The manufacture of sterile products is subject to additional GMP controls and relies heavily on the competency and knowledge of everyone involved in the process. This course covers all key aspects of sterile product manufacture, for both aseptically prepared and terminally sterilised products.Open discussion sessions on current best practices and regulatory trends in sterile product manufacture will be coupled with case studies to illustrate key points.

Course Content

• Review of international regulatory guidelines related to sterile product manufacture
• Review of current deficiencies in sterile product manufacture
• Basic microbiology and sources of contamination
• Review of critical control points for bio burden control in a typical aseptic process
• Sterilisation steps including terminal sterilisation
• Sterilisation processes for irradiation of components
• Classification and functionality of clean rooms and cleanroom design principles
• Challenges in aseptic manufacture
• Risk management of contamination in cleanrooms
• Risk assessment method, quantification of risk and management
• Garment gowning procedures and garment management
• Cleanroom behaviour, personnel movements, disinfection procedures
• Regulatory expectations for aseptic validation
• Designing, performing media fills and interpreting result
• Key aspects of quality critical utilities, including design, testing and operation
• Filtration types and theory, filter selection and integrity testing
• Auditing pharmaceutical QC laboratories
• Understanding the role and responsibilities of the QP
• Effective CAPA systems in sterile product manufacture
• Sterile product inspection techniques including manual, automated and regulatory trends

Our courses continue to remain popular because they provide delegates with a sound understanding of scientific principles in each technical area, complemented by interactive workshops, discussions, practical demonstrations, and case studies to put these principles into practice.