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Statistical Approaches to Addressing the Requirements of the New FDA Process Validation Guidance for Small Molecules * Jason Marlin, MS/T Statistics, Eli Lilly Co. Key Takeaways from The FDA Guidance for Industry, “Process Validation: General Principles and Practices,” January 2011 the level of sampling and testing in validation must be sufficient to confirm uniform product quality throughout the batch during processing the level of sampling and testing in validation must provide statistical assurance that the process is reproducible and consistently delivers quality products Considerations: 1A statistician’s review is required for approval of a Process Validation protocol to ensure the testing achieves the above requirements Statistical assurance statements 1The FDA Guidance (footnote reference 1) recommends this in Stage 3: “We recommend that a statistician or person with adequate training in statistical process control techniques develop the data collection plan and statistical methods and procedures used in measuring and evaluating process stability and process capability.” * Reality… Limited statistical resources Many PV protocols World-wide sites Need for general PV requirements. * What we did, in general… Readily Pass and Marginally Pass terminology are employed The terms Readily Pass and Marginally Pass were introduced in the FDA draft Guidance for Industry “Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessment,” published October 2003. * Attributes addressed by this work * UDU Unit Dose Uniformity is confirmed by two types of data in a PV. Blend Uniformity Potency samples are obtained to demonstrate uniformity of the blend for tablet and powder-filled capsules. Drug Product Dosage Form Uniformity Dosage unit samples are collected using an appropriate stratified sampling method. * Blend Uniformity Weight-Corrected Potencies * Used to demonstrate blend uniformity Follow PQRI guidance (readily m