clinical relevance and specifications tailored for intended use • Hypothesis testing for every batch – is this consistent with “Quality by Design” • Hypothesis testing at the “process validation stage”; quality assurance and verification for routine production operations • Complexity of PTIT with respect to explaining its meaning to the customers

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