To facilitate the preparation of Quality Assessment Reports (QARs), the International Generic Drug Regulators Programme (IGDRP) issued guidance to new and existing quality assessors on the assessment of the technical information contained in the quality module (Module 3) of active substance master files/drug master files (ASMFs/DMFs) and in marketing authorization applications (MAAs). IGDRP believes that “the publishing of this guidance may also be of benefit to national regulatory agencies who are not members of IGDRP, and to parties responsible for the preparation of quality information that is submitted to regulatory agencies.”
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