title: Statistical thinking and knowledge management for quality-driven design and manufacturing in pharmaceuticals.
abstract: The purpose of this article is to present the evolution of quality principles and how they have been implemented in the pharmaceutical industry. The article discusses the challenges that the FDA PAT Guidance and the ICH Q8, Q9 and Q10 Guidelines present to industry and provides a comprehensive overview of the basic tools that can be used to effectively build quality into products. The principles of the design of experiments, the main tools for statistical process analysis and control, and the requisite culture change necessary to facilitate statistical, knowledge-based management are also addressed.
authors.affiliation: European Medicines Agency, Quality Sector, Chemicals, 7 Westferry Circus, Canary Wharf, E14 4HB, London, UK.
authors.forename: Evdokia
authors.initials: E
authors.lastname: Korakianiti
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Rekkas
mesh_terms: D004345:Drug Industry / Q000592:standards*; D058436:Knowledge Management; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations