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- Hi, my name is Mahmut Levent. Iamp;#39;m going to present a poster on list of relevant quality guidances and common deficiencies observed during Drug Master file review. I would like to mention that this presentation is (indistinct) by Sad Ahmed. Purpose and objective. This presentation is intended to provide a non-exhaustive list of relevant guidances and discuss common deficiencies to improve submission quality. Poster is organized by CTD sections. Each session includes commonly observed deficiencies and relevant guidance that are helpful to address deficiencies. Section S.1. Guidances. Drug Master File guidance for industry. ANDAs, pharmaceutical solid polymorphism: chemistry, manufacturing and controls information. Examples of deficiencies. The general properties section S.1 fails to contain all relevant information. Please provide chilarity, polymorphism, hygroscopicity, melting range for the drug substance. Please provide a letter of authorization for each referencing applicat