Design of Stability Studies to Set Specifications and Maintain Quality.pptVIP

Design of Stability Studies to Set Specifications and Maintain Quality Over Shelf-Life: Outline Use of Stability Data Some Current Disconnects … Ideal Situation Goals of Stability Studies Some what ifs … Discussion Points for the Breakout Sessions Use of Stability Data Registration Stability Studies Demonstrate compliance with Expiry Specifications (Acceptance Criteria) Estimate the following properties which are then used to justify the proposed Expiry Specifications (ICH Q6B) and are also used to establish initial Internal Release Limits or Regulatory Release Specs Amount of Change over Shelf-Life Assay Variability Uncertainty in the estimate of the Amount of Change over Shelf-Life Used to Justify Proposed Shelf-Life (ICH Q1E) Use of Stability Data Annual Stability Studies Demonstrate ongoing compliance with Specifications by comparison of each individual reportable value to the Expiry Specifications Provide ability to assess consistency of Rate of Change of batches produced over time Provide additional data to estimate the following properties that are then used to establish or update Internal Release Limits Amount of Change over Shelf-Life Assay Variability Uncertainty in the estimate of the Amount of Change over Shelf-Life Provide baseline against which any future process change batches can be compared (comparability protocols) Used to Justify Shelf-Life Extensions Some Current Disconnects … ICH Q1E Describes calculations used to justify shelf-life Determine shelf-life as point at which lower 1-sided 95% confidence limit for the mean intersects the lower specification Assumes Specifications already exist with Shelf-Life justification the goal Assumes Specifications refer to the true batch mean and not all reportable values ICH Q6B Provides an overview of what considerations one should make when proposing and justifying Specifications Assumes shelf-life exists with Specification justification the goal Assumes the Specification re