DRUG STORAGE SYSTEM IN A HOSPITAL SETTING PHARMACY DEPARTMENT NATIONAL ORTHOPAEDIC HOSPITAL, DALA-KANO 28th OCTOBER, 2015 DRUG STORAGE SYSTEM IN A HOSPITAL SETTING BY PHARM.…

Code of Federal Regulations Parts 210 and 211 * Code of Federal Regulations 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding…

Getting Ready for the Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act) ILISA B.G. BERNSTEIN, PHARM.D., J.D. U.S. Food and Drug Administration…

1 Quality Issues for Clinical Trial Materials: The Chemistry, Manufacturing and Controls (CMC) Review Dorota Matecka, Ph.D. Office of New Drug Quality Assessment, CDER 2…

1. Efficacy with affordability 2. To strengthen our global presence as a recognized manufacturer of quality finished dosage formulations for patient compliance. 3. Working…

Slide 1 Post Approval Stability Studies LEARNING OBJECTIVES Awareness of ICH / EMA / other Stability Guidelines Understand minimum requirements for Routine Stability study…

Introduction Development of oral pharmaceutical drug products presents many technical and regulatory challenges. Speci¢cally, these include proper characterization of active…