statisticalmethodsforbiotechnologyproducts(編輯修改稿)
2025-08-13 17:23 本頁(yè)面
【文章內(nèi)容簡(jiǎn)介】 ies ? Equipment ? Containers and Closures ? Production and Process Controls ? Holding and Distribution ? Laboratory Controls ? Records and Report ? Returned and Salvaged Drug Products 2022/8/14 Copyright by Jenpei Liu, PhD。 Product Names for Illustration only and not for endorsement 15 Current Good Manufacturing Practice ? Quality Control Unit Statistical QC criteria Sampling and testing plan Acceptance and rejection levels ? Representative Samples Variability Confidence levels Degree of precision Top, middle, and bottom of the container ? Validation Accuracy and reliability Assay and process validation 2022/8/14 Copyright by Jenpei Liu, PhD。 Product Names for Illustration only and not for endorsement 16 Current Good Manufacturing Practice ? Process Controls Raw material inspection Inprocess materials testing Release testing ? Stability Testing Expiration dating period (or shelflife) Sample size (., at least three primary batches) Test intervals (., 0, 3, 6, 9, 12,18,…) Storage conditions Statistical methods 2022/8/14 Copyright by Jenpei Liu, PhD。 Product Names for Illustration only and not for endorsement 17 Introduction 1 2 … i … N1 N Raw Material Finish Product Manufacturing Steps i Unit Process Step (i) with Associated Process Characteristics Total Manufacturing Process = 1( U n it Pr o c e ss Ste p i)Ni ??2022/8/14 Copyright by Jenpei Liu, PhD。 Product Names for Illustration only and not for endorsement 18 2022/8/14 Copyright by Jenpei Liu, PhD。 Product Names for Illustration only and not for endorsement 19 From Roy and Ghazel (2022) Journal of Endocrinology. 2022/8/14 Copyright by Jenpei Liu, PhD。 Product Names for Illustration only and not for endorsement 20 From: Cronin, et al (Clinical Chemistry, 2022) 2022/8/14 Copyright by Jenpei Liu, PhD。 Product Names for Illustration only and not for endorsement 21 2022/8/14 Copyright by Jenpei Liu, PhD。 Product Names for Illustration only and not for endorsement 22 Process Controls Raw Material Inspection ? Random selection of drums ? Random samples from the top, middle, and bottom parts of each chosen drum ? Checking the strength: uniformity – mean and varibility ? Combination of different strengths from different drums for the desired strengths 2022/8/14 Copyright by Jenpei Liu, PhD。 Product Names for Illustration only and not for endorsement 23 Process Controls Example: 150ft3 Vblender Objective: potency and uniformity to meet the USP/NF spec
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