BIOTECH2007课件.pptVIP

Quality and Compliance Challenges for Biopharmaceutical Products Ramon Rivera Gonzalez, Ph.D. Director Quality Assurance Amgen Manufacturing, Limited Outline Background Information Regulatory and Process Challenges Quality by Design Risk Management Process Analytical Technology Key Quality Systems Deviations/Nonconformities Corrective and Preventive Actions Biological Product Deviations FDA and EMEA Observations Biotechnology Biotechnology is a set of scientific techniques used to derive valuable products from living organisms Applications biopharmaceutical drugs agriculture waste management Background information FDA- “sterile drugs should be manufactured by aseptic processing only when terminal sterilization is not feasible”. Parenterals -Drug administration other than by the mouth or rectum- ex. Injection, infusion or implantation. Biological products (vials or syringes) solubility, stability, maintain activity Biotechnology Biological Products Manufacturing Biological Products Manufacturing Bacterial Systems (+) Grow fast Easy to maintain High yield (-) Endotoxins Low expression or extracellular secretion No post-translational modifications machinery Mammalian Cells (+) Adequate conformation Post-translational modifications Preferred for complex proteins (-) Grow slower than bacteria Maintenance is expensive Usually lower yield Limited manufacturing applications Quality and the Product Life Cycle Adherence to regulations Control and maintenance of documentation Quality of suppliers, components and raw materials Reliability and consistency Monitor/audit of the manufacturing process Deviations, unexpected situations - product impact Correction and prevention - CAPA Lot release/rejection decision Customer complaints Continuous improvement Quality Systems Emphasis Quality Management Quality Assurance Risk Management Evaluation analysis and quality risk management tools Preventive Action Promote product and process improvement (i.e., con