Selenne Bañuelos, Janet Best, Gemma Huguet, Alicia Prieto-Langarica, Pamela B Pyzza, Shelby Wilson
Modeling the long term effects of thermoregulation on human sleep
Journal of theoretical biology
intermediate acceptance criteria foundation developing control strategies process validation stage 1 pharmaceutical industry drug substance product level intermediate acceptance criteria quality available referred specification limits however often remains challenge define acceptance criteria intermediate process steps available guidelines underpin importance intermediate acceptance criteria integral part setting control strategy manufacturing process guidelines recommend base definition acceptance criteria entirety process knowledge nevertheless guidelines remain unclear derive limits within contribution aim present sound data science methodology definition intermediate acceptance criteria putting guidelines recommendations practice ich q6b 1999 using integrated process model approach leverage manufacturing data experimental data small scale derive intermediate acceptance criteria novelty approach acceptance criteria based predefined outofspecification probabilities also considering manufacturing variability process parameters case study compare methodology conventional 3 standard deviations 3sd approach demonstrate presented methodology superior conventional approaches provides solid line reasoning justifying audits regulatory submission