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Tips to Streamlining the Drug Master File Process The meticulous detail of a Type II Drug Master Files (DMF) enables FDA to review and assess the chemistry, manufacturing, stability, purity, impurity profile, packaging and Good Manufacturing Practices data of Active Pharmaceutical Ingredients (API) or a finished drug dosage form Bryan Armentrout Bryan Armentrout is an expert in dairy, quality, system development, Safe Quality Foods, (SQF), Hazard Analysis and Critical Control Points (HACCP), design control, auditing, troubleshooting, recall, crisis management, and process improvement