原文始发于微信公众号(化学音乐文化):S1C4:Drug Product Submissions: eCTD Module 3
JanFourman,PhD, EdD,MBA, MSRA
扫描左侧二维码,获取视频课;扫描右侧二维码,获取音频课 Quality Data of Module 3:
Chemistry, Manufacturing and Controls (CMC)
Drug Substance and Product
Formulation
Packaging
Distribution
Defines package “labeling” and its purpose
Briefly reviews the label development processFrom Target Product Profile (TPP) to Printed Packaging Development (PPD)
PPD logistics
PPD challenges
Submission amendments
Misbranding
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